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Calls for Federal regulation of compounding industry increase

In continuing coverage, several news entities noted that the meningitis outbreak has prompted state and Federal lawmakers to call for calling for stronger government oversight of compounding pharmacies.

On NBC Nightly News (10/8, story 4, 2:20, Williams), NBC (Costello) reported, "As demand for the less expensive drugs has grown, so has the amount of companies who mix medications from 5,000 in 2009 to 7,500 in 2012. The compounders are regulated by states, not the FDA." Former FDA Chief Counsel Sheldon Bradshaw was shown saying, "It is hard to know whether...there are no risks with these compounded drugs, because they're under no obligation to report them to the FDA."

In a front-page story, the Wall Street Journal (10/9, A1, Martin, Burton, Dooren, Subscription Publication) reports that at present, Federal, state and state pharmacy boards have a part in regulating specialty pharmacies, but their drug products are not subject to the strict FDA approval process. But as the outbreak widened Monday, Rep. Ed Markey (D-MA) sent a letter to FDA Commissioner Margaret Hamburg, MD, calling for the agency to have a greater role in overseeing compounding facilities. The Journal quotes Rep. Markey as saying in the letter, "Compounding pharmacies currently fall into a regulatory black hole."

The Financial Times (10/9, Rappeport, Subscription Publication) quotes the FDA's Office Of Unapproved Drugs And Labeling Compliance Director Kathy Anderson as saying, that at present, "Compounding drugs are not approved by FDA and they don't undergo that same premarket approval" process that "FDA-approved drugs do."

Reuters (10/9, Morgan, Begley), noting that specialty pharmacies do not have to prove the safety and efficacy of the drug formulations they compound, says US Sen. Richard Blumenthal (D-CT) called for the FDA to the obtain full oversight of the industry. Reuters quotes Sen. Blumenthal saying that the compounding industry's present "relative immunity from standards of safety and effectiveness seems anomalous and unacceptable." Notably, Reuters points out that Blumenthal is a member of the Senate Committee on Health, Education, Labor, and Pensions, which supervises the FDA's jurisdiction.

CBS News (10/9) on its website posts a video of Vanderbilt University Medical Center Chair Dr. William Schaffner calling for "more government regulation" of compounding pharmacies on "CBS This Morning." According to the International Academy of Compounding Pharmacists, there are "7,500 compounding pharmacies" in the US, "representing 3 percent of prescriptions filled," and gaining "$3 billion" in revenue, annually. "They seem to have fallen into a regulatory gap. That's something that really needs to be addressed by the Congress," Dr. Schaffner stressed. "I really think that going forward we need to have a regulatory structure that doesn't permit this [meningitis outbreak] to happen," he added.

Meanwhile, the AP (10/9) reports that the Massachusetts Legislature's Public Health Committee Chair Rep. Jeffrey Sanchez "says legislative leaders are monitoring the latest developments from the federal Food and Drug Administration and Massachusetts Department of Public Health. The Boston Democrat said Monday he's hasn't ruled out the possibility of public hearings, but said right now he has more questions than answers." Sanchez explained that if "there is some action Massachusetts lawmakers can do to tighten state regulations, he wants to make sure he has all the information he needs before making any recommendations."

The Boston Herald (10/9, Cassidy, Remal) adds that on Monday, Massachusetts Secretary of Health and Human Services JudyAnn Bigby issued a statement saying, "Our joint response and investigation with the FDA will continue until we have all the answers and information we need to determine what if any regulatory changes need to be made at the state and federal level."

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