UPDATE 1-US House Democrats call for probe of meningitis outbreak

Tue Oct 9, 2012 6:59pm EDT

* House Democrats seek probe but Republican chairman mum

* Massachusetts lawmaker pledges bill to strengthen FDA

* Senators request briefing with FDA, CDC staff

By David Morgan

WASHINGTON, Oct 9 (Reuters) - Congressional Democrats on Tuesday called for a probe of a deadly meningitis outbreak in nine states, raising questions on issues ranging from the timing of the official response to the possible role of health insurers including Medicare.

The outbreak, which may have exposed as many as 13,000 people to tainted steroid injections for back and joint pain, could pose a challenge for Congress in the partisan pre-election atmosphere and as it faces a post-ballot fight over healthcare spending in deficit-reduction talks.

Lawmakers in both the House of Representatives and the Senate appear to be moving slowly on the issue so far.

At the center of the crisis is a Framingham, Massachusetts-based pharmacy involved in the largely unregulated practice of drug compounding, or altering approved medicines to meet the special needs of doctors and their patients. Health officials said on Tuesday that 11 people had died and 119 had been sickened by the contaminated drugs.

In a letter to the Republican chairman of the House Energy and Commerce Committee, 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.

They also expressed concern that some healthcare providers may have purchased the tainted treatments at a low price and then received full compensation from private health insurers and Medicare, the government healthcare program for the elderly and disabled.

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

The office of the House oversight committee's Republican chairman, Fred Upton, did not return phone calls or emails seeking comment.

SMALL MANUFACTURER

Democratic Senator Richard Blumenthal has called for a meningitis investigation by the Senate Health, Education, Labor and Pensions Committee, saying new legislation is needed.

That panel's Democratic chairman and Republican ranking member have instead requested a briefing with the staff from FDA and the U.S. Centers for Disease Control to determine what action, if any, Congress should take.

One Republican, Senator Richard Burr, issued a statement on Tuesday acknowledging that the outbreak raises important regulatory questions. But he stopped short of Blumenthal's call for a Senate probe and official hearings.

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.