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Breaking News: House Energy & Commerce Hearing 05.24.13
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House GOP Shows Little Support For Senate’s Compounding Pharmacy Bill

Source: AHCA Gazette

CQ (5/24, Ethridge, Subscription Publication) reports that although many Republicans on the House Energy and Commerce Health Subcommittee “said they would oppose” the Senate’s bipartisan legislation (pdf) for compounding pharmacy oversight, a few members at a hearing Thursday indicated they were willing to work to clarify aspects of the proposal. For example, Morgan Griffith of Virginia “said he could work on a bill that ‘will make it clear how we define’” compounding pharmacy versus drug manufacturer, and “which should be regulated by the FDA”; and Joe Barton of Texas suggested creating “legislation to clarify when a compounding pharmacy...is acting like a manufacturer. ‘If you and the stakeholders will begin to communicate with each other, I think this is a solvable problem,’ Barton told” FDA Center for Drug Evaluation and Research Director Dr. Janet Woodcock at yesterday’s hearing. In addition, some GOP members expressed concern that the Senate measure would grant too much authority to the FDA, whereas other Republican lawmakers worried the Senate bill’s new compounding manufacturer category would a compromise drug safety and reduce the strength of intellectual property protection.

        According to MedPage Today (5/24, Pittman), Dr. Woodcock said legislation “is needed to at least force such large-scale compounders to register with the FDA and submit adverse event reports like traditional drug manufacturers. ‘Right now we don’t know who they are. We don’t know where they are. And we don’t know what they’re making,’ Woodcock told lawmakers.”

        Markey Introduces Compounding Oversight Bill. Reuters (5/24, Clarke) reports Rep. Edward Markey (D-MA) on Thursday became the latest Federal lawmaker to propose a measure (pdf) that would bolster the FDA’s regulatory authority over the compounding pharmacy industry. Under the bill the Senate’s Health, Education, Labor and Pensions Committee approved, the FDA would have oversight for large compounders that produce sterile drugs in bulk and then sell them across state lines, but under Markey’s bill, the agency would not have primary regulating power over compounders, regardless of size, if they have operations in only one state. Another big difference between the two bills is that the Senate measure gives the FDA authority over compounders that produce sterile drug products whereas Markey’s proposal would give oversight to the agency for both sterile and non-sterile products that are mixed or manufactured by compounding pharmacies.

        Meanwhile, The Tennessean (5/24, Wilemon, 120K) notes that the Pharmaceutical Compounding Quality and Accountability Act, which the Senate’s HELP Committee approved Wednesday by voice vote, “is on its way to a vote before the full Senate.”

        Study Urges Lawmakers To Bolster FDA’s Authority Over Compounders. The Hill (5/24, Viebeck, 21K) “Healthwatch” blog reports that last fall’s “deadly meningitis outbreak will repeat itself” if the Food and Drug Administration is not granted ample power to “regulate high-volume drug compounders,” warns a study (pdf) released by the US Federation of State Public Interest Research Groups. The USPIRG analysis “found dozens of safety violations cited by the FDA in a decade of warning letters to compounding pharmacies,” which often “produced unapproved drugs, operated under unsanitary conditions and used unapproved, potentially unsafe ingredients.” Sen. Richard Blumenthal (D-CT), in a USPIRG statement announcing the report, said, “This ‘shadow industry’ of compounding pharmacies recklessly puts Americans’ lives at risk by ignoring basic standards for safety and cleanliness when performing large-scale compounding operations.”

        NABP To Help New Jersey Investigate Compounding Industry. The Newark (NJ) Star-Ledger (5/24, Friedman, 326K) reports that the New Jersey Attorney General’s Office “has hired pharmaceutical drug compounding experts to help with its ongoing investigation of the industry, after a recent discovery of mold in intravenous bags prepared by a Tinton Falls compounding business.” AG Jeffrey Chiesa announced Thursday that the “contract with the National Association of Boards of Pharmacy will employ member pharmacists and investigators to help state inspectors in their review.” Chiesa’s announcement came on the same day as the USPIRG released its report “detailing 10 years of safety violations by drug compounding pharmacies.”

 

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