1. Pink Sheet
  3. >>US FDA

Right-To-Try Legislation Must Change Language To Narrow Spectrum Of Patients, Gottlieb Says

 
• By Michael Cipriano

US FDA commissioner tells House hearing that the Senate's legislation in its current form could undermine the intent of addressing terminally ill patients.

Capitol House

The Senate's right-to-try legislation should be narrowed to specify patients who are "terminally ill" as a criterion for experimental drug eligibility from its current language of "a life-threatening disease or condition," US FDA Commissioner Scott Gottlieb urges lawmakers.

Testifying before the House Energy and Commerce Subcommittee on Health Oct. 3, Gottlieb cautioned that Sen. Ron Johnson's (R-Wisc.) right-to-try legislation, known as the Trickett Wendler Right-to-Try Act (S.204), would encompass too broad a patient population

More from US FDA

More from Agency Leadership

Safety Review Prompts EMA to Suspend Ixchiq Chikungunya Vaccine For Seniors

 
• By Neena Brizmohun

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.

Unlocking Opportunities: How To Engage With The EMA On Animal Testing Alternatives

 
• By Neena Brizmohun

The European Medicines Agency, like its counterpart in the US, is increasingly focusing on the use of alternatives to animal testing.

Tougher Approval Standards May Follow Vinay Prasad’s Appointment To Lead US FDA’s CBER

 
• By Sarah Karlin-Smith

Industry is concerned that Prasad may make regulatory flexibility tougher to obtain for cell and gene therapy, while vaccine and public health advocates are angry about Prasad’s criticisms of US COVID-19 policies.