Markey Bill Would Set Standards for FDA Oversight of Compounding Pharmacies

Posted November 1, 2012 at 12:00am

Massachusetts Democrat Edward J. Markey will introduce a bill Friday to clarify the Food and Drug Administration’s authority over compounding pharmacies, the first such bill since the September outbreak of fungal meningitis.

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

It would specify when the FDA can regulate compounding pharmacies, and when the pharmacies would be exempt from some regulations. It also would allow the FDA to provide waivers of its requirements for compounding pharmacies in certain circumstances.

Lawmakers of both parties have been looking into the issue of regulatory oversight for compounding pharmacies since the outbreak, linked to a company in Markey’s district that made a contaminated injectable steroid. Those investigations will be part of Congress’ agenda after the recess.

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

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.

But the increased attention on the issue may not lead to action on Markey’s bill in the few weeks remaining this session. The Energy and Commerce Committee is conducting an investigation into 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,” said a House Energy and Commerce aide. “The committee will remain in close contact with the agencies involved to determine how the system failed, how such an occurrence can be prevented, and ensure the public is safe and protected.”

And 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.

Details of Markey Bill

The FDA generally leaves oversight of compounding pharmacies up 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 that some compounding pharmacies act like traditional drug manufacturers, making large batches of drugs and essentially avoiding FDA oversight.

Under Markey’s legislation, the FDA could classify compounding pharmacies that act more like drug manufacturers. Those companies would have to register with the agency as manufacturers and would be subject to the same inspections as other manufacturers.

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 FDA regulations.

In addition, 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 of time 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 any potential safety problems or adverse events to the FDA. Patients would be notified that compounded drugs are not FDA-approved.

“Compounding pharmacies have been governed by fragmented regulations for too long, leading to the worst public health disaster in recent memory,” Markey said. He outlined his legislation Thursday at a press conference at the New England Compounding Center headquarters.

John Coster, senior vice president for government affairs at the National Community Pharmacists Association, said Markey’s bill could help address “anomalies” like the NECC.

“However, the proposed legislation also appears to create new overly broad requirements on traditional pharmacy compounding that could negatively impact both patients’ access to essential medications and the community pharmacists who provide them,” Coster said. He noted that his group will formally provide comments to Markey’s office after it finishes reviewing the legislation.

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.

As the number of people who have contracted meningitis from the NECC’s injectable steroid continues to grow, the Center for Medicaid and CHIP Services is advising states to prepare for treating patients. On Wednesday, the center told states to prepare for a rush of prescription requests for voriconazole, an anti-fungal drug the CDC recommends to treat infections caused by the contaminated product. It also told states to expedite all decisions about covering that drug and all other appropriate antifungal medications.

The center warned states that any delays could have “potentially life-threatening consequences” for patients with central nervous system or parameningeal infections and septic arthritis.