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As Meningitis Outbreak Spreads, FDA Implores Congress To Strengthen Safety Regulations

By Tara Culp-Ressler on October 12, 2012 at 10:30 am

"As Meningitis Outbreak Spreads, FDA Implores Congress To Strengthen Safety Regulations"

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Contaminated steroid shots that were compounded at a Massachusetts-based pharmacy company

Government regulators have upped the number of Americans who they believe could be at risk for contracting a deadly strain of fungal meningitis — which originated from contaminated steroid shots from a Massachusetts-based compounding pharmacy outside of the FDA’s regulatory power — to 14,000 people. FDA officials, who continue to investigate the outbreak, say they expect Congress to work with them to create a better regulatory system for overseeing compounded pharmacies in order to prevent future public health crises.

Since the thousands of U.S. pharmacies across the country that practice compounding — an attempt to keep down prescription costs by recombining medications and repackaging them for sale — do not technically count as drug manufacturers, the FDA currently has no authority to oversee them to ensure that their compounded drugs meet the agency’s safety guidelines. On a call with reporters, FDA officials said they expect lawmakers to recognize the need for additional regulations that will empower the agency to oversee this often-overlooked area of the pharmaceutical industry:

The outbreak resulted from contaminated vials traced to a compounding pharmacy in Framingham, Massachusetts that mixed the drug and sold it to 75 hospitals and pain clinics in 23 states. The U.S. Food and Drug Administration will work with Congress to create new regulations allowing the agency to better oversee the actions of such pharmacies in the future, said Deborah Autor, a deputy commissioner at the agency.

“We want to sit down with pharmacists and lawmakers and think about a scheme that recognizes that the industry and practice of pharmacy have evolved over time, and put in place a risk-based scheme,” said Autor, of the FDA’s global regulatory operations and policy unit, on the call. [...]

The outbreak highlights the need to ensure product safety, [Todd Weber, who is overseeing the federal probe for the Centers for Disease Control] said on the conference call. “We want patients to be confident that they’re not going to get a potentially devastating disease as a result of their care,” he said.

This week’s meningitis outbreak has led to the deaths of 14 Americans so far. Public health advocates have been calling for strengthened FDA regulations in this area for years, warning that the country will see more outbreaks like this in the future if regulations are not put in place, but the pharmaceutical industry has brought repeated lawsuits against the FDA over the past decade to chip away at the agency’s power over compounded drugs.

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