The debate comes in response to a multi-state outbreak of fungal meningitis linked to tainted steroid injections from the New England Compounding Center (NECC), a "non-traditional" compounding pharmacy whose activities fell through the regulatory cracks, according to the FDA.
That outbreak has killed 39 and sickened more than 600, according to the Centers for Disease Control, and Public Citizen warned Tuesday that the FDA's regulatory proposal would weaken oversight that might otherwise prevent future outbreaks.
"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, in a statement.
Traditional drug compounders customize medications for patients with special needs on a prescription-by-prescription basis. Most operate on a small scale, but firms like NECC have taken advantage of regulatory ambiguity to mass-produce drugs that do not meet existing safety standards.
FDA Commissioner Margaret Hamburg proposes to regulate the industry in two tiers — traditional and non-traditional. Public Citizen insists that non-traditional compounders should be classified as drug manufacturers and overseen under existing law.
"Hamburg’s proposal would not strengthen existing laws governing pharmacy compounding," the group said in a memo to reporters.
"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."
Hamburg has said that her agency is enfeebled by conflicting court decisions that make its enforcement actions difficult. The FDA also shares oversight responsibilities with state regulators, further complicating its task.
"The challenge we have today is that there is a patchwork of legal authorities that oversee the action we can take," Hamburg said in a November congressional hearing.
She called on lawmakers to clarify the scope of the FDA's authority.
"In light of growing evidence of threats to the public health, the administration urges Congress to strengthen standards for non-traditional compounding."