Contact: Ray De Lorenzi
202.965.3500, ext. 8369
New FDA Guidance Allows Drug, Device Companies to More Easily Push Products for Unapproved Use
Washington, DC—New Food and Drug Administration (FDA) guidance will put patients at risk from off-label uses of drugs and medical devices, said the American Association for Justice in comments sent today to the agency.
This guidance will allow drug and medical device companies to use journal articles to bolster arguments that their products should be marketed for off-label usage, even though the FDA did not approve the drug or device for that particular usage.
Just last week, the Journal of the American Medical Association (JAMA) included two studies which suggest that Merck & Co., the maker of Vioxx, had ghostwritten dozens of academic articles that promoted Vioxx and minimized the impact of patient deaths. The FDA’s guidance will only promote this practice for manufacturers.
“The latest JAMA is a wake-up call for the FDA that this proposed guidance is flawed and a danger to public health,” said AAJ President Kathleen Flynn Peterson. “Limited off-label use of drugs and medical devices is certainly valuable, but this recent unethical behavior inside the industry raises new alarms that must be addressed.”
Without additional safeguards in this guidance, doctors will likely increase their off-label prescribing without information on all potential side effects. For example, doctors prescribed anti-psychotic Risperdal to children after marketing materials did not include all the off-label side effects for younger patients. As a result, children in New Jersey and Florida developed lactating breasts, in some cases large enough to require double mastectomies.
“Manufacturers need to provide a fair balance of information so all potential risks are aired publicly,” said Flynn Peterson. “The FDA should shift its focus back to protecting patients and away from the profits of the drug and device industry.”
For a copy of AAJ’s comments, please contact Communications at 202.965.3500, ext.369.