Ever since the Food and Drug Administration Amendments Act (FDAAA) of 2007 required the FDA to tighten its rules for reviewing drugs through the ability to require post-marketing studies and additional clinical trials to address drug safety, biotech and pharma firms have complained that the agency needs to speed up its review of new medicines. Yet a legislative attempt to do just that has been squashed by a squabble between biotechnology and pharmaceutical companies over the need for reform, Bloomberg reports.
At issue is the Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) bill. The measure was drafted by Sen. Kay Hagan (D-NC) in collaboration with the Biotechnology Industry Organization (BIO).
According to a draft made public last year and reported on by several news outlets, TREAT would have allowed the review of new drugs under two new FDA approval pathways—progressive or exceptional—if they were designed to provide meaningful advances in the treatment of an unmet, serious or life-threatening condition. Drugs undergoing these accelerated reviews would be cleared based on any testing showing efficacy, including biomarker tests, early trial results, and interim data.
Smaller companies, mostly biotechs, endorsed TREAT, while pharma giants like GlaxoSmithKline and Pfizer mostly opposed. “It was very clear by creating a new track we were going to engender so much anxiety and suspicion up front that we were going to never get to the meat of the proposal,” Ron Cohen, CEO of Acorda Therapeutics, told Bloomberg. GSK confirmed its disagreement with TREAT, while Pfizer and a Hagan spokeswoman would not comment.
Another Bloomberg source offered a plausible explanation for the divide: The faster drug reviews take, the less that smaller biotechs need funding for research and trials from big pharma, according to Richard (Erik) M. Gordon, clinical assistant professor at the University of Michigan’s Ross School of Business. While big pharma has been more willing to undertake those partnerships rather than spend more for in-house R&D, it has come at a price to the biotechs, namely a cut of their sales.
Jim Greenwood, BIO’s president and CEO, told Bloomberg that Hagan is working on a compromise version of TREAT that would expand FDA’s existing accelerated-approval program for cancer and HIV drugs to include other medicines for fatal diseases or diseases with few or no treatment options. The rewritten bill, expected to be introduced later this year, would expand how companies can demonstrate to FDA the safety and efficacy of new treatments.
But with a major drug bill already before Congress, the fate of TREAT may be less in standing alone than in being incorporated into the fifth authorization of the Prescription Drug User Fees Act (PDUFA V), the subject of a House of Representatives subcommittee hearing on Tuesday. After all, BIO and its pharma industry counterpart, the Pharmaceutical Research and Manufacturers of America (PhRMA), spent close to a year in talks with FDA to hammer out PDUFA V. And a TREAT measure rewritten to incorporate big pharma concerns should likely pass enough muster with PhRMA to end up being folded seamlessly into the drug user fee measure, for approval by Congress later this year.