The Senate Judiciary Committee approved legislation on Thursday to limit the ability of branded pharmaceutical companies to block generic companies from accessing drug samples through REMS. But the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act could face an uphill battle to get a full Senate vote as the legislation is opposed by several high profile members of the chamber.
If passed, the legislation would allow generic companies to file a civil complaint against branded companies abusing REMS to block potential competitors.
In May, FDA published a list of companies that were accused by generics drugmakers of denying access to samples necessary to run tests required for regulatory approval. The list included 31 complaints against Celgene Corp. (NASDAQ:CELG).
In a statement issued Thursday, Celgene said, “The CREATES Act as currently written would undermine efforts to develop lifesaving medicines and would risk patient safety.” It added that the company supports finding a way forward on legislation that ensured patient safety and “reasonable liability safeguards.”
The bill, S. 974, was reported to the Senate floor with a bipartisan 16-5 approval, but no date has been set for a vote. The five against were Republicans Orrin Hatch (Utah), Ben Sasse (Nev.), Mike Crapo (Idaho), Thom Tillis (N.C.) and Jeff Flake (Ariz.).
In April, a House version of the legislation was introduced and was referred to both the Committee on the Judiciary and the Energy and Commerce Committee's subcommittee on health.
The Congressional Budget Office has estimated generic competition spurred by the CREATES Act would save the government $3.8 billion over 10 years, making the legislation a potential bargaining chip as an offset for future legislation with substantial costs attached.
In March, the CREATES Act was removed from a must pass omnibus budget bill despite bipartisan support and alignment with President Donald Trump's priorities (see BioCentury Extra, March 7).