Drug Safety Announcement Blitz Highlights Gottlieb's PR Savvy As Shutdown Drags On

Release of several different safety announcements showcases US FDA Commissioner Gottlieb's efforts to quell potential public concerns with an active communication strategy. 

FDA entrance sign 2016

A muscular public communications strategy has been one of the cornerstones of US FDA Commissioner Scott Gottlieb's tenure as head of the agency. And he is now using his now using his PR skills to home in on a topic of public interest as the federal government slogs through its third week of the shutdown: medical product safety.

While sponsors have begun to wonder whether the government shutdown will ultimately impact their drug review clocks, Gottlieb has done his best to provide public reassurances about FDA's role in regulating medical product safety

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Drug Safety

Safety Review Prompts EMA to Suspend Ixchiq Chikungunya Vaccine For Seniors

 

The European Medicines Agency is investigating whether Valneva’s Ixchiq is safe to use in the elderly, following reports of 17 serious adverse events, including two cases resulting in death, in people aged 62 to 89 years who received the vaccine. This follows actions by US and French authorities last month regarding Ixchiq’s use in people over 65.

Opioid Safety: US FDA Hears Mixed Messages On Adding Posmarketing Studies To Labeling

 
• By 

Some advisory committee members said adding quantitative data on misuse, abuse, opioid use disorder and overdose to labeling would be helpful, but others worried the two epidemiological studies were not sufficiently generalizable to a broader population.

US FDA Asks Adcomm If Opioid Postmarketing Studies Are Relevant, Warrant Action

 
• By 

Two US FDA advisory committees will discuss results from epidemiological studies that attempted to quantify the prevalence, incidence and risk factors for misuse, abuse, overdose and death with opioid analgesics.

US FDA Commissioner Makary Wants To Combine Adverse Event Reporting Systems

 

In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.

More from Pink Sheet

Recent and Upcoming FDA Advisory Committee Meetings

 
• By 

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 

Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.

EU Health Data Space May Speed Up R&D Through Access To Multi-Omics & Clinical Record Data

 

The European Health Data Space framework will allow companies to accelerate R&D processes and identify new molecular targets faster by facilitating centralized access to certain types of high-quality data, Finland’s Orion Pharma says.