Congress Takes Aim At FDA Over Meningitis Outbreak

Members of a congressional committee investigating the deadly U.S. meningitis outbreak on Wednesday accused the Food and Drug Administration of failing to prevent the crisis by moving too slowly against a Massachusetts pharmacy.

* Meningitis widow calls for congressional action

* Panel chairman said FDA has a lot to answer for

* FDA chief seeks clear authority over big compounders

* NECC co-owner refuses to answer questions

Members of a congressional committee investigating the deadly U.S. meningitis outbreak on Wednesday accused the Food and Drug Administration of failing to prevent the crisis by moving too slowly against a Massachusetts pharmacy.

Tainted steroids from the pharmacy have so far killed 32 people and sickened 438 people in 19 states, according to the U.S. Centers for Disease Control and Prevention. That number is expected to rise with as many as 14,000 people having been exposed to the drugs injected to ease back pain.

"After a tragedy like this, the first question we all ask is: could this have been prevented? After an examination of documents produced by the Massachusetts Board of Pharmacy and the U.S. Food and Drug Administration, the answer here appears to be yes," Cliff Stearns, Republican chairman of the oversight and investigations panel said at a hearing of the House Energy and Commerce Committee on Wednesday.

The panel hopes to learn why regulators took no action against Framingham, Massachusetts-based New England Compounding Center (NECC), which manufactured the tainted drug - despite repeated problems dating back to 1999, including adverse patient reactions to a sterile steroid treatment from as early as 2002.

Several members of congress in opening statements prior to hearing testimony from witnesses, pointed to regulators' failure to stop unsafe practices by NECC.

"The NECC was not unknown to its regulators," said Fred Upton, Republican chairman of the House Energy and Commerce Committee.

FDA and Massachusetts officials inspected the NECC over ten years ago after patients were hospitalized with meningitis-like symptoms and identified contamination in the same drug at issue in the current outbreak, Upton said.

"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," he said.

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.

However, U.S. Representative Henry Waxman of California, the committee's ranking Democrat, defended the FDA and turned his ire toward NECC.

"Let's not lose sight of the wrongdoers as we go around blaming regulators," Waxman said.

He noted, as Upton pointed out, that the FDA knew 10 years ago that there could be a meningitis outbreak due to practices at NECC "and it wasn't corrected by the company".

He said that FDA met with "stubborn refusals and a challenge to FDA's authority" from NECC officials.

Waxman called for bipartisan legislation that gives FDA clear and effective authority to prevent compounders from becoming dangerous drug manufacturers like NECC.

FDA Commissioner Margaret Hamburg, in testimony before the committee, asked Congress to strengthen federal authority over drug compounders that are not currently subject to the stringent FDA safety and efficacy standards imposed on drug manufacturers.

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.

Hamburg said the FDA should be given clear authority to test compounded drugs and inspect the records of "non-traditional" compounding pharmacies that pertain to prescriptions, shipping and volume of operations.

She said the FDA's ability to take action against these pharmacies had been hampered by gaps and ambiguities in the law and the agency's ability to take action against NECC was repeatedly contested by company officials.

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

Drug compounding has evolved in recent decades to include large-scale production that some experts view as drug manufacturing that should be subject to FDA regulation.

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.

"Non-traditional compounding should, because of the higher risk presented, be subject to a greater degree of oversight," Hamburg said.


The panel also heard testimony from the widow of one of the victims, Massachusetts Department of Public Health interim commissioner Dr. Lauren Smith and NECC co-owner Barry Cadden, who refused to answer any questions from the committee.

Cadden, a short, middle-aged man flanked by two attorneys, appeared before the committee with spiky close-cropped hair and a dark gray business suit.

He repeatedly cited his right to remain silent under the fifth amendment of the U.S. Constitution when asked to explain breakdowns in sanitary conditions at NECC that led to the meningitis outbreak.

The committee heard emotional testimony from 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.

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