- The Washington Times - Wednesday, May 2, 2007

It has been nearly three years since Merck voluntarily withdrew its painkiller Vioxx after a study showed an increased relative risk for heart attack and stroke. Congressional hearings were held in which it was alleged that the Food and Drug Administration failed to adequately protect the public against the risks of “unsafe” drugs.

An Institute of Medicine panel was convened to examine the ability of the agency to monitor the safety of medicines once they were on the market. It proposed limiting how drugs are prescribed through strict regulation and monitoring.

During this period, it was easy to forget, as former FDA Commissioner Mark McClellan has observed, that the percentage of drugs withdrawn from the market — 2 percent to 3 percent — remained about the same as it has since the FDA started keeping track in 1970.

Before the “who lost safety” hysteria, the FDA, as part of its nascent Critical Path program, had proposed collecting data on drug and device response that could not only be an early-warning system for potential safety problems but also serve as a clearinghouse for designing predictive models of drug development that could get a next generation of personalized medicines to patients.

In this respect, the FDA Revitalization Act is a step in the right direction. Initially, the bill, written by Sens. Ted Kennedy and Mike Enzi, adopted the Institute of Medicine’s recommendation to limit how all drugs are prescribed through the use of restrictive “risk management plans.” The bill also had onerous limits on providing information about new drugs to patients that were likely unconstitutional. Finally, the limits on financial conflicts associated with advisers to FDA advisory committees would have excluded even Nobel Prize winners with expertise in drug development but would have allowed former Institute of Medicine safety panelists with no Nobels, I presume, but who had stock options from insurance companies.

As Mr. Kennedy said in introducing the revised bill: The legislation is based on the drug safety legislation that he and Mr. Enzi introduced earlier this year, with important improvements suggested by members of our committee during the discussions that preceded the markup.

The heavy-handed Institute of Medicine recommendations are not, thankfully, in the bill. Instead there is an emphasis on developing public-private partnerships to create electronic databases to capture patient-level data on how people respond to medicines. This information can integrate genetic data to build a platform for the development and delivery of personalized medicine.

The bill also beefs up support for the a Critical Path Institute to sustain research supported by industry, academia, the FDA and the National Institutes of Health to translate the science of drug discovery into pathways for drug evaluation.

The bill still gives the FDA authority to ban consumer advertising, authority that is not likely to pass constitutional muster. We believe that a new generation of targeted therapies will, by definition, transform both the nature and scope of information provided to patients.

Ultimately, the future of the legislation rests not with its contents, but with those who will seek to tamper with it when it comes to the floor. In particular, senators from both parties are likely to try to add amendments for the forced importation of unsafe medicines from overseas to a bill intended to make medicines safer.

The amendments as currently constructed would require the following: 1) every company would have to sell as much of the products it now sells overseas to markets to foreign wholesalers or face criminal charges; 2) The FDA must come up with regulations and a process to certify that the drugs made for other markets — though they have different packaging, coatings, dosages and formulations — are just as safe and effective as drugs made exclusively for the American market; 3) establish a whole new division that would inspect overseas wholesale and shipping operations to ensure there is no counterfeiting; and 4) do this everywhere except in Canada, where commercial quantities of drugs from every country come in for reshipment without inspection.

Allowing such amendments to a bill designed to revitalize the FDA and restore its credibility is the closest Congress can get to voting on a sick joke.

The gap between the promise of medicine and what the FDA can do has grown in the past four years. As Mr. Kennedy himself noted: “We need brilliant researchers to develop the drugs of tomorrow, and also strong and vigilant watchdogs for public health to guarantee that new drugs and medical devices coming into use are safe and beneficial, and actually reach the patients who urgently need them. Congress has ample power to restore the luster that FDA has lost in recent years.”

Congress should not squander that power on political folly. It should pass the FDA Revitalization Act and build a bright future for the agency.

Peter J. Pitts is president of the Center for Medicine in the Public Interest and a former FDA associate commissioner. Dr. Robert Goldberg is vice president for research at the Center for Medicine in the Public Interest.

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