Drug Safety
ALSO NOTED: United Health Group in drug safety data deal; Red Cross criticized over relief work; and much more...
> The SEC has upgraded its investigation into the relationship between HCA and Senate Majority Leader Bill Frist (R-Tenn.) to a formal inquiry. Article
> The Guidant inquiry may be evolving into a criminal investigation. Article
> HIT: The FDA has signed a deal with …
... Read more...Crawford resigns as FDA chairman
Lester Crawford abruptly resigned his position as chairman of the Food and Drug Administration on Friday, a little more than two months after his confirmation. The Bush administration named Dr. Andrew von Eschenbach, current head of the National Cancer Institute, as the acting chief. The New York Times reports that von Eschenbach will work both jobs at once. A former cancer survivor who moved to the National Institutes of Health after working as the head of the MD Anderson Cancer …
... Read more...FDA weighs decision on BMS drugs this week
This week FDA regulators will review two potential blockbuster drugs from Bristol-Myers Squibb -- the rheumatoid arthritis drug Orencia and Pargluva, a treatment for diabetes. Industry observers say how the agency handles the decisions will reveal a lot about its approach to drug-safety in the post-Vioxx era. Research has raised questions about the safety of both drugs. A study released last week showed a substantially increased risk of infection for patients taking Orencia. Where is the …
... Read more...September hearings seen as test for FDA
The Food and Drug Administration will review three potential blockbuster drugs in early September. Observers say the agency may raise the bar after the high profile drug safety stories of the last year. The three new drugs include Pfizer's inhaled insulin Exubera and two drugs developed by Bristol-Myers Squibb: the new rheumatoid arthritis treatment Orencia, and Pargluva, which targets adult-onset diabetes.
- see this story in The Wall Street Journal (sub. req.)
Merck seen as 'behind' in first Vioxx trial
Many legal observers say testimony in the first half of the Ernst v. Merck trial has favored the plaintiff, a development which could be an ominous sign for the drug maker. The New York Times reports that after a bumpy start, plaintiff attorney W. Mark Lanier seems to be making progress in winning over the jury in the case. The evidence presented in the case appears to have bolstered Lanier's argument that Vioxx was responsible for the death of Robert Ernst. The occasionally …
... Read more...FDA commissioner draws fire from Democrats
A week after his confirmation as FDA commissioner, Lester Crawford found himself the target of criticism from House Democrats angry about the way his agency has responded to safety problems in the pharmaceutical and medical device industries. The showdown came at a congressional hearing on the agency's $1.5 billion budget for 2006. Crawford responded by defending his agency's track record as one of the best in the federal government. The FDA head fielded questions on the agency's handling …
... Read more...Editor's Corner
After the deal on filibusters and Newt and Hillary's unlikely pairing on health IT, politics resumed more or less as usual this week in Washington. That wasn't necessarily good news for the pharma industry. The "safe" choice for the FDA, Lester Crawford, finds his confirmation still on hold despite apparently not being a naughty boy on the taxpayer's dime. FDA gadfly David Graham won …
ALSO NOTED: Stem cell research backed by public; Graham critical of FDA safety plans; and much more...
> A new poll by Harris Interactive finds the majority of Americans favor federal funding for stem cell research. Story (Wall Street Journal sub. req.)
> The Wall Street Journal reports that venture capitalists want a change in the stem cell rules as well. …
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