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U.S. Congress takes aim at FDA over meningitis outbreak

By David Morgan and Bill Berkrot

WASHINGTON/NEW YORK (Reuters) - U.S. 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 U.S. 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 FDA already 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 U.S. 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 U.S. Representative Cliff Stearns of Florida. "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, Massachusetts-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.

HAMBURG GRILLED; NECC'S CADDEN TAKES THE FIFTH

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.

But 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 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.

Republican Tim Murphy of Pennsylvania angrily accused her of not accepting her responsibilities as a leader, while Lee Terry of Nebraska expressed exasperation when Hamburg failed to cite federal statutes that might need to 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," she added.

Much of the lawmakers' concern dealt with agency's reaction to problems at NECC that cropped up beginning in 2003 and involved FDA and state regulators in Massachusetts until 2006.

That period spanned of time when Republican George W. Bush was in the White House and defeated Republican presidential candidate Mitt Romney was the governor of Massachusetts. Hamburg joined the FDA in 2009.

DEMOCRATS DEFEND AGENCY

Democrats also criticized the FDA for its failures but still rushed to Hamburg's defense by saying the real blame should be laid at the feet of NECC and its officers.

"I have a feeling, Dr. Hamburg, that you're being picked on by Republicans because you're with the Obama administration," said Henry Waxman, the full House committee's ranking Democrat.

"You're in a no-win situation," he said.

Hamburg called on Congress to enact new legislation to give FDA clear authority to regulate large-scale compounding pharmacies and impose stricter standards with well-defined powers to inspect company records and products.

"This isn't, sadly, an isolated incident. This is the worst and most tragic. It should be the last wake-up call for us," Hamburg said of the meningitis outbreak.

"We really need a strong, clear and appropriate legislation. We cannot have a crazy quilt where different parts of the country are subject to different legal frameworks."

UNREGULATED COMPOUNDING

Drug compounding is a little-known practice in which pharmacists traditionally alter or recombine drugs to meet the special needs of specific patients with a doctor's prescription. It is overseen primarily by state authorities that are often ill-equipped for the job.

But in some cases, as with NECC, compounding has evolved to include large-scale production that some experts view as drug manufacturing that should be, but currently is not, subject to FDA regulation.

FDA and Massachusetts officials inspected NECC's labs in 2002 and 2003 after patients were hospitalized with meningitis-like symptoms. At the time they identified contamination in the same drug at issue in the current outbreak.

"Ten years later, we are in the midst of an unthinkable, worst-case scenario - the body count is growing by the day - and hundreds, hundreds - have fallen ill. Inexcusable," said Fred Upton, the full committee's Republican chairman.

Upton criticized FDA for not providing all the documents related to NECC or a clear timeline of events. He said his committee requested both more than a month ago.

Waxman called on the committee to come up with bipartisan legislation before the end of the year, saying that waiting longer would allow opponents of regulation to muster their forces, as they have done in the past.

But Republicans reacted coolly, with Stearns saying that passing new legislation would be difficult.

"If you don't have the authority, then we need to make sure it's there," Upton told Hamburg. "And it seems pretty reasonable to me that you did have the authority."

The panel also heard testimony from Dr. Lauren Smith, Massachusetts Department of Public Health interim commissioner, to whom lawmakers were respectful and complimentary.

The Massachusetts Board of Registration in Pharmacy, which does have oversight of NECC, failed to carry out sanctions against the company despite repeated problems that culminated in this year's outbreak.

Several lawmakers questioned Smith about relations between NECC and the Massachusetts pharmacy board, some saying reports of close ties among individuals could have encouraged state regulators to favor the interests of pharmacies over patients.

Waxman noted that weak sanctions to which NECC previously agreed occurred when Romney was governor of Massachusetts.

Delivering emotional testimony to kick off the hearing was the 78-year-old widow of a Kentucky judge who was among the first to die in the meningitis outbreak.

"It was such a useless thing that happened to my husband," Joyce Lovelace said, testifying from a wheelchair.

"I can't begin to tell you what I have lost," she said, her voice breaking with emotion. "I've come here begging you to do something about it."

Democrat Edward Markey, whose congressional district includes the town where NECC is located, said Congress would take action. "I commit to you and all the victims that we will not stop until this industry is safe," he said.

(Editing by Ros Krasny, Dan Grebler, Maureen Bavdek and Andrew Hay; Editing by Cynthia Osterman)

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