FDA failed to foil meningitis outbreak, House panel says
Published: 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.”
Show commenting policy
TribLive commenting policy
You are solely responsible for your comments and by using TribLive.com you agree to our Terms of Service.
We moderate comments. Our goal is to provide substantive commentary for a general readership. By screening submissions, we provide a space where readers can share intelligent and informed commentary that enhances the quality of our news and information.
While most comments will be posted if they are on-topic and not abusive, moderating decisions are subjective. We will make them as carefully and consistently as we can. Because of the volume of reader comments, we cannot review individual moderation decisions with readers.
We value thoughtful comments representing a range of views that make their point quickly and politely. We make an effort to protect discussions from repeated comments either by the same reader or different readers.
We follow the same standards for taste as the daily newspaper. A few things we won't tolerate: personal attacks, obscenity, vulgarity, profanity (including expletives and letters followed by dashes), commercial promotion, impersonations, incoherence, proselytizing and SHOUTING. Don't include URLs to Web sites.
We do not edit comments. They are either approved or deleted. We reserve the right to edit a comment that is quoted or excerpted in an article. In this case, we may fix spelling and punctuation.
We welcome strong opinions and criticism of our work, but we don't want comments to become bogged down with discussions of our policies and we will moderate accordingly.
We appreciate it when readers and people quoted in articles or blog posts point out errors of fact or emphasis and will investigate all assertions. But these suggestions should be sent via e-mail. To avoid distracting other readers, we won't publish comments that suggest a correction. Instead, corrections will be made in a blog post or in an article.
- California man named as bitcoin creator denies involvement
- Former National Security Agency contractor Snowden’s leaks to cost billions, take years to fix
- El Nino could bring relief to U.S.
- 5 more Duke Energy plants cited
- Health marketplace targets not signing up, survey shows
- Shuster plans oversight for DUI program
- Crisis stymies Obama getaway
- Holocaust survivor sues Germany in looted art claim
- Volunteers reconstruct World War II bomber plane
- Tenn. homicide suspect shot mom in 2004
- 18-year-old loses suit seeking parents’ support