Congress is moving quickly on FDA bill

Congress is quickly moving ahead on a must-pass Food and Drug Administration bill, and so far, negotiators have been able to avert any major controversies.
The House Energy and Commerce Committee’s Health Subcommittee is set to mark up its FDA bill Tuesday, and lawmakers are hoping to convene a full-committee markup just two days later.

Congress has until Sept. 31 — the end of the fiscal year — to reauthorize the user fees that the FDA collects from drug and medical device companies. The fees have to be renewed every five years, and the reauthorization usually becomes a vehicle for broader policy changes.
Energy and Commerce Republicans released their bill Friday, and seemed to steer clear of the biggest potential fault lines — such as proposals to alter the FDA’s core mission.
Steven Grossman, a regulatory consultant who writes a regular update called “FDA Matters,” said the negotiations have gone smoothly and lawmakers don’t seem dramatically far apart on most provisions.
“Right now I feel like they’re working pretty hard and staying within the channels of reasonable people disagreeing,” Grossman said.
The pharmaceutical industry’s leading trade group, the Pharmaceutical Research and Manufacturers of America (PhRMA), was still reviewing the Energy and Commerce proposals Monday, but a PhRMA official said the process has gone “really smoothly” so far.
Industry always pushes for a timely reauthorization, and the official said the pressures of election-year politics also helped build consensus for a quick, bipartisan process on the FDA bill.
The agency would lose a big chunk of important funding if the fees were allowed to run out, and pushing the debate down to the wire triggers layoff notices that the FDA would rather avoid sending, even though employees know they’ll ultimately be safe.
Industry, consumer groups and the FDA try to reach an agreement on certain provisions before Congress begins its work, and the PhRMA official said those talks helped get potential sticking points out of the way early.
Stakeholders were able to reach agreement on several issues that have been controversial in the past, including a new user fee for the companies that make generic drugs. Both the House and Senate bills include the new fee, and they also seek to fill in more details about fees that were authorized in President Obama’s healthcare law.
The Senate bill would add another 60 days to the FDA’s review process for new drugs, but the PhRMA official said the change will ultimately help prevent much longer delays that often come toward the end of the FDA’s reviews, just as companies are preparing to start marketing a new product.