In order to continue collecting such fees, the FDA is required to meet certain performance benchmarks, primarily related to the speed of certain activities within the NDA review process.

The move towards imposing user fees to pay for the regulatory review of new medicines was the result of dissatisfaction among consumers, industry, and the FDA.

The FDA argued that it needed additional staff to end its back-log of drugs awaiting approval for market.

For decades the FDA had asked for permission to implement user fees and the pharmaceutical industry generally opposed them, fearing that the funds would not be used to speed drug review.

The 1992 law became possible when the FDA and industry agreed on setting target completion times for reviews and the promise these fees would supplement federal appropriations instead of replacing them.

The activists won a major victory in 1989, when Burroughs Wellcome implemented a 20% price cut on AZT, then still the only treatment for HIV.

AIDS activists expressed their anger by trashing booths at medical conventions and continuing vocal public protests.

By August 1991, relations had warmed up so much that ACT-UP founder Larry Kramer wrote Bristol-Myers Squibb chief Richard Gelb a letter of congratulations on the imminent approval of Videx.

The law provided exemptions and waivers for applications from small businesses, drugs aimed at orphan diseases, or unmet public health needs.

[7] In order to avoid listing specific performance goals in statutory language Congress stated in the bill’s “Findings” that, "3) the fees authorized by this title will be dedicated toward expediting the review of human drug applications as set forth in the goals identified in the letters of September 14, 1992, and September 21, 1992, from the Commissioner of Food and Drugs to the Chairman of the Energy and Commerce Committee of the House of Representatives and the Chairman of the Labor and Human Resources Committee of the Senate, as set forth at 138 Cong.

[7] When Congress was debating the legislation that implemented PDUFA II Rep. Billy Tauzin, who later became head of PhRMA and one of those leading the call for a further streamlined review process, told a story of how a family friend had to travel to Mexico to obtain drugs that helped him overcome prostate cancer.

"[8] In testimony before Congress, James Swire, an AIDS activist and health educator who became infected with HIV in 1990, said the FDA has dramatically reduced the time needed to approve life-saving drugs using the money from PDUFA.

"[8] PDUFA III, part of the Public Health and Bioterrorism Preparedness Act, made appropriations for increased postmarket monitoring of new products and allowed the FDA to hire additional personnel to speed the reviews of new drugs.

The drug industry claimed that the FDA misinterpreted the section of PDUFA III authorizing user fees when deciding to charge for reviewing 505(b)(2) applications.

The Pharmaceutical Research and Manufacturers of America (PhRMA) strongly supported reauthorization of PDUFA, saying at the time that “PDUFA V can play a critical role in making more life-saving medicines available to patients in a timely manner, strengthening the scientific base of the FDA and providing a steady, reliable stream of resources for Agency scientists.

Kessler said the FDA achieved similar positive results with other PDUFA goals, including in its review time for efficacy supplements (requests to add a new indication or a new group of patients to an already approved drug), submissions for manufacturing supplements (for making significant changes in the way a drug is made or using a new manufacturing facility) and resubmissions (responses provided to questions or alleged deficiencies raised by the FDA).

[20] From 1993 through 1996, the years PDUFA I was in effect, the approval time for new drugs declined significantly while the number of new products increased.

[21] According to the Pharmaceutical Research and Manufacturers of America drug review time was cut roughly in half after the passage of PDUFA I.

[23] David Kessler described improved communication between the FDA and the drug industry on what data should be included in NDAs as an important benefit of PDUFA.

[19] User fees imposed under PDUFA are expected to add $707 million to the FDA budget in 2011, roughly a quarter of the agency's total spending.