May 13, 2013

I was stunned to read the uncritical editorial [“Concocting a cure,” May 7] lauding the draft Senate bill on pharmacy compounding. The Post’s statement that compounding pharmacies engaged in drug manufacturing, newly dubbed “compounding manufacturers,” would “meet the same standards as large drugmakers” is absolutely false.

Contrary to current law for manufacturers, under the Senate bill, compounding manufacturers would not be required to seek pre-market approval from the Food and Drug Administration (FDA) or meet some important federal labeling requirements. They could mass-produce new drugs without testing for safety and efficacy and would undergo inspections only after a drug is on the market. The FDA would have the burden of proving that the compounding manufacturers’ advertising was false or misleading, even for unsupported safety and efficacy claims.

The Senate proposal is a clear step backward, one that would profoundly weaken standards for ensuring the safety and effectiveness of a large class of manufactured drugs. The Senate should scrap the compounding manufacturing idea and focus on drawing a clearer line between traditional compounding and manufacturing, making it easier for the FDA to prevent abuses by traditional compounders through stronger registration and inspection requirements and a national “do not compound” list for dangerous or unapproved drugs.

Sidney M. Wolfe, Washington

The writer is director of the Health Research Group at Public Citizen.