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 Regulatory Articles

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).
 

AMA CME measure goes nowhere

Matthew Arnold June 16, 2008

A proposal by the American Medical Association's Council on Ethical and Judicial Affairs (CEJA) calling for the elimination of commercial sponsorship of medical education was referred back to the council, effectively tabling it for the year.
 

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.
 

GSK blood drug works same as placebo: FDA

Stephen McGuire May 28, 2008

GlaxoSmithKline's (GSK) experimental drug Promacta (eltrombopag) failed to significantly lower bleeding in patients with the rare blood disorder it was designed to treat, the FDA said.