Speeding Generic Approvals Gaining Support in FDA, Congress

FDA Commissioner Scott Gottlieb invited public comments about how his agency approves generic drugs in a public hearing set for July 18. In a blog post, Gottlieb said that he is aware that FDA regulations sometimes have led to delays in generic drug approvals and that his agency is looking at how the rules are “used and, in some cases, misused.”  The public meeting will address these issues.

Meanwhile, Senate Judiciary Committee Chairman Chuck Grassley (R-IA) sent a letter to Gottlieb urging the FDA to consider two bills he has sponsored to improve access to generics.  The first bill, S.974, would reform the REMS program by giving generic drug makers more access to samples of brand name drugs for testing. Gottlieb and others have suggested that the REMS program is being misused by brand drug makers to delay generic competition.

The other bill, S.124, would place limits on “pay-for-delay” lawsuits in which generic manufacturers agree to not compete with brand-name drugs for an agreed upon period (S.124).