Senate Judiciary Committee Votes to Advance CREATES Act

The Senate Judiciary Committee today voted 16 to 5 to report the Creating and Restoring Equal Access to Equivalent Samples Act (CREATES Act) to the Senate floor.

Under the CREATES Act, a generic or biosimilar developer can bring a civil action against an innovator drug company if it refuses to make available enough samples of a product for testing. It also allows the FDA to approve alternative Risk Evaluation and Mitigation Strategy (REMS) programs if a generic or biosimilar developer and the innovator company are unable to arrive at a single shared system.

The legislation, sponsored by Senator Patrick Leahy, D-Vermont, was first introduced in a different version in 2016 and, since then, has enjoyed broad bipartisan support. However, the bill languished without a vote as it faced opposition from pharmaceutical companies; The Hill reported in April 2018 that the Pharmaceutical Research and Manufacturers of America spent approximately $10 million on lobbying efforts—including efforts to halt progress of the CREATES Act—in the first quarter of this year.

Among the most vocal supporters of the bill is former Representative Henry Waxman, D-California, who co-sponsored (with Senator Orrin Hatch, R-Utah) the legal foundation for the US generics drug market: The Drug Price Competition and Patent Term Restoration Act of 1984, referred to colloquially as “Hatch-Waxman.”

Despite Waxman’s support, however, 1 of the 5 senators to vote against reporting the CREATES Act to the floor was Hatch; before the vote, Hatch noted that he has a “…keen interest in ensuring that we have a well-functioning generics industry,” and added that, while the CREATES Act has a “laudable goal,” its monetary caps on damages that generic and biosimilar development companies can seek are, in his view, high enough to incentivize “nonmeritorious litigation.”

Hatch added that he will be sponsoring an amendment to the bill designed to limit the challenges that generic and biosimilar developers can bring against innovator product sponsors. His amendment would force a challenger to choose between bringing a Hatch-Waxman suit or seeking an inter partes review proceeding; a company could not pursue both avenues to challenge a drug patent. The provisions of the amendment would also apply to post-grant review proceedings and to biosimilar litigation, he said.