* Senate Democrats, Republicans look to alter compounding
* Lawmakers discuss putting FDA in charge of state
* FDA warns that inaction could lead to new outbreaks
By David Morgan
WASHINGTON, Nov 15 Democratic and Republican
lawmakers said on Thursday they would alter the regulation of
drug compounding pharmacies in hopes of preventing more crises
like the rare fungal meningitis outbreak that has now cost 32
The outbreak of 461 cases in 19 states has been linked to
tainted steroid injections from a Massachusetts pharmacy and led
to public condemnation of the U.S. Food and Drug Administration
and state pharmacy regulators for failing to act against known
problems over the course of a decade.
A Thursday hearing before the Senate Health, Education,
Welfare and Pensions Committee brought the strongest signs so
far of bipartisan willingness to approve legislation that could
break down the current separation of powers between the FDA and
individual state regulators charged with overseeing drug
"Our first order of business (is) to answer these questions:
not just whose job was it to prevent this tragedy, but whose
job will it be to make sure it doesn't happen again," said
Republican Senator Lamar Alexander of Tennessee, the state that
has become the outbreak's epicenter with 83 cases and 13 deaths.
Alexander suggested the FDA could be given powers to certify
individual states as the primary regulators of large-scale
compounders and withdraw certification from those that fall
Senator Pat Roberts, a Kansas Republican long associated
with efforts to reform the current regulatory framework, said
the outbreak's repeated loss of life underscores the need for
"appropriate measures" to protect patients.
"In the face of such a tragedy, it is natural to want to
take action. And we will," said Senator Tom Harkin, the Iowa
Democrat who chairs the Senate committee.
The health disaster behind the debate centers on the
Framingham, Massachusetts-based New England Compounding Center,
which officials say produced epidural injections for back and
joint pain in unsanitary conditions and shipped more than 17,000
tainted doses to customers in 23 states between May and
But health officials say the current outbreak is only the
latest public health menace that has been linked to large-scale
compounding pharmacies, which are exempt from FDA manufacturing
standards for safety and efficacy and regulated largely by
states that critics say are often ill-equipped for the job.
The senators spoke about measures that could empower the FDA
to impose new federal production standards on large-scale
compounding pharmacies and certify state pharmacy boards to
regulate compounding while retaining the clear authority to step
in when necessary.
The appearance of bipartisan support in the Senate stands in
contrast with the Republican-led House of Representatives, where
Democratic calls for action were met by skepticism among
Republicans who argued at a Wednesday hearing that the FDA had
the authority it needed to act against NECC but failed to
protect the public.
"If we fail to act, this type of incident will happen again.
It's a matter of when, not if, I'm afraid," FDA Commissioner
Margaret Hamburg told the Senate panel.
WHO NEEDS AN FDA?
Lawmakers and regulators have made clear that their target
is not pharmacies that engage in traditional drug compounding, a
longstanding practice in which pharmacists alter or recombine
existing drugs to meet the special needs of specific patients
with individual prescriptions.
But in some cases, compounding has evolved to include
large-scale production that some experts view as drug
manufacturing that should be, but currently is not, subject to
Hamburg, who spent four hours facing withering Republican
attacks before the House Energy and Commerce Committee on
Wednesday, came under fire from senators of both parties for
actions not taken against problems identified at NECC during the
Bush and Obama administrations.
"Why do we even have an FDA and why do you have a job, if
the FDA can't stop back-alley large-scale drug manufacturing
that it knows about?" an exasperated Roberts asked the FDA
Roberts demanded that Hamburg say whether FDA had the
authority to act: "You said it was a gray area. I don't want a
gray area. I want a black or white answer!"
"We have authority. But it is limited and unclear and
contested," Hamburg replied.
"Well that's a hell of an authority," Roberts concluded.
Democratic Senator Richard Blumenthal, the first lawmaker to
call for a criminal investigation of NECC, confronted Hamburg by
asserting that having limited authority was no excuse for the
agency's lack of action.
"So is a lot of federal authority and state authority, and
it's used effectively to prevent wrongdoing and law breaking by
companies like NECC," the Connecticut lawmaker said.
Hamburg is calling on lawmakers in Congress to provide new
legislation that would leave traditional compounders to state
regulators but give FDA clear authority to register and regulate
"nontraditional" compounders involved in large-scale operations,
interstate commerce or production of sterile drugs.
Officials say the FDA's authority needs to be clarified in
part because of conflicting federal court rulings about whether
the FDA can regulate compounded products as "new drugs" under
the U.S. Food, Drug and Cosmetic Act.
A leading trade organization for compounding pharmacies told
the senators on Thursday that it favors congressional action to
address the impact of the court rulings, which prevent FDA
action in western states but allow it in the southwest.
"There's definitely clear confusion about authority," said
David Miller, chief executive of the Missouri City, Texas-based
International Academy of Compounding Pharmacists.
In written testimony to the committee, Miller said the
industry believes the problem to be companies who use the
compounding pharmacies to pursue illegal drug manufacturing and
that the FDA already has the authority it needs to stop them.