On September 22, 1992, the US Congress passed H.R.5952, the Prescription Drug User Fee Act (PDUFA), which was signed into law October 29, 1992. This Act allowed the pharmaceutical sponsor to “fund the US Food and Drug Administration (FDA) directly through “user fees” intended to support the cost of swiftly reviewing drug applications. With the Act, the FDA moved from a fully taxpayer funded entity to one supplemented by industry money. The PDUFA fees collected have increased 30 fold—from around $29m in 1993 to $884m in 2016.” PDUFA fee schedule is renewed every five years. [1, 2, 3]
New drugs have patents, which have a time limit before they expire, and research and development (R&D) costs cannot be recouped until a product gains regulatory approval. The FDA estimated a 30 day delay could cost the drug sponsor $10 million, and the regulator already had a backlog of drugs awaiting approval. A faster regulatory process was argued to be in the interest of the manufactures (lower cost to market), the regulator (fund more staff) and consumers (life saving drugs!). [1]
Spurred on by the AIDS and Cancer epidemics a presidential advisory panel on drug approval reported on August 16, 1990 that it “estimated that thousands of lives were lost each year due to delays in approval” and suggested it “should speed up approval of experimental AIDS and cancer drugs by requiring less evidence of the drugs’ effectiveness before they are put on the market”. [4, 5]
The regualtory staff are effectively hired by the pharmaceutical company to appove and market their products.
Between 1993 and 2003 the median approval time for priority New Drug Applications (NDA) and Biologics License Applications (BLA) decreased by over half — from 13.2 months to 6.4 months respectively, and standard approvals by one third from 22.1 months to 13.8 months. They increased efficiencies “while holding to the same high standard of evidence for drug safety and effectiveness”. PDUFA funding enabled increased review staff numbers to increase FDA-sponsor interactions for scientific and regulatory consultation at a number of critical milestones through-out drug development prior to submission (fig 3.1). [6]
On December 7, 1995 the FDA approved Roche Laboratories’ saquinavir, the first of a new category of drugs called protease inhibitors designed to prevent the HIV virus from replicating, in combination with older nucleoside analogue medications such as AZT, it took the FDA only 97 days after the agency received the marketing application to grant the red light. [5]
In June 2020 the British Medical Journal (BMJ) asked six leading global regulators in Australia, Canada, Europe, Japan, the UK, and US, “questions about their funding, transparency in their decision making (and of data), and the rate at which new drugs are approved” and they found that “industry funding of drug regulators has become the international norm.”