- The recent national meningitis outbreak, caused by contaminated medication from a large-scale compounding pharmacy, has prompted a call for increased FDA oversight over such establishments.
- While typically the jurisdiction of individual states, several state officials believe the FDA should have a role in regulating large-scale pharmacies, like the New England Compounding Center, where the tainted medication originated.
- The growth and evolution of the compounding pharmacy industry, where medication is tailored to specific patient needs, necessitates an updated legal framework and possibly more stringent regulations according to some healthcare officials.
- The FDA currently does not regulate compounding pharmacies to the same level as conventional pharmaceutical manufacturers, a discrepancy that has prompted calls for stronger regulation.
- The meningitis outbreak investigation revealed a potential risk of approximately 14,000 patients having received the contaminated steroid injections.
State public healthcare administrators request a more robust role from the U.S. Food and Drug Administration (FDA) in the auditing of large-scale compounding pharmacies, especially in light of recent tragic events.
Regulatory Concerns Post Meningitis Outbreak
The cause for this call to action came in the wake of a national meningitis outbreak resulting from contaminated medication vials intended for back and joint pain treatment, a meeting in our nation’s capital revealed.
The meeting in question comprised health officials from across all 50 states and representatives of the FDA, discussing possible regulatory issues. The contaminated vials were traced back to a specialized drug firm in Massachusetts, known as the New England Compounding Center. Escalating the tragedy was the revelation that the tainted vials had affected 620 individuals across 19 states, taking the lives of 39.
State or FDA Regulation?
While the oversight of pharmacies typically falls into the jurisdiction of individual states, certain states might lack the means to regulate large-scale establishments like the New England Compounding Center (NECC), as state officials pointed out.
Cody Wiberg, who leads the Minnesota Board of Pharmacy, added, “It’s unanimous amongst us all that the FDA should be involved when it comes to facilities similar in nature to the NECC. While most states are adequately equipped to manage compounding, the ability to regulate manufacturing enterprises on the scale of the NECC isn’t as commonplace.”
The Evolution of Compounding Pharmacies
Compounding pharmacies alter or mix ingredients creating medications that cater to specific patient needs. However, since the ’90s, such businesses have flourished. Dr. Margaret Hamburg, the FDA Commissioner, has been vocal about the legal framework not keeping pace with industry growth.
“The dynamics of healthcare and the role of compounding pharmacies have clearly evolved. This shift necessitates greater FDA oversight,” asserts Dr. Hamburg, expressing her opinions at a congressional hearing the previous month. Yet, she alongside others displayed apprehension that excessively stringent measures might negatively influence the health care system, most notably the capacity to individualize medications, an aspect experts consider pivotal.
Need for Enhanced Federal Oversight
Some detractors maintain that the FDA has not sufficiently carried out its duties. Michael Carome, deputy director of consumer advocacy group, Public Citizen’s Health Research Group, highlighted the need for a single federal standard, enforced by one agency, namely the FDA. “There has been a lapse in the enforcement of the standard,” says Carome.
The New England Compounding Center ceased functioning following the meningitis outbreak in early October.
Compounding Pharmacies and FDA Regulation
It’s important to understand that compounding pharmacies are not subjected to the same level of FDA regulation as typical pharmaceutical manufacturers. This discrepancy has invoked calls from Congress members for stronger FDA regulation of such businesses.
When asked to testify before a committee from the House of Representatives investigating the steroid/meningitis outbreak, the owner of the NECC refused last month. Meningitis is a condition that involves inflammation of the membranes surrounding the brain and spinal cord. The steroids in question were used on patients reporting back or joint pain.
FDA investigators performing an inspection of the NECC’s Framingham plant discovered foreign, “greenish-black” material in some vials of the injectable steroid suspected of causing the illnesses.
The CDC, along with state health departments, estimates that around 14,000 patients might have received steroid injections from the NECC.
For further details on injections for back pain, refer to the U.S. National Library of Medicine’s resource on the topic