In 2012, a major outbreak of fungal meningitis was traced to drugs compounded by New England Compounding Centers. The outbreak included approximately 750 confirmed cases and has resulted in 64 deaths to date. Tragedies of this scale have often been the impetus for major changes to federal food and drug laws in the past; the FDCA itself was enacted in 1938 in response to a tragedy in which the use of an improperly manufactured drug (elixir sulfanilamide) led to over 100 patient deaths.
Drug compounding is a process of combining different ingredients to create customized pharmaceutical products for patients. The practice predates the rise of mass-produced drugs in the United States, and was essentially unregulated by FDA for 50-plus years after passage of the FDCA.
In a Client Alert titled, "Major Changes in Drug Compounding and Drug Distribution Requirements (Part 1 of 2)", Epstein Becker & Green health care practice partners, James A. Boiani (D.C.) and Kim Tyrell-Knott (San Diego), provide an insightful analysis of the Drug Quality and Security Act (H.R. 3204).
According to Jim and Kim, the bill is compromise legislation crafted by the Senate Health, Education, Labor, and Pension (“HELP”) and House Energy and Commerce Committees, and is expected to pass the Senate soon after it reconvenes today. Once signed into law, H.R. 3204 will fundamentally change the regulation of drug compounding and drug distribution in the United States.
We look forward to the publication of Part 2 of their Alert concerning this important piece of legislation.
By William A. Ruskin
For more cutting edge commentary on developing issues, visit Toxic Tort Litigation Blog by William A. Ruskin of Epstein Becker & Green.
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