Dr. Margaret Hamburg Tapped As New FDA Commissioner

According to a report on NPR’s All Things Considered program, the Obama Administration has nominated Margaret Hamburg, MD to head the US Food and Drug Administration. Dr. Hamburg is a former health commissioner in New York City who has worked on issues surrounding infectious diseases and bioterrorism. In New York, she instituted a needle-exchange program to help prevent the spread of HIV. She also set up a program, in which health workers went to tuberculosis patients’ homes to help them manage their drug regimens.

A Harvard Med School graduate, Dr. Hamburg was an assistant secretary of health and human services during the Clinton administration and now works at the Nuclear Threat Initiative, which tries to cut the threat from nuclear, chemical, and biological weapons. She opposes abstinence-based sex education in public schools and has been a critic of the marketing practices of the pharmaceutical industry. Further, Dr. Hamburg is a leading advocate for changes in the nation’s public health policies and infrastructure, from local health departments to the highest levels of government. Finally, after eight years of mismanagement and poor leadership, the agency has somebody at the helm with intelligence, experience and is an advocate for change. 

Kudos to Team Obama!

Until next time...

Good Luck and Good Job Hunting (FDA is hiring)!!!!!

 

Peter Rost for New FDA Commish?

Sometimes reality is stranger then fiction. The Pharmalot blog reported today that US Senator Sherrod Brown, an Ohio Democrat, is nominating several candidates for the post and one of them is Peter Rost, MD!

For those of you who may not know Dr. Rost, he is a former Pfizer marketing executive who blew the whistle on some alleged marketing and sales violations at the drug maker. His court case is working its way up the judicial ladder and Dr. Rost apparently has the upper hand so far.

Pfizer fired Dr. Rost “for cause” after a raucous, public skirmish that went on for almost 2 years. After he left Pfizer, he wrote a book, worked for the Huffington Post and started his own blog, which currently has a post about his candidacy for the FDA Commissioner job. 

I first met Peter when he was still at Pfizer and I was organizing a meeting on drug reimportation (he is an ardent supporter). He agreed to talk at the meeting but unfortunately the conference was canceled for one reason or another. I have no doubt that he has the medical credentials and business acumen to handle the job. The one thing that worries me is his penchant for self promotion—something that is not a desirable trait in  an FDA Commissioner.

Time will tell. Personally, I would like to see Dr David Kessler come back and run the agency—another whistleblower (at UCSF) who ran the agency from 1990-1997 and did an outstanding job. The way things are going at FDA these days maybe being a whistleblower ought to be one of the requirement for the job!

Until next time…

Good Luck and Good Job Hunting

Changes at FDA? --Janet Woodcock Chosen (Again) to Head CDER

After an exhaustive nationwide search, FDA Commissioner Andrew von Eschenbach decided yesterday that Janet Woodcock, a career FDA staffer, was the best choice to lead the agency’s struggling Center for Drug Evaluation (CDER). For Dr. Woodcock who has been the acting head of CDER since September, this will be the second time that she was tapped to lead the center. She was previously appointed to the top CDER job in 1994 by then FDA Commissioner David Kessler (the last time FDA had any real leadership).

The inside skinny on the appointment is that she beat out Jesse Goodman for the position, another career FDA employee  who is currently the head of the agency’s Center For Biologics Evaluation and Research (CBER).  What surprises me the most about Woodcock's appointment is that after a nationwide search to find a new leader for CDER, von Eschenbach’s final choice was between two career FDA bureaucrats!  Why bring in an outsider with fresh new ideas when the best available talent in the land already works for you?

Don’t expect anything to change at the agency.  Dr. Woodcock tows the party line and is loyal to von Eschenbach (who by the way is a personal friend of the Bush family). It is no secret that FDA is broken and desperately needs to be fixed. Choosing a person to lead CDER (for the second time) who has been at FDA for almost her entire career, signals  that Commissioner von Eschenbach is neither ready nor willing to implement the systemic changes that are so drastically needed at the agency.  Maybe something will change at FDA when someone other than George W. Bush is in the White House?

Until next time….

Good Luck and Good Job Hunting!!!!!