Outbreak Prompts Markey to Seek Stronger Oversight of Compounding Pharmacies

Posted November 5, 2012 at 4:09pm

Massachusetts Democrat Ed Markey says he will introduce a bill Friday that would clarify the Food and Drug Administration’s authority over compounding pharmacies, the first such bill since the September outbreak of fungal meningitis.

Markey, a House Energy and Commerce Committee member, said his bill would end “this regulatory black hole by giving the FDA new, clear authority.”

The legislation would specify when the FDA can regulate compounding pharmacies, and when pharmacies would be exempt from some regulations. It also would allow the FDA to provide waivers for compounding pharmacies.

Lawmakers in both parties have been looking into regulatory oversight for compounding pharmacies since the outbreak, linked to a company in Markey’s district that made a contaminated injectable steroid. So far, the outbreak has caused 28 deaths and 377 cases of fungal meningitis in 19 states, according to the Centers for Disease Control and Prevention.

The Senate Health, Education, Labor and Pensions Committee will hold a Nov. 15 hearing on the outbreak’s implications for compounding pharmacies and how to prevent future contaminations.

But the increased attention may not lead to action on Markey’s bill in the few weeks remaining this session. Energy and Commerce is investigating the pharmacies but has not scheduled a hearing.

“We first need to fully gather and understand all the facts of what went wrong before determining how best to ensure such an outbreak never happens again,” an Energy and Commerce aide said.

The last time Congress clarified the FDA’s authority over compounding pharmacies, lawsuits followed, and conflicting court rulings since then have left the agency’s role unclear. The FDA generally leaves oversight of compounding pharmacies to the states and does not require compounded drugs to meet the same safety and efficacy requirements as other new drugs.

But Markey and other Democrats say some compounding pharmacies act like traditional drug manufacturers, making large batches of drugs and essentially avoiding oversight. Under Markey’s bill, compounding pharmacies that act more like drug manufacturers would have to register as manufacturers and would be subject to the same inspections as others.

Pharmacies doing traditional compounding — making drugs for specific patients with valid prescriptions, using safe and approved ingredients and not copying commercially available drugs — would be exempt from some regulations. The FDA could grant waivers for compounding pharmacies that are not manufacturers but want to compound drugs before receiving prescriptions, such as hospital pharmacies.

The agency could also waive its requirements for a limited period in the event of a drug shortage or to protect the public health.

The agency would maintain a publicly available list of drugs that are not safe or effective when compounded, and pharmacies would need to report potential safety problems or adverse events. Patients would be notified that compounded drugs are not FDA-approved.

Markey outlined his legislation Thursday at a news conference at the New England Compounding Center headquarters.

Earlier this week, Markey released a report that said the compounding industry has resisted increased regulation from the FDA and that state regulators have not had a consistent role in ensuring compounded drug safety.

Rep. Rosa DeLauro (D-Conn.) has said she plans to introduce legislation when Congress returns from recess that would give the FDA more authority over compounding pharmacies. Other lawmakers also have sought information on the pharmacy and its oversight, and some have called for hearings.