FDALegislativeWatch

FDA Staffing Problems Extend Beyond Funding Shortfalls; Culture Shift Sought

This article is reprinted from "The Pink Sheet" – January 7, 2008

FDA's efforts to increase personnel levels are hindered by the practicalities of finding, hiring, training and retaining qualified applicants, as much as by inadequate resources, according to agency observers.

Part D Claims Data Sharing: Lack Of Progress Gets MedPAC's Attention

The Medicare Payment Advisory Commission appears to be renewing its interest in shaking loose Part D claims data from CMS to help inform questions about drug access and health care quality under Medicare. The issue arose during discussion of the Medicare Part D program during a Nov. 8 MedPAC meeting in Washington, D.C. Panelists expressed disappointment that a CMS proposed rule on Part D data sharing has languished since it was published in October 2006.

FDA Reform Bill Could Still Face Administrative Gauntlet After Enactment

FDA has yet to determine how quickly it can exercise new authorities created by the FDA Amendments Act of 2007, agency officials told reporters Sept. 27, a few hours after President Bush signed H.R. 3580 into law.

FDA Bill Passes; Congress Adds $225 Million To Industry User Fee Burden

Final FDA reform legislation that cleared Congress adds an additional $225 million to industry's user fee tab over five years, but limits penalties that FDA can assess to enforce its new authorities to mandate labeling changes and postmarket studies.

FDA Reform Bill Clears Congress Despite Temporary Snag In Senate

The Senate passed the new FDA reform bill, H.R. 3580, by unanimous consent Sept. 20, a day after the House adopted the same measure.

Compromise FDA Reform Bill Passes House, Adds $225 Million In User Fees For Drug Safety

The U.S. House of Representatives voted 405-7 Sept. 19 to adopt compromise FDA reform legislation that increases prescription drug user fees by $225 million above the level agreed to earlier by FDA and drug manufacturers for fiscal years 2008-2012.

Discounted "Stopgap" PDUFA Renewal Might Prompt Faster FDARA Action

A proposal circulated by House Democrats to renew user fee programs for three months while negotiations on FDA reform legislation continue is "not an option," Senate Health, Education, Labor and Pensions Committee Ranking Republican Michael Enzi, Wyo., has declared.

FDARA Citizen Petition Provisions No "Silver Bullet," Bradshaw Tells GPhA

Provisions in FDA reform legislation that aim to limit the impact of citizen petitions on generic drug approvals are unlikely to provide the relief the generic industry seeks, according to outgoing FDA Chief Counsel Sheldon Bradshaw.

FDA Re-Org Makes Chief Of Staff Liaison Between Centers And Commissioner

A newly created FDA Office of the Chief of Staff will serve as the major point of contact between FDA centers and offices, and the Commissioner, according to an Aug. 30 Federal Register notice.

FDA Receives Assurances That PDUFA Remains Priority on Capitol Hill

As Congress prepared to adjourn for summer recess without reauthorizing the Prescription Drug User Fee Act, FDA Commissioner Andrew von Eschenbach sent an e-mail to agency employees Aug. 3 designed to lessen worries about job security.