Monday, September 30, 2013

'Brinksmanship' kept Congress from addressing issue

U.S. Sen. Debbie Stabenow said “political brinksmanship” has kept Congress from addressing real and important issues like the need for stronger oversight of large compounding pharmacies.
The Lansing Democrat said the fungal meningitis outbreak that began a year ago as a result of tainted steroids has not received proper attention in Congress.

“That is why I am continuing to fight for the Pharmaceutical Compounding Quality and Accountability Act that the Senate Health, Education, Labor and Pensions Committee has put forward in this effort to protect families,” Stabenow said in a statement emailed to the Daily Press & Argus.

She said she wants immediate passage of the compounding pharmacy bill.
Stabenow; U.S. Rep. Mike Rogers, R-Howell; and U.S. Sen. Carl Levin, D-Detroit, declined to be interviewed for this series. Their offices each issued statements.

Michigan was the hardest-hit of the 20 states where fungal meningitis cases occurred and were linked to injections of tainted steroids.

Nationwide, 750 cases of fungal infection were reported, resulting in 64 deaths, according to the latest statistics issued by the federal Centers for Disease Control and Prevention.
In Michigan, 264 cases resulted in 19 deaths.

Eight deaths occurred in Livingston County and one in Ingham County, which make up much of Rogers’ congressional district.

Kelsey Knight, Rogers’ spokeswoman, issued this statement: “Congressman Rogers is a senior member of the Energy and Commerce Committee, which has jurisdiction over federal health agencies including (the Food and Drug Administration), CDC, and (the National Institutes of Health). He continues to work with his colleagues to investigate this tragedy and ensure it never happens again. This ongoing investigation has thus far determined that a sole manufacturer — the New England Compounding Center in Framingham, Massachusetts — was responsible for tainted steroids which caused the outbreak.

“Unfortunately, hearings at the Energy and Commerce Committee have also found that FDA and Massachusetts regulators failed to do their jobs and did not take action even after knowing NECC was jeopardizing the safety of patients. This regulatory breakdown is unacceptable, and Congressman Rogers continues to examine all options for ensuring it does not happen again. One piece of bipartisan legislation currently being reviewed is H.R. 3089, the Compounding Clarity Act, which would provide FDA new authorities to oversee compounding pharmacies.”

Rogers was not a co-sponsor of the bill, but Knight said he supports it.

Levin’s office said he is pushing leadership to act quickly on a new compounding pharmacy bill.
“There has been a yearlong, high-priority effort in both houses of Congress to strengthen federal authority to regulate mass compounding facilities and lay the groundwork for a nationwide system to track prescription drugs so we can prevent future tragedies like this one,” Levin said by email in a statement issued Friday. “Earlier this week, a bipartisan group from the House and Senate reached agreement on legislation aimed at meeting those goals,” he added.

Stabenow said she led questioning of the Center for Medicare and Medicaid Services about the oversight of payments for compounded medications in the wake of the outbreak.

“This forced CMS to shed light on their process for responding when a pharmacy has received an FDA violation, and made it clear that more FDA oversight of large scale compounding pharmacies is needed to ensure that concerns are brought to the attention of CMS and medical providers,” she said.

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