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Public Citizen to Congress: Proposed Compounding Pharmacy Legislation Would Be a Major Step Backward for U.S. Drug Safety

Statement of Dr. Michael Carome, Deputy Director, and Sarah Sorscher, Attorney, Public Citizen’s Health Research Group

After a tainted drug from a New England compounding pharmacy killed 53 people and exposed a major safety problem posed by a growing illegal drug manufacturing industry, one would think that lawmakers would leap to correct the problem and boost patient safety.

Not this Congress. Senate lawmakers are proposing what amounts to a giant step backward for U.S. drug safety and quality control.

Draft legislation on pharmacy compounding released Friday, April 26, by the U.S. Senate Committee on Health, Education, Labor and Pensions (the Senate HELP Committee) would dramatically weaken patient protections by creating an extremely dangerous new class of drug manufacturers, confusingly called “compounding manufacturers.” (In contrast to drug manufacturing, pharmacy compounding involves a pharmacist preparing, in response to a physician’s prescription, an individually customized drug for one patient who has unique medical needs that cannot be met by a commercially available, Food and Drug Administration (FDA)-approved drug manufactured by a pharmaceutical company.)

These second-tier manufacturers would be permitted to mass-produce standardized drugs and sell across state lines without obtaining FDA approval or meeting federal labeling requirements intended to ensure the safe use of drugs — requirements currently mandated for all drug manufacturers.

Rather than strengthening the FDA’s authority over high-risk manufacturing activities, this bill would remove important federal requirements that protect patients from unsafe and ineffective drugs and bring about massive deregulation of a growing industry of second-tier drug manufacturing — an industry that has been permitted to thrive under the guise of “pharmacy compounding” in violation of current federal law due to lax FDA enforcement. Even worse, the substandard drugs manufactured by proposed second-tier “compounding manufacturers” would carry no warning label to notify hospitals, doctors and patients that drugs made by this industry are not approved by the FDA or evaluated by the FDA for safety, efficacy and accurate labeling.

Under current law, compounding pharmacies that mass produce standardized products, as opposed to producing customized drugs to meet an individual patient’s needs, are considered drug manufacturers and are subject to FDA regulation. As manufacturers, these firms can be prosecuted if they fail to register with the FDA, submit to FDA inspections, obtain FDA pre-market approval, follow good manufacturing practices, report adverse events or take certain steps to avoid false or misleading labeling.

In the past, the FDA has been slow to enforce these laws against companies calling themselves “compounding pharmacies,” even where they engage in manufacturing activity. The agency can correct that error by taking swift, aggressive action to identify and prosecute these companies under existing statutory authority.

Yet rather than pushing the FDA to fully use its existing authority and giving the agency enhanced authority to monitor and inspect all compounding pharmacies, the Senate HELP Committee proposal ratifies and endorses the FDA’s history of under-enforcement, allowing “compounding manufacturers” to continue manufacturing drugs under greatly weakened federal standards.

Under these clearly weakened standards, “compounding manufacturers” would only have to comply with limited federal requirements (such as good manufacturing practices, registration and some post-marketing inspection requirements), but could mass-produce new drugs without obtaining FDA premarket approval or complying with federal labeling requirements. As a result, “compounding manufacturers” could manufacture new drug formulations and combinations that have not been evaluated for safety and efficacy and could launch new, untested manufacturing processes without first receiving an inspection or approval by the FDA. They also would not be required to include labels that explain how to safely use the product, including indications for use, precautions and warnings about serious toxicities, and contraindications for use.

The proposed legislation also fails to adequately strengthen federal oversight of traditional compounding pharmacies. Under the new law, these companies would be entirely exempt from FDA authority, including registration and inspection requirements. This would make it harder for the FDA to police the line between traditional compounding and drug manufacturing, a major problem because the definition of “traditional compounding” in the statute is overly broad, ambiguous and subject to abuse.

The American public deserves better. Congress should reject the HELP Committee proposal and instead adopt legislation that would:

– Draw a single, clear line between traditional compounding and drug manufacturing, with no newly created category of second-tier, substandard drug manufacturers, called “compounding manufactures”;

– Provide adequate funding to the FDA to aggressively enforce existing laws against “compounding pharmacies” that cross the line into manufacturing;

– Strengthen the FDA’s authority to police the line between traditional compounding and drug manufacturing by requiring registration and granting the FDA authority to inspect for traditional compounding pharmacies, regardless of whether they engage in drug manufacturing activities; and

– Require clear, standardized warning labels to communicate to providers and patients who purchase traditional compounded products that the safety, efficacy and the accuracy of the product’s labeling have not been assessed by the FDA.