Alexander: New Drug Compounding Proposal Will Mean “When You Walk Into a Pharmacy or Facility, It Will Be Clear Who is in Charge”

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“When we met to discuss this legislation in November, I made it clear that I have a single goal here, or at least a primary goal, and that’s to make clear who’s on the flagpole, who’s accountable, to eliminate any confusion about responsibility.”  –Lamar Alexander

Washington, D.C., May 9 –At a hearing today (VIDEO HERE) of the Senate Health, Education, Labor and Pensions (HELP) Committee on proposed drug compounding legislation, Ranking Member U.S. Senator Lamar Alexander (R-Tenn.) told an official of the Food and Drug Administration that any efforts to mix oversight responsibilities for compounding manufacturers or pharmacies would “just leave us where we are.”

Alexander said: “It’s important for a facility to know that if it makes a sterile product, in advance of a prescription, and sells it across the state line, the facility has one regulator and that is the FDA, period. The doctor knows that, the customer knows that, the patient knows that, and the FDA knows that, and everybody knows that it is the FDA’s job to make sure that place is safe.”

The draft legislation, Alexander said, “tries to set clear lines for who’s in charge and when they’re in charge.”

Alexander said the committee would move quickly on the legislation and mark it up on May 22.

Alexander joined committee Chairman Senator Tom Harkin (D-Iowa), and Senators Pat Roberts (R-Kan.) and Al Franken (D-Minn.) in releasing the draft legislation for public input on April 26. The draft proposal clarifies authority over businesses that make compounded drugs by drawing a clear distinction between traditional compounding—which will continue to be regulated by state pharmacy boards—and a new category of “compounding manufacturers” that make sterile products without or in advance of a prescription and sell those products across state lines.

In his opening statement at today’s hearing, Alexander said: “The outbreak of fungal infections stemming from contaminated product from the New England Compounding Center has been a nightmare for Tennessee. We have had over 150 cases, 15 deaths. There was heroism on the part of state officials with the Department of Health who discovered the problem and helped alert other states about it and worked with the FDA.

“When we met to discuss this in November, I made it clear that I have a single goal here, or at least a primary goal, and that’s to make clear who’s on the flagpole, who’s accountable, to eliminate any confusion about responsibility.”

Alexander explained, “When I was a new governor, we had a cabinet meeting and we had a very important bill to pass so we all agreed to go back to work on it. When we got back together a week later, nothing had happened. So I said, ‘Let’s try something else.’” Alexander said he put a single individual “on the flagpole” and added, “‘If it passes, it’s to his credit, and if it doesn’t, it’s his fault.’” When the group met a week later, “the bill had passed.”

Alexander continued: “Admiral Rickover, with the nuclear Navy in the 1950s, told the captains of every nuclear submarine—he personally hired them and he told them they have two responsibilities – one was the ship and the second was the reactor, and that if anything went wrong with the reactor, the captain was personally responsible for it and his career in the Navy was probably in the dust if anything happened. As a result, during that entire time since the 1950s, there has never been a death as a result of a nuclear reactor on a naval submarine.”

Alexander said: “I’d like to see that kind of accountability here when we talk about pharmacies. We developed a bill working with FDA, state boards of pharmacy, pharmacists, doctors, hospitals – we worked together, many members of this committee, on a bill that passes that test and tries to set clear lines for who’s in charge and when they’re in charge. I hope to hear from the witnesses today what they think about this and how we can improve it.

“To briefly summarize, it creates three categories, one is the traditional drug manufacturer. FDA would continue to regulate that. The second one is a new category defined as ‘compounding manufacturers.’ These are businesses that make sterile products in advance of a prescription and sell them across state lines. These compounding manufacturers fill a need when the products made by drug manufacturers need to be tailored or combined for certain hospital patients. Hospitals increasingly turn to compounding manufacturers to make those changes to the drugs. This new category of compounding manufacturers will be regulated by the FDA.

“The third category is the traditional pharmacy, defined as pharmacies that sell compounded, non-sterile products (such as lotions), or only sell in their state, or receive prescriptions before beginning the compounding. States will continue to oversee and regulate these traditional pharmacies.

“When you walk into a facility, it will be clear who is in charge of regulating that facility.”

The draft legislation released on April 26 creates a uniform set of rules for compounding manufacturers across the country while preserving the states’ primary role in traditional pharmacy regulation.

Alexander sent letters to the Tennessee Board of Pharmacy, the Tennessee Department of Health, 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.

The 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.

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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