October 10, 2012 / 12:50 AM / 7 years ago

House, Senate lawmakers seek meningitis briefings

WASHINGTON (Reuters) - Leading lawmakers from the House of Representatives and the Senate on Tuesday asked federal health officials for briefings on a deadly meningitis outbreak in 10 states as a first step toward possible legislative action to strengthen federal drug safety regulations.

A sign for pharmaceutical compounding company New England Compounding Center (NECC), a producer of the steroid methylprednisolone acetate, is seen in Framingham, Massachusetts October 8, 2012. REUTERS/Jessica Rinaldi

Aides said the bipartisan leaders of oversight committees in both chambers hoped to learn more about the spreading outbreak before October 12 from staff members of the Food and Drug Administration and the Centers for Disease Control and Prevention, which warns that as many as 13,000 people may have been exposed to the fungal meningitis pathogen through tainted steroid treatments.

The requests are a sign of growing congressional concern about the outbreak that has killed 11 people and 119 as a result of contaminated injections for back and joint pain produced by a Framingham, Massachusetts-based pharmacy through a lightly regulated practice known as drug compounding.

Drugs are compounded when a pharmacy alters or recombines approved medication to meet the special needs of doctors and their patients.

“We intend to learn more from the FDA, CDC, and others who may provide insight into the details surrounding this outbreak and the prevention of future outbreaks,” Representative Fred Upton, Republican chairman of the House Energy and Commerce Committee, said in a letter to the two agencies coauthored by three Republicans and two Democrats from the panel.

“The committee has a long bipartisan history of conducting drug safety oversight and is very concerned about these recent developments,” they wrote.

Earlier in the day, Democratic Senate aides said the agencies were sent a similar request from Senator Tom Harkin, chairman of the Senate Health, Education, Labor and Pensions Committee, and the panel’s ranking Republican, Senator Mike Enzi.

An FDA spokeswoman said the regulatory agency would respond promptly to the lawmakers’ requests. CDC officials were not immediately available for comment.

Democratic lawmakers from both chambers have already called for an investigation into the outbreak and hearings as a prelude to possible legislation that could bring large-scale compounding pharmacies firmly under FDA scrutiny.

In a letter to Upton, three Democrats questioned whether efforts to identify the source of the outbreak were delayed by confusion surrounding the U.S. Food and Drug Administration’s authority over compounding pharmacies.

“This incident raises serious concerns about the scope of the practice of pharmacy compounding in the United States and the current patchwork of federal and state laws,” wrote the panel’s top Democrat, Representative Henry Waxman, who was joined by fellow members Frank Pallone and Diana DeGette.

Waxman and Pallone later joined their Republican colleagues to request the FDA and CDC briefing.

A fourth Democrat, Edward Markey, whose Massachusetts district includes Framingham, said separately that he would introduce legislation to strengthen the FDA’s regulatory authority.

Democratic Senator Richard Blumenthal has called for a meningitis investigation by Harkin’s committee, saying new legislation is needed.

The three House Democrats said the pharmacy at the center of the outbreak, the New England Compounding Center, appeared to stray far beyond a legal exemption for pharmacists that allows them to provide customized doses of medicine to individual patients.

Instead the lawmakers said NECC operated like a manufacturer, shipping more than 17,000 vials of compounded steroid injections to customers at 76 facilities in 23 states.

“Congress ... did not intend for a compounding pharmacy to be permitted to operate as a small drug manufacturer,” the lawmakers wrote.

Compounding is not subject to the safety and efficacy standards that FDA requires of drug manufacturers. Legal and public health experts say that creates a regulatory loophole for operators seeking to boost profits by compounding large volumes of drugs at prices far below those of FDA-approved products sold by manufacturers.

The regulatory question is also at the heart of conflicting federal court rulings on the FDA’s ability to scrutinize compounding pharmacies. Experts say the cases pose issues that may need to be settled by the U.S. Supreme Court.

The Democrats asked whether the FDA knew of the scope of NECC operations and whether the agency had clear authority to act.

They also raised questions about whether Massachusetts health officials took steps to ensure the safety of NECC products following earlier problems addressed by a 2006 consent agreement.

According to the letter, Congressional officials should also determine if there were legitimate scientific reasons for using the steroid treatment and whether patients and doctors were aware that the products were produced by compounding.

Reporting by David Morgan; Editing by Michele Gershberg, Claudia Parsons and Prudence Crowther

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