New Federal legislation will make the FDA more transparent and shine light on problems with drugs in clinical trials

The Food and Drug Administration will soon have new weapons for protecting the public from unsafe or ineffective drugs, but Congress stopped short of making the dramatic changes at the agency sought by consumer groups and drug safety advocates.
The FDA reform measures were attached to a bill reauthorizing the Prescription Drug User Fee Act, which charges the drug and medical device industries fees to generate about a quarter of the agency's funds. An Institute of Medicine report released in 2006 said relying on user fees contributed to a culture at the FDA where the agency charged with ensuring the safety of the nation's food and drug supply was more concerned with speeding new drugs to market than in protecting the public.
That warped culture created its own problems. A series of safety scandals -- from the removal of widely-prescribed pain drugs like Vioxx to fears that antidepressants were triggering suicide thoughts in adolescents -- created momentum for change that powerful industry trade groups the Pharmaceutical Research and Manufacturers Association and the Medical Device Manufacturers Association, couldn't sidetrack. The bills, which overwhelmingly passed both houses, gave the FDA power to:
Compel companies to put safety warnings on drug labels in a more timely fashion, and levy civil and monetary penalties if they fail to comply;
Require companies to monitor the use of riskier new drugs after they've been approved, and adopt strategies for keeping them out of the hands of patients who might suffer most from their side effects; and Create a better system for physicians to report adverse drug events among their patients.
This legislation "will help save countless lives in the future by more quickly detecting and warning of dangerous drugs," said Bill Vaughan, senior policy analyst for Consumers Union. "While there are further safety improvements we'd like to see, this legislation is a huge step forward -- probably the most important change in FDA powers since 1962" -- the year when drugs were first required to be effective as well as safe.
Notably absent from the legislation, however, was any curb on direct-to-consumer advertising. Many critics, including many physicians, claim these ubiquitous ads needlessly run up the cost of new medicine and make patients pressure physicians to prescribe drugs that may be inappropriate. While the FDA will get additional money to monitor drug ads, PhRMA and the nation's media companies successfully teamed up to eliminate more far-reaching curbs from the bill.
The bill also did nothing to reduce the agency's dependence on industry user fees or create an independent safety department within the FDA. Safety experts at the agency currently report to the officials who approve new drugs. Sen. Charles Grassley (R-) had pushed for giving those safety experts more power by creating a separate safety department with the power to veto new drug applications.
Instead, Congress enlarged the safety section within the office charged with approving new drugs and gave it the right to penalize companies that fail to complete post-marketing safety clinical trials that the agency asks for. About two-thirds of the clinical trials requested by the FDA at the time of a drug's approval never get completed.
Physicians and scientists who study new drugs, as well as the patients who volunteer to participate in clinical trials, also had something to cheer about in the legislation. The bill requires that all clinical trials get registered in a publicly-accessible database prior to enrolling its first patient. This should allow sick patients and their doctors who are seeking out experimental therapies to more easily find these trials.
At the same time, the law requires that trial sponsors publicly post the results of the trials within a year of their completion. This should enable independent researchers to identify and analyze all the clinical trials that have been done on a particular drug, which is one way of identifying safety problems that may not be apparent from just one or two trials that have been published in the academic literature or submitted to the FDA during the drug's approval process.
Dr. Steven Nissen of the Cleveland Clinic, who helped uncover the cardiovascular risks associated with Merck's Vioxx in 2001 and more recently with GlaxoSmithKline's diabetes drug Avandia, lobbied hard for the new disclosure requirements. "The problem we've had with companies refusing to reveal studies that show safety problems should come to an end," he said.
The legislation also provided additional protections for scientists working at the agency to publish their findings and speak out in public, even if they are voicing views that dissent from the FDA's overall evaluation. "The bill contains transparency language that will shine a light on the FDA drug approval process, ensuring that the dissenting views of drug reviewers are heard and not suppressed and ignored," said Francesca Grifo, senior scientist and director of the Scientific Integrity Program at the Union of Concerned Scientists.
Finally, companies will have slightly less influence over the outside advisory process at the agency. The FDA relies on more than 30 outside advisory committees to help its internal reviewers evaluate new drug and device applications. But about one in every four of those outside advisors -- usually physician-professors who teach at the nation’s 125 academic medical centers -- has financial ties to manufacturers or their competitors whose products come before the agency.
The legislation will reduce the number of advisors with such conflicts of interest by 25 percent over the next five years. 

Merrill Goozner is a health care journalist in Washington, D.C.

--By Merrill Goozner