August 30, 2016 - Bill of Health

By Rachel Sachs

For weeks now, the list price of Mylan’s EpiPen ($600 for a two-pack) has been exhaustively covered by journalists, debated by academics, and skewered by policymakers as an example of the pricing excesses of even generic pharmaceutical companies. Mylan’s latest response to the outrage? Announce that soon, it will be launching a generic EpiPen at a list price of $300 for a two-pack. I and others who study these issues full time cannot understand why Mylan thought this would work to quell the widespread indignation over its pricing practices.

The first red flag came when Mylan stated it would launch the product “in several weeks.” I often find myself defending the FDA against charges that it is too slow to approve new technologies, but let’s face it: it would be shocking news if they were able to approve a new version of anything in just a few weeks. Mylan has not had this in the works for months, so it seems that the new generic product is literally identical to the branded EpiPen – just with a different label. So, essentially, Mylan is preparing to cut the price of its product in half. (Even though that’s still higher than the price was just three years ago, before Mylan began its regular price hikes, and even though this should make us question their justifications for the $600 price.) Great, right? Not so fast.

What reasons (other than public relations) might Mylan have for introducing an authorized generic of this type and how might they attempt to use the two products to maintain their current level of revenues? By bringing the first generic EpiPen to market, Mylan has now planted its flag in the generics space. Although epinephrine (the drug inside the EpiPen) is now generic and cheap to produce and sell, companies do seem to find it difficult to replicate the device portion of the EpiPen, with Sanofi’s product recently removed from the market due to dosing issues and Teva’s application for a generic denied by the FDA with no public explanation just a few months ago. Mylan has now benchmarked a new price for those products if they return – they must price below $300 for a two-pack to compete effectively with Mylan. Read More

By Nicolas Terry and Frank Pasquale

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Our guest this week is Ameet Sarpatwari, an Instructor in Medicine at Harvard Medical School and an Associate Epidemiologist at Brigham and Women’s Hospital based in the Program On Regulation, Therapeutics, And Law (PORTAL) within the Division of Pharmacoepidemiology and Pharmacoeconomics. Ameet’s research focuses on the effects of laws and regulations on therapeutic development, approval, use, and related public health outcomes. He is currently examining the public health implications of variation in state drug product selection laws, the risk of re-identification under HIPAA pathways for data sharing for post-approval drug research, and the comparative safety and effectiveness of biosimilars.In the lightning round, Nic addressed the Notice Act and ongoing controversy over hospitals’ use of “observation status” to dodge readmissions penalties and game reimbursements. We also mentioned the strange politics of bill naming. (One also wonders what exactly vulnerable patients are supposed to do once they receive notice that they could soon be hit by huge bills.)

Nic also covered the FTC’s reversal of an ALJ’s judgment in LabMD, the case that keeps on giving. Frank riffed on an article “Medicaid Expansion’s New Cost Estimate Isn’t Alarming,” from the CBPP, and expressed some skepticism as to the degree to which episode payment models would assure better pay for hospital care.

Our conversation with Ameet focused on his many articles on counter-detailing, medical research ethics, the opioid crisis, and large firms’ misues of the FDA’s regulatory system. Links to all are available at his website.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw