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Bush, FDA changed rules to benefit off-label drugs

CORNELIUS, N.C. — CORNELIUS, N.C. - In the waning days of the Bush administration, the Food and Drug Administration completed new guidelines to make it easier for drug manufacturers to promote "off-label" prescription drug uses, which can be deadly for patients.

The move came despite criticism from Bush's own Department of Veterans Affairs, which said the change "favors business interests over public safety" and could lead to a "decline in drug safety." It was also crafted despite efforts by state and federal law enforcement experts to clamp down on off-label drug marketing.

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The new guidelines were issued four years after Robin Briggs of Cornelius, N.C., buried her husband, Doug, who committed suicide on a chilly Christmas Day after taking a drug off-label.

Doug Briggs, himself a physician, had taken a drug that the FDA had approved to treat epilepsy to ease his persistent back pain. It didn't do much for his back, but Robin Briggs said the drug's risk of producing suicidal behavior led to his death.

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As the Obama administration reviews all the midnight rules that the departing Bush administration issued, it will have to decide whether to try to modify or reverse this last-minute change in the FDA's oversight of off-label drug marketing.

Congressional leaders from both parties criticized the guideline when it was proposed last year. Sen. Charles Grassley, an Iowa Republican who has repeatedly investigated the FDA, said he had serious concerns about the proposal, which he said would deem appropriate something that "the FDA once considered evidence of unlawful marketing."

In the House of Representatives, Rep. Henry Waxman, a California Democrat, called the guideline a "long-coveted parting gift" for the pharmaceutical industry that "fundamentally undermines" the FDA's authority.

The use of drugs "off-label" - for reasons the FDA hasn't approved - has long been tolerated, and sometimes encouraged. For certain ailments, it can be helpful.

But the practice also can be dangerous. Nearly every drug has side effects, some of them serious. Those risks can be worth the potential benefit that comes with an FDA-approved, on-label use. With an off-label use, however, the risks remain, but the benefits are far less certain.

While it's legal for physicians to prescribe drugs off-label - often based on their reading of the latest medical research - it's illegal for drugmakers to push such uses.

In its final week, the Bush administration opened the door to some off-label marketing. In what's called a "guidance" document, the FDA specified how drug companies could hand out medical journal articles that highlight potential off-label drug uses.

The guidance was complicated, and the main players in the issue still disagree about what it means for FDA oversight of off-label marketing. The drug industry generally endorsed the guidance as helpful to doctors and patients. The Washington Legal Foundation, which has accused the FDA of overstepping its authority, said that any FDA involvement in the issue was an unfair restriction on free speech and that drugmakers should be free to share off-label information with doctors.

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But health advocacy groups, insurers and state prosecutors said that the change would do more harm than good.

To be sure, doctors can find good information on new drug uses by reading medical journals. The screening process for medical journals, however, is rarely as rigorous as the FDA's drug approval process. Without proper oversight, drugmakers can pay for flimsy research on off-label uses and then use the results to promote their drugs.

The Bush FDA issued the new guidance over the objections of Bush's Department of Veterans Affairs, which pays for drugs taken by its health system patients.

Two researchers writing in the Journal of the American Medical Association echoed those comments, saying that medical literature is often the victim of manipulation.

The FDA's Jarilyn Dupont said the agency tried to strike a balance between patients' interests and the medical community's free-speech rights.

"Doctors have the ability to read these articles on their own," she said. "So the question is, does it change the article if they are given it by a drug representative or they read it in a medical journal? The article is still the same."


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