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Off-Label Use

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More Information on Off-Label Use

  • Letter to Congress Opposing Draft Legislation That Would Expand Promotion of Medical Products for Unapproved Uses, July 11, 2017
  • Letter to Congress Opposing Legislation That Would Expand Promotion of Medical Products for Unapproved Uses, June 5, 2017
  • Comments to the FDA on Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products, April 19, 2017
  • Testimony Before the FDA’s Public Hearing on Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products, November 9, 2016
  • Press Statement: Lawmakers’ Proposal Would Turn Patients Into Guinea Pigs, May 27, 2016
  • Rapidly Increasing Criminal and Civil Monetary Penalties Against the Pharmaceutical Industry: 1991 to 2010, December 16, 2010
  • Allergan v. FDA (Can the FDA enforce regulations that restrict the promotion of off-label uses?), December 21, 2009
  • Comments on Draft Guidance for Industry on Off-Label Promotion of Drugs and Medical Devices, April 21, 2008
  • Letter Urging Action Against a Campaign Promoting the Unapproved Use of Topiramate (Topamax) for Treating Alcoholics, October 9, 2007
  • Public Citizen v. FDA (Seeking data on drug company payments to doctors), February 26, 2004
  • Public Citizen v. FDA, Agouron Pharmaceuticals, et al (Seeking records on off-label uses),  June 9, 2000

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Letter to Congress Calling for Amendments to S. 3799, the PREVENT Pandemics Act

March 14, 2022

Forum Article Published in Drug and Therapeutics Bulletin: Mandatory Disclosure of All Pharmaceutical and Medical Device Companies’ Payments to Healthcare Providers: Learning From the USA

December 7, 2021

Letter to Congress Opposing Draft Legislation That Would Expand Promotion of Medical Products for Unapproved Uses

July 11, 2017

Comments to the FDA on Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products

April 19, 2017

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