FDALegislativeWatch

FDA's Implementing Visionary: A Conversation With COO John Dyer

FDA's efforts to help usher in the bioinformatics era are personified by Deputy Commissioner for Operations John Dyer.

Congress Slams FDA Executives' Response To Staff's Food Safety Testimony

Members of Congress are accusing FDA senior officials of attempting to intimidate agency employees following their congressional testimony on FDA's food safety oversight performance.

FDA User Fee Reauthorization Passes House, Awaits Conference

The House passed broad-based FDA legislation July 11 that includes a package to reauthorize the medical device user fee program.

Overview of the Week's Top FDA Legislative Developments: July 30, 2007

    (Please Note: this section provides complimentary previews of all articles, links to this week's featured articles and links to other articles that require subscription or paid access)

FDA Revitalization Act

• Featured Article: FDA's Implementing Visionary: A Conversation With COO John Dyer   FDA's efforts to help usher in the bioinformatics era are personified by Deputy...  (July 30, 2007, "The Pink Sheet") - Complimentary access.
• FDA Creates Position To Respond To Congress's Request For Information   FDA has created the position of senior legislative analyst for oversight in... (July 30, 2007, "The Tan Sheet") - Requires subscription or paid access.

Food Safety

• Featured Article: Congress Slams FDA Executives' Response To Staff's Food Safety Testimony   Members of Congress are accusing FDA senior officials of attempting to...  (July 30, 2007, "The Tan Sheet") - Complimentary access.
• Hill Scrutiny Of FDA Staff Dissent Spills Over Into Food Safety   Members of Congress accuse FDA officials of attempting to intimidate FDA... (July 30, 2007 "The Pink Sheet") - Requires subscription or paid access.
• Blame China? Experts Advise Congress, Industry Take A Wider View   The global scope of food safety is becoming apparent, and recent problems with... (July 30, 2007 "The Tan Sheet") - Requires subscription or paid access.
• Drug Firms Model Ensuring Import Safety; China's Inconsistencies Worry FDA   Firms using Chinese imports to make dietary supplements and other products can... (July 30, 2007 "The Tan Sheet") - Requires subscription or paid access.

Medical Devices

Featured Article: FDA User Fee Reauthorization Bill Cleared For House Floor Action   A medical device user fee reauthorization bill was approved June 21 by the House... (July 23, 2007 "The Gray Sheet") - Complimentary access.

Rx Drug Safety

• Avandia Advisory Cmte. Could Be Observational Data's Coming Out Party   The recommendations from FDA's joint advisory committee review of a signal of... (July 30, 2007 "The Pink Sheet") - Requires subscription or paid access.
• Advisory Cmte. Conflict of Interest Waivers Common; Avandia Is High Water Mark   As currently convened, the majority of FDA advisory committee meetings on drugs... (July 30, 2007, Exclusive interview with "The Pink Sheet") - Requires subscription or paid access.

Patent Reform

Patent Reform Bill In House Limits "Inequitable Conduct" Defense   Amended patent reform legislation that cleared the House Judiciary Committee... (July 30, 2007 "The Pink Sheet") - Requires subscription or paid access.

Preemption Remains Conference Issue In FDA Bill As Both Sides Declare Victory

The impact of FDA reform legislation on product liability lawsuits could depend in large part on how the House and Senate resolve subtle differences in phrasing between the two chambers' bills.

DTC User Fees Rejected By House Approps Panel As FDA Safety Funds Get Boost

The House Appropriations Committee opted for using federal money, rather than fees from industry, to finance speedier FDA review of direct-to-consumer television ads when it approved a $1.7 billion fiscal year 2008 funding package for the agency July 19.

House, Senate Appropriations Committees More Than Match Request For FDA

House and Senate appropriators made certain in their recommendations for fiscal 2008 appropriations that FDA would be given opportunity to extend the scope of its oversight, with both houses of Congress more than matching the President's request.

House Members Question FDA Lab Closures As Food Safety Problems Mount

House Energy and Commerce Committee members say FDA's plans to close more than half its field labs heighten their concerns about its ability to secure the U.S. food supply.

Bush Establishes Import Safety Group As Congress Grills FDA On Food Safety

President Bush established a working group July 18 to help guarantee the safety of food and other products shipped into the U.S.

Patent Reform Bills Clear House And Senate Judiciary Committees

The House and Senate Judiciary Committees each approved versions of patent reform legislation the week of June 16 that respond to some concerns raised by drug and medical device lobbyists, but that still leave industry unsatisfied and primed to seek changes before the bills go to a floor vote.