* Briefings may lead to new action on drug safety
* Concerns about scope of pharmacy compounding, patchwork
laws
WASHINGTON, Oct 9 (Reuters) - Leading lawmakers from the
U.S. House of Representatives and the Senate on Tuesday asked
federal health officials for briefings on a deadly meningitis
outbreak in 10 states as a first step toward possible
legislative action to strengthen federal drug safety
regulations.
Aides said the bipartisan leaders of oversight committees in
both chambers hoped to learn more about the spreading outbreak
before Oct. 12 from staff members of the Food and Drug
Administration and the Centers for Disease Control and
Prevention, which warns that as many as 13,000 people may have
been exposed to the fungal meningitis pathogen through tainted
steroid treatments.
The requests are a sign of growing congressional concern
about the outbreak that has killed 11 people and 119 as a result
of contaminated injections for back and joint pain produced by a
Framingham, Massachusetts-based pharmacy through a lightly
regulated practice known as drug compounding.
Drugs are compounded when a pharmacy alters or recombines
approved medication to meet the special needs of doctors and
their patients.
"We intend to learn more from the FDA, CDC, and others who
may provide insight into the details surrounding this outbreak
and the prevention of future outbreaks," Representative Fred
Upton, Republican chairman of the House Energy and Commerce
Committee, said in a letter to the two agencies coauthored by
three Republicans and two Democrats from the panel.
"The committee has a long bipartisan history of conducting
drug safety oversight and is very concerned about these recent
developments," they wrote.
Earlier in the day, Democratic Senate aides said the
agencies were sent a similar request from Senator Tom Harkin,
chairman of the Senate Health, Education, Labor and Pensions
Committee, and the panel's ranking Republican, Senator Mike
Enzi.
An FDA spokeswoman said the regulatory agency would respond
promptly to the lawmakers' requests. CDC officials were not
immediately available for comment.
Democratic lawmakers from both chambers have already called
for an investigation into the outbreak and hearings as a prelude
to possible legislation that could bring large-scale compounding
pharmacies firmly under FDA scrutiny.
In a letter to Upton, three Democrats questioned whether
efforts to identify the source of the outbreak were delayed by
confusion surrounding the U.S. Food and Drug Administration's
authority over compounding pharmacies.
"This incident raises serious concerns about the scope of
the practice of pharmacy compounding in the United States and
the current patchwork of federal and state laws," wrote the
panel's top Democrat, Representative Henry Waxman, who was
joined by fellow members Frank Pallone and Diana DeGette.
Waxman and Pallone later joined their Republican colleagues
to request the FDA and CDC briefing.
A fourth Democrat, Edward Markey, whose Massachusetts
district includes Framingham, said separately that he would
introduce legislation to strengthen the FDA's regulatory
authority.
Democratic Senator Richard Blumenthal has called for a
meningitis investigation by Harkin's committee, saying new
legislation is needed.
The three House Democrats said the pharmacy at the center of
the outbreak, the New England Compounding Center, appeared to
stray far beyond a legal exemption for pharmacists that allows
them to provide customized doses of medicine to individual
patients.
Instead the lawmakers said NECC operated like a
manufacturer, shipping more than 17,000 vials of compounded
steroid injections to customers at 76 facilities in 23 states.
"Congress ... did not intend for a compounding pharmacy to
be permitted to operate as a small drug manufacturer," the
lawmakers wrote.
Compounding is not subject to the safety and efficacy
standards that FDA requires of drug manufacturers. Legal and
public health experts say that creates a regulatory loophole for
operators seeking to boost profits by compounding large volumes
of drugs at prices far below those of FDA-approved products sold
by manufacturers.
The regulatory question is also at the heart of conflicting
federal court rulings on the FDA's ability to scrutinize
compounding pharmacies. Experts say the cases pose issues that
may need to be settled by the U.S. Supreme Court.
The Democrats asked whether the FDA knew of the scope of
NECC operations and whether the agency had clear authority to
act.
They also raised questions about whether Massachusetts
health officials took steps to ensure the safety of NECC
products following earlier problems addressed by a 2006 consent
agreement.
According to the letter, Congressional officials should also
determine if there were legitimate scientific reasons for using
the steroid treatment and whether patients and doctors were
aware that the products were produced by compounding.
