Tuesday, August 20, 2013

Sens. Burr, Hagan back federal bill to make drugs safer

A federal bill backed by North Carolina Sens. Burr and Hagan to make drugs safer is making its way through the Senate right now.

This comes after a compounding pharmacy in Massachusetts sent out tainted drugs that killed more than 60 people last year.

Eyewitness News looked into why some pharmacist say if the proposal is passed it could have a negative effect on your family and pets.

At Stanley Apothecary they make customized medicines for people and animals who can't take commercially made medications. It's how pharmacist Doug Yoch has made his living for the past 10 years. Now he's worried a federal proposal could put some of his business in jeopardy.

"With not being able to provide those services we would ultimately be forced to let people go and there would be loss of jobs here," said Yoch.

Senate Bill 959 backed by North Carolina Sens. Richard Burr and Kay Hagan proposes to make safety changes to compounding pharmacies after more than 60 people died and more than 700 others were infected with fungal meningitis last year.

The New England Compounding Center is at the center of the outbreak for making the allegedly contaminated steroid injections for back pain.

The federal measure would require compounding manufacturers to be regulated by the FDA.

Part of it proposes to discontinue certain forms of time-released medications.

It could also affect medications for hormone replacement therapy, pain, autism spectrum disorder and even medicine for pets.

It would also exempt hospitals and health systems with compounding pharmacies.

Compounding pharmacies are currently governed by the state's pharmacy board. Yoch says after the outbreak all compounding pharmacies were inspected.

Yoch was a part of a committee that recommended changes.

"We basically looked at how we can revamp the state's oversight so that they would provide better training for the inspectors," he said.

Pharmacy customers we spoke to were disappointed to hear about the legislation.

"The reason I get this prescription here is because it is made for me and my body. If I didn't have a place to come to get this medicine compounded the way that it is here, I would be taking it another way that would be difficult," said customer Clarkie Brown.

The bill passed a first reading in a Senate health committee in May. Both Burr and Hagan are on the committee and helped prepare the bill. The measure's next stop is to the full Senate for consideration.

We reached out to Burr and Hagan for a response.

Burr said, "Securing our nation's drug supply chain is critical to the health and safety of the American people. The American people deserve the peace of mind to know that the medicines they take are safe and effective. This bill establishes a uniform system that improves the security and safety of drugs for consumers."

In a statement, Hagan said, "I visited with the family of Elwina Shaw, whose tragic death was a result of lax enforcement and a compounding manufacturer without any respect for the safety of its customers,  and I promised them that I would work to ensure that no other family would have to endure what Elwina's family went through . As a member of the Senate health committee, I have worked with my colleagues on a bipartisan bill that imposes higher quality standards for compounded drugs to make sure these medicines are safe and effective, and I am hopeful that the full Senate will consider the bill this fall."


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