FDA and Public Citizen: Bad Blood Brewing

Bad blood is brewing between the Food and Drug Administration (FDA) and Public Citizen.

Last month, Public Citizen called on the Department of Health and Human Services (HHS) Office of Inspector General to open an independent investigation into how the Food and Drug Administration (FDA) failed to use its established regulatory authority to protect the public from the dangerous practice of large-scale drug compounding that led to the widening fungal meningitis outbreak caused by tainted steroid injections.

So far, 409 people have been diagnosed with meningitis and other infections associated with the injections – and 30 of these had died.
Public Citizen condemned the FDA for making misleading statements to the public – particular claiming to lack “clear authority to take action earlier against” the New England Compounding Center (NECC), the company that produced large quantities of the contaminated steroid drug linked to the ongoing meningitis outbreak.

The Washington Post quoted Deputy FDA Commissioner for Global Regulatory Operations and Policy Deborah M. Autor as saying it was “really unfortunate that it sometimes takes a tragedy” to bring about change and calling for a “new regulatory scheme that appropriately controls the risk.”

“This attempt by one of the most senior figures within the FDA to deflect criticism for FDA failures that contributed to the meningitis outbreak is deeply troubling,” said Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group. “The claims by agency officials that the FDA lacks authority to properly regulate compounding pharmacies is contradicted by a long history of remarkably consistent statements and enforcement actions asserting the agency’s legal authority over such pharmacies.”

Prior warning letters from the FDA to several compounding pharmacies over the past decade, including one to the NECC in 2006, indicate that the agency considered these pharmacies to be engaged in drug manufacturing.

The pharmacies were considered by the FDA to be subject to the safety and effectiveness standards required for approval of new drugs, as well as the rigorous manufacturing standards designed to ensure that drugs are sterile and uncontaminated with such germs as bacteria or fungi before being sold and distributed, Carome said.

“Given its attempts to dodge responsibility in this matter, the FDA is clearly incapable of conducting an objective evaluation of its own policy, oversight, and enforcement decisions, which no doubt contributed to this ongoing preventable tragedy,” Carome said. “An independent investigation must be conducted and should identify all agency officials whose actions and decisions contributed to the FDA’s failure to prevent this public health catastrophe.”

This week, Public Citizen again attacked a high ranking FDA official.

This time it was Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.

What ticked off Public Citizen this time was an FDA statement expressing concern about an announcement by Ameridose that the company had voluntarily recalled all of its products after FDA inspectors found deficiencies in the company’s testing process for ensuring that its products were sterile.

Ameridose is owned by the some of the same people who own and operated the NECC.

The FDA expressed concern that this recall will worsen existing shortages of sterile injectable drugs.

“We have to balance the risk of lack of sterility assurance against the issues of products not being available,” Dr. Woodcock told the New York Times. “That’s a line we walk every day.”

Public Citizen’s Carome said that Woodcock’s statement “suggests that the agency is willing, in the face of drug shortages, to turn over production of drugs from mainstream drug manufacturers that are held by the agency to the rigorous regulatory standards for drug approval and manufacturing to companies that have not been – but under FDA’s existing legal authority could and should have been– held to those same high standards.”

“The FDA may previously have used concerns about drug shortages as an excuse to ineffectively regulate those drug manufacturing companies that acted under the guise of compounding pharmacies and engaged in large-scale production and national distribution of standardized versions of drugs without being required to adhere to established safety standards.”

“Any such decisions by the agency may well have contributed to the circumstances that allowed the current public health catastrophe to occur.”

Carome said that shortages often result when mainstream manufacturers of commercially available, FDA-approved drugs are cited for violations of the good manufacturing practice (GMP) regulations and need to upgrade their manufacturing facilities and procedures.

“The FDA should not permit compounding pharmacies to fill this gap because these companies have not demonstrated that their compounded products are safe and effective or, with limited exceptions, that they are manufactured in accordance with GMP regulations,” Carome said. “This is particularly true when uses of many of these drugs are elective and, in many cases, other commercially available FDA-approved versions are available or could become available through manufacturers that abide by the GMP regulations.”

“Allowing compounding pharmacies to take over market share for a drug also may discourage commercial mainstream drug manufacturers from resuming production of FDA-approved, higher-quality versions of drugs.”

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