Patient Advocacy Group asks FDA to Enhance its Enforcement of Unapproved Drugs Initiative

WASHINGTON--(BUSINESS WIRE)--The National Minority Quality Forum (The Forum) is launching a new public information campaign aimed to help educate consumers, physicians, and policymakers about the risks associated with prescribing and taking unapproved drugs that have not been subjected to the rigorous Food and Drug Administration’s (FDA) review and approval process. Unapproved drugs can be dangerous – or even deadly – to patients as a result of the lack of testing, unknown or unregulated ingredients, improper labeling, and as a result of this lack of information, the inability to predict drug to drug interactions.

“We believe it’s critically important that patients and healthcare providers recognize the potential dangers of prescribing and taking drugs that have not met the FDA’s rigorous standards”

“We believe it’s critically important that patients and healthcare providers recognize the potential dangers of prescribing and taking drugs that have not met the FDA’s rigorous standards,” The Forum president Dr. Gary Puckrein said. “The 'Did You Know Project' will serve as a resource for patients, physicians, healthcare providers, and policymakers as they make important healthcare decisions.”

The Forum’s, “Did You Know Project” will provide information on unapproved drugs through a number of resources available on the project’s website, www.DidYouKnowProject.com. This will include research, relevant news articles, and an interactive blog to discuss current and product information helpful to patients. In addition, those who want to take action will be able to send a letter directly to the FDA, his or her Member of Congress, or President Obama calling on them to do what they can to strengthen FDA’s commitment to the Unapproved Drugs Initiative.

Dr. Puckrein recently notified the FDA of the Forum’s “Did You Know Project” in a letter to Dr. Janet Woodcock, the FDA’s director of the Center for Drug Evaluation and Research. In the letter, Dr. Puckrein described the Project as an “educational resource to consumers, physicians and policymakers who want to learn more about risks associated with unapproved drugs in the marketplace.”

The best way to mitigate the potential for harm is for patients to use FDA approved drugs when possible. The FDA’s meticulous and proven approval process has meant a safer world for patients in the U.S. since the Agency’s creation. The FDA’s Unapproved Drugs Initiative was established in 2006 to respond to patient concerns over the potential dangers of taking unapproved drugs. The initiative specifically encourages pharmaceutical companies to follow FDA protocols to get unapproved drugs tested and, if found to be safe and effective by the FDA, approved. To incentivize companies to invest in improving their product and gain FDA approval, the Agency agreed to remove unapproved drugs from the marketplace. To date, however, although some unapproved drugs have been taken off the market, many still remain.

The Forum looks forward to working with the FDA to help address the issue of unapproved drugs in the marketplace and educate patients, physicians, healthcare providers, and policymakers about the need to ensure the safety of the nation’s drug supply.

About the National Minority Quality Forum

The National Minority Quality Forum is a non-profit organization that was founded in 1998 by Dr. Gary Puckrein in order to address the critical need for strengthening national and local efforts to use evidence-based, data-driven initiatives to guide programs to eliminate the disproportionate burden of premature death and preventable illness for racial and ethnic minorities and other underserved populations.