Drugmakers May Distribute Articles on Unapproved Uses (Update2)

By Catherine Larkin

Jan. 12 (Bloomberg) -- Drug and device makers may give doctors copies of medical journal articles that describe studies of existing products being tested for unapproved uses, U.S. regulators said, rejecting calls to limit the practice.

The Food and Drug Administration today made final a proposal announced in February to let companies distribute journal articles to medical professionals without first submitting them to the FDA for review. Articles had to be pre- screened under a law that expired on Sept. 30, 2006.

Critics on Capitol Hill, including Representative Henry Waxman, argued that company-funded research may be biased and circulating the studies may spur the use of unproven treatments. While the FDA said it can’t require that studies be submitted for review, the agency called for “well-controlled” studies that are considered to be sound scientifically.

“FDA recognizes that the public health can be served when health care professionals receive truthful and non-misleading scientific and medical information on unapproved uses of approved or cleared medical products,” according to guidelines posted today on the agency’s Web site.

The guidelines encourage companies to apply for expanded approval of products when studies suggest there may be benefits.

Off-Label Uses

Companies aren’t allowed to directly promote drugs and medical devices for conditions not approved by the FDA, though doctors may prescribe these so-called off-label uses. The new policy “caters to the industry’s desire” to market products without enough testing or review, Waxman said last year. Karen Lightfoot, a spokeswoman Waxman, the California Democrat who is chairman of the House Energy and Commerce Committee, didn’t immediately return messages seeking comment today.

The guidelines were commended by Alan Bennett, an attorney with Ropes & Gray, who serves as spokesman for a group of companies that have been lobbying for the FDA to clarify the rules since the old law expired.

“I don’t think this is a sea-change in the way that companies or anyone else operates,” Bennett said today in a telephone interview. “Doctors are really busy and they don’t have the time to go and find these articles often. It just makes their lives a little bit easier if companies can provide it for them.”

The companies that make up the lobbying group are Amgen Inc., AstraZeneca Plc, Bayer AG, Eisai Co., Genentech Inc., Johnson & Johnson, Eli Lilly & Co., Pfizer Inc. and Schering Plough Corp., according to Bennett.

To contact the reporter on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net .

Last Updated: January 12, 2009 16:04 EST

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