Retail News Breaks Archives
Consumers back FDA regulation of compounding, survey finds
September 18th, 2013
WASHINGTON – A new survey indicates strong consumer support for Food and Drug Administration regulation of pharmacy compounding.
The Working Group on Pharmaceutical Safety said Wednesday that the natonal telephone poll of 800 randomly selected registered voters, conducted by KRC Research, found that 77% are concerned that the FDA doesn't verify the safety, effectiveness or manufacturing quality of compounded drugs.
What's more, the survey revealed that 87% of respondents think it's "very important" that their doctor inform them if they are prescribed or administered a drug that's not FDA-approved.
The results of the survey come as Congress considers legislation to address the oversight of compounding pharmacies and one year after contaminated drugs produced at a compounding pharmacy, the New England Compounding Center (NECC), caused a deadly fungal meningitis outbreak that has claimed 64 deaths nationwide and sickened more than 700 others, the Working Group on Pharmaceutical Safety noted.
"These results show overwhelming support among Americans that the federal government should provide oversight to ensure the safety of the medications that doctors prescribe," stated Tommy Thompson, co-leader of the Working Group and chairman of TherapeuticsMD, a specialty pharmaceutical company. "Last year's meningitis outbreak and recent troubling findings following inspections of compounding pharmacies underscore the need for legislation that meets the simple and straightforward expectations of voters."
Other key findings of the survey include the following:
• 83% of voters polled said that if their doctor would like to prescribe a drug for them that is not FDA-approved, it's very important for their doctor to tell them about FDA-approved alternatives, if one exists.
• 86% are concerned that not every prescription drug sold to patients in the United States has been reviewed and approved by the FDA.
• 77% support legislation to give the FDA more authority to regulate compounding pharmacies and compounded drugs.
"Any legislative proposal should meet the common sense expectations of voters for oversight and disclosure," commented Sarah Sellers, a public health expert in pharmacovigilance and epidemiology, who is also a co-leader of the Working Group. "The message is clear: Close the loopholes that have endangered patient safety for too long."
Co-led by Thompson, former U.S. Secretary of Health and Human Services and governor of Wisconsin, and Sellers, a former research fellow in the FDA's Office of Compliance and a safety reviewer in the agency's Office of Safety and Epidemiology, the Working Group on Pharmaceutical Safety includes as participants the American Society for Reproductive Medicine; Asthma and Allergy Network Mothers of Asthmatics; Blue Ribbon Advocacy Alliance; Caregiver Action Network; Global Healthy Living Foundation; MD Support; Society for Women's Health Research; StopAfib.org; Terri Lewis, volunteer community manager of the Meningitis Outbreak Facebook page sponsored by The Tennessean; Auxilium Pharmaceuticals Inc.; K-V Pharmaceutical Co.; Mobius Therapeutics; and TherapeuticsMD.