Reuters: Regulatory News: UPDATE 3-U.S Congress takes aim at FDA over meningitis outbreak

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UPDATE 3-U.S Congress takes aim at FDA over meningitis outbreak Nov 14th 2012, 19:54 Wed Nov 14, 2012 2:54pm EST * Panel questions FDA authority, actions * FDA chief seeks clear authority over big compounders * NECC co-owner refuses to answer questions * Meningitis cases rise to 461 By David Morgan and Bill Berkrot WASHINGTON/NEW YORK, Nov 14 (Reuters) - Members of a congressional committee investigating the deadly U.S. meningitis outbreak accused the Food and Drug Administration on Wednesday of failing to prevent the crisis by moving too slowly against a Massachusetts pharmacy. Tainted steroids from the pharmacy, New England Compounding Center (NECC), have so far killed 32 people and sickened 461 in 19 states, according to updated figures from the U.S. Centers for Disease Control and Prevention. Those numbers are 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 the hearing of the House Energy and Commerce Committee. The panel aims to learn why regulators took no action against the Framingham, Massachusetts-based compounding pharmacy that 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. In a highly contentious hearing that lasted four hours, committee members repeatedly accused FDA Commissioner Margaret Hamburg of failing to answer questions about FDA authority and a lack of action against NECC. Hamburg in turn insisted that the FDA lacks clear authority to regulate compounding pharmacies due to conflicting court rulings and other regulatory ambiguities. She said new laws must be passed that give the FDA clear authority to regulate compounding pharmacies as it does large drug manufacturers. "This isn't, sadly, an isolated incident. This is the worst and most tragic. It should be the last wakeup call for us," Hamburg said of the deadly 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," she told the committee. 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 subject to FDA regulation. FDA and Massachusetts officials inspected the NECC more than 10 years ago after patients were hospitalized with meningitis-like symptoms and 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, Republican chairman of the House Energy and Commerce Committee. 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 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 the agency 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. HAMBURG IN HOT SEAT But Republican committee members repeatedly, and sometimes angrily, challenged Hamburg's contention that FDA lacked the authority to oversee compounders that had grown into defacto manufacturers. "We're just not buying it Ms. Hamburg," said Representative Michael Burgess of Texas, an obstetrician by profession. "Go look in the eyes of the victims and try to tell them that," said Republican Tim Murphy of Pennsylvania. Nebraska Republican Lee Terry was extremely combative with Hamburg, repeatedly asking for specific statutes that prevented FDA oversight of compounders and cutting off her attempts to respond. Terry went as far as accusing the commissioner of deliberately providing written testimony in the middle of the night so committee members had little time to review it. "I know that you're frustrated with my answers and I'm sorry. I can't just give 'yes or no' answers. This is complex," Hamburg told Murphy at one point. Murphy shot back that what victims were going through was complex. "Leadership is easy if you're willing to accept it. You are not." Florida Democrat Kathy Castor rose to Hamburg's defense in describing current laws on regulating compounders as varying from region to region, creating conflicting enforcement issues. "There is ambiguity. There is great ambiguity," she said. Waxman also attempted to rescue Hamburg, accusing Republican counterparts of playing politics. "I have a feeling, Dr. Hamburg, that you're being picked on by Republicans because you're with the Obama administration," he said. He pointed out that past FDA failures being referred to took place under a different commissioner during the Bush administration. The panel also heard testimony from the widow of one of the victims, as well as Massachusetts Department of Public Health interim Commissioner Dr. Lauren Smith, to whom congress members were respectful and complimentary, 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 wearing a dark gray business suit. He repeatedly cited his right to not incriminate himself 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 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 Mitt Romney was governor of Massachusetts. 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. Link this Share this Digg this Email Reprints

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