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More Information on the Drug Approval Process

Letter to the Executive Director of the European Medicines Agency on Bedaquiline, February 13, 2013
Letter to FDA Opposing Approval of Bedaquiline, December 21, 2012
Testimony on Rilonacept (ARCALYST) to the FDA's Arthritis Advisory Committee, May 8, 2012
Letter to the FDA opposing approval of the drug mirabegron, April 27, 2012
Comments on FDA Transparency, July 20, 2010
Testimony Encouraging Greater FDA Transparency, June 24, 2009
Testimony on Behind-the-Counter Availability of Certain Drugs, November 14, 2007
Petition to Require that Certain Advisory Committee Meetings Include an FDA Staff Presentation, June 21, 2007
Congressional Testimony on Development of Pediatric Therapies, May 22, 2007
Letter Regarding Prescription Drug User Fee Act, May 4, 2007
Comments on FDA Proposal on Access to and Charging for Investigational Drugs, March 19, 2007
Letter in the Lancet: Suboptimum Use of FDA Drug Advisory Committees, December 23, 2006
Letter Asking FDA to Demand Nico Worldwide Cease Marketing Nicotine Beverage, July 10, 2006
Regulatory Affairs Journal Article: The U.S. FDA at at Crossroads, July 2006
Statement on the 100th Anniversary of the FDA, June 27, 2006
Article in Law and Contemporary Problems: Access to Pharmaceutical Data at the FDA, Summer 2006
Testimony on Possible Switch of Orlistat (Xenical) to OTC Status, January 23, 2006
Letter Supporting the Strengthening of the Open Public Hearing as Part of FDA Advisory Committee Meetings, June 15, 2005
Testimony on Public Health Dangers of Prescription-to-OTC Switch of Lovastatin (Mevacor), January 14, 2005
Testimony on CDER's Risk Communication Failures, December 7, 2005
Letter Questioning the Actions of a Senior NIH Scientist and Former AstraZeneca Consultant, July 8, 2004
Public Citizen v. FDA (Seeking records on an unapproved use of a drug), February 26, 2004
Comments on the FDA Implementation of the Data Quality Act, June 13, 2002
Testimony on the Risk Management of Prescription Drugs, May 22, 2002
Testimony on FDA Risk-Management Concept Papers, April 3, 2003
Comments on the Disclosure of Conflicts of Interest for Participants in FDA Advisory Committees, March 5, 2002
Comments on the Prescription Drug User Fee Act (PDUFA), January 25, 2002
Comments Concerning Disclosure of Information on Investigational Products, April 18, 2001
Comments on FDA Proposed Changes to Disclosure of Information from FDA Advisory Committee Meetings, March 26, 2001
Testimony on Prescription Drug User Fee Act (PDUFA), September 15, 2000
Testimony on Problems with Prescription-to-OTC Switch of Cholesterol-Lowering Drugs, July 13, 2000
Testimony on Switching Drugs from Prescription to OTC, June 28, 2000
Study of the Drug Industry's Performance in Finishing Required Postmarketing Research (Phase IV) Studies, April 13, 2000
FDA Medical Officers Report Lower Standards Permit Dangerous Drug Approvals, December 2, 1998
Public Citizen v. FDA (Seeking records on discontinued drugs), January 5, 1994

More Information on Orlistat (Alli, Xenical)

Petition to Ban Orlistat (Alli, Xenical), April 14, 2011
Supplement to Petition to Ban Diet Drug Orlistat (Xenical), June 5, 2006
Petition to Ban Diet Drug Orlistat (Xenical), April 10, 2006
Testimony on Possible Switch of Orlistat (Xenical) to OTC Status, January 23, 2006
Testimony on Orlistat (Xenical), May 14, 1997

Testimony on Possible Switch of Orlistat (Xenical) to OTC Status

January 23, 2006

Testimony of Sidney M. Wolfe M.D. and Elizabeth Barbehenn, Ph.D.,
Public Citizen’s Health Research Group
Before the FDA Non-Prescription and Endocrine and Metabolic Drug Advisory Committees
Hearing on Possible Switch of Orlistat (Xenical) to OTC Status

View the presentation slides in pdf format

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