Statement by the National Minority Quality Forum on the FDA Report: “Ensuring Access to Adequate Information on Medical Products for All”

Released July 18, 2013

The National Minority Quality Forum commends the Food and Drug Administration (FDA) on the release of the report, “Ensuring Access to Adequate Information on Medical Products for All.” This report is an important step in advancing efforts to improve the quality and effectiveness of drugs, biologics and devices in racial and ethnic populations that are underrepresented in advanced clinical research, including Hispanics/Latinos, African Americans, and Asians/Pacific Islanders. The report, which was released by FDA on July 9, 2013, was mandated by Section 1138 of the Food and Drug Administration Safety and Innovation Act (FDASIA), which was signed into law on July 9, 2012.

The report outlines the steps that FDA will take to improve communications designed to inform and educate health care practitioners and patients on the benefits and risks of medical products. These enhanced communications will serve to reduce adverse events and increase medication adherence.

Most importantly, these improved communications will help create a universe of health care consumers who are more informed about medications and therapies currently on the market, and are more willing to participate in the advanced clinical research that is essential to the creation of a high quality health services research, delivery and financing system that meets the needs of all Americans.

“Increasing the diversity of the patient populations enrolled in all clinical trials is essential to the availability of best possible medical treatment to historically underrepresented populations, and to assure the safety and effectiveness of potential new medicines for the rapidly changing American demographic,” stated Dr. Gary Puckrein, President and CEO of the National Minority Quality Forum. “The National Minority Quality Forum has joined with the Pharmaceutical Research and Manufacturers of America (PhRMA) and Microsoft to launch a National Clinical Trial Network (NCTN) to enhance participation and diversity in clinical trials.”

Once fully operational, the NCTN will provide a unique internet-based resource that connects patients, medical researchers, healthcare professionals, clinical trial sponsors, and related organizations (e.g. patient and community organizations, and research centers) as well as disease, patient and investigator registries into a national collaborative research network. This network will help engage diverse populations who share a common disease experience and may benefit from novel therapies to facilitate their active and timely participation to clinical trials.

“We look forward to opportunities to partner with the Food and Drug Administration on the implementation of this communication plan, as well as on future efforts to increase the heterogeneity of clinical trial cohorts,” Dr. Puckrein concluded.

The National Minority Quality Forum (The Forum) is a Washington, DC-based not-for-profit, non-partisan, independent research and education organization dedicated to improving the quality of health care that is available for and provided to all populations. Visit our website at www.nmqf.org. Look for us on Facebook (National Minority Quality Forum), and follow us on Twitter (http://www.twitter.com/NMQF).