Wednesday, August 24, 2016

Shades of Questcor 3

Indeed, the price of an EpiPen standard two-pack gradually grew to about $600. The same two-pack cost only about $100 in 2009.

Meanwhile, epinephrine, which can be purchased alone, costs just a few dollars. The EpiPen, manufactured by the pharmaceutical company Mylan, offers a portable way to administer doses. "Some patients and physicians are resorting to buying epinephrine ampoules and filling their own syringes," said Dr. Thomas Casale, a professor of medicine at the University of South Florida and executive vice president of the American Academy of Allergy, Asthma, and Immunology (AAAAI).
Many adults and families of children with severe allergies are facing sticker shock when they pay for their EpiPens, especially amid back-to-school season.

Theresa Ray, a 30-year-old mother in Cincinnati, was surprised to find that purchasing two EpiPen two-packs for her 6-year-old son would have cost her family about $1,300, she said. Her son was diagnosed with food allergies five years ago.

"When we first bought them (about five years ago), it was around $100 or $150 for a twinpack, and at that time I remember thinking, 'Wow, that's kind of expensive.' Then, the next year, I found out they expired and we have to get them every year. They were more expensive, but by that time, only a couple hundred dollars," Ray said.

"Last year, we spent around $650 for a twinpack and this year, same thing," she said. "It was funny, I told my husband, 'I wonder why no one's talking about this. It's really weird no one's talking about EpiPens.' ... And then, I saw a news article on Facebook about it."…

Albuterol, an asthma medicine, has also increased in price in recent years.

A House of Representatives report found in 2014 that 10 generic drugs experienced price increases just a year prior, ranging from a 420% hike to more than 8,000%.

Now, the new study suggests that a combination of market exclusivity provisions granted to drug manufacturers, and coverage requirements imposed on government-funded drug benefits, are both driving the high costs of prescription drugs nationwide…

Kesselheim and his colleagues reviewed and analyzed previous papers published in medical and health policy journals from January 2005 to July 2016, taking a close look at how each explained the cause of rising drug prices and how to possibly reduce costs.

Based on their analysis, the researchers found that the primary reason for increasing drug spending is the high price of branded products.

While only about 10% of all prescription drugs in the country are brand-name drugs, such as the EpiPen, they account for a whopping 72% of drugs being sold, the researchers discovered...

Minnesota Sen. Amy Klobuchar has called on the Senate Judiciary Committee to hold a hearing to investigate the rising price of EpiPens.

"Patients all over the United States rely on these products, including my own daughter. Not only should the Judiciary Committee hold a hearing, the Federal Trade Commission should investigate these price increases immediately," Klobuchar, a Democrat, said in a written statement that was released on Saturday. "The Commission should also report to Congress on why these outrageous price increases have become common, and propose solutions that will better protect consumers within 90 days."

Iowa Sen. Chuck Grassley, a Republican, announced Monday that he had contacted the company Mylan seeking answers as to why there has been a steep price increase in the product in recent years. As the cost of EpiPens has been gradually rising, so has the number of patients in high-deductible health plans -- alas, the impact of the cost on patients seems to be a problem that's two-fold, said Dr. Purvi Parikh, an allergist and immunologist at NYU Langone Medical Center and an allergist with the Allergy & Asthma Network.

"While the price is increasing, the other issue now is that the health insurance plans have now put more and more responsibility on the patient," said Parikh, who also serves as Levin's doctor.
"It's definitely unfortunate because it's a necessary lifesaving medication. It's not really a luxury," Parikh said. "It's a single-use medication and you need it available everywhere you go, so often our patients will have multiple sets of EpiPens at home, school, work. So it's a huge cost on the patient. "Not only have I seen it save lives, but I've seen the opposite happen, of when an EpiPen wasn't available and both children and adults passed away."…

A spokeswoman for Mylan emailed a written statement from the company to CNN. In the statement, company officials indicated that they know more is needed to help patients with high-deductible insurance plans.

"With changes in the healthcare insurance landscape, an increasing number of people and families are enrolled in high-deductible health plans, and deductible amounts continue to rise. This shift has presented new challenges for consumers, and they are bearing more of the cost. This change to the industry is not an easy challenge to address, but we recognize the need and are committed to working with customers and payors to find solutions to meet the needs of the patients and families we serve," according to the company's statement.

Levin, the patient in New York, said that her EpiPen costs are partly covered by insurance, but she has to first pay a separate deductible under the category of injectables before she can purchase her EpiPens at the discounted insurance price.

"Five years ago, the deductible was only $100, but as the price increased, so did the deductible. So every new year, I always have to anticipate and pay the dreaded cost," she said.

Mylan offers a My EpiPen Savings Card to help consumers with cost. Last year, nearly 80% of commercially insured patients used the card to receive the device for free, according to Mylan. The company also has distributed more than 700,000 free EpiPens to schools nationwide.

Additionally, "there are some coupons available, which help lower the cost to patients, but there still is a considerable copay for most patients," said Casale, the AAAAI executive vice president. "Although the cost of epinephrine auto injectors has risen considerably, they are lifesaving and patients should do whatever they can to secure them."

Meanwhile, Kesselheim and his colleagues suggested short-term strategies to reducing high drug prices in their paper.

"We need to re-examine the market exclusivities provided by the government to manufacturers to ensure that they adequately protect innovative products without similarly applying to less innovative treatments that add cost without adding value," Kesselheim said. "More patients and physicians need to talk about the costs of medications with each other -- and express concern to their legislators -- so that evidence-based lower-cost alternatives can be found, if possible."


  1. It’s not the drug being delivered that brings the bucks, though—epinephrine’s a cheap generic. The cost trickery is in the delivery system, the Mylan EpiPen.

    The EpiPen’s been around since 1977, but Mylan acquired the autoinjector—which precisely calibrates the epinephrine dosage—in 2007. The patient now pays about 400% more for this advantage to receive a dollar’s worth of the lifesaving drug: EpiPens were about $57 when Mylan acquired it. Today, it can empty pockets of $500 or more in the U.S. (European nations take a different approach to these things).

    It’s what the market will bear, so what’s the problem, right? Only this: Somewhere, right now, a cash-strapped parent or budget-limited patient with a severe allergy will skip acquiring an EpiPen. And someday, they will need it in a life-threatening situation involving exposure to a trigger…and they won’t have it. And they will die. Because they couldn’t afford the delivery mechanism for $1 worth of a drug to keep them alive. Two turning points, a death and one company at the crossroads.

    According to NBC, Mylan’s profits from selling EpiPens, which they have aggressively, famously marketed with brilliant success, hit $1.2 billion in 2015. That year, Bloomberg reported that the epinephrine-delivery system represented 40% of Mylan’s operating profits. Bloomberg calls Mylan’s marketing of the EpiPen “a textbook case in savvy branding.”…

    The coup de grĂ¢ce that will divide the “have intervention for anaphylaxis” from the “have nots and might die as a result”? The EpiPens have an expiration date of one year. So if you don’t have a life-threatening allergic reaction within that year, that’s obviously a good thing—except that you’re out $400 or more and have to spend $400 more for that special device that delivers $1 worth of drug….

    A syringe doesn’t offer the benefit and safety advantage of a well-calibrated dose, and it carries the risk of injection into a vein, instead of muscle, which can be fatal. PBS reported the experience of one mother whose son has an extreme dairy allergy and whose insurance plan is high deductible. The price of two pens–$1,212—was more than her mortgage payment, so she turned to ampules of epinephrine and a syringe as the “rescue” med for her son. Her older son, PBS reports, who also has allergies, just carries around expired EpiPens…

    Given the Alice in Wonderland nature of this election season, it’s not that surprising to see distortion of reality and common sense infecting this EpiPen debacle. In this case, we come as close as humans can to a human pot calling a pharma kettle black: Martin Shkreli, poster boy for grasping pharma greed, actually commented to NBC News about Mylan that “these guys are really vultures” and asked, “What drives this company’s moral compass?”

    For the uninitiated, Shkreli is the fellow who bested Mylan’s 400% price increase when his company jacked up the price of a malaria-HIV drug 5,000%.

    Shkreli’s shenanigans earned him the moniker “pharma bro,” but the “bro” in the Mylan case is no bro: She’s “pharma sis” Heather Bresch, now the company’s CEO. The “textbook” marketing plan she hit on expanded the “find” target—one of the three goals of any pharmaceutical company—reaching for parents of children with allergies. The “what-if” fears of parents are a rich vein to tap, one that clearly has proved immensely valuable to Mylan.

    The “find” was a huge success. And once those parents were found, hitting the second goal of a pharmaceutical company—“start,” as in “start them on your product”—was almost inevitable. The question now is, in the face of prohibitive pricing, syringe-hacking and all of this negative publicity—in which even Martin “Pharma Bro” Shkreli sees a spot of moral high ground where he can stand—Can Mylan continue to hit that third aim: Keep?

  2. Mylan, in the face of heated criticism over price hikes for its EpiPen emergency allergy treatment, is bulking up programs that help patients pay for the drug.

    The generic drugmaker laid out a plan on Thursday to expand its patient assistance program and offer $300 savings cards for its EpiPen 2-Pak.

    There is no change in the price of the treatment, however, which is what has drawn ire both in Congress and from families that have had to shell out increasingly large sums for the potentially life-saving treatment.

    Mylan has hiked prices for EpiPen as frequently as three times a year over the past nine years. A two-dose EpiPen package cost around $94 nine years ago but has climbed more than 600 percent to an average cost of $608 in May, according to the Elsevier Clinical Solutions' Gold Standard Drug Database.

    Mylan did not immediately return calls from The Associated Press early Thursday about the drug's price.

    Mylan N.V. said it's doubling eligibility for its patient assistance program, which it said will get rid of out-of-pocket costs for uninsured and underinsured patients and families. It also noted that the $300 savings card will cover about half the cost patients who would otherwise have to pay the full list price.

    Patients will also be able to order the injected emergency medicine for severe allergic reactions directly from the company, to help lower costs, Mylan said...

    Last year, more than 3.6 million U.S. prescriptions for two-packs of EpiPens were filled, according to data firm IMS Health. That earned Mylan nearly $1.7 billion.

  3. And while it’s incredibly scary, the worst case scenario is exceedingly rare: Between 1999 and 2009, deaths from anaphylactic shock in the United States ranged from 186 to 225 deaths per year. To put that in perspective, about 4,800 American adults die from choking on their food every year. But Mylan hasn’t yet found a way to extract $1 billion from the Heimlich maneuver.

    “We’re only touching about 2 million, 2.5 million people and believe it’s well, well above that, people that are are risk for anaphylactic shock,” said Heather Bresch, Mylan’s CEO, in October of 2011. At the time, the EpiPen had roughly 98 percent market share, essentially dominating the market.

    But Mylan wanted more, and a series of savvy maneuvers allowed them to get it. From FDA policy changes that expanded the number of consumers to which the product could be marketed, to legislation signed in 2013 that put EpiPens in schools across the country, the federal government has helped Mylan stack the deck for its product. Oh, and Sarah Jessica Parker helped too...

    Mylan acquired the EpiPen when it bought a group of medications from drug company Merck in 2007. At the time, the product only produced about $200 million in revenue. Today, according to Bloomberg, it makes about $1 billion per year for the formerly US-based company, now headquartered in the Netherlands after a corporate inversion last year.

    The EpiPen is no longer covered by patent protection, but it still has no real competitors...

    So what can a company like Mylan do to increase profits on an old product, like EpiPen, when it’s already captured 98 percent market share and has no real competitors?

    One option is to increase prices. The second is to increase the size of the market by convincing regulators, like the FDA, that the product should be marketed directly to a wider swath of the population. Then, a company can swoop in with high-profile (albeit backdoor) endorsements, from people like Sarah Jessica Parker, to increase awareness about the conditions that EpiPen treats. Or, better still, why not push to have institutions like public schools incentivized under federal law to carry the product? Mylan has spent the past decade doing all of the above...

    And parents who now see EpiPens as a necessity are fearing for their children’s lives when they can’t access the drug. Especially when the new normal established by public awareness campaigns is that people at risk for anaphylactic shock should have multiple EpiPens—at work, in the car, at home, at school, and on their person...

    “This outrageous increase in the price of EpiPens is occurring at the same time that Mylan Pharmaceutical is exploiting a monopoly market advantage that has fallen into its lap,” Senator Amy Klobuchar from Minnesota said in a recent statement criticizing Mylan’s business practices.

    But Congress spent the past few years helping Mylan get into schools with virtually no thought to the fact that it had a monopoly on a life-saving drug.

    In 2013, President Obama signed the School Access to Emergency Epinephrine Act. It was that rare piece of legislation that both Democrats and Republicans agreed upon (Klobuchar was a co-sponsor of the legislation)...

    Mylan has a program that distributes free EpiPens to schools. So I asked Mylan over email if its program restocks the product for a certain number of years after they expire. The company didn’t respond to my question and instead sent a generic prepared statement: “Since the start of the EpiPen4Schools® initiative in 2013, more than 700,000 free EpiPen® Auto-Injectors have been distributed, and more than 65,000 schools, approximately half of all U.S. schools, have participated in the program,” the relevant part of the statement reads.

  4. EpiPen prices aren't the only thing to jump at Mylan. Executive salaries have also seen a stratospheric uptick.

    Proxy filings show that from 2007 to 2015, Mylan CEO Heather Bresch's total compensation went from $2,453,456 to $18,931,068, a 671 percent increase. During the same period, the company raised EpiPen prices, with the average wholesale price going from $56.64 to $317.82, a 461 percent increase, according to data provided by Connecture.

    In 2007 the company bought the rights to EpiPen, a device used to provide emergency epinephrine to stop a potentially fatal allergic reaction and began raising its price. In 2008 and 2009, Mylan raised the price by 5 percent. At the end of 2009 it tried out a 19 percent hike. The years 2010-2013 saw a succession of 10 percent price hikes.

    And from the fourth quarter of 2013 to the second quarter of 2016, Mylan steadily raised EpiPen prices 15 percent every other quarter.

    The stock price more than tripled, going from $13.29 in 2007 to a high of $47.59 in 2016.

    And while sales of the life-saving drug rose to provide 40 percent of the company's operating profits in 2014, as Bloomberg reported, salaries for other Mylan executives also went up. In 2015, President Rajiv Malik's base pay increased 11.1 percent to $1 million, and Chief Commercial Officer Anthony Mauro saw his jump 13.6 percent to $625,000.

  5. In what other markets can a business jack up its prices without alienating its customers and pushing them toward competitors? Answer: when that market has no other competitors. Emily Willingham of Forbes explained it aptly with a recent article titled, “Why Did Mylan Hike EpiPen Prices 400%? Because They Could.”

    In early 2016, Sanofi, Mylan’s primary competitor, discontinued its line of Auvi-Q auto-injectors, similar to Mylan’s product. With Auvi-Q out the picture, Mylan gained 98 market share of epinephrine injectors.

    But surely a new business will take advantage of this public relations debacle, enter the market, and offer a more affordable option, right?

    From the time this bill was introduced to the date it was signed by Obama, Mylan’s stock was up nearly 20%.

    Unfortunately – and as no surprise to libertarians and free market advocates – federal regulators continue to buffer the padding that surrounds Mylan’s monopoly. Shortly after the Auvi-Q recall, Teva Pharmaceutical Industries pitched a generic version of the EpiPen. However, the Food and Drug Administration (FDA) squashed their efforts, citing “major deficiencies” in their application. Teva plans to appeal the decision, but won’t be able to effectively move forward until 2017 at the earliest.

    Teva isn’t alone in this struggle. Windgap Medical, a Boston startup, and Adamis, a small biotech firm based in San Diego, have both struggled to bypass FDA’s barriers of entry in the marketplace as well.

    If you need further convincing that the FDA impedes the market, consider the following:

    The average time it takes for a drug to go from the lab to the medicine cabinet is 12 years

    Only 1 in 5,000 new drugs will make it through the FDA approval

    Based on the regulatory burden of creating new medicine, the average price tag for research and development for a new compound is $2.6 billion…

    Those companies who “paid to play” are providing a textbook example of crony capitalism, not free market capitalism.

    Mylan’s monopoly was also bolstered by the White House. In 2013, President Obama signed into law the School Access to Emergency Epinephrine Act. The program incentivizes the school system to stockpile EpiPens by dangling the carrot of federal grant monies in front of financially beleaguered school districts. From the time this bill was introduced to the date it was signed by Obama, Mylan’s stock was up nearly 20%.

    But this little piece of legislation pales in comparison to the benefit doled out by the Affordable Care Act. Following Obamacare’s codification, net spending on prescription drugs increased nearly 20%. Meanwhile, the pharmaceutical industry experienced a renaissance era of whirlwind profits: estimates of profits over the next decade range from $10 billion to $35 billion – a hefty door prize for the industry lobbyists who crafted the ACA legislation.

    The EpiPen is not a microcosm; the cost of other prescription drugs are also on the rise. A House of Representatives report found that ten different drugs experienced even larger price hikes, starting as low as 420% and as high as 8,000%.

  6. This is especially worrying because Mylan has a near monopoly in the business, especially after one of its competitors issued a recall last year. Doctors have likened its brand dominance in schools to that of Kleenex. Many schools have emergency epinephrine in stock and there are states pushing for legislation to make that mandatory.

    The increase is so high that Pharma Bro and person that hates Gawker Martin Shkreli, who for months was the most hated person on the internet after his company, Turing Pharmaceuticals, acquired a 62-year-old anti-parasitic drug and jacked the price from $13.50 a pill to $750, spoke out against the move.

    “These guys are really vultures. What drives this company’s moral compass?” he told NBC News...

    In an earlier emailed statement, Mylan said its prices have “changed over time to better reflect important product features and the value the product provides,” and that “we’ve made a significant investment to support the device over the past years.”

    According to a financial report released last week, Mylan’s sales have gone up, thanks in part to the EpiPen.

    With good insurance, and with the help of coupons, it’s possible to pay very little for an EpiPen. However, those without adequate insurance in the United States are left without many alternatives, especially in pharmacies...

    “The drug industry’s greed knows no bounds,” Sanders said. “The only explanation for Mylan raising the price by six times since 2009 is that the company values profits more than the lives of millions of Americans.”

    NBC stated that while there isn’t a House committee investigation in the works, there is a lawsuit on the way.

    “I’ve been looking at EpiPen for years,” said Ari Kresch, CEO of 1-800-LAW-FIRM. “It’s a very cheap drug but I haven’t been successful in getting any experts to tell me why the price has gone up as much as it has.”

    It’s just worrying that through all of this, Shkreli is using the issue to be the voice of reason. When he calls out your company, you know you’ve screwed up.

  7. Outrage over the massive EpiPen price hike feels like deja vu. A year ago, America was in shock when a drug called Daraprim that's used by some AIDS and transplant patients skyrocketed overnight from $13.50 to $750 a pill.

    Hillary Clinton tweeted that the 5,000% spike was "outrageous" and amounted to "price gouging." Nothing about the drug itself had changed except this: a new company -- Turing Pharmaceuticals -- had bought the rights to distribute it. The Daily Beast dubbed Turing's CEO "the most hated man in America."

    A year later, one pill of Daraprim costs $375 for many patients.
    Turing hails this as a 50% reduction in price, but doctors are livid. The drug still costs 2,500% more than before the hike.

    "It remains criminal," say Dr. Wendy Armstrong, a medical professor at Emory University and head of the Infectious Diseases Program at Grady Health System in Atlanta, Ga. "It's still an immense financial burden for a drug that should be $1 a pill."

    Turing says it has put in place programs to "ensure access to Daraprim for every single patient who needs the drug, regardless of ability to pay." Controversial CEO Martin Shkreli also left the company late last year.

    But doctors say the reality is Turing has created an expensive, bureaucratic hurdle for patients to get a drug that can save their life. And now other companies appear to be following the "Turing playbook."…

    Dr. Judith Aberg was one of the first to sound the alarm bell by speaking to the New York Times. She's head of infectious diseases at the Icahn School of Medicine at Mount Sinai in New York City and a well known HIV and AIDS researcher.(continued)

  8. (continued)"A year later, it's still frustrating," Dr. Aberg told CNNMoney. "What's more frustrating is that other companies are following Turing's lead. At some point, our economy can't support this."
    This week, outrage erupted again over the dramatic rise in costs of EpiPens that many rely on to save them from life-threatening allergic reactions. A standard two-pack of EpiPens now costs about $600. The price was $100 in 2009.

    The CEO of the company that makes the EpiPens is using many of the same arguments that Turing did when it raised the price of Daraprim. She's blaming the broken health care system, arguing programs are in place to help those with great financial need and saying the company needs profits to fund research. Former Turing CEO Shkreli has been tweeting his support.

    Daraprim still only costs $1 or $2 a pill abroad. Turing only has the U.S. rights to distribute it. Doctors around the world have flooded Dr. Aberg's inbox with offers to send her supplies from their countries.

    "It's not illegal what they've done [at Turing], but it's unethical and immoral," says Dr. Aberg "This is affecting patient care."

    As hospitals try to keep costs downs, doctors have been discouraged from using Daraprim. Dr. Aberg says her team used to prescribe it about five times a month. Now they're down to using it once, if that. They have turned to alternatives that aren't nearly as well tested with unknown side effects.

    "That doesn't make patients feel confident. It doesn't make us feel confident," she says. The main ingredient in Daraprim is now available compounded with another drug. Imprimis Pharmaceuticals sells this alternative compound for $1 a pill.

    Turing has made a big deal about programs it has created to reduce the costs for patients. For instance, it says that the drug is available for free to people with deep financial need.
    But Dr. Aberg has watched her patients have to "jump through the hoops" to get it. Patients have to prove both financial need and health status, something that's difficult to focus on when their lives are in danger. In June, one of her patients gave up on the process. The patient switched therapies, only to suffer a negative side effect.

    The application also requires patients to sign broad disclosures "to use and disclose all of my individually identifiable health information." Dr. Aberg says some patients, especially with HIV and AIDS, are hesitant to do that.

    Turing argues that "approximately two-thirds of Daraprim sales are to federal and state health programs that pay Turing just 1 cent per pill."

    It's true that Medicaid and certain AIDS clinics -- known as 340B programs -- get a reduced rate. But again, patients have to apply to be in those programs and facilities. Dr. Armstrong currently has a patient with a brain infection who she's trying to get into a 340B program.

    "This is a big burden for someone with a very significant brain infection and (not able to think clearly) currently," says Dr. Armstrong. "It's layers or hurdles for people that already have challenges."

    Then there's people with insurance. An expensive drug like Daraprim is often put in a top tier, meaning a patient has a higher than normal copay.

    Even at a 20% copay, a four-month supply of Daraprim at two pills a day would mean a patient paying about $18,000 out of pocket.

  9. “It just felt nefarious,” said Ms. Kantayya, whose health insurance covers the cost of EpiPens for her husband, who has an allergic condition. “Just because we’re not paying for it, we’re still paying for it in terms of social cost,” she said. Then she thought, ‘Why don’t I do a petition, and maybe something will be done about this.’”

    She went online to, a service that collects signatures and then sends them to designated lawmakers, and created the petition “Stop the EpiPen Price Gouging,” which went live onJuly 11.

    Then Ms. Kantayya shared the link with her 836 Facebook friends, with a post that began, “Stupid pharmaceutical company!”

    What happened next is a lesson in the power of social media to help create a groundswell, particularly among a group as committed and motivated as the parents of children with food allergies, who must often buy multiple pens for home, school and day care. In just 45 days, Ms. Kantayya’s petition grew from a few dozen signatures to more than 80,000 people who sent more than 121,000 letters to Congress...

    So how did the EpiPen come to epitomize unfair drug pricing? While the price of the EpiPen did not increase overnight, data show that Mylan had been steadily increasing prices, first by about 10 percent, twice a year, but more recently in about 15 percent increments. This summer, as parents bought EpiPens for summer camp and back to school, many were paying higher out-of-pocket costs because of high deductibles and co-payments imposed by their insurance companies...

    One of them was Jennifer Vallez, an illustrator in Ellington, Conn., whose 9-year-old daughter, Lola, has a peanut and tree nut allergy. Because her insurance policy has a $2,000 deductible, her pharmacist told her the cost to refill an EpiPen prescription would be $600.

    “It’s just morally so wrong,” said Ms. Vallez, a high school friend of Ms. Kantayya and the second person to sign the petition. She also shared it with her 533 Facebook friends. “I have a lot of friends with children with allergies, so we all are pretty adamant about this kind of stuff and support each other,” she said.

    At the same time, Ms. O’Brien, who founded and wrote a popular book on the food industry called “The Unhealthy Truth,” began hearing more concerns about EpiPens from her 165,000 followers on Facebook and Twitter.

    “Something has to be done, so we are doing it,” she wrote on July 21 on her public Facebook page. “Stay tuned and read about the price gouging of American parents.” The post was shared 727 times.

    A week later, Georgina Cornago Cipriano, whose son Giovanni died at age 14 as a result of a food allergy, posted an article on Ms. O’Brien’s website about Mylan’s “EpiPen profiteering.”

    “How can they not care?” she asked. “What can we do?” Her post was shared 477 times, reaching more than 110,000 people...

    What’s so unusual about the pricing furor is that it has been orchestrated almost solely by parents and family members of people who use EpiPens. Patient advocacy groups, which typically are vocal on all issues related to food allergies, have been largely silent.

    Some of the most prominent groups — Food Allergy Research & Education (FARE), the Asthma and Allergy Foundation of America (AAFA) and Allergy & Asthma Network — have partnerships with Mylan for patient awareness campaigns and other programming. The groups are not required to disclose how much money they receive from the drug company; but Mylan, in its 2015 Social Responsibility report, lists all three as “allies.”

  10. Mylan said on Monday it would launch the first generic to its allergy auto-injector EpiPen at a discount of more than 50 percent to the branded product's list price.

    The company reduced the out-of-pocket costs of EpiPen for some patients last week amid a wave of criticism from lawmakers and the public over the rapid escalation in the product's price in the past few years.

    Mylan said it expected to launch the generic product "in several weeks" at a list price of $300. The branded product costs about $600. EpiPen cost about $100 in 2008.

    Mylan is the latest company to be caught up in the growing outrage at apparently egregious drug price increases. Valeant Pharmaceuticals International Inc and privately held Turing Pharmaceuticals have both been publicly excoriated for similar price increases.

  11. Mylan blames "the system," saying that families are paying both rising costs for their product and rising insurance premiums. In large part, they are right. The Affordable Care Act provides broken coverage for more people — which is better than fewer people, but still broken. Within that broken system, many sellers are free from competition, and each can seek to maximize its share of an expanding and only elastically limited pool of health-care dollars. The only issue is how much leverage over the consumer each seller has — how "essential" its product or service is. In some instances, patent protection can increase that leverage. In others, the key factor can be first-mover advantages, brand recognition, or costs of entry for potential competitors.

    Mylan should be concerned about the reputational risk it runs. Its financial results have been stellar, with revenue up nearly 39 percent since CEO Heather Bresch took over. It may point the finger at the returns enjoyed by other parties in its supply chain to the consumer. But using those rewards as the rationale for further price increases for itself sounds a lot like arguing that its own share of a large pie should be even bigger, regardless of the impact on many consumers. This echoes the frequent over-emphasis (or even sole emphasis) on shareholder value.

    Ignoring Mylan's full community of stakeholders might well yield political action to the long-term detriment of the shareholders. Or at some point, Mylan's brand value could cease to be a deterrent to new competition, and become rather a marketing point for a potential competitor.

    And running an income-conditioned subsidy program is not the comparative advantage of a private business, and is clearly not the answer to this much bigger issue.

    An ultimate solution requires a competitive health-care system. If each family could choose the health-care plan that meets its needs, on a cost-responsible basis, plans would have to seek out supplies of products like the EpiPen at prices that their enrollees could afford. That could give a market opportunity to a new producer willing to accept an earth-bound rate of return.

    The system is broken. Fixing it would resolve the moral dilemmas presented by the EpiPen episode.

  12. Mark Baum believes the relentless EpiPen price hikes are "shameful" and his company is plotting a $100 alternative for the lifesaving allergy treatment.

    Baum, known for offering a $1 substitute for the $750 AIDS drug Daraprim, told CNNMoney on Tuesday that his company Imprimis Pharmaceuticals (IMMY) has been quietly working on a compounded version of EpiPen for months. The company hopes to have it ready by the end of the year.

    The plans come amid the latest price gouging scandal over the 400% increase in EpiPen prices by Mylan (MYL). The drug maker and its CEO Heather Bresch have become the newest faces of corporate greed. In response to the outcry, Mylan took the unusual step of announcing a fast-track launch of its own $300 generic EpiPen.

    But Baum says his version of EpiPen would cost very little to make. He pointed that one milligram of epinephrine, which is three times more than what's needed in an EpiPen, costs just a few bucks.
    "The cost of epinephrine is literally less than a Big Mac," he said of EpiPen's main ingredient.

    The auto injector is available for between $3 and $7. He believes he can make a customizable version of EpiPen and sell it profitably for less than $100, without gouging the public.

    "We don't have the desire to charge the public even $300, for something that costs so little," Baum said.

    "That's not how I want to live my life."

  13. A group of 20 senators called the recent price-lowering overtures from the company that makes the EpiPen emergency auto-injector a “well-defined industry tactic to keep costs high through a complex shell game.”

    The sheer number of senators – 19 Democrats plus independent Sen. Bernie Sanders – represents a ratcheting-up of the stakes over the dramatic price increases of the emergency epinephrine product from Mylan NV. Mylan has sought recently to quell criticism by announcing discount programs and, on Monday, other plans soon to offer a generic version at half price.

    Mylan has faced a backlash from Congress, as well as from parents of children with severe and life-threatening allergies, over its nearly 550% list-price increase over eight years. Since it acquired the rights to the EpiPen in late 2007, Mylan has increased the list price of a two-pack to $608.61.

    In a letter Tuesday to Mylan chief executive Heather Bresch, Sen. Elizabeth Warren and colleagues described Mylan’s discount programs as “short-term co-pay assistance for expensive drugs,” but noted that “insurance companies, the government and employers still bear the burden of these excessive prices.”

    The higher insurance and government costs, the senators wrote, “are eventually passed on to consumers in the form of higher premiums.” They added that the generic price that will be offered by Mylan “is still three times higher than the cost of the branded EpiPen in 2007.”

    Mylan didn’t immediately comment on the letter or on the broader pricing dispute.

  14. There already is a cheaper alternative to the EpiPen. The Food and Drug Administration approved it in 1939; it is called Adrenaclick. The indications for use of the EpiPen and Adrenaclick are the same: life-threatening allergic reaction called anaphylaxis.

    I am allergic to certain insect stings, and my physician prescribes a generic epinephrine auto-injector, distributed by Lineage Therapeutics. After insurance, I pay $10 for a two-pack of injectors. According to Consumer Reports, “EpiPen isn’t the only epinephrine injector on the market; the authorized generic of Adrenaclick (epinephrine auto-injector), is a cheaper option — we found it for $142 at Walmart and Sam’s Club using a coupon from GoodRx. . . . Both auto-injectors contain the same drug, epinephrine, available in the same dosages.”

    If the FDA and news outlets would educate the public about this alternative, meaningful competition and market forces would quickly bring down the cost of the EpiPen.

  15. Dear Heather,

    You got greedy. Really greedy.

    Mylan’s $600 EpiPen and its newly proposed $300 generic auto-injector both price a life-saving medication out of reach for many hardworking American families. The EpiPen costs only a few dollars to make, yet you have increased its price by $500 in less than a decade. You claimed on Monday that you will soon offer a generic at “half” of the price.

    Allergy families know the truth. You are going to sell us a generic version of the EpiPen ― the same product that was on the market in 2007 for $100 ― at a 300% markup.

    Did you think that we would thank you for this? Or did you simply think we’d be confused and wouldn’t notice?

    The fact that you are cutting the price in half and it’s still three times more expensive than it was less than a decade ago underscores just how unrelenting your greed has been during this time.

    Allergy families can’t budget and save up as if we are buying a car. We will always need this life-saving medication. It expires every year and the struggle for many families to afford new EpiPens begins anew. Most families can’t get by with a single EpiPen pack, either. Our family requires three packs and our daughter isn’t even in daycare or school yet. I know several families that require five or six EpiPen packs…

    You claim that lowering the price of EpiPens would be a hardship for Mylan, yet your salary has increased over 670% since you first acquired the product nine years ago. With an annual salary of $19 million, it seems that there is no level of compensation great enough to satiate your desire to acquire more wealth.

    You rake in millions for yourself and, hopefully, we buy ourselves another year of life-saving medicine, or maybe just enough medicine to get us through the next anaphylactic attack…

    You can go on television and act as if you care about EpiPen access issues. You can pretend to be unaware of the impact that your price gouging strategies has had on allergy families over the past nine years. You can offer coupons, new unaffordable products, and all the excuses you can muster. You can do all of this while claiming to understand severe allergies and to be an advocate for allergy sufferers.

    There is one thing that you can’t do. You can’t buy your way into our community by sponsoring a couple of our organizations. The money that you provide to some of the causes that our community cares about is not actual support. In fact, it’s not even your money. It’s just a small fraction of the proceeds that you have essentially robbed from hardworking families.

    Your refusal to cut the price of EpiPens makes it clear that you value Mylan’s profits and your own personal enrichment more than the life of my daughter and the millions of American families that require multiple EpiPens to keep our loved ones safe.

    Your philanthropy doesn’t make you compassionate, Heather. It makes you a hypocrite. You will never be a member of our community because you don’t care about my daughter’s life or the lives of millions of children and adults like her. You are not one of us. You have proven that we can never trust you…

    You have done me one great favor, Heather. Your actions will provide my daughters an example of how not to live their lives.

    They will be compassionate human beings.

    They will grow up to be strong intelligent women.

    They will look out for others and be empathetic in all that they do.

    They will never choose personal enrichment over saving the lives of others.

    They will be positive role models that their own children can be proud of.

    In short, they will be nothing like you, Heather Bresch.

  16. Valeant Pharmaceuticals International (NYSE:VRX) is being sued by unionized police and hotel workers on charges that it violated racketeering laws regarding its ties to now-defunct pharmacy Philidor RX. The company is accused of racketeering by forcing members of the unions to pay high prices for prescriptions, according to the complaint, which was filed in US District Court. The plaintiffs are seeking compensatory damages for health plans it bought between 2013 and 2015, according to news reports. Valeant is alleged in the class-action suit to have pushed patients toward brand-name drugs rather than toward less-expensive generic equivalents, according to news reports.

    The company was grilled earlier this year amid allegations of price gouging. Former Chief Executive J. Michael Pearson left Valeant after testifying before the Senate about the sharp increase in prices for some drugs. One patient with rare disorder called Wilson’s Disease testified that the copay for her medication jumped from $700 a year to $10,000 a year as Valeant raised the price more than 3,000%. The latest drug-pricing scandal has come after Mylan increased the wholesale price of its EpiPen product, used to treat anaphylaxis, by more than 400% since 2007 while giving Chief Executive Heather Bresch a more than 600% compensation increase.

  17. Members of the Senate Special Committee on Aging are calling for Mylan, the maker of the EpiPen, to brief members of Congress about the drastic price increase of the medication since 2007.

    U.S. Senators Susan Collins and Claire McCaskill sent a letter to Heather Bresch, the CEO of Mylan, asking her to explain why the price of an EpiPen has spiked 400 percent since 2007.

    “We are concerned that these drastic price increases could have a serious effect on the health and well-being of every day Americans," the senators wrote in a letter addressed to Bresch. "As leaders of the Senate Special Committee on Aging, we are particularly concerned that seniors have access to EpiPen® because, according to Mylan’s website, older Americans ‘may be at an increased risk of having a more severe anaphylactic reaction if they are exposed to biting and stinging insects.’”

    The senators told Bresch to come to Capitol Hill "at a mutually convenient time no later than two weeks from today.”

    The company has come under fire in recent days over the cost of the popular EpiPen, the most common epinephrine injector on the market. Other members of Congress, including Sen. Chuck Grassley of Iowa and Sen. Richard Blumentahl of Connecticut, have written to Mylan about their concerns.

    Today, Democratic nominee Hillary Clinton released a statement calling the price hike "outrageous."

    "I believe that our pharmaceutical and biotech industries can be an incredible source of American innovation, giving us revolutionary treatments for debilitating diseases," she said in a statement. "But it's wrong when drug companies put profits ahead of patients, raising prices without justifying the value behind them."...

    The American Medical Association has also released a statement imploring Mylan to reduce the price of the drug.

    "Although the product is unchanged since 2009, the cost has skyrocketed by more than 400 percent during that period. The AMA has long urged the pharmaceutical industry to exercise reasonable restraint in drug pricing, and, with lives on the line, we urge the manufacturer to do all it can to rein in these exorbitant costs," AMA officials said in a statement today. "The high cost of these devices may either keep them out of reach of people in need or force some families to choose between EpiPens and other essentials."

  18. An Ohio woman on Tuesday filed a proposed class action lawsuit against Mylan Pharmaceuticals Inc (MYL.O) in an Ohio county court, claiming sharp price hikes for the company's EpiPen device violated the state's consumer protection law...

    The company has defended EpiPen's high price, saying it spent hundreds of millions of dollars to improve the product. It has also said it recoups less than half the list price for EpiPens.

    Tuesday's lawsuit was filed in the Court of Common Pleas for Hamilton County, Ohio, by Cincinnati resident Linda Bates, whose son requires an EpiPen.

    “The outrageous, unconscionable and immoral high prices set by Defendant is nothing more than price gouging,” the complaint says.

    It says the price increases violated the Ohio Consumer Sales Practices Act, which prohibits “unconscionable” acts in connection with consumer transactions, including taking advantage of a consumer’s “physical infirmities.”...

    Nonetheless, U.S. Senators Richard Blumenthal and Amy Klobuchar, both Democrats, on Tuesday called on the U.S. Federal Trade Commission to issue a subpoena to Mylan about EpiPen's pricing.

    The same day, New York Attorney General Eric Schneiderman announced he was launching his own investigation of whether Mylan violated antitrust laws in its contracts to provide EpiPens to some school systems.

    The company is also facing a separate proposed class action lawsuit accusing it of gouging consumers by selling EpiPens only in packs of two. It was filed in late August in federal court in Michigan.

  19. First, it was Valeant Pharmaceuticals and its 300% and 700% price hikes on two crucial heart medications. Then, it was Turing Pharmaceuticals and its 5,455% price increase on a lifesaving anti-parasitic medicine. And now, it’s Mylan and its 548% boost in the prices of EpiPens, meaning people with severe allergies may not be able to afford the tools that keep them alive.

    It’s become a familiar dance: A drug company buys a well-established medication developed by another company. It raises the price by an obscene amount. The public reacts with outrage. Congress proclaims the need for inquiries.

    And nothing changes...

    Mylan, Turing and Valeant may be the most egregious examples, but they’re not the only ones. Trends in the pharmaceutical industry show steady, steep price increases. A recent survey of 3,000 prescription medications found that prices more than doubled for 60 drugs and at least quadrupled for 20 drugs—and that was just since December 2014. On average, the cost of drugs is increasing at 10% a year.

    While 10% may not seem so bad by comparison, consider that the current rate of inflation is only %1. Unrelenting increases are driving up the cost of hospital stays, insurance premiums, out-of-pocket expenses and health-care costs overall.

    Hospitals like Cleveland Clinic, where I work, have no choice but to pay these overinflated prices. To withhold Turing’s Daraprim from an HIV patient—or Valeant’s Isuprel from a heart patient—because of the drug’s price tag would be unethical. To forgo the use of a life-saving drug because it costs too much creates ethical challenges. Like all hospitals, we are feeling the pinch. In 2015, we saw an unexpected increase in drug costs of $42 million.

    Ban direct-to-consumer advertising...Only two countries allow direct-to-consumer advertising—the U.S. and New Zealand, whose residents happen to take significantly more prescription drugs than those in comparable countries...

    Eliminate “pay-to-delay” payments. When a brand-name drug’s patent is about to expire, competing manufacturers begin to consider making a generic alternative, which will cost less than the brand-name drug and cut into its profits. To stop that from happening, the manufacturers of brand-name drugs will pay the generic manufacturers to not produce a generic version...

    Allow some drug imports when companies egregiously raise prices.

    Eliminate patient assistance co-pay cards...Eliminating a co-pay saves patients’ money but shifts the payment burden to insurance companies, which is eventually passed on to consumers.

    After being grilled and shamed at congressional hearings, Valeant responded to its 718% increase and promised customers like us a 30% discount. To date, it never happened. And even if it does, a 30% discount after a 700% price increase doesn’t seem like an even trade-off to me.

  20. An open letter to Mylan CEO, Heather Bresch

    In light of recent news regarding EpiPens, I would like to give you an opportunity to justify your pay increase from $2,453,456 in 2007, to $18,931,068 in 2015. In that time, the wholesale cost of an epipen has gone from $56.64 to $317.82. By the way, the cost of a 1 ml amp of epinephrine is $4.49. So, I give you the opportunity to justify the increase in the cost of an epipen, as well as the increase in your salary.

    I know you must have an explanation.

    As a practicing Emergency Medicine physician, I have cared for nearly 50,000 patients in my career. As a team, my nursing staff, techs, medical assistants, Physician Assistants, are all trained to save lives. WE frequently care for acute anaphylactic and allergic reactions. So, while I know you must have an explanation to my question, here are some things I know you do not know.

    You do not know the look on a patient’s face when they are struggling to breath after a bee sting.

    You do not know the fear a patient has when their lips and tongue are so swollen, there is barely an airway to care for.

    You have never heard the sound of stridor when air can barely make its way to the lungs.

    You have never seen the look of a parent when their child is unresponsive.

    You have never had to debate whether you need to give epinephrine to a patient in anaphylactic shock who has underlying cardiac disease with the knowledge that the drug may save their life, but may cause a heart attack.

    You have never attempted to intubate a patient in respiratory failure after a bee sting.

    You have never watched your own child, while on vacation, eat a peanut butter sandwich, which they have done so many times before, but breakout in a severe rash and receive a prescription for an epipen, only to be told that the pharmacy doesn’t take accept your insurance and you have to pay $500 out of pocket for a potential life saving medicine.

    You have never performed CPR on a child.

    You have never told a parent that their child died.

    These are things that you do not know. However, I DO. I HAVE DONE THEM!!! WE DO. MY TEAM HAS DONE THEM!!!

    So, please Ms. Bresch, justify your increase of 461% for a medication that costs $4.49, to the point that patients and families who may not have insurance have to make a decision that could lead to death. Justify your pay increase by 671%.

    Justify your greed.


    Mark A. Kenton D.O.

  21. Despite a withering 4-plus hours of questioning by members of a congressional committee yesterday, Mylan CEO Heather Bresch did not give a direct answer as to why the company had substantially and consistently raised the price of its EpiPen over the past 8 years…

    Kaiser reported that Medicare Part D spending on EpiPens had increased 1151% from 2007 to 2014, while the number of users had only risen 164%. Medicare beneficiaries also saw a big jump in their out-of-pocket spending, from $30 per pen in 2007 to $56 per pen in 2014.

    Despite repeated requests during the House Oversight and Government Reform Committee hearing, Bresch offered no explanation for the price increase. But she did express regret about the controversy. "I wish we had better anticipated the magnitude and acceleration of the rising financial issues for a growing minority of patients who may have ended up paying the full wholesale acquisition cost price or more," Bresch read from a prepared statement. "We never intended this."…

    Republicans and Democrats alike vented at Bresch. Some members noted that their own families carried EpiPens. But none suggested price caps, price negotiations, or any other potential solution to what they labeled as excess. Instead, most vowed continued support of the free market.(continued)

  22. (continued)Bresch told the committee that Mylan was not unduly profiting from EpiPen sales. After subtracting rebates to insurers, government agencies, and pharmacy benefit managers, as well as the cost of producing and marketing the EpiPen, the company only makes $50 per pen in profit, she said.

    Members questioned her math. "Your numbers just don't add up," said ranking minority member Rep. Elijah Cummings (D-Maryland). "It's some fishy business," said Committee Chairman Jason Chaffetz (R-Utah), who said it seemed like Bresch was not being "honest and candid."

    He and Cummings said they expected fuller answers to their inquiries within 10 days — essentially, by early October…

    Other members said Mylan seemed to be the latest example of drug company excess, specifically mentioning former Turing Pharmaceutical CEO Martin Shkreli and Valeant Pharmaceuticals, both of which had been brought to Capitol Hill to account for exorbitant pricing of their products.

    Noting that Shkreli had invoked the Fifth Amendment in refusing to testify before the committee, Cummings said that Bresch had provided so little information that "you might as well have taken the Fifth, too." He added, "I don't think you have been frank with us."

    Mylan used "a simple but corrupt business model," which involved taking an older, cheap medication and raising the price as high as possible, said Cummings.

    Several members of the committee said that Mylan might be engaging in anticompetitive practices, since EpiPen accounts for 94% of the epinephrine autoinjector market. It's not the first time antitrust concerns have been raised. In August, Sen. Amy Klobuchar (D-Minnesota) asked the Federal Trade Commission to investigate the company's pricing practices.

    Mylan CEO Bresch said that Mylan's plan to introduce an authorized generic version of the EpiPen — announced in late August — should alleviate concerns about pricing and lack of competition, as the generic would list for $300 for two pens.

    House members were not impressed. "That's a crock," said Rep. Buddy Carter (R-Georgia) in response to Bresch's contention that the generic was equivalent to a price cut. "Don't try to convince me that you are doing us a favor here," said Carter, who is a pharmacist. "This is a shell game. That's all it is," he said, adding that Mylan could have reduced the price on the brand name EpiPen, especially because the generic will be identical to the brand name product.

    "Suddenly, feeling the pressure, Mylan has offered a generic version and cut the price in half," said a dubious Chaffetz. "So that does beg the question what was happening with that other $300."

    Undaunted, Bresch, at a different point in the hearing, said the company would also address pricing concerns by introducing an EpiPen with a longer shelf life. The current product expires after 12 months. Mylan will very soon seek FDA approval for an EpiPen that will last 24 months, said Bresch…

    Both Republicans and Democrats also criticized the perks and salaries of Mylan's top executives, with Chaffetz pointing out that five top executives had earned $300 million over the past 5 years. Bresch's $18 million salary in 2015 came under fire as well…

    The House members also asked Bresch about a USA Today article that alleged that her mother, Gayle Manchin, had helped boost EpiPen sales through her position as head of the National Association of State Boards of Education in 2012. Manchin, who is married to Bresch's father, Sen. Joe Manchin (D-West Virginia), reportedly pushed schools to stock autoinjectors — at a time when Bresch was CEO of Mylan and when Mylan dominated the market.

  23. Drugmaker Mylan Inc. swung to a third-quarter loss, mainly due to a big settlement for overcharging the federal government for its controversial EpiPen, the emergency allergy injector whose price Mylan has repeatedly jacked up. The results missed Wall Street expectations, and Mylan reduced its 2016 profit forecast.

    In early October, Mylan said it would pay $465 million to settle allegations that it overbilled Medicaid for years for its life-saving EpiPen. The settlement with the Department of Justice follows news that EpiPen has been incorrectly classified since late 1997 as a generic product under the Medicaid health program for the poor and disabled, rather than as a brand-name drug, which requires rebates to Medicaid nearly twice as high as for generic medicines.

    That charge, other litigation costs and higher spending on marketing, administration and research doubled Mylan’s operating expenses in the latest quarter.

    On Wednesday, Mylan reported a third-quarter loss of $119.8 million, or 23 cents per share, after reporting a $428.6 million profit in the same period a year earlier. Earnings, adjusted for non-recurring costs, came to $1.38 per share, well below the $1.50 per share analysts expected.

    Mylan has become the latest poster child for pharmaceutical industry price-gouging, for hiking the price of a pair of EpiPens from $94 in 2007, when it acquired the product, to $608 this year, despite making no substantive improvement to EpiPens over that stretch. Meanwhile, analysts and others have estimated that it costs less than $10 to produce one EpiPen.

  24. The U.S. Senate Judiciary Committee urged federal antitrust regulators on Monday to launch a probe into whether EpiPen maker Mylan NV broke the law by preventing schools from purchasing competing allergy treatments.

    The bipartisan request to the Federal Trade Commission by Senate Judiciary Chairman Charles Grassley and Ranking Member Patrick Leahy comes just a few weeks before the committee is slated to convene a hearing to scrutinize a pending $465 million settlement that Mylan has said will resolve claims it underpaid rebates to state and federal Medicaid programs.

    "Due to the dramatic increase of the price of drugs across the board, the FTC should be vigilant in its scrutiny of this market," the lawmakers wrote.

    In a statement emailed to Reuters, a Mylan spokeswoman defended the company's 'EpiPen4Schools' program, saying it has no purchase requirement for schools to participate and that it offers schools four free EpiPens per calendar year also without purchase restrictions.

    Previously, schools that wished to purchase additional EpiPens could do so in some cases with a discount and a "limited purchase restriction," but no such restriction remains in place today, she added.

    A spokeswoman for the FTC declined to comment on the letter.

    Mylan has come under fire in recent months by lawmakers for hiking the price of EpiPen to more than $600 for a package of two in less than a decade.

    Last month, it said it had reached a $465 million settlement with the Justice Department to resolve claims it misclassified the EpiPen as a generic drug instead of a branded one, thereby underpaying rebates for Medicaid.

    The Justice Department has yet to publicly acknowledge the settlement, which will be discussed at the Nov. 30 hearing.

    Also on Monday, three members of the Senate Judiciary Committee asked the company when it plans to reimburse the Department of Defense for any overcharging on EpiPen.

    Separately, the West Virginia Attorney General's Office is investigating Mylan over antitrust concerns and the rebates, while the New York Attorney General is scrutinizing Mylan's contracts with schools for the EpiPen for possible violations of state antitrust laws.

    Courtesy of:

  25. The United States has joined the list of countries covered by a voluntary recall of EpiPen auto-injectors for anaphylactic shock on account of a defective part that may result in the device failing to inject a potentially life-saving dose of epinephrine, the US Food and Drug Administration (FDA) announced today.

    Mylan, the company that markets the device, announced earlier this month that it was recalling one lot of roughly 80,000 EpiPens in Australia, Europe, Japan, and New Zealand. It reported two instances of the device failing to deliver its dose. The patients in question, however, were treated successfully with backup, functioning EpiPens.

    Pressing the EpiPen into a person's thigh — the prescribed area for administration — causes a needle to penetrate skin and inject epinephrine into muscle. The defective part may require a person to use increased force to activate the needle, or it may prevent the EpiPen from working at all, according to Mylan.

    The company announced today that it was expanding the recall not only to the United States, but also other markets in North America and South America.

    In the United States, the recall applies to 13 lots of both EpiPen and EpiPen Jr. auto-injectors distributed between December 17, 2015, and July 1, 2016. Patients can receive another EpiPen or an authorized generic version at their pharmacy, Mylan said. In the meantime, they should continue to carry and use their current EpiPen until they acquire a replacement.