Senator Manchin Goes to White Oak
This article was originally published in RPM Report
Executive Summary
The open public hearing portion of an advisory committee is often emotional and sometimes persuasive. It is not usually a forum for a give-and-take with a sitting US Senator. But it was during a two-day review of the DEA scheduling status of hydrocodone combos.
You may also be interested in...
Primatene HFA Turned Down By FDA Panel; Will Capitol Hill Accept Decision?
The Primatene Mist phase-out has been a topic of interest for one prominent Republican Congressman, Texas’ Michael Burgess. He’s been eager for FDA to approve a replacement, but Armstrong’s reformulation doesn’t look ready just yet. In an interview, Burgess says he won’t tell FDA what to do – but will keep a close eye just the same.
Zogenix Zohydro Launch Will Test FDA’s Balanced Approach On Opioid Pain Reviews
FDA approved Zogenix’ single-entity hydrocodone product following a negative advisory committee meeting, and is facing ongoing opposition as the drug’s launch begins. The agency argues the risk is consistent with other extended-release opioids – and abuse-deterrent technology is too new to require.
Sen. Burr Tries To Pull FDASIA Over For Speeding As Senate Sends Bill To White House
The North Carolina Republican spends more than two hours talking about the user fee bill and other issues in an apparent effort to delay a final vote, but the Senate easily passes it.