One of the most difficult legal issues today involves settlements by which brand-name drug companies pay generic firms to delay entering the market. Such conduct requires courts to consider not only patent and antitrust law, but also the Hatch-Waxman Act, the complex regime governing behavior in...

The Supreme Court's decision in FTC v. Actavis has received widespread attention for its antitrust analysis of settlements by which brand-name drug companies pay generics to delay entering the market. Much of the attention has focused on the continued enforcement of these “reverse payment”...

The generic industry lobby, Association for Accessible Medicines (“AAM”), often represents the public interest. In the pharmaceutical industry, it challenges brand drug companies' anti-competitive conduct. It fights for lower prices for consumers. And it has built up goodwill for its work in...

As part of the FDA's hearing on "The Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access," I offer testimony that does two things.First, it shows how the balance has tilted away from generic access, pointing as examples to settlements, product hopping, REMS patents, and...

Two principles collide in the pharmaceutical industry. On the one hand, the U.S. Food and Drug Administration (“FDA”) approves potentially dangerous drugs under Risk Evaluation and Mitigation Strategies (“REMS”) programs when a drug's benefits outweigh its risks. But on the other hand,...

Rising drug prices are in the news. By increasing price, drug companies have placed vital, even life-saving, medicines out of the reach of consumers. In a recent development, brand firms have prevented generics even from entering the market. The ruse for this strategy involves risk-management...

One of the tools brand-name drug companies have used to delay generics involves the filing of questionable citizen petitions with the FDA. This short comment applauds the agency for addressing this pressing issue and offers modifications that would make the proposed guidance stronger.The FDA can...

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...