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.