Newsletter - February 18, 2021
FDA Points at the Disconnect in What it Tells Companies and What They Disclose
Only 16% of the times when a company gets a Refuse to File (RTF) notification, it tells the public about it, and even then, only 5% of the times, the company accurately discloses the reasons for the refusal, FDA reports. Companies obviously want to control the negative information about their applications and FDA want to shine light on that. ...Read More
Plavix Case: Deceptive Marketing or Regulatory Non-Compliance
In a stinging rebuke of their policy to withhold critical information about Plavix from FDA and the public, a judge in Hawaii fined BMS and Sanofi $834 million. Although the judge found the companies guilty of deceptive marketing, the ruling document describes a detailed timeline of information available to the company....Read More
FDA Points at the Disconnect in What it Tells Companies and What They Disclose
Only 16% of the times when a company gets a Refuse to File (RTF) notification, it tells the public about it, and even then, only 5% of the times, the company accurately discloses the reasons for the refusal, FDA reports. Companies obviously want to control the negative information about their applications and FDA want to shine light on that. ...Read More
Plavix Case: Deceptive Marketing or Regulatory Non-Compliance
In a stinging rebuke of their policy to withhold critical information about Plavix from FDA and the public, a judge in Hawaii fined BMS and Sanofi $834 million. Although the judge found the companies guilty of deceptive marketing, the ruling document describes a detailed timeline of information available to the company....Read More
