Drug Safety
June 2005
BNA's Web Watch is prepared by Laura
Gordon-Murnane. E-mail suggestions for future weekly topics
always welcome.
Federal Government
Congress
Chuck
Grassley – Letter to FDA Commissioner Lester M. Crawford
- Grassley Continues Push For Transparency, Accountability And Independence
At FDA (June 8, 2005)
Proposed Legislation
S.930
Food and Drug Administration Safety Act of 2005 (Introduced in Senate)
Title: A bill to amend the Federal Food, Drug,
and Cosmetic Act with respect to drug safety, and for other purposes.
Sponsor: Sen Grassley, Chuck [IA] (introduced 4/27/2005)
Cosponsors (3)
Latest Major Action: 4/27/2005 Referred to Senate
committee. Status: Read twice and referred to the Committee on Health,
Education, Labor, and Pensions
S.470
Title: A bill to amend the Public Health Service
Act to expand the clinical trials drug data bank.
Sponsor: Sen Dodd, Christopher J. [CT] (introduced
2/28/2005) Cosponsors (4)
Latest Major Action: 2/28/2005 Referred to Senate
committee. Status: Read twice and referred to the Committee on Health,
Education, Labor, and Pensions.
H.R.2090
Food and Drug Administration Improvement Act of 2005 (Introduced
in House)
Title: To amend the Federal Food, Drug, and Cosmetic
Act to provide for the deposit in the general fund of the Treasury
of fees that are collected from manufacturers of drugs and devices
under chapter VII of such Act, to terminate the authority of the
Food and Drug Administration to negotiate with the manufacturers
on particular uses of the fees, to establish a Center for Postmarket
Drug Safety and Effectiveness, to establish additional authorities
to ensure the safe and effective use of drugs, and for other purposes.
Sponsor: Rep Hinchey, Maurice D. [NY-22] (introduced
5/4/2005) Cosponsors (4)
Latest Major Action: 5/23/2005 Referred to House
subcommittee. Status: Referred to the Subcommittee on Health.
Congressional Hearings
House Committee on Government Reform
May 5, 2005 - Full
Committee Hearing on Ensuring the Safety of FDA-Approved Drugs
Related Documents
Opening Statement - Chairman
Davis' Opening Statement
Witness Testimony
Testimony
of Dr. Steven Galson, Director, Center for Drug Evaluation and
Research, Food and Drug Administration, accompanied by Dr. John
Jenkins, Director, Office of New Drugs and Dr. Paul Seligman, Director,
Office of Pharmacoepidemiology, Center for Drug Evaluation and Research,
Food and Drug Administration
Testimony
of Dr. Dennis Erb, Vice President of Global Strategic Regulatory
Development, Merck & Company, Inc.
Testimony
of Mr. John E. Calfee, Resident Scholar, American Enterprise
Institute
Testimony
of Dr. Michael Wilkes, Vice Dean for Medical Education, School
of Medicine, University of California, Davis
Senate Committee on Health, Education, Labor, and Pensions
Ensuring
Drug Safety: Where Do We Go From Here?
March 3, 2005
Dr. Janet
Woodcock
Dr. Cecil
B. Wilson
Mr. Keith
L. Carson
Dr. Raymond
Woosley
Dr. Bruce
Psaty
Senate Committee on Health, Education, Labor, and Pensions
FDA’s Drug Approval Process: Up to the Challenge?
March 1, 2005, 9:30 am
Dr. Sandra
Kweder
Ms. Nancy
Davenport-Ennis
Dr. Thomas
Fleming
Dr. David
Fassler
Dr. Scott
Gottlieb
Ms. Abbey
Meyers
Mr. William
B. Schultz
FDA, Merck and Vioxx: Putting Patient Safety First?
November 18 , 2004
Member Statements:
Charles
Grassley, IA
Max
Baucus, MT
Witness Statements:
Panel I
Dr.
David J. Graham, MPH, Associate Director for Science, Office
of Drug Safety, Center for Drug Evaluation and Research, U.S. Department
of Health and Human Services, Food and Drug Administration, Washington,
DC
Panel II
Dr.
Gurkirpal Singh, Adjunct Clinical Professor of Medicine, Division
of Gastroenterology and Hepatology, Department of Medicine, Stanford
University School of Medicine, Stanford, CA
Dr.
Bruce M. Psaty, PhD, Professor, Medicine & Epidemiology,
University of Washington, Cardiovascular Health Research Unit, Seattle,
WA
Panel III
Dr.
Sandra L. Kweder, Acting Director, Office of New Drugs, Center
for Drug Evaluation and Research, U.S. Department of Health and
Human Services, Food and Drug Administration, Washington, DC
Panel IV
Mr.
Raymond V. Gilmartin, Chairman, President & Chief Executive
Officer, Merck & Co., Whitehouse Station, NJ
Food and Drug Administration
FDA
Announces Membership of Drug Safety Oversight Board
FDA
Statement on Vioxx and Recent Allegations and the Agency's Continued
Commitment to Sound Science and Peer Review (No |
