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Yesterday,
Food and Drug Administration Commissioner Dr. Margaret Hamburg appeared at a
hearing before the House Energy and Commerce Subcommittee on Oversight and
Investigations in which both Democrats and Republicans leveled sharp criticism
upon the FDA for its role in failing to prevent what became a deadly meningitis
outbreak caused by tainted steroid products from the New England Compounding
Center. Major print media and Washington insider sources carrying the story
underscore the harsh nature of the criticisms leveled at the FDA, particularly
from Republicans. After admitting that her agency could have acted in a more
aggressive fashion and conceding the need for better policing of compounding
pharmacies, Hamburg took the opportunity to ask for Federal legislation
requiring all compounding pharmacies to register with the FDA.
The Washington Post (4/17, Kindy) reports,
"After reviewing 27,000 pages of documents from the Food and Drug
Administration, Republicans and Democrats came to different conclusions about
the agency's ability to prevent one of the worst public health crises in
American history." Yesterday, "Republican members of the House Energy
and Commerce Committee said...that its six-month investigation into the FDA's
role in last fall's meningitis outbreak shows the agency knew for a decade
about serious safety lapses at the specialized pharmacy that made the tainted
drugs but failed to act." In addition, Dr. Hamburg, the "only person
scheduled to testify at the hearing, was sharply criticized about the agency's
efforts with the" New England Compounding Center (NECC).
The New York Times (4/17, A15, Tavernise,
Subscription Publication) reports that on Tuesday, Dr. Hamburg "told
Congress...that her agency should have acted more aggressively against
compounding pharmacies like the one that was responsible for a deadly
meningitis outbreak last fall. In a hearing before a House Energy and Commerce
subcommittee, she said the agency had become overly concerned about avoiding
lawsuits, and as a result did not police the industry as effectively as it
could have." Hamburg stated, "I think we allowed ourselves to be far
too cautious because of fears of litigation that might further undermine our
authority."
The Los Angeles Times (4/17, Morin) "Science
Now" blog reports that Commissioner Hamburg "endured heavy criticism
Tuesday as House members accused the agency of failing to act on complaints
against the New England Compounding Center, the Massachusetts firm linked to an
outbreak of deadly meningitis. Under harsh questioning from Republican and
Democratic lawmakers, FDA Commissioner Margaret Hamburg conceded that her
agency could have handled the situation better." Hamburg told the
committee, "I wish we had been more aggressive, and I can assure you that
we are being more aggressive now."
The AP (4/17) reports, "Republicans and
Democrats took turns chastising the FDA for not being aggressive enough in
going after compounding pharmacies like the New England Compounding Center, the
specialty pharmacy which produced tainted pain injections that have sickened
more than 700 people and killed 53 others. In the second hearing on the
outbreak, FDA Commissioner Margaret Hamburg reiterated that her agency needs
clearer authority to go after compounding pharmacies, which have challenged the
FDA's authority in court since the 1990s." According to Hamburg, the FDA
"is working to crack down on compounding pharmacies, despite legal
challenges."
Bloomberg News (4/17, Edney) points out,
"Republicans have questioned whether the FDA could have shut down the
pharmacy based on incidents dating as far back as 2002. They also want to know
why the FDA didn't re-inspect NECC after stating it would in a 2006 warning
letter and related correspondence two years later." However,
"Democrats on the committee came to the FDA's defense, citing a law that
left the agency with ambiguous authority over compounding pharmacies, as well
as industry lobbying to undermine federal regulation and failures by states to
oversee the businesses adequately."
The Tennessean (4/16, Barton) reports that Hamburg
"described the evolution of large-scale compounders like NECC, with
production far exceeding that of neighborhood pharmacists who compound, or mix
drugs, in response to prescriptions that apply to just one patient. 'It is
clear that the industry and the health-care system have evolved and have
outgrown the law, and FDA's ability to take action against (large-scale
compounding) has been hampered by gaps and ambiguities in the law, which have
led to legal challenges to FDA's authority to inspect pharmacies and take
appropriate enforcement actions,' Hamburg testified."
Modern Healthcare (4/17, Block, Subscription
Publication) reports that at yesterday's hearing, Hamburg "warned
lawmakers...that if Congress doesn't clarify and strengthen the FDA's authority
over certain types of compounders, another NECC-type situation could happen."
In particular, "Hamburg asked for legislation that requires all
compounders to register with the agency. In addition, she called for uniform
quality standards to abide by and mandatory reporting of adverse events to the
FDA. Currently, section 503(a) of the Food, Drugs and Cosmetics Act exempts
compounders from certain regulations that apply to other drug
manufacturers."
The Hill (4/17, Viebeck)
"Healthwatch" blog quotes Hamburg as saying, "The tools we have
for regulating these firms are simply not the right fit." She called
"for new powers to regulate firms like the NECC, which fall between
compounder and drug manufacturers. States traditionally oversee the former
category, while federal authorities oversees the latter."
CQ (4/17, Ethridge, Subscription Publication)
reports that "Democrats on the subcommittee agreed that confusion
prevented the agency from acting effectively to respond to complaints and
concerns with the company. Several backed Hamburg's request for Congress to act
to clarify the agency's authority, as well as give it new regulatory powers
over compounding pharmacies." But, "Republicans said they were not
sure that the agency was ready to implement any new authorities, and several
accused the agency of using the conflicting court decisions as an excuse for
not taking more aggressive action."
Also covering the story are Politico (4/17, Norman), Reuters (4/17, Clarke), the NBC News (4/17, James) "Vitals"
blog, and MedPage Today (4/17, Pittman).
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