* Regulators seek stronger FDA role following meningitis
* Lawmakers to seek answers on why NECC stayed in operation
* Massachusetts named NECC co-owner to regulatory board
* Watchdog executives convicted of crimes related to FDA
By David Morgan
WASHINGTON, Nov 13 U.S. and state health
regulators called on Congress on Tuesday to s trengthen federal
oversight of compounding pharmacies as lawmakers prepared for
two days of hearings on a deadly fungal meningitis outbreak
linked to a compounded steroid.
But the main federal regulator, the U.S. Food and Drug
Administration, said in a statement to Reuters that it faces
legal restrictions in regulating drug compounders such as the
New England Compounding Center. The Massachusetts pharmacy was
at the center of the outbreak that has infected 438 people,
including 32 who have died, in 19 states.
The chief public health officer for Massachusetts also urged
immediate congressional action to bolster federal oversight of
the little-known, lightly regulated compounding industry, which
is primarily overseen by state pharmacy boards.
"It is clear that the patchwork of disparate state
regulations is not enough to keep the public safe," Dr. Lauren
Smith, interim commissioner of the Massachusetts Department of
Public Health, said in written testimony filed with a U.S. House
of Representatives oversight panel.
Lawmakers hope to shed light on why regulators failed to act
against NECC despite multiple problems dating back to 1999. They
also are focusing on whether new legislation may be needed to
grant FDA clear authority to police the drug compounding
"FDA's authority over compounding pharmacies is more limited
by law and needs to be strengthened," said the federal agency's
statement to Reuters. "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 oversight and
"Legal authority over compounding has been complicated by
court decisions that have cast doubt on FDA's authority to
regulate compounders," the report said. "Compounders operate in
a regulatory gap between state-regulated pharmacies and
federally regulated drug manufacturers."
Smith and FDA Commissioner Margaret Hamburg are scheduled to
testify on Wednesday before the panel, the House Energy and
Commerce subcommittee for oversight and investigations. A second
congressional hearing is scheduled to take place before the
Senate Health, Education, Labor and Pensions Committee on
The Massachusetts health commissioner, who took office less
than three weeks ago, said she is determined to find out why the
Massachusetts Board of Registration in Pharmacy voted to
sanction the company in September 2004 but ultimately agreed to
a far weaker consent agreement with NECC in January 2006.
"I will not be satisfied until we know the full story behind
this decision," she said in her written testimony.
Smith said the Massachusetts pharmacy board's executive
director and staff attorney learned in April 2006 that
executives from a company hired to ensure NECC's compliance were
convicted of federal crimes related to defrauding the FDA.
"However, we found no evidence to indicate that the
executive director or staff attorney ... provided this crucial
information to the board. Nor did they see fit to send
inspectors back to NECC in 2006 to determine if they were
fulfilling the requirements of the corrective action plan,"
But in May 2006, the board affirmed NECC to be in compliance
with the consent agreement.
Smith also believes the board would have acted immediately
against NECC last July -- a month before it produced the final
doses of steroid injections linked to the outbreak -- if board
staff had told board members about a complaint against NECC
brought by Colorado authorities.
Earlier this month, the state fired board director James
Coffey and board counsel Susan Manning for failing to act on the
The Massachusetts pharmacy board was left to oversee NECC's
operations in 2003 when state and FDA officials agreed that its
activities did not constitute a manufacturing operation that
would need to meet stringent federal standards for safety and
efficacy, the FDA acknowledged on T ues day.
The decision was originally disclosed on Monday by a House
Republican staff report.
Where to draw the line between drug manufacturing and drug
compounding is a central question for Congress as lawmakers
debate the potential need for new legislation to expand the
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 who 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 of 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
Smith's written testimony also shows that NECC co-owner
Barry Cadden was named to a state task force to study oversight
of the compounding pharmacy industry in 2002. The task force met
for two years and discussed potential regulatory changes.
But there is no record of formal recommendations and no
changes were ever adopted.