The Food and Drug Administration has agreed to work toward faster, more predictable reviews of new prescription drugs in return for hundreds of millions of dollars in continuing fees from drugmakers, under a draft agreement unveiled by the agency.
FDA, drugmakers agree to extend user-fee plan
The deal comes after months of closed-door meetings between FDA and drug industry officials working to extend a 2-decade-old program that supplements the agency's budget with company fees. The latest agreement would require the FDA to provide more frequent updates on the status of certain drug reviews.
The deal must be approved and drafted into law by Congress before it expires on Oct. 1, 2012. Lawmakers already have granted three 5-year extensions to the program. Since it passed in 1992, the Prescription Drug User Fee Act has allowed the FDA to hire hundreds of additional scientists in return for meeting certain performance goals.
Last fiscal year, the FDA collected $573 million in user fees under the program, making up 62% of its total budget for prescription drug reviews. The portion of FDA's budget underwritten by industry has steadily increased since 1992, drawing criticism from consumer advocates that the agency has become financially dependent on the companies it regulates. Ten years ago the industry contributed about 49% of FDA's drug review budget.
The increased private funding also has become a point of concern for some companies, which worry they could be asked to pay even more in fees if Congress cuts federal spending.
The Biotechnology Industry Organization endorsed the plan in a statement Thursday but stressed that Congress should continue funding the FDA at current levels.
Financial details of the latest version of the agreement were not released, but it would require FDA to provide more meetings and updates to companies that have submitted first-of-a-kind drugs for review.
Separate but similar talks between the FDA and medical device makers are dragging out over a number of disagreements. Those companies have made shorter review times a priority, though the FDA says that goal will require significantly more funding, according to minutes from a recent meeting. The FDA is hoping to reach an agreement in a few weeks, though “industry indicated it was more important to ‘get it right' than to be finished by a certain date,” according to the minutes.
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