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FDA Promises to Flex Regulatory Muscle to Oversee Compounding Pharmacies, but May Need Help

Following on the fungal meningitis outbreak, ongoing inspection issues raise new questions about how to prevent further drug-related outbreaks at pharmacies that custom-blend medications
fungal meningitis



Glenn Roberts

Black particles floating in vials of supposedly sterile medicine; poor air filtration systems; insufficient microbiological testing: These are just some of the issues federal drug inspectors discovered in recent inspections of compounding pharmacies like the one linked to a deadly fungal meningitis outbreak this fall.

Months later questions linger about how to best regulate compounding pharmacies like these and avert future tragedy. Federal drug inspectors recently tried to step up their oversight but faced stiff opposition, sometimes being denied access altogether. Twice they had to go to court and return with U.S. marshals in tow—causing delays of days or weeks, U.S. Food and Drug Administration Commissioner Margaret Hamburg told the House Energy and Commerce Subcommittee on Oversight and Investigations on April 16. Ultimately, the FDA’s recent flurry of inspections has been hampered by a complex patchwork of state and FDA oversight regulations, she said. Those delays can be crucial considering the significance of what FDA officials may find inside.

Exactly who can regulate these facilities that increasingly mix medications for patients, hospitals and clinics across the country continues to be a contentious issue since the deadly outbreak that began in September killed 53 and sickened more than 700.

Hamburg said that regulatory uncertainty continues to put Americans at risk. Compounding pharmacies, she said, may fall through the cracks, leading to future outbreaks like the fungal meningitis outbreak that resulted from tainted spinal steroid medications blended at the New England Compounding Center (NECC) in Framingham, Mass. “I am worried that if we do not work together there may be future problems of this magnitude,” she said. “We definitely need additional authority. At the present time compounding pharmacies, under existing laws, are not required to register with us, so we don’t know who they are and what they are making,” she noted.

Traditionally, compounding pharmacies were small mom-and-pop shops that created medications in response to specific prescriptions. For example, they would create liquid forms of pill medication for children or alter drug dosages. Over time this industry has grown and changed. Now an estimated 2,800 of these specialty pharmacies exist, Hamburg said. These shops may function more like drug manufacturers—filling large orders unrelated to specific prescriptions and sending them across state lines.

Regulations have not kept pace with this evolving landscape. The FDA maintains there is no way to know how many pharmacies are acting as compounders or what they are making. Typically, compounding pharmacies are regulated only by state pharmaceutical boards, whose standards and requirements vary; the compounders are not subject to the same oversight as drug manufacturers, which are subject to FDA rules. “We are concerned about this evolving new hybrid of compounding pharmacy that is making sterile products in advance of prescription and selling across state lines,” Hamburg said, “We do believe we need new authorities to adequately regulate them.”

Conflicting court decisions on this topic caused FDA to slow its inspections around the time of the fungal meningitis outbreak while it clarified its legal scope of action, Hamburg said. "I wish we had been more aggressive, and I can assure you that we are being more aggressive now," she added.

In the absence of new legislation the FDA has stepped up its inspections in recent months. And House Republicans charged that this new wave of activity underscores that the agency actually can inspect facilities without any new legislative authority—it has just failed to do so. Republicans pointed to FDA documents given to the committee that showed a host of complaints against the NECC  through the years. "Ten years of warning signs, alarm bells and flashing red lights were deliberately ignored," said subcommittee chairperson, Rep. Tim Murphy (R–Pa.).

“I think we all agree that the FDA could’ve done a stronger job and that we are committed to doing so going forward, “ Hamburg said at the hearing.

Since the NECC incident there have been seven additional recalls of sterile compounded and repackaged drug products by different pharmacies, according to the FDA.

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