11 results

• Problems with Gabapentin Misuse are a Sign of Improper Prescribing: Report

  September 13, 2022

  Martha Garcia

  A new report warns that off-label prescribing is a driving factor behind increasing gabapentin misuse and overdoses.

• Bayer Whistleblower Settlement Over Trasylol, Avelox and Baycol Results in $40 Million Payment

  September 7, 2022

  Irvin Jackson

  Bayer has agreed to pay $40 million to resolve a whistleblower lawsuit which accused it of kickback schemes and off-label marketing of the drugs Avelox, Baycol and Trasylol.

• Whistleblower Lawsuit Over AstraZeneca Off-Label Marketing Ends in $2.4M Verdict

  June 24, 2021

  Irvin Jackson

  An Oregon jury wants AstraZeneca to pay $2.4 million for violating a former employee's whistleblower rights after she claimed the company was illegally marketing the asthma drug Symbicort.

• Most Doctors Say FDA Should Continue To Restrict Off-Label Drug Marketing: Study

  January 29, 2019

  Irvin Jackson

  A new survey finds that most doctors are against drug companies promoting medications for uses not approved by the FDA.

• Antidepressant Prescriptions For Non-Approved Indications Often Not Supported By Science: Study

  February 28, 2017

  Irvin Jackson

  Antidepressants are often prescribed off-label despite a lack of scientific evidence that they work well for uses not approved by the FDA, according to a new study.

• FDA Issues New Draft Guidance On Medical Product Communications

  January 20, 2017

  Irvin Jackson

  The FDA has issued a new draft guidance on how medical product manufacturers can add information that is not on the drug's labels to promotions and advertising without misbranding their products.

• FDA Weighs Risks, Benefits, Of Relaxing Off-Label Marketing Restrictions

  November 11, 2016

  Irvin Jackson

  The FDA was urged by industry to relax restrictions on off-label drug marketing at a hearing this week, while critics warned that such a move would endanger patient health and safety.

• Lawmakers’ Move To Allow off-Label Marketing Opposed By Public Citizen

  June 9, 2016

  Irvin Jackson

  A consumer watchdog group is warning that proposed legislation to loosen off-label marketing restrictions for drugs could put patients at risk.

• Drug Company Settlements On Decline As Enforcement Wanes: Public Citizen Report

  April 14, 2016

  Irvin Jackson

  A Public Citizen report warns of a steep decline in settlements and financial penalties leveled against drug companies by state and federal agencies in recent years.

• Off-label Drug Use Increases Risk of Adverse Events in Adults: Study

  November 6, 2015

  Irvin Jackson

  A Canadian study finds patients are more at risk of drug side effects when they are prescribed drugs for unapproved and untested uses.