WASHINGTON – Members of the U.S. House of Representatives’ Energy and Commerce Committee should reject two bills that would undermine regulatory standards for ensuring that drugs and medical devices are safe and effective for each marketed use, Public Citizen and 12 other groups said in a letter sent to committee members today.
H.R. 1703 (the Medical Product Communications Act of 2017) and H.R. 2026 (the Pharmaceutical Information Exchange Act), both being considered for inclusion in legislation to reauthorize the U.S. Food and Drug Administration’s (FDA’s) user fee programs, would threaten patient safety by allowing pharmaceutical and medical device companies to significantly expand the marketing and promotion of their products for unapproved (off-label) uses.
“It is critically important that all medications and risky medical devices continue to undergo rigorous independent FDA review to ensure that they are safe and effective for all intended uses,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “But under H.R. 1703 and H.R. 2026, Big Pharma and the medical device industry would be able to circumvent FDA review. Congress considered similar dangerous legislation during the drafting of the 21st Century Cures Act and wisely rejected it, and we urge Congress to once again do the same.”
The FDA, on behalf of the public, has a strong interest in evaluating the safety and effectiveness of medical products for any additional uses that were not evaluated at the time of the products’ initial approval. For example, the agency may approve a prescription that poses a serious risk to a patient’s immune system to treat cancer but not to treat a headache. Indeed, a therapy that is reasonably safe for one use can be life-threatening for another.
Although prescribing drugs and devices for unapproved uses is common, scientific evidence supporting most such uses often is lacking, the letter said. For example, a recent study conducted in Canada found that the vast majority of off-label uses of drugs – 81 percent – lacked strong scientific evidence of usefulness for patients. Even worse, patients who received a prescription for an unapproved use were 54 percent more likely to suffer adverse reactions requiring cessation of usage compared with patients taking medications for approved uses.
H.R. 1703 and H.R. 2026 were introduced in the U.S. House in March and April, respectively. Both bills were referred to the House Energy and Commerce Committee’s Subcommittee on Health.
After-the-fact enforcement of safety and efficacy standards for marketing of medical devices and prescription medications is inadequate to protect patient safety; these bills must be rejected, the groups said.
Groups joining Public Citizen in sending the letter are:
Annie Appleseed Project
Association for Medical Ethics
Breast Cancer Action
Breast Cancer Consortium
Citizens Commission on Human Rights
Doctors for America
Health Global Access Project
Jacob’s Institute of Women’s Health
National Center for Health Research
The Society for Patient Centered Orthopedics
The TMJ Association
Treatment Action Group
View the letter here.