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Monday, December 10th, 2007

The Food and Drug Administration is developing a proposal for how drug companies can inform doctors about drug uses that aren’t FDA approved, a contentious but important area of promotion for the industry.

While it is legal for physicians to prescribe drugs or use medical devices in ways not specifically approved by the FDA, companies that make the products aren’t allowed to market such practices. A number of drug makers have been prosecuted for allegedly pushing to increase “off-label” use.

According to a draft of the proposal, the FDA is considering guidelines that would say manufacturers may give doctors articles from medical journals and materials drawn from scientific reference texts that discuss off-label uses of drugs and medical devices. The draft was released Friday by Rep. Henry Waxman (D., Calif.), who criticized it, saying it “would carve a large loophole in the law.” Supporters of allowing distribution of such materials say companies should be allowed to provide doctors with accurate and unbiased information.

Separately, the FDA Friday released a harsh report from a group of its own advisers that warned the agency isn’t equipped to deal with emerging scientific developments. The report said that “science at the FDA is in a precarious position: the agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities.”

The report, from a subcommittee of the FDA’s outside Science Board that included members and advisers from industry as well as academe, echoed past critiques that have said the agency needs substantial new resources. But it was unusually blunt in pointing to specific areas of science where the agency was falling behind, including its information-technology resources, which the report termed “obsolete.” Today, “not only can the agency not lead, it cannot even keep up with the advances in science,” the report said.

An FDA spokeswoman declined to comment on the contents of the report, which will be discussed in a public meeting on Monday. The agency is expected to get some additional funding from increased industry user fees under a bill that recently passed Congress.

On the matter of so-called off-label promotion of drugs and medical devices, there has long been debate, including court battles, about what falls over the legal line. The current legal situation is muddy. A 1997 law that laid out conditions under which companies could distribute certain information about off-label uses expired at the end of September.

According to the draft, the agency would lay out details on what types of publications are appropriate, as well as certain other requirements, such as that the materials come with a copy of the drug or device’s FDA-approved label.

Mr. Waxman said the proposal would allow companies to promote off-label uses. In a letter to the company, he wrote that articles in medical journals may provide “a distorted picture of a drug’s safety or effectiveness,” because journal editors may not know the full story behind a study — such as whether its design was changed, or if negative results were left out of an article.

On the other side, courts have pressured the FDA to avoid restricting companies’ free-speech rights. “Off-label prescribing is very often the standard of care,” and companies should be able to give doctors “truthful, non-misleading information” about such uses, said Daniel Troy, a former FDA chief counsel who previously helped argue against the agency in a major suit over restrictions on off-label promotion. Mr. Troy now represents drug companies and others in private practice.

An FDA spokeswoman declined to comment on the proposal and said the agency would respond directly to Mr. Waxman.

The FDA’s draft proposal seems to try to strike a middle ground, allowing companies to distribute information about off-label uses but setting limits on the practice. Among other restrictions, the draft suggests that letters to the editor of a medical journal wouldn’t quality and that the scientific articles would have to be peer-reviewed. In addition, if the conclusions in a particular article have been disputed, it would have to be distributed along with another article showing the opposing view.

Write to Anna Wilde Mathews at anna.mathews@wsj.com

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This entry was posted on Monday, December 10th, 2007 at 4:57 pm and is filed under Breaking News, Business News . You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.

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