Strong Support for Effective FDA Regulation of Compounding Pharmacies

Voters Expect to Be Informed If They Are Prescribed A Drug Not Approved By the FDA 
WASHINGTON – As Congress considers legislation to address the oversight of compounding pharmacies, a new, independent survey released today highlights the large gap between voters’ expectations that the medications they receive are FDA-approved and loopholes in federal law that enable some pharmacies to avoid Food and Drug Administration (FDA) regulation. The results of the survey come 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 new, national survey of 800 randomly selected registered voters polled from Sept. 3–8, found a strong majority (77%) are concerned that FDA does not verify the safety, effectiveness, or manufacturing quality of compounded drugs, and nearly all (87%) believe it is “very important” that their doctor inform them if they are prescribed or administered a drug that is not FDA approved. Conducted by KRC Research and commissioned by the Working Group on Pharmaceutical Safety, voters were surveyed to help inform policymakers regarding the expectations of the public.
“These results show overwhelming support among Americans that the federal government should provide oversight to ensure the safety of the medications that doctors prescribe,” said Governor 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.” 
 87% say it is very important for their doctor to inform them if they prescribe non-FDA approved prescription drugs
 83% say if their doctor would like to prescribe a drug for them that is not FDA-approved, it is very important for their doctor to tell them about FDA-approved alternatives, if one exists
 77% are concerned that the FDA does not verify the safety, effectiveness, or manufacturing quality of compounded drugs
 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,” said 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.”