October 13, 2010
NMQF CEO Applauds FDA for Removing Unapproved Colchicine from Market
Gary Puckrein calls on drug stores to follow FDA’s directive and protect patients
WASHINGTON, DC: Gary Puckrein, President and CEO of the National Minority Quality Forum (The Forum), recently spoke out in support of the Food and Drug Administration’s (FDA) actions taken to remove unapproved colchicine products from the marketplace.
“We applaud the FDA for the steps they’ve taken to protect patients by directing the removal of unapproved colchicine products from the market,” Dr. Puckrein said. “Unapproved colchicine has been associated with over 150 deaths, and with an approved version of this drug available, there was no reason why patients were being exposed to potential harms from untested colchicine. Now it’s time for the drug stores, pharmacy chains, and distribution lines to follow the FDA’s directive and act in the best interest of patients by taking unapproved colchicine off store shelves.”
On September 30, 2010, the FDA ordered manufacturers of unapproved single-ingredient colchicine products to stop manufacturing the drugs by mid-November and to stop shipping them by the end of December.
Dr. Puckrein also encouraged the FDA to continue protecting patient safety by removing other unapproved drugs from the market when possible.
“While the FDA’s removal of unapproved colchicine is an important step in the right direction, thousands of unapproved drugs remain on the market,” Dr. Puckrein said. “These drugs pose a threat to patients and we hope the FDA will continue to remove these drugs from the market when approved versions are available.”
Unapproved drugs have never been though the rigorous FDA approval process that best ensures patient safety in the United States. Devoid of FDA-approved labels that include vital safety information on proper dosage, regimen, and safe use, these untested products can be harmful or even deadly to patients, mostly due to adverse drug to drug interactions or adverse reactions to the drug itself.
The National Minority Quality Forum, a research and educational organization which works to ensure that high-risk racial and ethnic populations and communities receive optimal health care, is currently conducting an educational campaign called the “Did You Know Project,” which aims to educate Americans on the risks associated with the use of unapproved drugs.
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.