Orthopaedic Alerts - Implant Recall

In the wake of the recent national meningitis outbreak, lawmakers are taking action to uncover what led to the deadly events and to prevent such a health scare from happening again in the future.

Dr. Margaret Hamburg (seen at right), U.S. Food and Drug Administration commissioner, will testify before the Energy & Commerce Committee of the House of Representatives on Nov. 14 and the Senate health committee the next day. She is expected to address what other FDA officials said last month — that the agency may need to be more involved with regulating compounding pharmacies.

The 419 cases of meningitis reported to the Centers for Disease Control and Prevention have been linked to contaminated steroid injections from the New England Compounding Center (NECC) in Massachusetts. The shots were used by doctors to relieve patients’ back pain. Thirty people who contracted meningitis have died, The Boston Globe reported.

Should Compounding Pharmacies Come Under FDA Oversight?

At issue is whether some compounding pharmacies, such as NECC, are supplying such large orders that they are, in fact, operating more like a drug manufacturer and should be subject to FDA oversight. Compounding pharmacies traditionally create customized prescriptions placed by doctors for individual patients and are regulated by state health boards. In the past, when the FDA has tried to step in, the courts have ruled it has exceeded its authority, the newspaper reports.

Recent inspections by the FDA and the Massachusetts Department of Health of the NECC facilities have turned up unsterile conditions, including “green and yellow residues, water droplets and standing water in or around production rooms that were supposed to be sterile,” The Globestates.

Also invited to the first congressional hearing about the meningitis outbreak are Barry Cadden, co-founder of NECC, and James Coffey, director of the Massachusetts Board of Registration in Pharmacy.

Emergency Rules Put into Place

Last week, the Massachusetts Board of Registration in Pharmacy announced new emergency rules that will allow the state to track drugs distributed by compounding pharmacies. In doing so, it hopes to be able to determine which facilities fall under FDA licensing regulations and also to receive notice of when such companies are being investigated by another state or national agency.

In addition, Massachusetts will have the authority to act more quickly in halting production at a compounding pharmacy and in quarantining medicines suspected of contamination.

On the national level, Massachusetts Congressman Ed Markey proposed federal legislation that would close the gap in oversight and give the FDA further responsibility when it comes to compounding pharmacies.

“No one should live in fear that their medicine is unsafe, and these actions at the state and federal level will help ensure we’re at the forefront of efforts to protect public health,” interim state public health commissioner Dr. Lauren Smith said in a statement.