Conflict Over Conflicts: FDA Advisory Committee Rules May Be Ripe For Change
This article was originally published in RPM Report
Executive Summary
Recruitment of FDA advisory committee members has been a persistent challenge for the agency—especially since the conflict of interest rules were tightened five years ago. While FDA has improved the number of vacancies on its expert panels, it has yet to meet its goals—especially in the Center for Drugs. Congress is considering loosening the restrictions. Will that help, or simply fuel criticism of the process?
You may also be interested in...
CDER Advisory Panel Vacancies Remain High As Overall FDA Rates Improve
Empty slots on CDER advisory panels holding agency back from meeting goal vacancy rate as other centers fill more panel slots.
Lone Wolfe: Drug Industry Critic Ends Tenure As Advisory Committee Member With Rare Decisive Vote
Sidney Wolfe’s stint as permanent member of the Drug Safety and Risk Management Advisory Committee ended May 31; his final meeting was the May 23 review of Xarelto for ACS. That gave him a second chance to vote against the product. A look back at Wolfe’s tenure shows he was a sure “no” vote when he sat on a panel—but that his service can hardly be construed as having damaged the industry.
An Emerging Approval Trend At FDA: More First-Time Sponsors
There is a surprising trend in the list of FDA approvals in 2011: an increase in the number of small biopharma companies opting to forgo Big Pharma partnerships and submit new product applications on their own. Here’s how these “emerging sponsors” are changing the way FDA does business—for big and small companies alike.