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May 16, 2013

Public Citizen to Congress: New Bill on Pharmacy Compounding a Major Step Backward for U.S. Drug Safety

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

Two weeks ago, Public Citizen expressed grave concernsto the Senate Health, Education, Labor & Pensions (HELP) Committee that its draft proposal on pharmacy compounding would weaken existing laws governing drug manufacturing. The proposal would create a new regulatory class of drug manufacturers, confusingly called “compounding manufacturers,” that would be exempt from federal premarket approval and related labeling requirements.

The bill on pharmacy compounding, S. 959, introduced in the Senate on Wednesday, offers no significant improvement over the draft. The American public deserves much better.

Under current law, a pharmacy that engages in large-scale, standardized drug production is considered a drug manufacturer and must obtain new drug approval from the Food and Drug Administration (FDA) to market a drug legally in the United States. In contrast, a pharmacy that engages in traditional pharmacy compounding prepares, 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, FDA-approved drug.

Public Citizen would support legislation that clarifies the line between traditional compounding and drug manufacturing and assists the FDA in policing compounding pharmacies to ensure that they don’t engage in illegal manufacturing or other dangerous activities.

The current proposal does not clarify the line between traditional compounding and drug manufacturing. Instead, it creates a third regulatory category of “compounding manufacturers” which, contrary to current law for drug manufacturers, would not be required to seek pre-market approval from the FDA or meet some important federal labeling requirements. Rather, they would be subject to an entirely different regulatory scheme from other manufacturers. They could mass-produce new drugs without testing for safety and efficacy and would undergo inspections only after a drug is on the market. This scheme represents an unacceptable step backward from the strict standards currently required for all drug manufacturers in the United States, and would result in the further growth of substandard – and what is currently illegal – drug manufacturing that has been allowed to thrive under the guise of pharmacy compounding.

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 manufacturers”;
  • Provide adequate funding to the FDA to aggressively enforce existing laws against so-called “compounding pharmacies” that engage in illegal drug manufacturing or other dangerous activities;
  • Provide the FDA with sufficient authority to police that line between drug manufacturers and compounding pharmacies to ensure that the latter do not engage in illegal manufacturing or other dangerous activities, by requiring registration, and granting the FDA authority to inspect the records of traditional compounding pharmacies and to create a list of drugs that should not be compounded; 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.



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