WASHINGTON Dec 5 Two Democratic lawmakers in
the U.S. House of Representatives introduced legislation on
Wednesday aimed at bolstering federal oversight of compounded
drugs like the tainted steroid injections blamed for a deadly
fungal meningitis outbreak.
But the legislation is not likely to move forward in the
Republican-controlled chamber. In fact, aides from both parties
said neither the House nor the Democratic-led Senate is expected
to vote on meningitis legislation this year, given the little
time remaining and the overarching focus on so-called "fiscal
cliff" deficit-reduction talks.
Some Democratic lawmakers have warned that enacting tighter
federal standards for compounded drugs could become more
difficult in the new year, as the meningitis outbreak wanes and
loses public attention.
The outbreak, linked to steroid injections from the
Massachusetts-based New England Compounding Center, has sickened
541 people, 36 of whom have died, according to the U.S. Centers
for Disease Control and Prevention.
The public health disaster has also spawned several
investigations including a U.S. grand jury probe.
Drug compounding is a traditional pharmacy practice in which
pharmacists alter or recombine drugs to meet the special needs
of individual patients with a physician's prescription. The
practice is regulated mainly by state pharmacy boards that do
not impose the stringent safety and efficacy standards that the
Food and Drug Administration requires of drug manufacturers.
But in the past few decades, some compounding pharmacies,
such as NECC, have become large operations selling thousands of
drug doses to clinics, hospitals and other healthcare providers
across state lines.
Critics say those operations rival drug manufacturers in
scale and should be subjected to strict FDA standards. But past
attempts to strengthen federal regulation has been defeated by
industry lobbying and legal maneuvering.
FDA has lately come under fire in Congress, mainly from
Republican lawmakers who say it has the authority to act against
problem compounders but failed to take effective action against
NECC despite problems dating back ten years.
Public Citizen, an advocacy group that tracks drug safety
issues, has called for an investigation of FDA's failures and
urged the agency to inspect other compounders where problems
have also surfaced over the past several years.
The legislation introduced on Wednesday by Democratic
representatives Rosa DeLauro of Connecticut and Nita Lowery of
New York is the second House Democratic measure to emerge since
the outbreak first surfaced in mid-September.
The bill, known as the SAFE Compounding Drugs Act, would
require compounding companies to register with the FDA, allow
the agency to set minimum production standards and impose new
labeling restrictions on compounded drugs.
Representative Ed Markey, a Democrat from Massachusetts,
also introduced a measure to address FDA's authority last month.
The agency itself has called on Congress to allow it to set
national standards for large drug compounding operations. FDA
officials are scheduled to discuss a potential new regulatory
structure during a meeting with state officials on Dec. 19.