Posted by You read correctly. If the US Senate does not pass an FDA funding bill today, 2,000 employees, nearly one-quarter of the FDA staff, will be relieved of their duties. (There were 8,157 FDA employees in 2006 – source). The House has already passed the bill but there are concerns:
Senate staffers were poring over the bill’s 400-page text, and leaders were hoping to be able to pass it by voice vote. But some Senate Republicans raised concerns. “We’re getting a bill that has been mashed together at the last minute,” said a GOP aide involved in negotiations with the House. “It’s very worrisome.”
The legislation, which the House passed 405 to 7, would renew and increase fees drug and medical device makers pay that fund much of the FDA’s analysis of drugs submitted for approval. It also would overhaul the drug safety system so problems that emerge after medications have been approved for use can be spotted faster.
Yes, “renew and increase fees drug and medical device makers pay that fund much of the FDA’s analysis of drugs submitted for approval,” refers to PDUFA (pronounced puh-DOOF-uh) or the Prescription Drug User Fee Act. Dr David Michaels has a lovely post on this legislation at The Pump Handle and the good folks there have a whole category devoted to PDUFA. From a New England Journal of Medicine article quoted by Dr Michaels:
One FDA scientist who was often criticized for being too concerned about drug-risk data was told by his supervisor to remember that the agency’s client was the pharmaceutical industry. “That’s odd,” he replied. “I thought our clients were the people of the United States.”
In the late 1980s and early 1990s, many groups including HIV/AIDS advocates complained (rightfully) that the FDA was taking too long to approve drugs for life-threatening diseases. The FDA response was that they were too short-staffed to handle the volume of new drug applications (NDA). The passage of PDUFA in 1992 allowed drug companies to pay fees that essentially cover new labor in FDA to evaluate NDAs more rapidly. Revere at Effect Measure and his commenters note that this well-meaning legislation has now been taken to suggest that drug companies underwrite the US drug regulatory authority such that the viability of the agency depends on the contributions of drug companies.
The major concern, among others, is that PDUFA does little to fund post-marketing surveillance of drug toxicity – the time where we really get a feel for how safe a drug is. It’s all well and good to assess drug safety among a few thousand carefully selected patients in highly-controlled clinical trial environments; it’s another thing entirely when a drug is released to millions or tens of millions of genetically-diverse patients taking numerous other drugs. The latter case is where PDUFA funds might be better spent.
Moreover, if the FDA is going to lay off 25% of its workforce if the new funding bill is not passed, what does that tell us about how much of the agency is funded by drug company fees?
Rather than increase the fees paid by drug companies, why not propose a funding bill that does away with this apparent conflict of interest?
I certainly support a strong FDA that can balance its duty to the public health with the need to get life-saving medicines to the public as soon as possible. But everything has its cost.
If we’ve learned anything over the last several years, assurance of drug safety is not an area where we should skimp.
September 21, 2007
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