Monday, August 26, 2013

Improve scrutiny of tailor-made drugs

To ensure FDA oversight of large-scale compounding “pharmacies,” Congress may require some partisan healing of its own.

Southwest Virginians affected by a deadly meningitis outbreak last year wait impatiently for Congress to tighten regulatory control over drug compounding facilities like the one that produced tainted steroid injections linked to the disease.

There is hope — if the House and Senate can pull out of the mire of partisanship long enough to come together on a remedy that will protect the public.

Virginia’s 9th District Rep. Morgan Griffith says he is working on legislation to make it clear the federal Food and Drug Administration has authority to inspect compounding pharmacies like the one in Massachusetts linked to the tainted medicine. He hopes to file the bill next month in the House.
In the Senate, meanwhile, the Health, Education, Labor and Pension Committee unanimously approved a bill late last month to increase the FDA’s regulatory power over compounding pharmacies. It goes next to the full Senate, where it will meet industry opposition.

Compounding pharmacies custom mix drugs for patients in doses or forms generally not available commercially when standard formulations do not fit individual needs. Typically, the facilities fall under the oversight of state pharmacy boards because they turn out small numbers of customized formulas to fill special orders placed by doctors.

Investigators of the fungal meningitis outbreak last year, which killed two people in Southwest Virginia and a total of 63 in 20 states, linked the outbreak to injections of tainted steroids made by the New England Compounding Center. The facility, now closed, was geared up for mass production and nationwide distribution.

Griffith thinks that, under current law, the FDA could have treated NECC as a drug manufacturer and stepped in, but did not; the FDA commissioner says the agency needs a stronger law.

The Senate bill would create a separate category of compounding pharmacies that would fall under FDA oversight. A coalition of pharmacies associations, among other groups, opposes that route.
Its members say the Senate plan would give the agency the power to ban custom compounded bio-identical hormones doctors use to treat menopausal and PMS symptoms in women and low testosterone in men.

Griffith is working on a more narrowly focused bill, an effort that shows enough flexibility, at least, to acknowledge the need for regulatory control.

If it gains enough favor to pass in the Republican House, it would go to the Senate, where a somewhat broader bill has been reported out of committee with bipartisan support.

The hope is that tighter oversight will not become yet another victim of hyperpartisanship.

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