Balancing Act

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.

Michelle Hoffman

Capitol actions

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 of Americans".

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."

Public matters

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.

A widely cited statistic holds that two-thirds of all drug withdrawals occur within the first three years of release, so several organizations—Consumers Union and the Institute of Medicine among them—have suggested imposing a two- or three-year moratorium on these ads following a drug's release. That would give drug manufacturers and regulators time to gather accurate safety data about the drug and, said Consumers Union, "result in a major reduction in the use of drugs eventually found unacceptably risky."

With Senate approval, PDUFA will now go to the House for a vote—expected in July. Perhaps between now and then, US representatives will impose the advertising moratorium and make the bill one that truly protects the public from unsafe drug claims as well as unsafe drugs.

Michelle Hoffman is editor in chief of Pharmaceutical Technology, mhoffman@advanstar.com