New FDA Guidelines Easing Drugmakers' Promotion Of Off-Label Uses Met With Endorsements, Criticisms

Main Category: Pharma Industry / Biotech Industry
Also Included In: Regulatory Affairs / Drug Approvals;  Pharmacy / Pharmacist
Article Date: 03 Feb 2009 - 5:00 PDT

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McClatchy/Philadelphia Inquirer on Monday examined guidelines released by FDA in the last week of former President George W. Bush's term that make it easier for drug manufacturers to promote "off-label" uses for prescription drugs. The use of medications for reasons not approved by FDA "has long been tolerated, and sometimes encouraged," according to McClatchy/Inquirer. It is legal for physicians to prescribe drugs for off-label uses but it is illegal for drugmakers to market drugs for off-label uses (Adams, McClatchy/Philadelphia Inquirer, 2/1).

However, FDA officials in January posted guidelines online that allow pharmaceutical companies to cite peer-reviewed medical journal articles to promote drugs for unapproved uses to physicians. 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 are not required to submit the articles to FDA under the new guidelines. FDA said it cannot require a review of the studies but called for "well-controlled" studies that are considered scientifically sound (Kaiser Daily Health Policy Report, 1/13).

According to McClatchy/Inquirer, the new guidelines are "complicated, and the main players in the issue still disagree about what is means for FDA oversight of off-label marketing." The drug industry "generally endorsed" the new guidelines, saying they give helpful information to physicians and patients. McClatchy/Inquirer reports that physicians "can find good information on new drug uses in medical journals" and that "for certain ailments, including cancer," use of off-label treatments "can be helpful." However, "the practice can also be dangerous" because "with an off-label use, the risks remain but the benefits are less certain."

The guidelines were also met with criticism. The Department of Veterans Affairs opposed the new guidelines, saying the change "favors business interests over public safety" and might contribute to a "decline in drug safety." According to McClatchy/Inquirer, the screening process for medical journals is "rarely as rigorous" as the FDA drug approval process, and as a result, drugmakers could "pay for flimsy research on off-label uses and then use the results to promote their drugs." VA in a letter to FDA wrote, "Second-rate 'studies' published in journals with questionable peer-review processes will be used to convince physicians to use drugs for an ever-increasing number of unapproved uses."

According to McClatchy/Inquirer, lawmakers, health advocacy groups, insurers and state prosecutors also expressed concern regarding the new guidelines. Sen. Chuck Grassley (R-Iowa) said the practice would legitimize something FDA "once considered evidence of unlawful marketing," adding, "A legislative fix may be in order." Rep. Henry Waxman (D-Calif.) said the guidelines would undermine FDA's authority and were a "long-coveted parting gift" on behalf of the Bush administration for the pharmaceutical industry. McClatchy/Inquirer reports that the Obama administration will have to decide whether to modify or reverse the guidelines.

Jarilyn Dupont of FDA said the agency was attempting to balance patients' interests with free-speech rights entitled to the medical community. She said physicians can read articles on off-label uses on their own. Dupont 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?" She added, "The article is still the same" (McClatchy/Philadelphia Inquirer, 2/1).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation.

© 2009 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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