* Agency has met with many stakeholders to press its plan
* Meningitis outbreak infects 620, killing 39
* House Republican accuses FDA of withholding documents
By David Morgan
WASHINGTON, Dec 19 The top U.S. drug regulator
on Wednesday urged state officials to help close regulatory
loopholes involving the safety of compounded drugs, such as the
tainted steroid injections at the center of a deadly fungal
At a day-long meeting with officials from all 50 states,
Food and Drug Administration Commissioner Dr. Margaret Hamburg
called for new regulations to head off future public health
Health officials should have clear authority to monitor drug
compounding operations and act before problems that endanger
public safety erupt, she said.
"We have all been stunned and horrified by the magnitude of
the devastation," Hamburg told state delegates.
"Clearly, it's imperative that we close the gaps in
oversight," she added. "The fungal meningitis outbreak is the
most tragic but not the only example of why we must act now."
In one of the biggest U.S. public health crises, 620 people
in 19 states since mid-September have contracted fungal
meningitis traced to epidural injections for back and joint pain
produced by Massachusetts-based New England Compounding Center.
Thirty-nine patients have died and as many as 14,000 other have
been exposed to the tainted drugs, according to the U.S. Centers
for Disease Control and Protection.
The state health and pharmacy board officials made up the
latest gathering of stakeholders FDA has approached with a plan
the agency hopes Congress will turn into legislation.
In the weeks before Wednesday's meeting, the FDA held
discussions about the regulatory landscape with over 50 groups
representing pharmacies, consumers, hospitals, clinics and
But states could be most central to the questions about
regulation because they currently serve as the main regulators
of drug compounders.
Drug compounding is a traditional pharmacy practice that
occurs when a licensed pharmacist alters or recombines drug
products in response to a physicians' prescription for a
specific patient, who may be unable to take the standard version
of a treatment due to age, allergies and other conditions.
In recent decades some compounding pharmacies, including the
now-shuttered NECC, have dramatically expanded into large-scale
production that rivals those of full-fledged manufacturers but
escapes the stringent safety and efficacy standards that FDA
imposes on drug makers.
The FDA plan would leave states with responsibility for
overseeing traditional compounding pharmacies but impose new
federal standards on large-scale compounders that could be
carried out by the agency, or in partnership with states, with
clearer congressionally mandated authority.
Experts say some state governments could be ill-equipped to
take on large-scale compounding oversight, especially at a time
of tight budgets.
State officials at the FDA meeting appeared to be divided,
with some saying they are adequately funded and staffed while
others said a new federal role may be necessary to ensure
regulatory consistency across state lines.
"Do the states have the ability right now to provide
oversight if you consider what an entity like NECC was doing?"
said Cody Wiberg, executive director of the Minnesota Board of
Pharmacy. "The answer to that question is that it depends on the
FDA officials say their current authority is limited by
conflicting federal court rulings over the years that prohibit
the agency from inspecting company records and facilities in
some U.S. states but allow it in others.
But critics, including many Republican lawmakers, say FDA
has enough authority and instead fell down on the job.
Last month Hamburg came under withering attack during a
House of Representatives committee hearing from Republicans who
accused FDA Of failing to exercise its authority to act against
NECC, despite problems dating back a decade, including earlier
instances of contaminated steroids.
On Wednesday, the Republican chairman of the House Energy
and Commerce Committee accused FDA of failing to provide
requested internal documents dealing with meningitis outbreak.
"Without this information, we are unable to identify any
possible weaknesses and as a result, the necessary corrections,"
committee chairman Fred Upton said in a statement.
Some critics also claim that Hamburg's plan could jeopardize
drug safety, if new rules allow large-scale production to go
forward under safeguards less strict than those now applied to
"The FDA's proposal for oversight of 'non-traditional'
compounding, if implemented, would decriminalize what is now
illegal drug manufacturing conducted under the guise of pharmacy
compounding," Dr. Michael Carome of advocacy group Public
Citizen's health research group said in a statement.
The window of opportunity for legislation is closing, but
some experts remain optimistic about the prospect for action in
2013 given the scale of the meningitis outbreak and ongoing
investigations in the House and Senate.
"They're working very hard on this," said Allan Coukell,
medical programs director for the Pew Charitable Trusts. "All
the signals are that this will be an issue for them to focus on
in the next Congress."