* Compounding trade group wants oversight kept with states
* Group blames FDA, Massachusetts regulators for failures
* Accuses NECC of "blatant disregard" for rules
By David Morgan
WASHINGTON, Nov 15 U.S. states should remain the
primary regulators for compounding pharmacies, rather than the
U.S. Food and Drug Administration, despite a deadly fungal
meningitis outbreak that has killed 32 people since September,
an industry group said on Thursday.
The International Academy of Compounding Pharmacists,
headquartered in Missouri City, Texas, told a U.S. Senate
oversight panel that the meningitis outbreak raging across 19
states occurred because regulatory officials at both the state
and federal levels failed to take action under current laws.
The company, Framingham, Massachusetts-based New England
Compounding Center (NECC), faces several investigations
including a federal criminal probe over unsanitary conditions at
its production site and operations that critics say amounted to
drug manufacturing that eluded scrutiny by FDA and the
Massachusetts Board of Registration in Pharmacy.
"Massachusetts' board obviously failed to execute its
responsibilities both to its citizens as well as patients in
other states," the industry group's Chief Executive David Miller
said in written testimony submitted to the Senate Health,
Education, Labor and Pensions Committee.
"The state and the FDA should have worked together to force
the pharmacy to register as a manufacturer," he said. "NECC
showed blatant disregard for existing rules and regulations."
Miller submitted his testimony ahead of a Senate committee
hearing to examine the cause of the meningitis outbreak and
determine whether new federal legislation may be necessary to
bolster FDA authority over pharmacies that compound drugs in
large quantities, especially sterile products.
The outbreak has produced 461 cases of rare fungal
meningitis, and more are expected with as many as 14,000 people
exposed to methylprednisolone acetate epidural injections that
NECC sold in 23 states for treatment of back and joint pain.
The House of Representatives Energy and Commerce Committee
held a similar hearing on Wednesday at which Republican
lawmakers charged that FDA had the authority to act against NECC
but failed to do so in time to avert the public health crisis.
FDA Commissioner Margaret Hamburg and Dr. Lauren Smith,
interim commissioner of the Massachusetts Department of Public
Health, both told House lawmakers that current laws which leave
oversight of compounders to states are inadequate and that new
legislation is needed to bolster FDA authority to register and
regulate large-scale compounding operations.
Hamburg complained that her agency routinely faces lawsuits
and other challenges when they attempt to scrutinize compounding
pharmacy operations. Legal action has already produced
conflicting federal court rulings about FDA powers in different
parts of the country.
But Miller said FDA is already capable of regulating
pharmacies that engage in manufacturing or run afoul of state
"Since the practice of pharmacy is already regulated at the
state level, the majority of policy and oversight is best if
implemented, addressed, enforced at the licensure level," he
said in testimony released by the Senate committee.
"States have the ability to remove a pharmacy's license if
that pharmacy is not operating within its licensure
requirements," Miller added.
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 critics say
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
While Republicans remain skeptical about the need for new
legislation, Democrats in the House and Senate have called for
bipartisan action before the end of this year.