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The Salem lawmaker said compounding pharmacies should be overseen by the FDA.
Friday, August 23, 2013
Nearly a year after a meningitis outbreak killed two people and sickened dozens in Southwest Virginia, a local lawmaker is drafting legislation as Congress starts to address the issue.
U.S. Rep. Morgan Griffith, R-Salem, said he hopes to file a bill next month that will clarify how the Food and Drug Administration regulates facilities like the one linked to the outbreak.
New England Compounding Center, a so-called compounding pharmacy in Massachusetts, has been blamed in lawsuits for mass-producing tainted steroids that made their way to the Roanoke Valley, where patients who received injections of the drug for back pain came down with fungal meningitis.
At issue is whether facilities such as NECC are pharmacies, which fall under state control, or manufacturers, which are regulated by the FDA.
The way Griffith sees it, the FDA had authority under current law to step in and stop problems with contamination at NECC — and possibly prevent the outbreak.
“In my opinion, the FDA dropped the ball,” Griffith said this week.
With a bill that he hopes will gain bipartisan support, Griffith plans to set out in greater detail how a facility like NECC is actually a drug manufacturer subject to FDA oversight.
The congressman is being pushed at every turn by Ben Foutz, whose 16-year-old son, Zac, became seriously ill after receiving an injection of the tainted drug at a Roanoke clinic.
Foutz is “very frustrated, and I don’t blame him,” Griffith said. “His son’s life has been dramatically altered by what I would consider the culpable behavior of NECC, and by the negligent behavior of the cop on the beat, and that would be the FDA.”
To Foutz, one of the biggest frustrations in the slow pace of Congress, which is currently taking a summer break from a session that has produced more partisan bickering than legislation.
“It’s been almost a year [since the outbreak] and they still haven’t got anything passed,” Foutz said.
“I’m not trying to make this a Democrat-Republican issue, I’m just trying to say, why can’t Democrats and Republicans come together?”
The stakes extend far beyond Southwest Virginia. Since the outbreak began, there have been 749 confirmed cases of meningitis and 63 deaths in 20 states, according to the U.S. Centers for Disease Control and Prevention.
Lawsuits filed in Roanoke 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 and high-risk knockoff.
While the lawsuits wind through court, Congress is attempting to find a way to tighten federal regulation.
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, mass producing drugs and distributing them across the country.
“Unfortunately, the NECC tragedy is not an isolated incident,” said Sarah Sellers of the Working Group on Pharmaceutical Safety, an advocacy group that is pushing for legislative reform.
In May, another meningitis outbreak was linked to a compounding pharmacy in Tennessee, the group said in a June news release announcing its formation.
FDA Commissioner Margaret Hamburg wrote in a blog post in April that a stronger law is needed for the agency to do its job.
“It may surprise some people to know that, even in light of the recent tragic events, some of the firms we inspect still challenge our authority to conduct full inspections of their facilities,” Hamburg wrote.
Earlier this summer, a measure in the Senate was voted out of committee. The bill would create a special category of compounding pharmacies that will fall under FDA authority.
Griffith is taking a different approach, crafting legislation that will more clearly put facilities like NECC in the manufacturing category.
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