Acting with unusual speed and in the wake of a major fungal meningitis outbreak, officials of the U.S. Food and Drug Administration have announced plans to implement a new law regulating drug compounders.
In a news conference just five days after the new statute was signed into law by President Obama, FDA Commissioner Margaret A. Hamburg conceded that the law does not give her agency all the powers it would have liked but called it “a step forward.”
She said the new law should be “a great relief” to both health-care providers and patients.
The law does give the agency increased regulatory power, including on-site inspections, over those drug compounders who voluntarily choose to register with the agency, Hamburg said. The implementation will include a campaign to get physicians, hospitals and other health-care providers to use only those firms that choose to register, she said.
The Drug Quality and Security Act was passed in response to the fungal meningitis outbreak that killed 64 patients, including 16 treated in Tennessee. A now-defunct Massachusetts drug compounder, which shipped thousands of fungus-tainted vials of methylprednisolone acetate across the country, has been blamed for the outbreak.
Hamburg said a series of non-binding guidance documents was issued detailing how the agency intends, at this point, to begin the registration process. Once companies register, they will be subject to FDA inspection and will be required to file reports twice a year detailing just what drugs they are compounding.
“We do appreciate having greater clarity. There are, of course, other authorities we would like to have seen,” Hamburg said, citing as an example the authority to inspect company records.
She noted that the measure also eliminates a section in the old law limiting advertising. That provision was declared unconstitutional in a court case, which in turn led to confusion over the FDA’s regulatory authority.
Jane Axelrad, associate FDA director, said the agency does not now know how many companies fit into the new category of drug outsourcers created by the law.
“It’s too early to estimate,” she said, adding that it could be from 700 to 1,000.
Hamburg said the agency will have to rely on state regulators to help spot companies that should be registered or that deserve closer scrutiny. The law does call for increased communication between state pharmacy boards and the FDA.
FDA spokeswoman Erica Jefferson said that the law also provides that the added revenue generated by the companies registering as compounders will be available to fund the program.
Officials of the Tennessee Pharmacy Board say they don’t yet know whether the new federal law will require any changes in state statutes or regulations.
The new law has come under criticism from advocacy groups and a drug compounders’ association. Dr. Michael Carome of Public Citizen has warned that the statute eliminates a requirement that drugs be compounded only for a specific patient with a written prescription.
Under the new federal law, compounding pharmacies that agree to issue drugs only with patient-specific prescriptions would be exempt from registration.