Washington, DC – U.S. Senator Ben Cardin (D-MD) praised the U.S. Food and Drug Administration (FDA) for its latest initiative to help eliminate health disparities. As a result of a Cardin Amendment to the 2012 FDA Safety and Innovation Act (FDASIA), the FDA has released a comprehensive communication plan designed to ensure that physicians and patients are made aware of information identifying particular subpopulations that may experience adverse effects to drugs, biologicals or devices on the market.
The July report, “Ensuring Access to Adequate Information on Medical Products for All,” establishes channels for such information to be communicated through safety alerts, changes to the label or labeling of drugs (including black box warnings), health advisories, and electronic communications.
“Doctors and patients need complete, timely data to make informed decisions about which therapies are best suited for a given situation. Where we know that there are racial and ethnic differences in responses to drugs and medical devices, that information should be made routinely and easily available, said Senator Cardin. “Inequalities in health status and health care exact an enormous human and economic toll on our nation. It’s why Congress created Offices of Minority Health throughout HHS—-to focus on mechanisms to improve the health of our fastest-growing communities and eliminate the disparities that are evidenced by higher rates of debilitating diseases such as heart disease, diabetes, and cancer. The FDA Office of Minority Health can play a leading role in this effort.
“Today, warnings and safety precautions are included as part of the FDA’s initial approval process, and they may also be required, after the drug has been approved and sold for months or years. But additional side effects or risks may become known once a product is on the market. For example, there are racial and ethnic differences in responses to some pharmaceuticals, but they may not become known until the drug is in wide use, certainly beyond the constraints of a controlled clinical trial. Minority populations are traditionally underrepresented in clinical trials even though they are disproportionately affected by diseases these trials cover,” Senator Cardin added. “While we work to improve participation rates in trials going forward, we must make ensure that patients and the providers who treat them have access to the most up-to-date information to ensure safety and efficacy for all patients.”
The FDA Communication Plan is subject to a 60-day comment period.