Finally, Generic Competition—and Lower Prices—for EpiPen

FDA acts on a key FREOPP recommendation for lowering the price of unaffordable prescription drugs.
August 23, 2018
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In my FREOPP paper on prescription drug price reform, The Competition Prescription, I highlighted a key barrier to affordable prescription drug prices: federal laws and regulations that preclude competition for drugs whose patents have long expired.

Off-patent drugs with specialized delivery devices. A third category of off-patent drugs with high prices are generic drugs delivered via specialized, and often patented, devices.

In 2005, the FDA announced it would ban the use of chlorofluorocarbons in asthma inhalers. Though the underlying medicines most common to treat asthma have long been off-patent, the requirement for new CFC-free inhalers led to the long extension of market monopolies for companies like GlaxoSmithKline, which created a proprietary inhaler for Advair, its combination of two off-patent drugs: fluticasone and salmeterol. FDA regulations have made it effectively impossible for generic manufacturers to prove bioequivalence to products like Advair without violating the branded company’s intellectual property. In 2017 alone, the FDA has rejected attempts by Mylan, Hikma, and Vectura to develop generic versions of Advair.

In 2016, Mylan attracted controversy for raising the price of its EpiPens, which deliver epinephrine in the event of a life-threatening allergic attack called anaphylaxis, from $100 to $600 per pen. Epinephrine, also known as adrenaline, was first isolated in 1901, and has long been off-patent. But Mylan’s autoinjector has been approved by the FDA specifically for treatment of anaphylaxis, and the agency has made it extremely difficult for would-be competitors to gain approval for similar devices.

On August 16, FDA Commissioner Scott Gottlieb announced that the FDA had approved the first generic version of EpiPen. In my latest post for Forbes, I talk about this important development, and the value of Congressional action in making clear that the FDA should approve complex generics where there is therapeutic equivalence, even if the delivery devices aren’t identical.

The best way to fix this problem is for Congress to amend the Food, Drug, and Cosmetic Act to include a new generic pathway for complex drugs that are either complex because of their composition (comprising a heterogeneous mixture of many compounds) or their mode of delivery.

But, fortunately, we don’t have to wait for Congress to act. The FDA already has the legal authority to approve complex generics, and Commissioner Scott Gottlieb has made this one of his top priorities. “We remain committed to doing our part to provide scientific and regulatory clarity for sponsors seeking to develop complex generics,” he said in a statement, “as well as prioritize the approval of medicines with little or no generic competition as part of our overarching effort to remove barriers to generic development and market entry of critically important medicines.”

Part of a broader reform package

Gottlieb’s efforts are part of a broader effort by the Trump administration to lower drug prices through competition. In just over three months since the administration launched its drug price reform plan, it has made incremental but meaningful progress on several key issues, in particular by issuing or proposing reforms of outdated regulations.

More here.

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