WASHINGTON Nov 13 The U.S. Food and Drug
Administration called for congressional action to strengthen the
agency's authority over compounding pharmacies, as lawmakers
prepared for two days of hearings on a deadly fungal meningitis
outbreak linked to compounded steroids.
In a Tuesday statement issued to Reuters, the U.S. regulator
also acknowledged that it had agreed with Massachusetts state
officials in 2003 to designate the company now at the heart of
the outbreak as a compounding pharmacy exempt from the strict
safety standards FDA imposes on drug manufacturers.
The decision put state regulators in charge of overseeing
developments at Framingham, Massachusetts-based New England
Compounding Center after problems surfaced in 2002.
Where to draw the line between drug manufacturing and drug
compounding is a central question for Congress. The House of
Representatives and the Senate are hosting separate hearings to
determine whether to give the FDA new authority over compounding
pharmacies to head off future public health crises.
The current outbreak, linked to tainted steroid injections
from New England Compounding Center, has afflicted 438 people,
including 32 who have died, according to the U.S. Centers for
Disease Control and Prevention.
"FDA's authority over compounding pharmacies is more limited
by law and needs to be strengthened," the agency's statement
said. "We look forward to working with Congress to prevent this
from happening again."
Those sentiments were echoed on Tuesday by a new report from
the minority Democratic staff of the House Energy and Commerce
Committee panel for oversight and investigations, which will
hold the week's first meningitis hearing on Wednesday.
The second hearing is scheduled for Thursday before the
Senate Health, Education, Labor and Pensions Committee. FDA
Commissioner Margaret Hamburg is scheduled to testify in front
of both panels.
"Legal authority over compounding has been complicated by
court decisions that have cast doubt on FDA's authority to
regulate compounders," the House Democratic report said.
"Compounders operate in a regulatory gap between state regulated
pharmacies and federally regulated 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. It is overseen mainly by
state authorities that are often ill-equipped for the job.
The activity has evolved in recent decades to include
large-scale production that some experts view as drug
manufacturing that should be subject to FDA regulation.
Not everyone agrees that the FDA needed new authority to
stop New England Compounding Center from operating, however.
Advocacy group Public Citizen earlier this month called on
the Obama administration to launch an independent probe into the
FDA's lack of action against NECC. The group alleges that the
FDA already has the authority it needs, but that agency
officials failed to take steps that could have prevented the
On Monday, the majority Republican staff on the House
committee released its own report that said government
regulators decided in 2003 that NECC was not a drug manufacturer
that would have been subject to direct FDA oversight.
The agency acknowledged in its statement that FDA and
Massachusetts state officials agreed NECC was operating as a
compounding pharmacy after inspections in 2002 and 2003 that
followed reports of health problems linked to two sterile drugs,
including steroid injections.
"Since states have day-to-day authority of compounding
pharmacies," the FDA said on Tuesday, "the state of
Massachusetts oversaw corrective actions by the firm with regard
to its sterility practices."