GPhA says congressional action is only remedy after study estimates $5.4 billion in potential savings is lost annually because of brand manufacturers using REMS to prevent generic competition.
The generic industry’s campaign to end some brand companies’ practices of using REMS to prevent competition appears to remain in the education phase with no specific legislative solution upcoming and no obvious regulatory answer.
The group now has some data to bolster its claim that Risk Evaluation and Mitigation Strategy abuse must be stopped....
The findings are consistent with some other research and likely are due to obesity patients becoming more connected to needed health care services.
Ultragenyx said talks with the FDA about a path forward after receiving a CRL for UX111 have been productive despite the recent upheaval at the agency.
Many agency stakeholders believe Vinay Prasad may be forced to change his regulatory approach at least somewhat after receiving a second chance to lead the US FDA's biologics center.
The new CDER director focused on plans to improve morale during an Aug. 8 townhall, but staff comments indicate that may be a challenge.
Eli Lilly's CEO argued that pricing reforms aimed at existing drugs would be “hard to sustain or justify,” while other companies suggested a growing interest in direct-to-consumer sales programs.
New CDER Director George Tidmarsh promised to keep politics out of drug approvals, but suggested during a meeting with staff that he could not insulate the drug center from political pressures coming from those above him.
Companies in Europe cannot delay business decision making much longer to wait for more certainty on major US policy shifts on tariffs and pricing.
