Showing posts with label House Energy and Commerce Committee Schedule for Reforming the Drug Compounding Regulatory Framework. Show all posts
Showing posts with label House Energy and Commerce Committee Schedule for Reforming the Drug Compounding Regulatory Framework. Show all posts

Saturday, July 13, 2013

House Energy and Commerce Committee Schedule, Witnesses, Background Memo, Discussion Draft for Reforming the Drug Compounding Regulatory Framework


WASHINGTON, DC – The House Energy and Commerce Committee today announced its hearing and markup schedule for the week of July 15, 2013. Beginning on Tuesday, the Subcommittee on Health will consider ideas for reforming the regulation of drug compounding. Also on Tuesday, the full committee will begin its markup of six important energy, health, and jobs bills. Thursday, the Subcommittee on Commerce, Manufacturing, and Trade will explore the federal government’s role in protecting consumers after data breaches and the Subcommittee on Oversight and Investigations will discuss the Obama administration’s recent decisions to delay Obamacare’s employer mandate and to scale back verification of exchange applicants’ information.

On Tuesday, July 16, the Subcommittee on Health will hold a hearing on “Reforming the Drug Compounding Regulatory Framework.” The hearing will examine potential legislative options for reforming the regulation of drug compounding and clarifying the authority of state and federal regulators. The subcommittee previously examineddrug compounding on May 23, and the ongoing effort builds on the Oversight and Investigations Subcommittee’sinvestigation into the deadly fungal meningitis outbreak stemming from tainted steroid injections produced by the New England Compounding Center. The Majority Memorandum, a witness list, and bill text are posted here and below. Witness testimony will be available at the same link as they are posed.




Background Memo
H.R. 2186--To amend the Federal Food, Drug, and Cosmetic Act to provide for the compounding of drug products

S. 959--To amend the Federal Food, Drug, and Cosmetic Act with respect to compounding drugs

Discussion Draft--To amend section 503A of the Federal Food, Drug, and Cosmetic Act with respect to pharmacy compounding

Witnesses:
Panel I

Janet Woodcock, M.D.
Director
Center for Drug Evaluation and Research
Food and Drug Administration (FDA)

Panel II

Jeffrey Francer
Assistant General Counsel
Pharmaceutical Research and Manufacturers of America

David Gaugh
Senior Vice President for Sciences and Regulatory Affairs
Generic Pharmaceutical Association

B. Douglas Hoey
Chief Executive Officer
National Community Pharmacists Association

David G. Miller
Executive Vice President and CEO
International Academy of Compounding Pharmacists

Carmen Catizone
Executive Director
National Association of Boards of Pharmacy

Kasey Thompson
Vice President
American Society of Health-System Pharmacists

Allan Coukell
Senior Director, Drug and Medical Devices
The Pew Charitable Trusts
Congress:
113th