FDA Approves New Guidelines To Allow Drugmakers To Share Unapproved Drug Uses With Physicians

Main Category: Primary Care / General Practice
Also Included In: Pharma Industry / Biotech Industry;  Regulatory Affairs / Drug Approvals
Article Date: 14 Jan 2009 - 4:00 PDT

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FDA officials on Monday posted guidelines online that allow pharmaceutical companies to cite peer-reviewed medical journal articles to promote drugs for unapproved uses to physicians, the AP/Salt Lake Tribune reports. Drugmakers are not permitted to promote products for so-called "off-label" uses, but FDA allows companies to distribute articles regarding unapproved uses provided they appear in a peer-reviewed journal. A law that expressly allowed the practice expired in September 2006, and drugmakers have since lobbied for its renewal. Under the expired law, companies were required to submit reprints of the articles to FDA before sending them to physicians. Drugmakers would not be required to submit the articles to FDA under the new guidelines (Perrone, AP/Salt Lake Tribune, 1/12). FDA said it cannot require a review of the studies but called for "well-controlled" studies that are considered scientifically sound, according to Bloomberg (Larkin, Bloomberg, 1/12).

In addition, FDA said the new guidelines are intended to discourage ghostwriting, in which drugmakers pay academics to take credit for articles that were written by the company. The guidelines recommend that companies disclose all financial relationships with the authors of the articles and list authors' affiliations (AP/Salt Lake Tribune, 1/12). According to Reuters/New York Times, the action "could help companies expand the markets for medicines and medical devices" (Reuters/New York Times, 1/13).

Reaction
House Energy and Commerce Committee Chair Henry Waxman (D-Calif.) and other Democrats said the changes make it easier for drugmakers to promote potentially dangerous medical practices. Some lawmakers, including Waxman, have said the guidelines represent a step away from better enforcement standards in the pharmaceutical industry (AP/Salt Lake Tribune, 1/12). Waxman said, "In the final hours of [the Bush] administration, political appointees at FDA have given drug companies a long-coveted parting gift." He added, "This fundamentally undermines the requirement that companies prove to FDA that each new use is safe and effective" (CongressDaily, 1/13).

According to the AP/Tribune, FDA remains supportive of distributing articles regarding experimental uses for drugs. The agency said, "The public health may be advanced" by the exchange of information regarding unapproved uses of drugs, and such practices might "constitute a medically recognized standard of care." Alan Bennett, an attorney representing the pharmaceutical industry, said, "Physicians need timely access to the latest medical information to keep abreast of the best practices in patient care" (AP/Salt Lake Tribune, 1/12).

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