April 17, 2014 SIGN IN | REGISTER

Markey Bill Would Set Standards for FDA Oversight of Compounding Pharmacies

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.

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