The US Food and Drug Administration has always found itself with a nearly impossible balancing act. On one hand, it is responsible
for the safety and efficacy of drugs released on the market—a process that requires a lot of care and no small amount of time.
On the other hand, with so many promising new drugs in the pipeline, the agency is under pressure to speed approvals to get
much needed, sometimes desperately needed, drugs to market as quickly as possible. What to do? Expediting drugs to market
suggests rushing some safety tests. Performing time-consuming and sometimes irrelevant analyses of drug safety might delay
drugs from getting to the people who don't have time to wait.
Critics of FDA feel the agency's budget has been imbalanced, historically favoring speed to market over safety. In a 2005
policy statement, the Consumers Union, publisher of Consumer Reports, noted:
"Tens of thousands of people have died and been injured under the current system, which emphasizes getting drugs to market,
while giving short shrift to determining the safety of those drugs once they are in the marketplace and in use by millions
As this issue went to press, the Senate sought to redress that imbalance. In approved legislation, the Senate increased funds
to FDA for postapproval surveillance of drugs. The additional funds are to be paid by companies that "use" FDA—that is, pharmaceutical
and biotech companies submitting drugs for marketing approval. In addition to improving the agency's premarket process for
assessing drug safety and efficacy, the Prescription Drug User Fee Act (PDUFA) provides funds to track the safety of drugs
once they are released. According to a May 9, 2007 report in the New York Times, the bill doubles the maximum civil fine to $2 million for any drug maker that violates an FDA safety plan. FDA could also
order changes in a label or require additional clinical trials for a drug that's already on the market. (Under the current
system, clinical testing is not resumed after the drug is released.) Furthermore, the bill requires the government to establish
a public database of clinical trials and their results, making it "difficult for drug companies to hide evidence of safety
problems," which, noted the Times report, some lawmakers felt had been the case in the past.
The bill has received widespread approval among representatives of the pharmaceutical industry. In a statement issued the
day the bill was passed, Billy Tauzin, president and CEO of Pharmaceutical Research and Manufacturers of America (PhRMA),
said, "In general, the legislation passed by the Senate will preserve—and even strengthen—the FDA's ability to do its job."
I am delighted that postapproval surveillance is coming into equilibrium with preapproval surveillance. But oversight can
be more rigorous still. Specifically, I am concerned about the drug's introduction to the public. I am concerned about direct-to-consumer
advertising. The PDUFA bill that just gained approval in the Senate sets aside funds for FDA to review these ads and empowers
the agency to impose fines for false or misleading commercials. But I wish it had gone further.
Consumers Union conducted a survey of direct-to-provider and direct-to-consumer ads produced between January 1997 and November
2002, and its findings, summarized in the 2005 report, included "a broad and disconcerting range of misleading messages."
The report went on to say that in spite of an "upturn in strong warning letters," for which the Union congratulated FDA, nothing
had changed in the "type of abuses detected" in 2005.