FDA has acknowledged that, under former commissioner von Eschenbach, it may have been influenced by the "extreme" and "persistent" pressure applied by four congressmen in approving the Menaflex knee patch. The New York Times goes into more detail:

Publicist and NYU business school adjunct professor Paul Osterreicher had a very interesting analysis of FDA's communications and public relations crisis in PR Week.   So why should I care about FDA's problems, you ask? Because some of them are pharma's problems too... and, in fact, they're shared by any company or individual who deals with complex, "sound-bite-defying" issues that are publicized, in real time, via media and Web 2.0 tools.

Below, a brief excerpt with some key points:

Biswant Korrapati, CEO of Move Records which presents rapper Mekka Don (a trained lawyer), apparently used to work at Novartis. 

Several names are being bandied about as leading candidates for the position of FDA commissioner in the Obama adminstration. They include Duke University's Robert Califf, Cleveland Clinic's Steven Nissen, Baltimore health commissioner Joshua Sharfstein, and George Washington U. professor Susan Wood.

Just saw the Obama/Biden "fact sheet for science" outlining some ambitious goals for the incoming Administration.  Its cornerstones:

I’m typing these notes, wedged sideways so that my laptop will fit on an empty middle seat, as I fly home from ISPE’s annual meeting.  (A friendly warning:  if you are over 5’4” tall, don’t travel on Spirit Airlines unless

a. you absolutely have to, or

Which presidential candidate, if elected, would be a better supporter of the pharmaceutical industry? There's no telling, but the money for now is with Obama over McCain, says a recent Bloomberg report. (Apologies that it's a few weeks old, but it's worth recycling.) Neither candidate is exactly on the industry's good list, but Obama is at least drawing more pharma donations of late, in part because of McCain's touting the fact that he has a history of taking on special interests such as tobacco and pharma.

Who'll get the pharma vote? In Pharma Marketing Blog's unofficial running poll, Obama outpaces McCain by nearly 2 to 1. No word yet on how pharma perceives the Biden-Palin matchup.

--PWT

The California state assembly has passed SB 1307, a measure that sponsor Sen. Mark-Ridley Thomas says is designed to ensure patient safety, but will in actuality yet again push back the proposed compliance date for drug manufacturers and distributors to meet electronic pedigree requirements to 2015--rather than the 2011 (and 2009) previously designated.

California's inability to nail down a firm compliance date and hold manufacturers' feet to the fire will certainly heighten calls for federal pedigree legislation. More to come . . .

--PWT

Representative Dingell and Senator Grassley have big plans for an FDA overhaul, and expanded powers for the Agency.  More from the Wall Street Journal.  But one persistant question:  Why must the Agency still oversee both food and drugs?  Drugs are challenging enough as it is, and getting more challenging by the day.

John McCain is not your typical Republican.  Remember the debates last year, and the "evil pharma" sound bite?  Bloomberg recently estimated (as Pharmalot reported last month) that McCain's winning could cost the industry over $40 billion over the next 10 years. Yet Billy Tauzin, head of PhRMA (like quite a few others in the industry) has reportedly sent him a campaign contribution.  More here from The Hill.com