FDA guidance offers potential for off-label usage
ROCKVILLE, Md. The Food and Drug Administration on Friday potentially kept the door open for pharmaceutical manufacturers to detail doctors on off-label use of their products.
Specifically, the agency issued draft guidance on “Good Reprint Practices” for industry use in the distribution of medical or scientific journal articles and reference publications that involve unapproved uses of FDA-approved drugs and medical devices.
“Articles that discuss unapproved uses of FDA-approved drugs and devices can contribute to the practice of medicine and may even constitute a medically recognized standard of care,” stated Randall Lutter, FDA deputy commissioner for policy. “This guidance also safeguards against off-label promotion.”
Once the practice is codified by the FDA, pharmaceutical manufacturers may be able to promote commonly-accepted, peer-reviewed off-label use of their medicines—which in turn could fuel sales of those products and increase the need for education among other healthcare professionals, such as pharmacists or nurse practitioners.
Critics of the proposal are afraid of just that—that pharmaceutical companies will promote off-label to help drive profits. Rep. Henry Waxman, D-Calif., worried that the proposed rule “caters to the industry’s desire to market their products without adequate testing or review” in an interview with the New York Times published Friday.
The Internal Medicine World Report in October published a report on off-label medicine use as a growing trend in the industry. The report included published studies that indicated Provigil, a medicine for sleep disorders, may show promise for bipolar depression; that statins don’t prevent prostate cancer; and that off-label use of the calcium-channel blocker verapamil, indicated for arrhythmias and high blood pressure, for the prevention of cluster headaches may lead to heart problems, among other studies.
Previously, Section 401 of the Food and Drug Administration Modernization Act set out guidelines that allowed the dissemination of information on unapproved uses of FDA-approved products. As long as the guidelines were met by the manufacturers, the dissemination of such materials was not viewed by the FDA as evidence of an intent to promote the product for an “off-label” use. However, Section 401 expired Sept. 30, 2006.
The FDA’s “Good Reprint Practices” draft guidance recommends principles manufacturers should follow when they distribute scientific or medical journal reprints, articles, or reference publications. Some of the principles include ensuring that the article or reference be published by an organization that has an editorial board. The organization also should fully disclose any conflicts of interest or biases for all authors, contributors or editors associated with the journal article. Articles should be peer-reviewed and published in accordance with specific procedures.
In addition, the draft guidance recommends against distribution of special supplements or publications that have been funded by one or more of the manufacturers of the product in the article, and articles that are not supported by credible medical evidence are considered false and misleading and should not be distributed.
The FDA retains legal authority to determine whether distribution of an article or publication constitutes promotion of an unapproved “new use,” or whether such activities cause a product to be considered misbranded or adulterated under The Federal Food, Drug and Cosmetic Act.
The FDA is currently fielding public comments on the draft guidance.
Isma Benattia named Wyeth Consumer Healthcare head of global R&D
MADISON, N.J. Wyeth Consumer Healthcare announced that Isma Benattia has been named executive vice president of Global Research and Development, effective immediately.
In her new role, Benattia will be in charge of bringing new products to market and managing regulatory necessities regarding Wyeth’s over-the-counter products.
Benattia has served at Wyeth Pharmaceuticals since 2003, where she most recently was vice president in charge of Global Labeling. She previously held the position of executive medical director of neuroscience, where she played a leading role in managing scientific and regulatory issues involving Effexor, Wyeth’s second largest brand in terms of global revenue.
Prior to joining Wyeth, Benattia led global clinical programs for major products at Pfizer and Eli Lilly. She holds Master’s degrees in Pharmacology and Psychotropic Drugs; Methodology of Clinical Research and Medical and Marketing Management.
Study shows Relacore may reduce acne flare-ups
NEW YORK Carter Reed on Friday released studies that suggests its dietary supplement diet aid Relacore may be useful in reducing acne flare-ups.
“One of the reasons Relacore has been so successful is because people buy it along with other diet pills or to use in conjunction with any sensible diet and exercise plan,” stated Gina Daines, Carter-Reed’s director of marketing. “Now when it comes to acne, we’re seeing the same phenomenon—those who buy popular anti-acne treatments, like Proactive, are picking up a bottle of Relacore to expand and complete their anti-acne regimen, using Relacore to help prevent the stress-related increase, duration, frequency and severity of acne flare-ups.”