Nov. 4, 2016
Public Citizen to FDA: Strong Limits Needed on Promoting Medical Products for Unapproved Uses
Public Citizen Experts Testify at FDA Hearing on Manufacturers’ Off-Label Communications About Their Medications, Medical Devices
WHAT: Three Public Citizen experts will testify at a U.S. Food and Drug Administration (FDA) public hearing (PDF) on “off-label marketing” – the pharmaceutical and medical device industry practice of marketing medications and medical devices for unapproved uses. Doctors are permitted to prescribe medicines and devices for off-label uses, but manufacturers are prohibited from touting their products for those uses. In recent years, however, the industry has claimed a First Amendment right to distribute materials about unapproved uses of medical products and is pushing the FDA to relax restrictions. The FDA has proposed policy guidance that would permit additional off-label promotion by manufacturers.
Public Citizen will explain that restrictions on marketing for unapproved uses are crucial to protecting patient health. Off-label promotion threatens patients because it undermines the long-standing regulatory framework for ensuring that medications and medical devices are safe and effective for their intended uses.
The experts testifying:
- Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group, will present data on how often medications are prescribed for off-label uses, how often such uses lack adequate evidence of effectiveness and the increased frequency of side effects in patients taking off-label therapies.
- Dr. Michael Carome, director of Public Citizen’s Health Research Group, will discuss why a manufacturer’s claim that a product is safe and effective for off-label use is no substitute for the FDA’s independent, objective approval. Carome also will share the many ways peer-reviewed journal articles (which the industry wants to use to tout off-label uses) can be flawed, including by outright fraud, biased study design and incomplete reporting of data.
- Robert Weissman, president of Public Citizen, will explain that disseminating preliminary study results to doctors to support off-label uses can be misleading and that restrictions on promotion for unapproved uses are necessary to protect the public.
WHEN: The two-day public hearing is from 9 a.m. to 5 p.m. on Nov. 9 and 10. Public Citizen experts will be testifying at about 4 p.m. on Nov. 9.
WHERE: The Great Room (Room 1503), Building 31 Conference Center, FDA White Oak Campus, 10903 New Hampshire Ave., Silver Spring, Md.
WHO: Robert Weissman, president, Public Citizen
Dr. Sidney Wolfe, founder and senior adviser, Public Citizen’s Health Research Group
Dr. Michael Carome, director, Public Citizen’s Health Research Group