I am turning this into my drug thread.... So I can keep track of what
is going to happen within the FDA. I hope you dont mind?


Drugmakers Lobby for Obama to Name Woodcock as FDA's Chief

By Justin Blum

Nov. 6 (Bloomberg) -- Drugmakers are lobbying for President-elect
Barack Obama to name Janet Woodcock, a senior official of the Food and
Drug Administration, as the agency's next commissioner, according to
people associated with the industry.

Patient advocacy groups critical of the FDA say Obama should instead
consider cardiologist Steven Nissen or Baltimore City's health
commissioner, Joshua Sharfstein. Both have pressed the FDA for changes
on drug safety.

The FDA and its current commissioner, Andrew von Eschenbach, have
faced criticism from lawmakers who say the agency has approved unsafe
medications and hasn't done enough to prevent tainted imports of food
and drugs from entering the U.S. Von Eschenbach, who was appointed by
President George W. Bush, plans to submit his resignation before Obama
takes office, according to agency spokeswoman Judy Leon.

``The best and most likely candidate is going to be a top clinician
already in or around the agency who is seen as an independent and
career scientist,'' said Scott Gottlieb, a deputy commissioner of the
agency under Bush, in an e-mail. Gottlieb is now a resident fellow at
the American Enterprise Institute, a research organization in
Washington.

Representatives of drugmakers are advocating Woodcock, 60, to
lawmakers to serve as commissioner on either an acting or permanent
basis, according to two people associated with the industry who spoke
on condition of anonymity.

The Pharmaceutical Research and Manufacturers of America, a
drugmakers' trade association in Washington, declined to discuss
individual candidates.

$2 billion Budget

Obama and his advisers haven't indicated who they are considering to
head the agency that polices food, drugs and cosmetics. The
commissioner, who must be confirmed by the Senate, oversees an agency
that employs about 11,000 people and has a budget of more than $2
billion.

Obama campaigned for president promising to overhaul the U.S. health-
care system, and he spoke at times about the need to improve food and
drug safety.

Presidents typically have first hired a secretary of Health and Human
Services, who in turn helped pick an FDA commissioner. Former Senator
Tom Daschle and Kansas Governor Kathleen Sebelius are contenders for
health secretary, according to people in contact with Obama's health-
care advisers.

Woodcock, named head of the FDA's drug division in March, is an
internist and rheumatologist. She joined the FDA in 1986, according to
the agency's Web site, and previously served as deputy commissioner
and chief medical officer. Advocacy groups questioned whether she
would get the job, saying she wouldn't be seen as someone who would
significantly change the agency.

Woodcock declined to comment, according to the FDA's Leon.

Cancer Research Group

Woodcock is also among a number of candidates supported by Ellen
Sigal, chairwoman of Friends of Cancer Research, based in Arlington,
Virginia. The group, which receives some of its funding from
drugmakers, seeks to raise awareness and speed up finding ways of
preventing and treating cancer.

``You have an agency that has been grotesquely under- funded,'' Sigal
said in a telephone interview. ``Their infrastructure needs to be
rebuilt.''

Another FDA insider, its chief scientist, Frank Torti, has spoken with
Obama representatives about the agency, according to a source familiar
with the conversation. Torti declined to comment, according to Leon.

Torti, 61, joined the agency in May after serving as chairman of the
cancer biology department and director of the Comprehensive Cancer
Center at Wake Forest's School of Medicine in Winston-Salem, North
Carolina.

A critic of the FDA, Diana Zuckerman, said in a telephone interview
that she is discussing the possibility of recommending FDA candidates
with a coalition of groups. Zuckerman is president of the National
Research Center for Women & Families, an advocacy group in
Washington.

Nissen, Sharfstein

Among candidates Zuckerman said she would support are Nissen, 60, head
of cardiology at the Cleveland Clinic in Ohio, and Sharfstein, 39, a
pediatrician who is commissioner of the Baltimore City Health
Department.

Nissen disclosed heart risks associated with GlaxoSmithKline PLC's
diabetes drug Avandia in a May 2007 study, and he has criticized the
agency's handling of drug safety. Even some of his supporters said he
may be an unlikely choice for the job because he would face strong
opposition from drugmakers.

Sharfstein also was named as a likely candidate by Ipsita Smolinski,
an analyst for J.P. Morgan Securities Inc., in a note to investors
yesterday.

Sharfstein gained prominence last year after petitioning the FDA to
ban marketing of over-the-counter cough and cold medicines marketed to
young children. Sharfstein previously worked for Representative Henry
Waxman, a California Democrat. Sharfstein declined to comment on the
FDA position.

No Discussion

Nissen said in a telephone interview that he hadn't discussed the job
with Obama or his advisers. ``When the time comes, if somebody
approaches me, I'll certainly talk to them,'' Nissen said.

Zuckerman also backs Susan Wood, a professor at George Washington
University in Washington who previously was the FDA's assistant
commissioner for women's health. Wood served on an Obama campaign
advisory panel on women's health policy.

``Whoever the FDA commissioner is needs to reestablish the trust of
the American people,'' said Zuckerman. ``There are a lot of years'
worth of decisions that have really eroded the public confidence.''

She said the agency should have taken stronger action on drug safety
and faulted its handling of Avandia and Merck & Co.'s painkiller
Vioxx.

Wood, 50, said in a telephone interview that she hadn't spoken with
Obama representatives about the job.

To contact the reporter on this story: Justin Blum in Washington at
[EMAIL PROTECTED]

Last Updated: November 6, 2008 17:15 EST


http://www.bloomberg.com/apps/news?pid=20601124&sid=al49I5JmbAks&refer=home

On Nov 5, 8:49 pm, "Mercury.Sailor" <[EMAIL PROTECTED]> wrote:
> Can Obama's Win Lead to Meaningful Health Care Reform?
>
> Let's start with some good news: The days of Big Pharma's dominance
> over Washington may be coming to an end. No more drug companies
> ripping off the taxpayers thanks to a Bush-approved Medicare bill that
> made it illegal for the U.S. government to negotiate volume discounts
> with Big Pharma. An Obama presidency will stick it to Big Pharma and
> work to help lower the cost of prescription drugs for consumers. (But
> that's not really a health care solution. It's just making dangerous
> drugs cheaper.)
>
> You can also say goodbye to any kind of ridiculous pre-emption ruling
> that would grant Big Pharma blanket immunity against claims by victims
> who are harmed by their dangerous products. An Obama presidency will
> very likely see the passage of laws reinstating the rights of
> consumers to sue companies who sell them dangerous products, even when
> they're approved by the corrupt, fraudulent U.S. Food and Drug
> Administration.
>
> Here's an important question: Could an Obama presidency prioritize
> meaningful FDA reform and the restoration of health freedoms for all
> Americans?
>
> http://www.naturalnews.com/024705.html
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