The U.S. for the first time would have uniform regulations to help identify stolen or fake drugs, and makers would get more scrutiny, under a draft bill from the Senate and House committees that oversee pharmaceutical safety.
The measure would let the Food and Drug Administration collect and spend fees to cover costs of inspections and licensing. It also would impose handling and record-keeping requirements and create notification rules for drugs that are potentially unsuitable for distribution.
The measure responds to regulatory gaps revealed by investigations into 50 meningitis-related deaths last year that resulted from tainted medications linked to a compounding pharmacy. It would replace a patchwork of state laws governing distribution of drugs through about 4 billion prescriptions a year filled by compounding and traditional pharmacies, the Senate Health, Education, Labor and Pensions and House Energy and Commerce committees said in a statement.
"This legislation will improve the safety of compounded drugs by clarifying the oversight responsibilities of the FDA over large-volume compounders and by holding facilities to high quality standards," Iowa Democrat Tom Harkin, who heads the Senate committee, said in a statement. "This bill also calls for an unprecedented tracing system that will track prescription drugs from manufacturing to distribution."
The FDA said last year that it had discovered counterfeit versions of Roche Holding AG's cancer medicine Avastin -- with no active ingredient -- in boxes identifying the contents as Altuzan, Turkey's version of Avastin, which hasn't been approved for use in the U.S. In 2008 the FDA recalled Baxter International Inc.'s blood thinner heparin; during the crisis, neither the FDA nor Baxter was able to re-create the supply chain, taking weeks to get close to the source, according to a report last year by the Institute of Medicine, part of the Washington-based National Academies of Sciences.
Under the proposed legislation, manufacturers, repackagers, wholesale distributors and dispensers would, within seven years, be maintaining and sharing records of key information about each drug's distribution history.
The measure would let drug compounders register as outsourcing facilities subject to the same FDA oversight as traditional pharmacies. That would enable the FDA to identify providers and products, get reports on adverse reactions and make risk-based inspections.
The FDA came under criticism from Congress for failing to close New England Compounding Pharmacy Inc. before the company shipped fungus-tainted medications to customers across the U.S. in last year's meningitis outbreak. The company subsequently filed for bankruptcy. The FDA told lawmakers that its legal authority over compounding pharmacies needed to be clarified.
The relevant committee chairmen and the panels' top minority members reached a rare bipartisan accord yesterday after the Republican-controlled House passed a supply-chain bill, H.R. 1919, and the Democratic-majority Senate panel approved compounding pharmacy legislation, S. 959.
Compounding pharmacies prepare personalized prescriptions and are regulated by state health authorities. Some companies also produce larger amounts of blended medicines.
A Senate committee staff report released in May found that in the eight months after the meningitis outbreak caused by contaminated compounded drugs, at least 48 compounding companies were found to be producing and selling drugs contaminated or created in unsafe conditions. In at least three cases, visible contamination was spotted in widely distributed sterile compound drugs.
The report also found that according to FDA documents between 2001 and 2011, at least 25 deaths and 36 serious injuries, including hospitalizations, were linked to large-scale drug compounding companies, including 13 deaths in 2011. The figures may understate the actual number of adverse events because current law doesn't require reporting of those events.
A separate account of adverse events and complaints linked to drug compounding companies from 1988 to 2005 showed at least 38 deaths, including six infants or children, and 210 injuries came from drugs that were contaminated, mislabeled or caused lethal overdoses because they contained more of the active pharmaceutical ingredient than indicated.
The Senate report concluded that "to reduce the risk to the public health from compounded drug products, it is essential that a clear statutory framework be enacted -- one that requires compounding manufacturers to engage in good manufacturing practices, to better ensure the drugs produced are sterile and contain the correct amount of the active pharmaceutical ingredient."