On Eve of FDA Meeting, Public Citizen Warns That Proposed Framework for Regulating Compounding Pharmacies Would Endanger Public Health

Note: The FDA is holding a meeting at 3 p.m. on Wed., Dec. 19, in Silver Spring, Md., at which FDA and state officials will share their perspectives on the FDA's proposal for oversight of drugs made by compounding pharmacies.

As the U.S. Food and Drug Administration (FDA) prepares to hold a public meeting Wednesday on a new framework for regulating compounding pharmacies, Public Citizen is expressing grave concern that the proposed changes would endanger public health.

In a letter sent today to Secretary of U.S. Health and Human Services Kathleen Sebelius, Public Citizen criticized FDA Commissioner Margaret Hamburg for both undermining her agency's authority in congressional testimony last month and offering a plan that would effectively weaken the agency's oversight of drug manufacturing.

Hamburg testified before House and Senate lawmakers on Nov. 14 and 15 during hearings investigating a fungal meningitis outbreak caused by contaminated injectable steroid drugs manufactured by the New England Compounding Center (NECC) in Framingham, Mass., which killed 37 people this fall.

Citing Hamburg's statements, Public Citizen concluded in its letter that the commissioner's testimony was evasive, included numerous inaccuracies and reflected an ongoing effort by the FDA to dodge responsibility for agency policy, oversight and enforcement failures that contributed to the fungal meningitis outbreak.

Public Citizen also cited other statements by Hamburg that appear to show a striking disregard for the importance of regulatory requirements for premarket review and approval of new drugs, good manufacturing practices and appropriate labeling -- all of which are vital to ensuring the safety and quality of the nation's drug supply.

During her appearances before Congress, Hamburg proposed two levels of oversight of pharmacy compounding. The first, "traditional," would include tailoring custom-made medicines for patients with individualized medical needs. Traditional compounding serves an important public health need and under the FDA's proposal would be regulated primarily by state boards of pharmacy.

The second level, "non-traditional," would cover activities that should be regulated under existing law as drug manufacturing. In recent years, many firms have used compounding as a guise to set up large drug manufacturing operations while avoiding FDA oversight. These activities are subject to FDA oversight, but the agency has been slow to enforce the laws governing drug manufacturing against compounding pharmacies.

Hamburg's proposal would not strengthen existing laws governing pharmacy compounding, Public Citizen said. Instead, it would weaken laws governing drug manufacturing by legalizing an entirely new tier of drug manufacturers that would be subject to substandard requirements for ensuring the efficacy, safety, quality and adequate labeling of drugs.

"The FDA's proposal for oversight of 'non-traditional' compounding, if implemented, would decriminalize what is now illegal drug manufacturing conducted under the guise of pharmacy compounding, and ensure the continuing occurrence of serious disease outbreaks caused by tainted drugs in the future," said Dr. Michael Carome, deputy director of Public Citizen's Health Research Group. "The proposal would legitimize current abuses to the system and put the public at risk."

Hamburg said the FDA's new plan was necessary because the agency lacks clear authority to regulate compounding pharmacies. But Public Citizen has shown that this claim contradicts previous assertions made by the FDA repeatedly over the past decade, including in numerous warning letters sent to compounding pharmacies.

Public Citizen calls on Sebelius to do the following:

- Reject Hamburg's dangerous legislative proposal and instead support alternative legislation that would strengthen existing laws by clarifying (a) the line between traditional pharmacy compounding and drug manufacturing and (b) the federal standards governing traditional compounding.

- Compel the FDA to use its existing authority to the fullest extent possible to enforce all provisions of the law for any company that manufactures drugs under the guise of pharmacy compounding.

- Direct the FDA Commissioner and her staff to be more forthcoming with the American public about the FDA's failures that contributed to the current fungal meningitis outbreak. In her testimony before a Senate committee on Nov. 14, Hamburg tried to blame the state of Massachusetts for the regulatory failures that led to the fungal meningitis catastrophe.

- Investigate who in the Center for Drug Evaluation and Research assisted the commissioner in preparing her testimony before Congress.

"Rather than undermining the FDA's authority, Commissioner Hamburg should be steadfast in acknowledging and enforcing the agency's current legal authority over all types of drug manufacturing," Carome said. "The commissioner's statements ultimately represent an extraordinary failure in leadership."

To read the letter, visit https://www.citizen.org/hrg2087.