By Blair Childs, Senior Vice President of Public Affairs, Premier
Members of the Premier alliance commend House Judiciary Subcommittee Chairman Tom Marino (R-PA) and Ranking member David Cicilline (D-RI on Regulatory Reform, Commercial and Antitrust law for exploring the issues associated with drug makers blocking generic drug competition in the market.
As we noted in our drug policy roadmap, some manufacturers to exploit FDA Risk Evaluation and Mitigation Strategy (REMS) rules by creating narrowed distribution networks that refuse product sales to generic and biosimilar competitors. This prevents them from conducting bioequivalence testing. Since these tests are required for FDA approval, the practice has the net effect of extending patents and denying patients access to more affordable generic alternatives, adding $5.4 billion in unnecessary costs to the healthcare system.
To address this issue, members of Premier strongly support enactment of the CREATES Act, which would put a stop to this anti-competitive behavior. The bill expressly prohibits branded manufactures from blocking generic and biosimilar competitors from accessing samples. In closing this loophole, the legislation will give generic drug makers a clear pathway for market entry and unleash competitive forces that are truly needed to create a healthy marketplace for pharmaceuticals.
-By Blair Childs, Senior Vice President of Public Affairs, Premier