Meningitis Outbreak Prompts New Federal Legislation

Posted by Pharmacist on December 27, 2012

On Thursday November 1, 2012 Rep. Edward Markey, D-Mass., announced his plans to introduce the Verifying Authority and Legality in Drug Compounding Act (VALID). Markey says this new law will grant the Food and Drug Administration (FDA) clear authority to monitor compounding pharmacy practices in the United States.

 

Congressman Markey’s district is home to the New England Compounding Center, most recently associated with the meningitis outbreak in October of this year. According to Markey “The VALID Compounding Act ends this regulatory black hole by giving the FDA new, clear authority to protect patients and oversee these companies.”

 

And while the industry supports efforts to improve safety standards, there is concern the proposed legislation is too broad. “As currently drafted, the legislation would grant new powers to an already stretched FDA to regulate traditional pharmacy compounding, and create new roadblocks for patients by requiring waivers for pharmacists to make medications that they have been making safely and effectively for decades,” according to John Coster, SVP government affairs for the National Community Pharmacists Association.

 

Others believe the bill is the right step. Diana Zuckerman, president of the Cancer Prevention and Treatment Fund says “This bill will save lives by ensuring that compounding pharmacies play by the rules that are essential to protect patients.” She added, “This month’s tragic meningitis outbreak from contaminated steroid injections was absolutely preventable. We call on Congress to work in a bipartisan manner to pass congressman Markey’s legislation, which is necessary to protect our families from these predictable, preventable tragedies.”

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