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July 16, 2013

Pharmacy Compounding Bills Would Endanger Patients, Public Citizen Tells Lawmakers

Comments Submitted to House Subcommittee Call for Stronger FDA Oversight

WASHINGTON, D.C. – Three proposed bills related to federal oversight of pharmacy compounding would put patients at significant risk by allowing companies calling themselves compounding pharmacies to manufacture drugs without meeting the same safety standards required of brand name and generic drug manufacturers, according to comments submitted by Public Citizen to the Health Subcommittee of the House Energy and Commerce Committee for its hearing today.

The comments acknowledge legitimate medical needs for traditional drug compounding, the individualized production of medicines according to a physician’s prescription for a patient with unique medical needs. But Public Citizen criticizes three pending pieces of legislation for weakening the Food and Drug Administration’s (FDA) ability to police the activities of large-scale compounding manufacturers that would serve a larger group of patients. These companies mass-produce standardized drugs, engaging in activities that exceed the scope of traditional compounding practice, and should be regulated as drug manufacturers under federal law. The three bills would weaken federal drug manufacturing standards by permitting compounders to engage in scaled-up manufacturing activity without first seeking new drug approval or meeting important federal labeling requirements.

The three proposals are the Pharmaceutical Compounding Quality and Accountability Act (S. 959), Verifying Authority and Legality in Drug (VALID) Compounding Act (H.R. 2186) and a draft bill recently proposed by U.S. Rep. Morgan Griffith (R-Va.).

The proposed measures come after a tainted injectable steroid drug made by the New England Compounding Center sickened 749 people, 61 of whom have died.

“Rather than strengthening the oversight of traditional pharmacy compounding, any of these bills, if enacted, would undermine the strict legal standards for ensuring the safety and effectiveness of manufactured drugs that have been in place in the U.S. for more than half a century,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group and the co-author of today’s comments. “To varying degrees, the proposed bills 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.”

Public Citizen argues that S. 959 would create a “second, substandard tier of drug manufacturers, confusingly called ‘compounding manufacturers,’” which would not be required to get new drug approval by the FDA or comply with the standard federal labeling requirements. “All drug manufacturers should be held to the same standards,” the comments say.

The draft bill proposed by Griffith would allow drugs to enter the market with minimal standards of safety oversight. The standards are similar to those allowed by S. 959 and would maintain an “advanced compounding” provision that has been abused by compounders in the past. It also permits unlimited non-patient-specific purchasing by health care providers of compounded drugs to be administered in a health care setting – a category of drugs that already is high-risk.

The VALID Compounding Act would allow pharmacy compounders to scale up their manufacturing without seeking new drug approval by permitting them to compound without individual patient-specific prescriptions as long as the pharmacy registers with the FDA and follows other conditions yet to be specified.

While there are important differences between the three bills, none would require compounding pharmacies that mass-produce standardized drugs to seek pre-market approval from the FDA or meet important federal labeling requirements. Pre-market approval is necessary to show that a drug is safe and effective, and to verify that manufacturing practices are appropriate and the finished product meets quality standards before it is sold. Labeling requirements ensure that important safety information and directions for use are accurately communicated to health care providers and patients.

“Despite several hearings to date, none of the proposed solutions would make patients safer and end the compounding pharmacy health crisis,” said Dave Sterrett, health care counsel at Public Citizen.

Public Citizen outlined four things a bill should do to ensure improved safety for consumers:

- Draw a clear line between drug manufacturing and compounding, with no loopholes for large-scale production of unapproved drugs;

- Strengthen the FDA’s ability to monitor this dividing line by requiring compounders to register with the FDA and giving it authority to inspect traditional pharmacies;

- Prevent dangerous compounding of high-risk drugs by giving the FDA authority to identify dosage forms and active ingredients that cannot be compounded; and

- Require clear, standardized warning labels displaying to providers and users of compounded products that they are not FDA-approved.

Read today’s comment here. Our May 3 comments about the Senate HELP Committee Draft Proposal for Regulatory Oversight of Compounding Pharmacies are here.

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