Markey report: More FDA oversight of compounding pharmacies needed in light of state ‘deficiencies’

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Five House Democrats sent letter to boards of pharmacy requesting information

 

Rep. Ed Markey (D-MA) yesterday released a report that argued for more FDA authority over certain compounding pharmacies based on findings that show they are “largely untracked, unregulated, and under-inspected by states across America,” according to a news release from his office.

The report, State of Disarray: How States’ Inability to Oversee Compounding Pharmacies Puts Public Health at Risk, resulted from a letter sent by Reps. Markey, Henry Waxman (D-CA), John Dingell (D-MI), Frank Pallone Jr. (D-NJ), and Diana DeGette (D-CO) to boards of pharmacy in all states, territories, and Washington, DC, requesting answers to six questions. All boards of pharmacy—except Rhode Island, Guam, Puerto Rico, and the U.S. Virgin Islands—responded to the letter.

These Members of Congress are Democratic members of the House Energy & Commerce Committee, and all but Pallone are members of its Subcommittee on Oversight and Investigations (with Dingell as a nonvoting member). Markey’s report came before today’s House Energy & Commerce Subcommittee on Oversight and Investigations hearing, with FDA Commissioner Margaret A. Hamburg as the only scheduled witness.

“Deficiencies associated with state record-keeping, communication, resources, and specialized expertise combined with the inability of any single state to monitor the adequacy of compounding pharmacy safety in 49 other states appear to be systemic barriers to relying solely on the states to assure the safety of compounded drug products,” according to the report. “The FDA needs clear, unambiguous authority that would enable it to set and enforce safety standards for the riskiest and largest compounding pharmacies, as well as those that sell compounded drugs across state lines.”

Markey’s report follows up on his first report, Compounding Pharmacies, Compounding Risk, released October 29, 2012. On November 2, 2012, he introduced the Verifying Authority and Legality in Drug (VALID) Compounding Act to give FDA new authority to oversee compounding pharmacies operating as drug manufacturers but preserve state regulatory authority for traditional small compounding pharmacy activities. Markey’s actions took place in the wake of the fungal meningitis outbreak linked to the now-shuttered New England Compounding Center that was located in his congressional district.

The report’s main findings include the following:

  • State boards of pharmacy generally do not know which pharmacies engage in compounding, do not know whether pharmacies ship compounded drugs across state lines, and do not know which pharmacies manufacture large quantities of compounded drugs.
  • Only 13 state boards of pharmacy know which pharmacies are providing sterile compounding services and only 5 of these states have inspectors who are trained to identify problems with sterile compounding.
  • States typically do not maintain pharmacy inspection records that enable them to identify systemic and repeated compounding pharmacy safety problems that originate either in state or out of state.
  • States are unable to effectively police compounding pharmacy activities in other states. When issues arise with out-of-state pharmacies, states do not consistently inform the origination state or FDA.
  • Despite general increases in board of pharmacy budgets, the number of pharmacy inspectors has remained consistently low. States usually do not distinguish between inspections of traditional and compounding pharmacies.

 

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