The Tennessean says Public Citizen sent HHS Secretary Kathleen Sebelius a letter expressing “strong opposition” to and “great concern” with FDA Commissioner Dr. Margaret Hamburg’s proposals for improved oversight of compounding labs in the wake of the fungal meningitis outbreak. In the letter, the consumer advocate said, “Dr. Hamburg’s performance in the wake of the preventable fungal meningitis tragedy demonstrates a remarkable failure of leadership.” In regards to Hamburg’s proposed legislation to recognize compounding labs as large-scale manufacturers, Public Citizen “asked Sebelius to reject the proposal, compel the FDA to use its existing authority to the fullest extent, direct Hamburg to be more forthcoming about the agency’s failures leading up to the outbreak and probe into preparations before her testimony to Congress.”
The Hill quotes in its “Healthwatch” blog a statement from Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group, “The FDA’s proposal for oversight of ‘non-traditional’ compounding, if implemented, would decriminalize what is now illegal drug manufacturing conducted under the guise of pharmacy compounding, and ensure the continuing occurrence of serious disease outbreaks caused by tainted drugs in the future.” FDA Commissioner Hamburg “proposes to regulate the industry in two tiers – traditional and non-traditional. Public Citizen insists that non-traditional compounders should be classified as drug manufacturers and overseen under existing law.”
CQ quotes from the Public Citizen letter, “Hamburg made numerous statements that directly undermined the FDA’s existing authority over compounding pharmacies that engage in drug manufacturing, as well as other statements that appear to show a striking disregard for the importance of regulatory requirements for premarket review and approval of new drugs, good manufacturing practices (GMP), and appropriate labeling – all of which are vital to ensuring the safety and quality of the nation’s drug supply.”
CDC: Tennessee leads states in deaths from fungal meningitis outbreak. USA Today says the CDC released updated numbers on Monday that show Tennessee leading states with the most deaths, 14, from the fungal meningitis outbreak. Michigan “has the second-most deaths with 10, followed by Indiana with seven.” Nationwide, the outbreak “has now sickened 620 people, killing 39 of them. The number of sickened rose 5 percent from last week.”
Lawmakers back SAFE Compounded Drugs Act. The WWNT 1450AM (AL) website reports that Sen. Lamar Alexander (R-TN) and Democratic lawmakers Sen. Tom Harkin (IA) and Rep. Rosa DeLauro (D-CT) support the SAFE Compounded Drugs Act that would expand the size and regulatory scope of the FDA, “raising concern from experts who fear that the legislation would have adverse consequences for the pharmaceutical industry.” Dubbed by DeLauro as a response tot he fungal meningitis outbreak, the SAFE Compounded Drugs Act “would establish an FDA database on the pharmacies for use by the FDA and states in oversight of drug compounders.” It also “would require the FDA to set minimum production standards and direct the FDA to offer training to state regulators.”
From the American Association for Justice news release.