Check It Out:

What are your favorite local places for shopping, pampering or entertaining? Vote now in this year's Best Of Holiday Shopping readers' choice poll.

Morgan Griffith-led bill aims at scrutiny of labs that mix drugs

The Republican representative from Salem is one of the lawmakers who want compounding pharmacies regulated by the FDA.

Morgan Griffith

Laurence Hammack | 981-3239

Friday, September 13, 2013

U.S. Rep. Morgan Griffith, R-Salem, has teamed up with two Democrats on a bill that would tighten government scrutiny of compounding pharmacies like the one linked to a meningitis outbreak in Southwest Virginia.

The bill filed Thursday seeks to clarify the authority of the U.S. Food and Drug Administration over certain types of pharmacies that in the past have mass-produced drugs and distributed them across the country.

One of the facilities that escaped FDA regulation was the New England Compounding Center of Massachusetts.

The compounding pharmacy has been blamed in lawsuits and government reports for producing tainted steroids that made their way last fall to the Roanoke Valley, where patients who received injections of the drug for back pain came down with fungal meningitis.

“As we approach the anniversary of the fungal meningitis outbreak that devastated so many families across the nation, including Southwest Virginia, it is vital for Congress to take action to prevent another public health crisis,” Griffith said.

Co-sponsoring the bill with Griffith are Rep. Gene Green, D-Texas, and Rep. Diana DeGette , D-Colorado.

“This bipartisan proposal would prevent another NECC-type outbreak from occurring,” Griffith said.

Nationwide, 64 people died and 750 became ill in October’s meningitis outbreak. In Southwest Virginia, there were two deaths and dozens of serious contaminations.

There has been confusion in the past over whether facilities such as NECC are pharmacies, which fall under state law, or manufacturers, which are regulated by the FDA.

Compounding pharmacies are generally small operations that mix — or compound — drugs for specific patients, pursuant to doctors’ prescriptions. Because they typically make drugs in forms that are not commercially available, compounding pharmacies have not routinely been regulated by the FDA.

Critics contend that federal authorities have known for years that NECC was stretching the definition of a compounding pharmacy.

Griffith’s bill seeks to clear up ambiguities in the Food, Drug and Cosmetic Act , putting pharmacies like the New England Compounding Center in the manufacturing category.

It also would protect traditional pharmacies that compound drugs pursuant to a specific prescription and require the FDA to better communicate with state pharmacy boards when concerns about a drug first arise.

The proposed legislation differs from a version in the Senate, which calls for a special category of compounding pharmacies to fall under federal authority. Griffith’s bill could go to the House Energy and Commerce Committee, of which he and his two co-sponsors are members, or directly to the House floor as early as next week.

Lawsuits have alleged that methylprednisolone acetate , an epidural steroid injection produced by NECC, was contaminated at its Framingham, Mass, facility, possibly by debris from a trash dump located next door.

The trail of culpability extends to Roanoke, the lawsuits allege, where Insight Imaging administered more than 600 doses of the drug with little concern for its safety.

A $25 million lawsuit filed by the family of a Salem man who died from taking the contaminated drug accuses the clinic of systematically misrepresenting the steroid — telling patients that it was an FDA-approved drug made by pharmaceutical giant Pfizer, while overbilling them for the cheaper, high-risk knockoff.

Saturday, September 14, 2013