This short comment offers five proposals that could encourage a more robust market for biosimilars, targeting REMS denials, non-REMS denials, citizen petitions, and disparagement, and discussing coordination with the FTC

My testimony to the Health Subcommittee of the House Energy & Commerce Committee supports legislation being considered to lower high drug prices.First, I support the CREATES Act and FAST Generics Act, which would ensure that generic companies receive the samples they need to enter the...

The antitrust analysis of product hopping is nuanced. The conduct, which consists of a drug company's reformulation of its product and encouragement of doctors to switch prescriptions to the reformulated product, sits at the intersection of antitrust law, patent law, the Hatch-Waxman Act, and...

In FTC v. Actavis, the Supreme Court held that settlements by which brand drug firms pay generics to delay entering the market could violate antitrust law. In the period since the decision, the lower courts have made clear that “payment” extends beyond cash to encompass non-cash forms of...

Brand firms have delayed generic competition even when there are no (or weak) patents. This testimony to the FTC highlights 6 such behaviors: (1) pay-for-delay settlements, (2) product hopping, (3) citizen petitions, (4) "REMS" restrictions, (5) non-REMS distribution restrictions, and (6)...

As CEO of Turing Pharmaceuticals, Martin Shkreli made worldwide headlines by obtaining marketing rights to pyrimethamine (Daraprim) and quickly increasing the price 5000 percent, from $13.50 to $750 per pill. In addition to increasing price, Turing initiated another less widely appreciated move...

Drug prices are in the news. “Pharma Bro” Martin Shkreli increased the price of Daraprim, a treatment for fatal parasitic infections, by 5000%. Mylan found itself on the hot seat for raising the price of the anaphylaxis-treating EpiPen 15 times in 7 years, resulting in a 400% increase to...

FTC v. Actavis was a landmark antitrust decision. In rejecting the “scope of the patent” test that had immunized settlements by which brand-name drug firms pay generic companies to delay entering the market (“exclusion payment settlements”), the Supreme Court made clear that such...

A lot changed between 2008 and 2015. Lindsay McSweeney's stewardship cemented the importance of CPI Antitrust Chronicle. Standard-essential patents, the smartphone patent wars, and patent trolls thrust themselves onto the IP/antitrust scene. But perhaps the most significant change is the...