FDALegislativeWatch

Increased CDRH Post-Approval Vigilance Plays Out In Medtronic X-Stop Trials

This article is reprinted from "The Gray Sheet" - January 28, 2008.

Medtronic clinical executive Ruchir Sehra says CDRH's newfound rigor in the postmarket area is evident in its approach to the firm's post-approval study of the X-Stop spinal implant.

"They seem to be encouraging more post-approval follow-up," said Sehra, VP-clinical and research of Medtronic's spinal and biologics business in Sunnyvale, Calif.

Assault on Drug Marketing Tactics Becomes Drug Specific On Capitol Hill

This article is reprinted from "The Pink Sheet" - January 28, 2008

Pharmaceutical firms avoided a moratorium on direct-to-consumer television ads in the FDA Amendments Act, but that victory seems of little comfort now as Congress undertakes a wide-ranging probe of industry marketing practices.

A flurry of letters from House Energy and Commerce Committee leaders last week continued to question the motives of Merck and Schering-Plough in delaying the release of data from the ENHANCE trial for Vytorin.

Senators Oppose Patent Reform Provisions; GSK Also Urges Revisions To Bill

This article is reprinted from "The Pink Sheet" - January 28, 2008.

As patent reform legislation heads toward the Senate floor, members of the biotech and pharmaceutical industries are imploring legislators to alter key provisions. And a group of senators is criticizing the bill's formulation for apportioning damage awards in infringement suits.

GlaxoSmithKline sent a letter to Sen. Patrick Leahy, D-Vt., chairman of the Senate Judiciary Committee, and ranking member Arlen Specter, R-Pa., requesting that the Senate delete a provision that would require patent applicants to report all information relevant to the patentability of their inventions.

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.

DTC User Fee Program Suspended By Congress; FDA Gets More Review Funds

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

Congress has increased the amount of federal money available to fund FDA review of direct-to-consumer television ads rather than appropriate user fees negotiated by FDA and industry to speed up the ad review process.

FDA Coffers Fill With Funds, But No Money For Reagan-Udall Or Lab Closures

This article is reprinted from the January 7, 2008 issue of "The Pink Sheet"

FDA enters 2008 with the financial wherewithal to go full speed ahead in hiring and establishing the safety programs authorized by the FDA Amendments Act, following President Bush's signing of an omnibus fiscal 2008 appropriations package on Dec. 26.