The Senate approved the Drug Quality and Safety Act by voice vote Monday. It passed the House in September.
Advocates, including public health groups and most industry stakeholders, say it’s a significant step forward for the security of the country’s drug supply. The president is expected to sign the legislation.
“Americans must have the confidence that their drugs — whether obtained at a hospital, at a doctor’s office or at the pharmacy counter — are safe, and that is exactly what this bill does,” Sen. Tom Harkin (D-Iowa), said in a statement. Harkin and Sen. Lamar Alexander (R-Tenn.) led the legislative effort in the Senate.
The bill encourages compounding pharmacies like the Massachusetts facility behind last year’s fungal meningitis outbreak to register for FDA regulation. The agency’s stamp of approval, while not mandatory, is expected to carry a significant advantage in the marketplace of hospitals and other providers that want assurances they are buying quality compounded drugs.
The legislation was spurred by a nationwide outbreak of fungal meningitis linked to contaminated steroid injections made by the New England Compounding Center. More than 750 people got sick and 64 died, according to the Centers for Disease Control and Prevention. NECC and a sister facility have been shut down and are now embroiled in lawsuits.
In the wake of the outbreak, state and federal authorities stepped up enforcement action on this niche industry, which produces bulk quantities of sterile injectable drugs and other products. Investigations in the House and Senate found the FDA’s oversight had been inadequate, in part due to conflicting court rulings on the agency’s authority. The bill is designed to address that.
The bill also will require a federal prescription drug track-and-trace system that will allow drugs to be followed from the manufacturer through the distribution system to the pharmacies that dispense them. It’s intended to prevent counterfeit or contaminated drugs from entering the market downstream in the supply chain and to allow faster recall of bad products.
Current “drug pedigree” requirements vary state by state. Rigorous provisions in California law were slated to start taking effect next year, and stakeholders in the pharmaceutical supply chain had put pressure on Congress to pass a law that would pre-empt the patchwork of state requirements.
The track-and-trace system gradually phases in over 10 years, at which point each package of drugs will be electronically traceable throughout the system. Compounding facilities are expected to begin the FDA registration process next year.
Both measures “are going to help ensure that the drugs Americans are taking are high quality and are safe,” said Gabrielle Cosel, manager of drug safety at The Pew Charitable Trusts.
Read more: http://www.politico.com/story/2013/11/senate-passes-drug-compounding-safety-bill-100011.html#ixzz2l6KxKU6d