Alexander, Colleagues Release Draft Legislation to “Help Ensure That a Tragedy Like Last Year’s Meningitis Outbreak Never Happens Again”

Posted on April 26, 2013

Draft legislation preserves the states’ primary role in traditional pharmacy regulation and clarifies FDA authority over those making sterile products without prescriptions and shipping across state borders 

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 “Last year’s meningitis outbreak was a nightmare for Tennesseans, and this legislation will help ensure that it never happens again. Our goal with this bill is to put an end to FDA inaction and make it clear who is on the flagpole—who is in charge and accountable for oversight of these pharmacies and manufacturers.” –Lamar Alexander

WASHINGTON, April 26 – U.S. Senator Lamar Alexander (R-Tenn.), the Ranking Member of the Senate Health, Education, Labor and Pensions (HELP) Committee, with Chairman Tom Harkin (D-Iowa) and members of the committee today released draft legislation that offers “the best way to help ensure that last year’s meningitis outbreak never happens again—by making clear who is responsible for overseeing our nation’s compounding pharmacies and manufacturers.”

The draft legislation makes a clear distinction between traditional compounding—which will continue to be regulated by state pharmacy boards—and compounding manufacturers that make sterile products without or in advance of a prescription and sell those products across state lines. Those compounding manufacturers would be regulated by the Food and Drug Administration.

Alexander said: “Last year’s meningitis outbreak was a nightmare for Tennesseans, and this legislation will help ensure that it never happens again. Our goal with this bill is to put an end to FDA inaction and make it clear who is on the flagpole—who is in charge and accountable for oversight of these pharmacies and manufacturers. 

The draft legislation creates a uniform set of rules for compounding manufacturers across the country while preserving the states’ primary role in traditional pharmacy regulation.

In addition to distinguishing between pharmacies and manufacturers, and clarifying proper oversight of each, the draft legislation sets forth requirements on compounding manufacturers. They must register with the FDA and tell the agency what products they have made, make products under a pharmacist’s oversight and in compliance with good manufacturing practices, and investigate and report adverse events. 

The draft legislation allows FDA to identify categories of drugs that currently cannot be safely compounded, preserves and enhances current protections regarding the ingredients from which drugs are compounded, and preserves the line between compounding manufacturers and traditional manufacturers by placing prohibitions on wholesale distribution of compounded products.

The draft bill also would encourage communication among states and increase communication between states and the FDA. If FDA receives a complaint from a state regulatory agency about a traditional pharmacy in another state, the FDA must relay that information to the relevant state pharmacy board within 15 days.

Senator Alexander, along with Chairman Harkin and Senators Pat Roberts (R-Kan.) and Al Franken (D-Minn.) and other members of the HELP Committee are requesting stakeholders provide feedback, including their level of support for the overall proposal, in addition to any comments regarding the feasibility of this framework, and any technical feedback to help improve the draft bill

Alexander has sent letters to the Tennessee Board of Pharmacy, the Tennessee Department of Health, the Tennessee Board of Pharmacy, the Tennessee Pharmacists Association, the Tennessee Medical Association, the Tennessee Hospital Association, and the Tennessee Board of Medical Examiners, requesting their feedback on the draft legislation.

Today’s draft legislation comes after a Senate committee hearing and joint oversight report last November on the deadly meningitis outbreak, where Alexander called for a new model of oversight of sterile compounding pharmacies and committed to working with Chairman Harkin on legislation this year. The Committee plans to have a hearing in early May to discuss the legislative proposal.

Last October, Alexander, along with a bipartisan group of senators serving on the HELP Committee, sent letters to the FDA, Massachusetts Board of Pharmacy, and New England Compounding Center (NECC) owners, seeking information about the lack of FDA oversight and how the outbreak was allowed to occur.  This draft legislation was informed by over 30,000 pages of documents reviewed by staff.

Alexander also sent a letter with Sen. Bob Corker (R.-Tenn.) to FDA Commissioner Margaret Hamburg asking for clarity regarding existing laws governing oversight of compounding pharmacies like NECC and information about any inspections of NECC and actions taken since the FDA warned the center in December 2006.

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