By Paul C. Barton / Tennessean Washington Bureau
WASHINGTON - As Congress prepares for hearings on
meningitis-related deaths and illness tied to a compounding pharmacy,
some observers wonder if lawmakers will raise all of the right
questions, including why compounders get so much drug business in the
The Subcommittee on Oversight and Investigations of
the House Energy and Commerce Committee convenes its inquiry on
Wednesday, followed by the Senate Health, Education, Labor and Pensions
Committee on Thursday.
They are both probing what could have
prevented the recent onslaught of fungal meningitis cases caused by
contaminated steroid drugs coming from the New England Compounding
Center in Framingham, Mass.
So far, 438 people have been infected
in 18 states, causing 32 deaths. Tennessee has had 81 cases, second only
to Michigan's 128. But no state has seen more deaths related to the
drugs than Tennessee, with 13.
As hearings start, said Coral
Gables, Fla., trial attorney Gary Alan Friedman, representatives and
senators should be asking: Is all of this compounding really necessary?
getting the attention it deserves, he said, is the background role
played by the major pharmaceutical companies that produce the
off-the-shelf drugs that large-scale compounders - such as NECC - often
mix to produce the customized pharmaceuticals many patients need.
believes the major pharmaceutical companies, which operate under much
stricter regulation and quality-control standards, could be producing
many of the drugs that come from compounders but don't want to because
it means going through extra regulatory hoops with the U.S. Food and
"It's really inexcusable. There is no reason for any of this to be happening," Friedman said.
he claims, the major pharmaceutical companies have a financial
incentive to sell mass quantities of their off-the-shelve drugs to
large-scale compounders - like NECC - and let them do the mixing.
"They do it with kind of a wink and nod," Friedman said of the major drug makers.
lobbying group for major drug companies, the Pharmaceutical Research
and Manufacturers Association of America, said in a statement late
"Patient safety is the priority for America's innovative
biopharmaceutical companies. Safety should always be at the forefront of
the development, manufacturing and delivery of medicines, and
biopharmaceutical research and manufacturing companies are rightly
subject to rigorous pre- and post-approval safety standards set by the
It added: "The compounding company identified in the recent
meningitis outbreak is not an FDA-regulated manufacturer, although the
scope of this company's distribution of compounded products would seem
to require consistent regulation to allow for the best possible care and
safety of patients."
The statement did not directly address Friedman's concerns.
Friedman said, should examine the FDA approval process so that major
pharmaceutical companies have more interest in making some of the
products left to compounders.
While following the meningitis
cases, Friedman himself has been busy representing clients who have gone
blind and experienced other problems after receiving contaminated doses
of the drug Avastin from compounders.
Although normally a cancer
drug, Avastin in these cases was being used to combat macular
degeneration. It is the type of specialized, "off-label" use of a drug
that major drug manufacturers don't want responsibility for, Friedman
Some of the defendants in cases recently brought by
Friedman in Florida include the drug-store chain Walgreens, a compounder
and distributor; InfuPharma, a Florida compounder; and Genentech Inc., a
major drug manufacturer.
Patients, he added, often have no idea that so many parties are involved in supplying their medicines.
other observers say Congress needs to get a handle on the size and
shape of the compounding industry. Since the meningitis outbreak
started, various figures in the thousands have been bandied about to
describe just how many compounders there are.
"I don't think
anybody has any good numbers on this," said Allan Coukell, specialist on
medical issues for the Pew Charitable Trusts.
"The real challenge is coming to grips with how this industry has grown and changed over the years."
since both state governments and the FDA claim jurisdiction over
companies like NECC, Congress needs to examine how well state and
federal regulators communicate with each other and coordinate their
Also, "we need to look very carefully at what quality control standards are in place," Coukell said.
Michael Carome, who tracks medical issues for the watchdog group Public
Citizen, said the FDA has a lot to answer for in these hearings.
has argued that the FDA, under Depression-era legislation, already has
all the authority it needs to regulate compounders such as NECC.
Congress needs to ask, he said, is what kind of follow-up there was
after the FDA first started issuing warnings to NECC about its
compounding processes in 2005.
"I think they need to focus on
where the failure occurred," Carome said. "Until then, it's premature to
jump in with new laws and regulations."