Senate Votes on Healthcare While House Schedules Hearing on FDA Approvals

On Tuesday, the Senate held a procedural vote that will allow a debate over healthcare reform to proceed. The vote came after Senator John McCain (R-Arizona) returned to the Capitol, despite his recent diagnosis of brain cancer, to vote in favor of advancing the bill. Two Republicans, Lisa Murkowski (Alaska) and Susan Collins (Maine) joined Democrats in voting no on the motion to proceed. Republican Senators Shelley Moore Capito (West Virginia), Rand Paul (Kentucky), and Dean Heller (Nevada) had previously expressed reservations about the bill, but voted in favor of advancing the bill to a debate.

Today’s vote allows the Senate to begin amending the narrowly passed House version of the healthcare bill, which is widely expected to emerge as a “skinny repeal” of the Affordable Care Act (ACA), which would make fewer changes to existing law than would the House version of the proposed legislation. Senator McCain, speaking after the vote, said that such a bill would be “imperfect,” but that it “might provide workable solutions to problems that Americans are struggling with today.”

While all eyes have been on the Senate, the House has been quietly preparing to address another key issue affecting healthcare; on Thursday, the House of Representatives Judiciary Committee will hold a hearing titled “Antitrust Concerns and the FDA Approval Process.” The hearing, which will be conducted by the Judiciary’s Subcommittee on Regulatory Reform, Commercial, and Antitrust Law, is expected to deal with proposed legislation to facilitate the development of generics and biosimilars. Inside Health Policy reports that a source familiar with the scheduled hearing expects the proceedings to deal with the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act.

The CREATES Act, which has bipartisan support, would provide access to equivalent samples for testing by biosimilar and generics manufacturers, and would facilitate judicial review in lawsuits concerning innovators’ improper withholding of samples from competitors. The text of the act cites risk evaluation and mitigation strategies (REMS) as both an essential feature of the development of generics and biosimilars and also a potential avenue for abuse by innovators seeking to stifle competition, which the bill calls “contrary to the policy of the United States to promote competition in the market for drugs and biological products.”

Slated to testify at Thursday’s hearing is Scott Gottlieb, MD, commissioner of the FDA. At last week’s public meeting on the Hatch-Waxman Amendments, Gottlieb heard from a variety of stakeholders who criticized the ability of innovators to use REMS to block competitors from obtaining samples. Gottlieb himself has said that he seeks to address concerns surrounding dubious uses of REMS, noting that “some branded companies may be using the statutory default requirement to have a single shared REMS across both the branded and generic versions of a drug as a way to block generic entry. They might prolong negotiations with the generic firms over the implementation of these single shared systems, which could delay the entry of safe and effective generic drugs onto the market.”