The FDA’s objectivity when approving new drugs has been called into question numerous times, and many argue that the agency is indebted to the biopharmaceutical industry. According to reports, the industry pays three-quarters of the FDA’s budget used for the drug review process. This number is simply mind-boggling.
No other federal agency is supported to this extent by the industry it regulates. In fact, given this degree of support, it is safe to assume that the FDA would jump through hoops to meet the needs of the biopharmaceutical industry.
The groundwork for the relationship between the FDA and the pharmaceutical industry was laid about 25 years ago. It has led us to the point where we are today, with private industry (Big Pharma) providing most of the financial support for a federal agency (the FDA). It began when the US was in the midst of a “drug lag.” The FDA was lacking resources, and therefore drugs were being approved in the US much slower than they were in Europe. Over half of all drugs approved in the US had already been approved in Europe more than a year earlier.
The lag left physicians, advocacy groups, pharmaceutical companies and patients all worried that crucial new drugs were being withheld from Americans.
As a solution, Congress enacted the Prescription Drug User Fee Act (PDUFA) of 1992. This was an instrument through which charges were imposed on pharmaceutical companies for each new drug application (NDA) filed.
They used the money they made (known as “user fees”) to hire 600 new drug reviewers and support staff. This new team of pharmacologists, chemists, medical officers and other experts were assigned the task of clearing the backlog of NDA’s awaiting approval by the FDA.
As incentive to agreeing to the “user fees”, the FDA promised the pharmaceutical industry that they would shorten review times of NDA’s to twelve months for the applications considered “standard” and to six months for applications that were a priority because they involved critical advances over existing treatments.
Over the years, the PDUFA Act has consistently been renewed, and last year PDUFA VI was passed. It is no surprise that the “user fees” have increased over the years, from $208,000 per NDA in 1995 to a whopping $2,421,495 for the fiscal year 2018.
Today, the FDA is increasingly green-lighting expensive drugs despite little-known or dangerous side effects and no real evidence that they curb or cure disease. Once widely criticized for moving slowly, today the FDA reviews and approves drugs faster than any other regulatory agency in the world. Between 2011 and 2015, the FDA reviewed new drug applications more than 60 days faster on average than the European Medicines Agency.
With such a rigged set-up, it is no wonder the FDA is increasingly fast-tracking expensive drugs with significant side effects and unproven health benefits. Undoubtedly, the set-up surely pleases the group funding most of the the expenses in the first place – the pharmaceutical industry.