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FDA failed to foil meningitis outbreak, House panel says

| Wednesday, Nov. 14, 2012, 8:34 p.m.

WASHINGTON — Republican lawmakers accused federal health regulators on Wednesday of failing to prevent a deadly fungal meningitis outbreak by not acting much earlier to shut down the compounding pharmacy at the center of the crisis.

As Congress began debate on whether new laws are needed to help the Food and Drug Administration police the little-known drug compounding industry, Republicans in a committee hearing warned against the knee-jerk adoption of new regulation.

Instead, Republican members of the House Energy and Commerce Committee asserted that the FDA had the authority needed to move against errant pharmacy operations, long before the rare meningitis cases began appearing in September.

Tainted steroid injections produced over the summer by the New England Compounding Center have killed 32 people and sickened 461 in 19 states so far, according to the Centers for Disease Control and Prevention. The numbers are expected to rise, with as many as 14,000 people having been exposed to the drugs used for back and joint pain.

“After a tragedy like this, the first question we all ask is: could this have been prevented?” said Rep. Cliff Stearns, R-Fla. “The answer here appears to be yes.”

Stearns chairs the Energy and Commerce Committee's subcommittee on oversight and investigations, which held Wednesday's hearing. A second hearing on the meningitis outbreak is scheduled for the Democratic-controlled Senate on Thursday.

Congressional investigators are trying to learn why regulators took no action against the Framingham, Mass.-based compounding pharmacy that manufactured the tainted drug despite problems dating back to 1999, including adverse patient reactions to a sterile steroid treatment as early as 2002.

Some of Wednesday's contentious four-hour hearing amounted to a tug-of-war between Republicans skeptical of the need for more federal regulation, and Democrats and regulators who contend that primary responsibility for regulating large-scale compounding pharmacies can no longer be left to states alone.

NECC co-owner Barry Cadden also appeared under subpoena, flanked by two attorneys. He refused to answer questions, invoking his constitutional rights against self-incrimination six times before being dismissed.

The centerpiece of the proceedings was a withering attack on FDA Commissioner Margaret Hamburg by Republicans, who accused her of dodging questions about the agency's authority and withholding documents sought by congressional investigators.

“This was a complete and utter failure on the part of your agency,” Stearns told Hamburg, while chastising her for not answering “yes” or “no” when asked if the FDA could have shut NECC down before the company shipped more than 17,000 vials of the steroid methylpredinsolone acetate to customers in 23 states.

“That is a very, very complex question in that the legal framework for FDA activities is very, very unclear,” responded Hamburg, telling the panel that FDA authority over pharmacies has been regularly challenged in legal cases that have led to conflicting federal court rulings.

Rep. Tim Murphy, R-Upper St. Clair, angrily accused her of not accepting her responsibilities as a leader, while Rep. Lee Terry, R-Neb., expressed exasperation when Hamburg failed to cite federal statutes that might need modification.

“I know that you're frustrated with my answers, and I'm sorry. I can't just give ‘yes or no' answers,” said Hamburg. “We have ambiguous, fragmented, unclear and contested authorities.”

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