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 Government Articles

"Academic detailing" bill introduced

Matthew Arnold July 31, 2008

A group of senators and representatives is introducing a bill that would fund a test-run for so-called "academic detailing," whereby supposedly unbiased health professionals funded by non-commercial entities detail doctors just as drug company sales reps do.
 

FDA oversight limited on off-label promotion

Ben Comer July 29, 2008

A new GAO report finds the FDA incapable of reviewing all drug advertising -- including the identification of off-label promotions -- due to the quantity of submissions and the variety of materials.
 

Waxman: Part D brought pharmas $3.7 billion "windfall"

Matthew Arnold July 25, 2008

The Medicare prescription drug benefit has goosed pharma industry profits to the tune of $3.7 billion, said a report from Rep. Henry Waxman's Committee on Oversight and Government Reform.
 

Massachusetts dumps gift ban, punts on data

Matthew Arnold July 16, 2008

Massachusetts lawmakers trashed a proposed gift ban hotly contested by biotechs, a key industry in the state, and put off the effective date of a provision banning commercial use of prescriber data.
 

Pfizer's Saxton: healthcare professionals must lead CME

Matthew Arnold July 15, 2008

Pfizer med ed head Mike Saxton dismissed the notion that the company was bowing to pressure in its decision to eliminate direct support for CME programs sponsored by medical education and communication companies (MECCs).
 

PhRMA Code cracks down on gifts to docs

Matthew Arnold July 10, 2008

PhRMA revised its Code on Interactions with Healthcare Professionals to sharply limit gifts to physicians.
 

FDA consolidates drug application responses

Ben Comer July 09, 2008

The FDA will change the way it responds to drug applications, eliminating "approvable" and "not approvable" letters.
 

Bill would trump pre-emption ruling on devices

Ben Comer June 26, 2008

New legislation in the Senate would reverse a Supreme Court pre-emption ruling on medical devices.
 

FDA to Merck: Wait until 2013 for cholesterol drug

Stephen McGuire June 23, 2008

Merck may have to wait until 2013 before the FDA reconsiders approval of its cholesterol drug known as Cordaptive (MK-0524A).
 

Grassley: researchers misreported commercial pharma payments

Ben Comer June 09, 2008

Harvard researchers failed to report pharmaceutical company incomes, a possible violation of university rules and federal law. The story was first reported on Sunday, in the New York Times.