* 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 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
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."
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 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.