The prominent consumer watchdog group Public Citizen indicates that a senate bill designed to restructure federal oversight of pharmacies may actually put Americans at risk, allowing compounding pharmacies to mass produce drugs without seeking FDA approval.
In testimony (PDF) submitted to the House Health Subcommittee this week, Public Citizen indicates that the FDA already has the authority to regulate compounding pharmacies, and that a proposed bill could hamper that ability. The bill, S. 959 (PDF) is one of three legislative proposals designed to strengthen regulations of compounding pharmacies that are now being debated in congress.
Concern over the regulation of compounding pharmacies comes in the aftermath of a fungal meningitis outbreak that began last fall and has killed more than 60 people nationwide and sickened more than 700 people after they received contaminated epidural steroid injections.
Poor manufacturing practices at the New England Compounding Center (NECC) in Framingham, Massachusetts has been been blamed for the outbreak, and concerns have been raised about how this one pharmacy was able to ship thousands of vials of mixed medications to providers nationwide with little or no oversight.
At a hearing this week, the FDA’s Center for Drug Evaluation and Research director Janet Woodcock told lawmakers that compounding pharmacies have drifted away from their traditional role of filling specific medications on a per-patient basis. She called on congress to clarify and strengthen the agency’s power to regulate them.
“NECC was not an isolated incident,” Woodcock said in her testimony (PDF). “Indeed, over the past 20 years, we have seen multiple situations where compounded products have caused deaths and serious injuries.”
Woodcock indicated that it was a matter of when, not if, there was another contamination outbreak linked to compounding pharmacies. However, Republican lawmakers have been skeptical, indicating that the FDA already has the power to regulate compounding pharmacies and that the agency failed to take appropriate actions to recognize and stop the practices at NECC.
Traditionally, compounding pharmacies are only supposed to make drugs that are not otherwise available for local hospitals on a per prescription basis. NECC had sales representatives hawking the tainted shots from coast to coast. Following the outbreak, records show that the FDA knew about the problem, but did little to stop it because FDA officials did not think they had the authority to regulate compounding pharmacies.
The reason Public Citizen and many others are concerned about the proposed legislation is because compounding pharmacies that take on the role of mass drug manufacturer are able to do so without seeking an FDA new drug approval, and Public Citizen warns that S. 959 will codify that into law, opening the door for more outbreaks.
The bill would create a new, hybrid regulatory tier called “compounding manufacturers” exempt from the FDA’s new drug approval process and federal labeling requirements, Public Citizen claims in its comments.
“We do not believe that new conditions and limitations are appropriate for these entities,” Public Citizen wrote. “Instead, we believe that all companies that wish to engage in drug manufacturing should be required to obtain new drug approval.”
The group urged the rejection of all three currently proposed pieces of legislation and called for a bill that would draw a clear line between drug manufacturers and compounding pharmacies, and strengthen FDA authority over them.
Public Citizen also called for new labeling requirements for compounded drugs that would alert patients that they are not FDA approved and that the accuracy of the product’s labeling has also not been assessed by the FDA.