Promoting competition among new drugs does not necessarily mean encouraging development of so-called "me-too" products and the limited band-width of FDA's document redaction effort may mean the release of complete response letters is not prioritized, FDA Commissioner Scott Gottlieb told the Pink Sheet in a recent interview.
Q&A With US FDA Commissioner Scott Gottlieb
US FDA Commissioner Scott Gottlieb sat down with the Pink Sheet and Medtech Insight reporters for an exclusive chat about his ongoing regulatory work and plans for the future.
More from Agency Leadership
• By
With review and development uncertainly increasing, "it’s going to take longer for certain targets … to progress to a place where they’ve been derisked enough that big pharma is ready to write a big check," said Andrew Goodman of Paul Hastings.
• By
The biotech CEO said the Trump Administration’s treatment of FDA employees, including the HHS secretary’s comments about industry capture, are insulting to agency staff, but he is encouraged by FDA Commissioner Martin Makary’s talk of a new conditional approval pathway.
• By
FDA Commissioner Martin Makary's remarks that his special assistant Tracy Beth Høeg will "be involved in other approval procedures" besides Novavax's COVID-19 vaccine application could be a dramatic change in operations, potentially making the approval system unpredictable.
• By
FDA Commissioner Martin Makary said in an interview that he will use the current structure to reform the agency. He also plans to address employee morale.
More from Pink Sheet
Non-Submissions To UK HTA Body Could Increase Unless Commercial Environment Improves, Warns Industry
• By
Finding ways to lower the rebates paid by the pharmaceutical industry to the UK government and fostering partnerships to make the UK a more attractive launch market could help reduce the number of terminated technology appraisals conducted by NICE, the health technology appraisal institute, says the UK pharmaceutical industry.
• By
Blood cancer therapies were most proportionately impacted by the failure of pharmaceutical companies to submit evidence on their cancer therapies to England’s health technology appraisal body, shows analysis by the Pink Sheet.
• By
Employers and other health plan sponsors may need to push for better targeted reforms that lower cost sharing for patients.