Tuesday, November 12, 2013

Senate poised to act on compounding bill Nov. 12, 2013 6:43 PM

A bill to close loopholes for compounding pharmacies is expected to reach President Obama’s desk this week, addressing the regulatory environment that allowed fungi-laden medicine to cause a deadly outbreak of meningitis.
The U.S. Senate is poised to pass legislation, already approved by the House of Representatives, that defines the authority of the U.S. Food and Drug Administration to regulate compounding pharmacies that make drugs in large quantities. The bill came about because of an ongoing outbreak of fungal infections that has sickened 751 people with 64 deaths.
Sixteen of those deaths, caused by spinal injections of a contaminated drug made by a Massachusetts-based compounder, have occurred among patients treated in Tennessee.
U.S. Sen. Lamar Alexander, R-Tenn., spoke on the Senate floor Tuesday in advance of votes to move the Drug Quality and Security Act past the objections of U.S. Sen. David Vitter, R-La. Vitter had put the bill on hold, a privilege that any senator can invoke.
The Senate voted 97-1 to advance the bill past Vitter’s objections, clearing the way for a second vote on the legislation itself.
Besides closing regulatory loopholes for compounding pharmacies, the bill would establish a tracking system using serial numbers to protect against counterfeit, stolen and other compromised medicines.
“We have an opportunity to act together,” Alexander said. “I hope we do. The families affected by this tragedy of contaminated steroid injections that caused fungal meningitis in many states, especially Tennessee, expect us to act.”
He shared the story of a Nashville resident who died from the disease, Diana Reed, who with her husband founded a faith-based child-care center to serve low-income families and then became his caregiver after he was stricken with amyotrophic lateral sclerosis, commonly known as Lou Gehrig’s disease. She was 56.
Alexander related how a thousand people went to her funeral and how her church has tried to provide the same level of care to her husband that she gave.
He repeated the warning of FDA Commissioner Margaret Hamburg that other outbreaks would occur if Congress did not close regulatory loopholes.
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