HELP Committee Schedules Compounding Pharmacy Hearing

The May 9 hearing follows introduction of a bill by four members of the committee to clarify state and federal authorities' oversight responsibilities.

The U.S. Senate's Health, Education, Labor and Pensions Committee has scheduled a hearing May 9 about improving oversight of compounding pharmacies such as the New England Compounding Center, some of whose products are involved in a multi-state outbreak of fungal meningitis. It began in September 2012 when NECC recalled three lots of preservative-free methylprednisolone acetate associated with the outbreak.

The committee's chairman, Sen. Tom Harkin, D-Iowa, introduced a bill April 26 along with Ranking Member Sen. Lamar Alexander, R-Tenn., Sen. Al Franken, D-Minn., and Sen. Pat Roberts, R-Kan., to clarify the compounding oversight responsibilities of state and federal authorities. The bill would amend the Federal Food, Drug, and Cosmetic Act with respect to compounding drugs. It distinguishes between traditional compounding, which would continue to be regulated primarily by state pharmacy boards, and compounding manufacturers that make sterile products without, or in advance of, a prescription and sell them across state lines. These would be regulated by the Food and Drug Administration.

Harkin called the bill "a significant step forward in protecting the public from unsafe compounded products. By clarifying FDA authority over high-risk compounding practices, this bill will enhance protections for patients taking compounded drugs and help prevent crises like last year's tragic meningitis outbreak," he added.

"When drugs are prescribed to make a patient healthier -- and in many cases, save a life -- that patient should know their prescription is exactly what the doctor ordered," Franken said. "We've seen far too many deaths in this country because some pharmacies have acted more like drug manufacturers, without following rigorous safety rules. This legislation will keep Minnesotans safe by ensuring that drug manufacturers have appropriate oversight and that responsible pharmacies don't see any unnecessary restrictions."

The committee's hearing is scheduled to include five witnesses:

  • Dr. Janet Woodcock, director, Center for Drug Evaluation and Research, Food and Drug Administration
  • Carmen S. Catizone, executive director, National Association of Boards of Pharmacy, Mount Prospect, Ill.
  • Allan Coukell, director, Medical Programs, The Pew Charitable Trusts, Washington, D.C.
  • David G. Miller, executive vice president and CEO, International Academy of Compounding Pharmacy, Missouri City, Texas
  • Dr. Kasey K. Thompson, vice president, Office of Policy, Planning and Communications, American Society of Health-System Pharmacists, Bethesda, Md.

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