FDA told to talk before enforcing pharmacy law

The Senate Appropriations Committee has told the Food and Drug Administration to reach out to stakeholders such as physicians, patients and pharmacists before releasing new guidances for compounding pharmacies.

Under the 2013 Compounding Quality Act, the FDA has greater oversight and funding to regulate compounding pharmacies. However, in a new report the committee is also requiring the agency to meet with stakeholders before issuing further guidances.

{mosads}According to Sen. Lamar Alexander (R-Tenn.), the committee’s ranking member, physicians, patients and pharmacists have told him the agency has not consulted with them to address their concerns before developing a new guidance. 

The FDA was granted additional powers last year to oversee compounding centers after dozens of people died and hundreds across the country were infected with fungal meningitis from contaminated vials produced by the New England Compounding Center. 

At Alexander’s request, the committee has asked the FDA to reach out before moving forward on the law.

“The purpose of the compounding law is to end confusion and improve communication so we can help prevent another tragic meningitis outbreak,” he said. “If FDA isn’t sitting down with doctors, patients, and pharmacists and communicating how it is implementing the law, then I will stay on FDA until it does.” 

In March, the FDA held a large inter-governmental working meeting of state and federal officials that included representatives from state boards of pharmacies and health departments to talk about implementing the law. 

The agency also put out a draft guidance on compounding pharmacies in April that allows all stakeholders to comment until June 2. 

– This article was updated May 27 at 10:50 am.