The New York Times reports, "More Sway for F.D.A. Is Object of New Bill," by Sabrina Tavernise.
A bipartisan committee of lawmakers from the Senate and the House reached a compromise on Wednesday on legislation that would give the Food and Drug Administration greater control over compounding pharmacies. But analysts said it was still unclear whether the law would actually make drugs safer.
Lawmakers said the bill’s primary function was to help prevent another national health disaster like the meningitis outbreak last year that was traced to a large Massachusetts-based compounding pharmacy, a company that mixes specialty medicine. More than 60 people died and more than 700 were sickened after receiving injections of a contaminated steroid made by the pharmacy, the New England Compounding Company.
The F.D.A. has argued repeatedly that it has limited authority over compounders, which are now regulated by state boards of pharmacy, even though many ship drugs across state lines.
The bill’s authors argued that it would give the agency broader powers by placing some compounding pharmacies in a separate category that would require them to behave much like traditional drug manufacturers: to alert the authorities when something goes wrong with their products, to register with the F.D.A. and to allow agency officials into their facilities for inspection, much as traditional drug manufacturers do.
The Hill posts, "Lawmakers strike agreement on compounding pharmacy regulation," by Elise Viebeck.
Lawmakers said the new bill would apply uniform national standards to pharmacy compounding while enacting a track-and-trace system to ensure drugs are safe throughout the supply chain.
Currently, a patchwork of state and federal regulations complicates oversight of drug compounders, who either customize medications on a prescription-by-prescription basis or produce drugs in large quantities like a manufacturer.
Under the Drug Quality and Security Act announced Wednesday, traditional compounders would largely remain under the jurisdiction of state boards of pharmacy while larger operations would be regulated by the Food and Drug Administration (FDA).
Lawmakers had urged for a clarification of the FDA's duties following a multistate outbreak of fungal meningitis that has killed more than 60 people since last year.
The deaths were caused by tainted steroid injections produced by the New England Compounding Center, a now-shuttered company whose safety violations were never fully penalized by regulators.
The outbreak prompted a series of hearings in both the House and Senate and a vigorous debate over whether the FDA deserved new powers to oversee compounding.
"Federal legislation, on compounding pharmacy oversight, winning bipartisan support," is the AP report by Steve LeBlanc, via MassLive.com.
The Food and Drug Administration would have greater oversight over large volume compounding pharmacies, like the Massachusetts company that triggered a deadly meningitis outbreak, under federal legislation winning bipartisan support.
Iowa Sen. Tom Harkin, the Democratic chairman of the Committee on Health, Education, Labor, and Pensions, said Sept. 25 that the bill calls for an "unprecedented tracing system that will track prescription drugs from manufacturing to distribution."
The FDA would be able to monitor the pharmacies much the way they regulate drug-makers, including through inspections. The system would replace what critics say is the existing patchwork of federal regulations over the pharmacies.
The bill was prompted by the 2012 meningitis outbreak tied to the now-shuttered New England Compounding Center in Framingham that killed at least 64 people and sickened 750 more. Inspections subsequently found unsanitary conditions at the company's facility.
"U.S. congressional panels agree on bill to regulate drug compounding," is Reuters coverage by Toni Clarke.
The bill, called the Drug Quality and Security Act, comes in response to a deadly outbreak last year of fungal meningitis that killed more than 50 people and was traced to a tainted steroid sold by the New England Compounding Center in Framingham, Massachusetts.
The legislation is expect to pass smoothly and quickly through the full House and Senate.
Traditionally, pharmacists who compound medication mix tailored doses for individual patients in response to specific prescriptions. Over the last decade the practice has mushroomed, with some pharmacies selling thousands of doses of regularly used mixtures without prescriptions for physicians to keep for future use.
The legislation would draw a distinction between traditional compounding pharmacies and those such as NECC which ship sterile products across state lines. These larger organizations, to be known as "outsourcing facilities," would be regulated by the FDA but be exempt from the full spectrum of regulations that apply to traditional pharmaceutical companies.
Traditional compounding pharmacies would continue to be regulated by state boards of pharmacy.
Previous attempts to create national standards to track and trace drugs have foundered amid complaints from companies that they would be too costly to implement.
But concerns over counterfeit drugs have been growing. Last year, fake vials of Roche Holding AG's cancer drug Avastin appeared in the United States from Britain where it was purchased from a Turkish wholesaler.
The World Health Organization estimates that less than 1 percent of medicines available in the developed world are likely to be counterfeit. Globally, that number is around 10 percent.
Earlier coverage of compounding pharmacy problems begins at the link.