While often held in high esteem, the FDA has seen its reputation tarnished in recent years by adverse drug regulation experiences, apparent conflicts of interest, and problems with consistent agency leadership.
Examples of problems at the FDA
- The COX-2 inhibitor disaster that led to the withdrawal of rofecoxib (Vioxx) from the market due its association with adverse cardiovascular effects; a problem the company may have hidden from physicians and the public through manipulation of research reports.2
- The recent addition of black box warnings on selective serotonin reuptake inhibitor (SSRI) labels to warn of a potential association with suicidal behavior in adolescents after publicity that some FDA scientists were prevented from presenting this information to review panels.
- A plea bargain agreement in which Pfizer agreed to pay $430 million to resolve charges that Warner-Lambert, a company it took over, paid doctors to prescribe gabapentin (Neurontin) for off-label uses including bipolar disorder, attention deficit/hyperactivity disorder, and alcohol withdrawal seizures. Although physicians can prescribe drugs for whatever reason they choose, pharmaceutical companies are prohibited from promoting drugs for unapproved uses.3
- A lack of strong leadership with acting commissioners leading the agency 3 of the past 5 years. The last permanent commissioner resigned in September 2005 after 2 months in the position amidst accusations that he or his family had financial interests in some of the companies regulated by the agency.4
Given these and other negative events in conjunction with the dramatic increase in prescription drug use by Americans—up 60% in the past decade to 3.1 billion prescriptions in 2004 with reports of 375,000 adverse events—it’s not surprising that a recent survey showed the public wants a stronger FDA. In fact, two thirds support the creation of an independent oversight panel, 70% want the FDA to improve its gathering and reporting on possible harms of drugs and medical devices after their approval, and many believe that industry has too much influence over agency decisions.5
How the FDA performs its job matters very much to physicians, the public, and business. In recent months, outside experts and the FDA itself have proposed changes in how the agency handles new drug approvals that will affect all its stakeholders. Before reviewing those proposals, it’s worth understanding how the approval process works.
The FDA’s responsibities
The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety and efficacy of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation—a list that accounts for at least 20% of consumer spending. It does this on a budget of about $1.7 billion and 10,000 employees. In comparison, the Department of Agriculture has a budget 50 times larger and a workforce 10 times larger.1
Speeding approval of new drugs
In the early 1990s, Congress responded to complaints about the FDA’s slow drug approval process, particularly regarding HIV drugs, by passing the Prescription Drug User Fee Act (PDUFA). The law mandated that pharmaceutical companies pay fees to the FDA that were then used by the agency to speed up the approval process by hiring more staff and adhering to a strict timetable for review. The PDUFA accomplished its goal; for instance, priority review drugs had their time to approval drop from a median of 14.9 months in 1993 to 6.7 months in 2003, and standard review drugs went from 27.2 months to 23.1 months during the same period.6 Ironically, in spite of the quicker approval process, in 2005, pharmaceutical companies had a record low number of FDA drug approvals—only 20 as opposed to 36 in 2004.7
As quality improvement experts say, however, you often get exactly the results your system was built for. Thus, it is not surprising that in recent years some FDA scientists have complained of increasing time pressures to perform reviews, increased pressure to approve drugs, and inability to communicate directly with the companies about the drugs they were reviewing so as to clarify study designs and data analyses.8
In addition, many observers believe that having the industry support the FDA budget (about $300 million/year) presents a potential conflict of interest for the agency, particularly in the current pro-business climate of the Bush administration.
Given these reports as well as the adverse drug safety events that have occurred recently, Congress and independent scientists are now calling for more attention to safety and less focus on the approval timetable.
How the drug approval process works