A lack of reliable, timely and easy-to-access data is restricting the FDA's ability to stay on top of safety issues that it commits to tracking following expedited approval of new drugs, according to a report published by the Government Accountability Office that examined both fast track and breakthrough designations.
The NIH said it will fund a set of genome sequencing and analysis centers to focus on understanding the genomic bases of common and rare human diseases. The National Human Genome Research Institute (NHGRI) launched the Centers for Common Disease Genomics (CCDG), which will use genome sequencing to explore the genomic contributions to common diseases such as heart disease, diabetes, stroke and autism, and also announced the next phase of a complementary program, the Centers for Mendelian Genomics (CMG), which will continue investigating the genomic underpinnings of rare, typically inherited diseases such as cystic fibrosis and muscular dystrophy. Pending the availability of funds, NHGRI will fund the CCDG and CMG programs for roughly $240 million and $40 million, respectively, over four years.
Claiming a victory of sorts, the Federal Trade Commission (FTC) pointed to a sizeable reduction in the number of pay-for-delay settlements between brand and generic drug companies following the 2013 Supreme Court ruling that exposed such settlements to antitrust challenges. Out of 160 final drug patent settlements in fiscal 2014 – the first full year following the court's 5-3 decision in FTC v. Actavis Inc. – the FTC flagged 21, or 13 percent, as potential pay-for-delay agreements because they included both explicit compensation from the brand manufacturer to the generic firm and a restriction on when the generic could be marketed. That's about half the number identified in fiscal 2012, which hit a record of 40 potential reverse-payment settlements out of a total of 145 final settlements, the commission said in a report.