Mystery Adcomm Revealed
This article was originally published in RPM Report
Executive Summary
In 2011, FDA held an unusual closed-door advisory committee meeting on a Phase III product – with Public Citizen’s Sid Wolfe as one panelist. The identity of the drug was finally revealed ahead of a second, open committee meeting.
You may also be interested in...
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.
Drug Shortage Could Be Addressed By ‘Resilience Rating’ From Private Entity Under HHS Plan
US HHS is proposing a public-private partnership to assign ratings to manufacturers based on quality/resilience of supply, tied to a purchasing incentive program for providers. The non-agency approach may be key to overcoming industry and political objections.
Drug Shortage Could Be Addressed By ‘Resilience Rating’ From Private Entity Under HHS Plan
US HHS is proposing a public-private partnership to assign ratings to manufacturers based on quality/resilience of supply, tied to a purchasing incentive program for providers. The non-agency approach may be key to overcoming industry and political objections.