FDA may get two more months to review new drugs

U.S. regulators and the drug industry want to extend by two months the deadline for the Food and Drug Administration to approve or reject new drugs.

The extended timeline was tucked into the proposed deal the FDA forged with the prescription drug industry on the fees companies pay for drug reviews. The FDA posted the proposal on its website on Thursday.

The FDA said it would need an extra 60-day “filing date” before the clock starts ticking on its 10-month deadline to review new drugs, or six months for a priority review.

The new five-year agreement, which will be put out for public comment, comes as the FDA faces increased criticism from congressional Republicans and the industry for being too slow in approving new products, which they say stifles innovation and job creation.

“People are kind of scratching their heads” over the longer review time, said an industry source familiar with the negotiations on the user fees.

“But the idea is that FDA will use those two months to really prepare for the review ... so the hope is that it gives us more predictability and makes everything shorter in the long-run.”

The Prescription Drug User Fee Act (PDUFA), first enacted in 1992, gives the FDA millions of dollars annually to review new products for the U.S. market in exchange for quicker approvals and other promises.

Congress must reauthorize the current PDUFA legislation before it expires in September 2012. The FDA’s new fee agreement with industry, which would kick in at the beginning of 2013, would be part of the reauthorization legislation .

MORE FEE FLEXIBILITY

The fees system is controversial, with some critics contending they influence the FDA, which is supposed to protect the health and safety of consumers.

Currently, about a third of the agency’s funding comes from makers of drugs and medical devices—and that could grow if the FDA reaches a final agreement with generic drugmakers.

In 2010, the FDA collected $922 million in user fees out of a total budget of about $3.28 billion. The agreement with the prescription drug industry would increase user fees 6 percent over levels in 2012 for an estimated total of about $713 million in 2013, FDA Commissioner Margaret Hamburg said in Congressional testimony in late July.

The FDA also wants more flexibility on how it spends the money. Some of the fees will go toward drug safety, rare diseases and for training FDA staff in new technologies and science—part of a broader push to improve the agency’s scientific expertise.

“If you look at the original PDUFA, all of that went directly to just review processes,” said Ryan Hohman, the director for communications and policy at Friends of Cancer Research, a think-tank and advocacy group.

“But the FDA and industry stepped back and recognized that in the economic environment, they need to have the increase in science or else they won’t be able to approve these drugs at a speedy time for patients.”

The FDA must still agree on the specifics of its user-fee program with the medical device industry, which started paying fees in 2002. It is also planning a new fee program with makers of generic drugs and ‘biosimilars’—copycat versions of brand-name biotech drugs.

###

By Anna Yukhananov

WASHINGTON