The CREATES Act (Creating and Restoring Equal Access to Equivalent Samples Act), currently pending in Congress states as its aim to promote drug price competition by removing an impediment to the development and approval of lower cost generics or biosimilars.
Currently some branded companies are using safety requirements, including restricted distribution programs and REMS requirements, as a pretext for refusing to sell samples of their brand-name products to companies interested in developing generic and biosimilar products. As a consequence, some generic drug manufacturers have complained about the inability to obtain branded product samples required to prove bioequivalence. In practice, this means that drugs subject to a REMS restriction may be inaccessible to the generic companies, even after the patents covering the product have expired. For example, the FDA reported last year that in 2016 FDA received more than 150 inquiries from generic companies complaining they could not obtain samples of a branded drug for bioequivalence testing. The CREATES Act was introduced to address this issue.
Many generic drug and biosimilar manufacturers have come out in favor of this legislation, “if they say no, we can’t move forward,” said Bruce A. Leicher, senior vice president and general counsel at Momenta Pharmaceuticals, “it’s a perfect way to block development of competitive, affordable products.” Major drug industry trade groups, however, continue to lobby Congress to block the CREATES Act, asserting that safety issues are a key concern in the generic products space. The Massachusetts Biotechnology Council, representing one of the biggest industries in the Bay State, is one such group opposed to the proposed law. They believe the CREATES Act “is an unnecessary solution to a problem that doesn’t exist . . . [and they do not] support the creation of legislation that will penalize the original innovators of lifesaving therapies and do little to benefit patients,” according to MassBio’s chief executive Robert Coughlin.