Healthy Skepticism Library item: 15037

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Publication type: news

Adams C.
Obama may look at FDA's new guidelines on off-label drug marketing
Star Telegram 2009 Feb 1
http://forum.opiates.com/index.php?tid=20&tpg=1

Full text:

In the waning days of the Bush administration, the Food and Drug Administration finalized new guidelines to make it easier for drug manufacturers to promote “off-label” prescription drug uses, which can be deadly.

The move came despite criticism from then-President George W. Bush’s 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.

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, a physician, took the epilepsy drug Neurontin for his persistent back pain. It didn’t do much for his back, but Robin Briggs said the drug changed his demeanor and led to his death.

Federal officials have since told Pfizer and other makers of anti-epilepsy drugs to add suicide-risk warnings to their drugs’ packaging labels. Robin Briggs sued Pfizer and the maker of a generic version of the drug. The case is pending.

As the Obama administration reviews all the 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.”

“A legislative fix may be in order,” Grassley said Thursday.

In the House of Representatives, Rep. Henry Waxman, D-Calif., 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. It can be helpful for certain ailments.

But the practice can also 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.

Over the past five years, federal prosecutors and state attorneys general have brought more than a dozen cases against drugmakers for off-label marketing and won more than $6 billion in criminal and civil settlements, according to the Government Accountability Office and the Department of Justice.

In January, two of the nation’s largest drugmakers, Pfizer and Eli Lilly and Co., said they’d agreed to two of the biggest off-label settlements ever.

“The FDA has been abysmal policing this area,” said Connecticut Attorney General Richard Blumenthal, who helped engineer a major off-label case against drugmaker Cephalon. “One reason the states have been more and more active is that the federal government has been asleep at the switch.”

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.