Sens. Collins and Warren want FDA to have economic trigger to speed generics; CDER's Woodcock says it's possible but needs clear legislative definition.
FDA may want to stay out of drug-pricing issues, but Congress could use its expedited approval system to force it into the fray.
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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.
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.
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.
Employers and other health plan sponsors may need to push for better targeted reforms that lower cost sharing for patients.
