Nov. 9, 2016

Allowing Pharmaceutical and Medical Device Manufacturers to Promote Their Products for Unapproved Uses Harms Patients, Threatens Public Health; Public Citizen Calls for Strong Limits on Such Promotion

Public Citizen Experts Testify at FDA Hearing on Manufacturers’ Off-Label Communications; Agency Should Reject Industry’s First Amendment Claim

WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) should strongly limit – not extend – off-label marketing practices because it endangers patients, Public Citizen experts will tell the agency today. Research shows 80 percent of unapproved (“off-label”) uses lack sufficient evidence of effectiveness and are associated with a more than 50 percent increase in side effects compared to on-label uses.

“The FDA would be reckless to weaken rules and allow the pharmaceutical and medical device industry to promote products for which they are not proven to be safe and effective,” said Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group. “Opening the door to the promotion of potentially dangerous products undermines the entire FDA approval process. The FDA needs to slam this door shut.”

Wolfe, Robert Weissman (president of Public Citizen) and Dr. Michael Carome (director of Public Citizen’s Health Research Group) are scheduled to testify today at an FDA public hearing on the pharmaceutical and medical device industries’ push to market medications and medical devices for unapproved uses. Doctors are permitted to prescribe medicines and devices for unapproved uses, but manufacturers are prohibited from touting their products for those uses.

In recent years, the industry has incorrectly 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.

In addition to presenting data highlighting the dangers of prescribing medical products for uses not proved to be safe and effective, Public Citizen explained:

  • Why a manufacturer’s claim that a product is safe and effective for an unapproved use is no substitute for the FDA’s independent, objective review of the underlying evidence for each proposed use;
  • 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; and
  • That the FDA has robust authority to maintain and strengthen restrictions on the promotion of products for unapproved uses, because such promotion is evidence of intent to engage in impermissible marketing.

“If manufacturers are able to engage in de facto marketing for unapproved uses, by virtue of making broad promotional claims for unapproved uses, then the entire FDA regulatory regime is threatened, with grave potential consequences,” said Weissman. “The First Amendment does not require the FDA to permit manufacturers to make such claims, and the agency should reject industry pleas to do so.”

View Wolfe’s and Carome’s written testimony.