FDA may be allowed an extra 2 months to review new drugs

By Dr. Ananya Mandal, MDSep 2 2011

The deadline for approval or rejection of new drugs by the Food and Drug Administration (FDA) could be extended by two months say U.S. regulators and drug industry officials.

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

Drugmakers such as Pfizer Inc. and Eli Lilly & Co. also agreed with regulators on a 6 percent increase in review fees as part of reauthorizing the drug-approval process through fiscal 2017. The increase is expected to add $40.4 million to user-fee revenue in fiscal 2012, bringing the fiscal 2013 total to $712.8 million, Karen Riley, a spokeswoman for the FDA, said. The agency in turn will have to meet with companies in the midst of reviews to raise concerns and ensure that evaluations are carried out in a timely way.

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 agreement “should allow more timely access to safe and effective new medicines,” said David Wheadon, senior vice president for scientific and regulatory affairs at lobbying group the Pharmaceutical Research and Manufacturers of America, in a statement.

Drug safety also will be strengthened through standardization of the requirements for risk strategies the FDA mandates of some medicines and support for the use of an online drug safety tracking system to assess post-market risks, Wheadon said.

Jim Greenwood, president of the Biotechnology Industry Organization, a lobbying group in Washington for biologic drugmakers, said in a statement the agreement “would restore FDA's review performance.”