Showing posts with label Compounding legislative proposals considered at House hearing. Show all posts
Showing posts with label Compounding legislative proposals considered at House hearing. Show all posts

Monday, July 22, 2013

GREAT READ! Compounding legislative proposals considered at House hearing


Griffith’s discussion draft becomes public; FDA, pharmacy and other groups testify
The Republican-controlled House Energy & Commerce Subcommittee on Health on July 16 held a hearing to examine three compounding legislative proposals, namely the Senate Health, Education, Labor, & Pensions (HELP) Committee bill (S. 959), a bill introduced by former House Democrat Sen. Ed Markey (D-MA) (H.R. 2186), and a discussion draft put forward by Rep. Morgan Griffith (R-VA). Unlike the two bills sponsored by Democrats, Griffith’s draft proposal contained no new authorities for FDA.
“We are not trying to take anything away from the current FDA authority,” Griffith said deep into the nearly 3-hour hearing. “We are trying to clarify without going too far.”
Materials for the July 16 hearing, Reforming the Drug Compounding Regulatory Framework, were posted on the House Energy & Commerce website. These materials include S. 959, H.R. 2186, Griffith’s discussion draft, and written testimony from the witnesses’ organizations, including FDA on the first panel and the National Community Pharmacists Association (NCPA), American Society of Health-System Pharmacists (ASHP), Pharmaceutical Research and Manufacturers of America (PhRMA), Generic Pharmaceutical Association, Pew Charitable Trust, International Academy of Compounding Pharmacists (IACP), and National Association of Boards of Pharmacy (NABP) on the second panel.
At issue in the drive by Congress to address the regulatory gray area occupied by the evolving compounding industry is section 503A of the Federal Food, Drug, and Cosmetic Act, which was added to the law in 1997. Section 503A exempts compounded drugs from three of the law’s provisions, including the premarket approval for new drugs, the requirement that a drug be made in compliance with current Good Manufacturing Practice (cGMP) standards, and the requirement that the drug bear adequate directions for use, provided certain conditions are met, according to FDA’s written testimony. Subsequent court decisions have “amplified the perceived limitations and ambiguity associated with FDA’s enforcement authority over compounding pharmacies.”

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