8:56 PM, Nov 12, 2012
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 first place.
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?
Not 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.
Friedman 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 Drug Administration.
"It's really inexcusable. There is no
reason for any of this to be happening," Friedman said.
Instead, 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.
The lobbying group for major drug
companies, the Pharmaceutical Research and Manufacturers Association of America,
said in a statement late Monday:
"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 FDA."
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.
Congress, 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 claims.
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.
Meanwhile, 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."
And 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 oversight.
Also, "we need to look very carefully at
what quality control standards are in place," Coukell said.
Meanwhile, Michael Carome, who tracks
medical issues for the watchdog group Public Citizen, said the FDA has a lot to
answer for in these hearings.
Carome has argued that the FDA, under
Depression-era legislation, already has all the authority it needs to regulate
compounders such as NECC.
What 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."
Contact Paul C. Barton at pbarton@gannett.com.
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