Monday, September 30, 2013

House Passes Bill That Would Give Drug Makers More FDA Scrutiny

The U.S. House passed legislation that would give the government its first uniform rules to help identify stolen or counterfeit drugs and would put manufacturers under greater regulatory scrutiny.
The voice vote on H.R. 3204, which was written in response to dozens of deaths linked to contaminated medicines, sends the measure to the Senate.

“Bad actors concerned more with profit than public health will not be able to operate with impunity again,” said Representative Gene Green, a Texas Democrat.

The bill would let the Food and Drug Administration collect and spend fees to cover costs of inspections and licensing, impose handling and record-keeping requirements, and create notification rules for drugs that are potentially unsuitable for distribution.

The legislation was introduced in response to regulatory gaps revealed by investigations into meningitis-related deaths last year that resulted from tainted medications linked to a compounding pharmacy. Its provisions 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 approving the measure Sept. 26.

“How we got here is a tragedy,” said Representative Timothy Murphy, a Republican from Pennsylvania, said during today’s debate.

The FDA came under criticism from Congress for failing to close New England Compounding Pharmacy Inc. before the Framingham, Massachusetts-based 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, which the lawmakers said would happen if this bill becomes law.

The FDA reported last year that it had discovered counterfeit versions of Roche Holding AG (RHHBY:US)’s cancer medicine Avastin -- containing no active ingredient -- in boxes identifying the contents as Altuzan, the version of the drug that is sold in Turkey and hasn’t been approved for use in the U.S. In 2008 the FDA recalled Baxter International Inc. (BAX:US)’s blood thinner heparin due to contamination of an ingredient imported from China; 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 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 larger drug compounders that produce pharmaceuticals by the batch, rather than one prescription at a time, register as outsourcing facilities subject to FDA oversight. That would enable the FDA to identify providers and products, get reports on adverse reactions and make risk-based inspections.

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 last year’s 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.

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