Friday, August 4, 2017

Compounding Bill Could Bring Outbreak Recurrence

By Walter F. Roche Jr.

"Our job is to find out how this happened and then to make sure it doesn't happen again." U.S. Rep. H. Morgan Griffith Sept. 12, 2013

A Virginia congressman who said his district was among the hardest hit in the nation by the 2012 fungal meningitis outbreak, is now seeking to strip a key provision of the law passed to prevent a recurrence  of that deadly public health crisis.
U.S. Rep. H. Morgan Griffith filed a bill recently that would eliminate a requirement that drug compounders obtain a patient specific prescription before compounding even a single dose of a drug.
Dr. Michael Carome of Public Citizen said in an interview this week that passage of the Griffith bill would "clearly guarantee" a recurrence of the 2012 outbreak which sickened 778 patients in 23 states, killing at least 76 of them.
Griffith did not respond to requests for comment.
In the wake of the outbreak Griffith, a Republican whose district is in Southwest Virginia, made a point of stressing how his district was "particularly hard hit."
At a Nov. 14, 2012 congressional hearing on the outbreak he said two deaths already had been reported and as many as 1,415 area residents had been notified they had been injected with contaminated steroids from the same drug compounder, the New England Compounding Center.
He recounted a telephone conversation he had with the father of a 16-year-old, the youngest known victim of the outbreak.
Griffith told those at the hearing that it was unclear whether the teenager would recover despite his youth.
When the current law won final congressional approval, Griffith hailed its passage.
The new Griffith bill was immediately endorsed by the International Academy of Compounding Pharmacists, a group that lobbies in behalf of compounding pharmacists.
The group's political action committee donated $5,000 to Griffith's campaign committee 15 days after he filed the bill.
Carome noted that his organization did not support the 2013 law, because it created a new category of mass drug producers, known as outsourcers, that do not need to meet the same standards as major drug producers.
"We opposed the creation of that new category," he said.
But,  Carome noted, the new law does require the mass compounders to follow standards known as GMP or Good Manufacturing Practices. He said that requirement would not apply to compounders under the Griffith proposal.
"This bill would allow any compounder to mass produce," he said, adding that it was clear that the bill was filed at the behest of the compounders association.
Griffith was a major participant in the Nov. 14, 2012 hearing before the subcommittee on oversight and investigations during which  committee members grilled officials of the U.S. Food and Drug Administration about its failure to prevent the fungal meningitis outbreak.

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