Tc
Wed, Sep-28-05, 06:49
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?D-
R_ID=32750
FDA Commissioner Crawford Resigns
FDA Commissioner Lester Crawford on Friday "abruptly"
resigned two months after his confirmation to the position,
the AP/Chicago Sun-Times reports (Neergaard, AP/Chicago
Sun-Times, 9/24). In an e-mail to FDA employees, Crawford
wrote that "after three and a half years as deputy
commissioner, acting commissioner and, finally, as
commissioner, it is time, at the age of 67, to step aside"
(Carey, CQ HealthBeat, 9/23). In a letter to President Bush
on Friday, Crawford said that his resignation was "effective
immediately." Crawford, a veterinarian and a food safety
expert, became FDA deputy commissioner in 2002 and later
became acting agency commissioner. The Senate confirmed
Crawford as permanent FDA commissioner in July. Christina
Pearson, a spokesperson for HHS Secretary Mike Leavitt,
declined to comment on whether the Bush administration had
asked Crawford to resign, which she called a personnel issue.
One federal official, who spoke on the condition of
anonymity, said that the resignation involved financial
information Crawford did not fully disclose to the Senate
before his confirmation (Pear/Pollack, New York Times, 9/24).
Other sources familiar with FDA said that the Bush
administration asked Crawford to resign for undetermined
reasons (Kaufman, Washington Post, 9/24). Leavitt accepted
the Crawford resignation "with sadness," Pearson said,
adding, "We thank him for his service and wish him well"
(Wall Street Journal,
9/23).
'Stormy Tenure' Crawford has had a "stormy tenure" at FDA,
which in recent years has faced criticism over emergency
contraception and prescription drug safety, among other
issues, the Post reports (Kaufman, Washington Post,
9/24). Since 2002, FDA has "been rocked by disputes over many
issues," such as the safety of the COX-2 inhibitor Vioxx,
regulation of cardiac defibrillators and other medical
devices, the safety of antidepressants in children and
delays on an application to allow over-the-counter sales
of emergency contraception, the New York Times reports. A
Senate committee also investigated an alleged
extramarital affair between Crawford and a woman who
worked at FDA. In addition, Crawford allegedly used
federal funds to take the woman on official trips for
which she was not needed and helped the woman secure a
promotion at FDA. The committee found that Crawford had a
close relationship with the woman but no evidence of an
extramarital affair (New York Times, 9/24).
NCI Director Named as Acting Commissioner Bush on Friday named
Andrew von Eschenbach, director of the National Cancer
Institute, as acting FDA commissioner (Wilde Mathews, Wall
Street Journal, 9/26). He said that FDA should make new
medications available "as rapidly as possible" for patients
with life-threatening diseases. In addition, he said that he
would seek "an appropriate balance" in the evaluation of the
risks and benefits of medications at FDA (Pear/Pollack, New
York Times, 9/25). However, he said, "I believe it's still
important to ask the question, 'How can we accelerate the
timeline? How can we make certain we are getting these
interventions to the patients as quickly as possible?'"
(Lumpkin, AP/Long Island Newsday, 9/26). Von Eschenbach said
that the FDA approval process for new medications represents
the "gold standard" but added that, "no matter how good it is,
the question always has to be asked, can we make it better?"
He said that FDA should consider revisions to reduce approval
times for new medications "within the context of continuing to
assure their efficacy and safety," adding that "speed does not
mean recklessness." Von Eschenbach, who will continue to serve
as NCI director, said that he will make a "full commitment" to
leadership at NCI and FDA and that he remains "totally,
completely and absolutely dedicated" to NCI. He also said that
FDA should make safety information available to patients. "I
absolutely believe in openness and being transparent and being
clear," he said (Wall Street Journal, 9/26).
Issues With New Commissioner Appointment According to the
Times, FDA likely "will be without a permanent commissioner
for some time" because past experience "shows that it is
difficult for any nominee to obtain broad support in the
Senate." FDA has had a permanent commissioner for about 18
months of the four and a half years of the Bush presidency
(New York Times, 9/24). Pharmacologist Raymond Woosley, who
withdrew from consideration for FDA commissioner in 2001 to
accept a different job, said that Senate confirmation could
prove difficult. Woosley said that the appointment of an FDA
commissioner "really should be taken out of the realm of
politics," adding, "It's a public health job. The head of the
CDC isn't a political appointment, and it's in the same
realm." Alaistair Wood, a Vanderbilt University
pharmacologist, said, "The issue is, once you've involved
politics in the drug approval process, there's no way to put
that genie back in the bottle." Steven Burrill, CEO of a
California-based biotechnology investment company, said that
Bush might not nominate a new FDA commissioner for 18 months
(Rubin, USA Today,
9/25).
Reaction Sen. Chuck Grassley (R-Iowa) praised the Crawford
resignation, adding, "FDA scientists and employees are by and
large hardworking and committed to fulfilling the agency's
mission. They deserve a commissioner who will reinvigorate the
agency" (Kaufman, Washington Post, 9/24). Grassley said, "In
recent years, the FDA has demonstrated a too-cozy relationship
with the pharmaceutical industry and an attitude of shielding
rather than disclosing information. The opportunity to name a
new commissioner is a chance to take the agency in a necessary
new direction" (CQ HealthBeat, 9/23). Sen. Hillary Rodham
Clinton (D-N.Y.) said, "With the resignation of Dr. Crawford,
the FDA has a real opportunity to restore its battered
reputation and nominate a leader with vision and drive to
ensure that the FDA upholds its gold standard of drug
regulation" (Kaufman, Washington Post, 9/24). Sen. Barbara
Mikulski (D-Md.) criticized the leadership of Crawford as
"tepid and passive," adding, "Every day, I have grown more
concerned about what's going on." She said that she hopes the
Crawford resignation will serve as a "move toward reforming
FDA." Peter Lurie of Public Citizen said, "In his watch, some
of the worst drug disasters in the last decade took place"
(Rockoff, Baltimore Sun, 9/24). However, Peter Pitts, a former
associate FDA commissioner under Crawford, said that Crawford
"started to lift the veil on how the FDA does business, which
was long overdue" (New York Times, 9/24).
Editorial FDA has lacked a permanent commissioner for more
than half of the Bush presidency, which is "not a healthy
situation for any agency, and certainly not for one whose
jurisdiction covers one-quarter of the nation's economy and
touches on so many critical issues of public health,"
according to a Post editorial. The editorial adds, "Also
unhealthy are the suspicions -- which increasingly appear to
have some grounding -- that the supposedly independent agency
has been relentlessly politicized." The editorial concludes
that Bush "should move quickly to nominate -- and the Senate
should, after careful consideration, confirm -- a
commissioner with staying power: someone with scientific
expertise, management abilities and strength of character to
do one of the most important jobs in government" (Washington
Post, 9/24).
****
Here is a bit about Crawford:
Lester M. Crawford, Ph.D., D.V.M., Director, Center for Food
and Nutrition Policy (CERES Forum) at Georgetown University.
That center formed a partnership with the Grocery
Manufacturers of America in 1998 (http://www.gmabrands.com,
9-15-00); the Center also receives funding from the Sugar
Association (see Maureen Storey, below). Previously: Research
and development at American Cyanamid; Director, Center for
Veterinary Medicine at FDA; Administrator, USDA Food Safety
and Inspection Service; Executive Director, Association of
American Veterinary Medical Colleges; VP, National Food
Processors Asso. (http://www.ceresnet.org, September 15, 2000)
Member, FDA Food Advisory Committee that reviewed olestra
(1995). Foodfit.com advisory board
(http://www.foodfit.com/about/advisoryBoard.asp; November 11,
2000) (see also Corporate Funding Database, CSPI, under
Georgetown Center for Food and Nutrition Policy)
****
I think it is time to get someone with impeccable credentials
and independence from industry into this office and thoroughly
clean up this rats nest of corruption that is called the FDA.
TC
R_ID=32750
FDA Commissioner Crawford Resigns
FDA Commissioner Lester Crawford on Friday "abruptly"
resigned two months after his confirmation to the position,
the AP/Chicago Sun-Times reports (Neergaard, AP/Chicago
Sun-Times, 9/24). In an e-mail to FDA employees, Crawford
wrote that "after three and a half years as deputy
commissioner, acting commissioner and, finally, as
commissioner, it is time, at the age of 67, to step aside"
(Carey, CQ HealthBeat, 9/23). In a letter to President Bush
on Friday, Crawford said that his resignation was "effective
immediately." Crawford, a veterinarian and a food safety
expert, became FDA deputy commissioner in 2002 and later
became acting agency commissioner. The Senate confirmed
Crawford as permanent FDA commissioner in July. Christina
Pearson, a spokesperson for HHS Secretary Mike Leavitt,
declined to comment on whether the Bush administration had
asked Crawford to resign, which she called a personnel issue.
One federal official, who spoke on the condition of
anonymity, said that the resignation involved financial
information Crawford did not fully disclose to the Senate
before his confirmation (Pear/Pollack, New York Times, 9/24).
Other sources familiar with FDA said that the Bush
administration asked Crawford to resign for undetermined
reasons (Kaufman, Washington Post, 9/24). Leavitt accepted
the Crawford resignation "with sadness," Pearson said,
adding, "We thank him for his service and wish him well"
(Wall Street Journal,
9/23).
'Stormy Tenure' Crawford has had a "stormy tenure" at FDA,
which in recent years has faced criticism over emergency
contraception and prescription drug safety, among other
issues, the Post reports (Kaufman, Washington Post,
9/24). Since 2002, FDA has "been rocked by disputes over many
issues," such as the safety of the COX-2 inhibitor Vioxx,
regulation of cardiac defibrillators and other medical
devices, the safety of antidepressants in children and
delays on an application to allow over-the-counter sales
of emergency contraception, the New York Times reports. A
Senate committee also investigated an alleged
extramarital affair between Crawford and a woman who
worked at FDA. In addition, Crawford allegedly used
federal funds to take the woman on official trips for
which she was not needed and helped the woman secure a
promotion at FDA. The committee found that Crawford had a
close relationship with the woman but no evidence of an
extramarital affair (New York Times, 9/24).
NCI Director Named as Acting Commissioner Bush on Friday named
Andrew von Eschenbach, director of the National Cancer
Institute, as acting FDA commissioner (Wilde Mathews, Wall
Street Journal, 9/26). He said that FDA should make new
medications available "as rapidly as possible" for patients
with life-threatening diseases. In addition, he said that he
would seek "an appropriate balance" in the evaluation of the
risks and benefits of medications at FDA (Pear/Pollack, New
York Times, 9/25). However, he said, "I believe it's still
important to ask the question, 'How can we accelerate the
timeline? How can we make certain we are getting these
interventions to the patients as quickly as possible?'"
(Lumpkin, AP/Long Island Newsday, 9/26). Von Eschenbach said
that the FDA approval process for new medications represents
the "gold standard" but added that, "no matter how good it is,
the question always has to be asked, can we make it better?"
He said that FDA should consider revisions to reduce approval
times for new medications "within the context of continuing to
assure their efficacy and safety," adding that "speed does not
mean recklessness." Von Eschenbach, who will continue to serve
as NCI director, said that he will make a "full commitment" to
leadership at NCI and FDA and that he remains "totally,
completely and absolutely dedicated" to NCI. He also said that
FDA should make safety information available to patients. "I
absolutely believe in openness and being transparent and being
clear," he said (Wall Street Journal, 9/26).
Issues With New Commissioner Appointment According to the
Times, FDA likely "will be without a permanent commissioner
for some time" because past experience "shows that it is
difficult for any nominee to obtain broad support in the
Senate." FDA has had a permanent commissioner for about 18
months of the four and a half years of the Bush presidency
(New York Times, 9/24). Pharmacologist Raymond Woosley, who
withdrew from consideration for FDA commissioner in 2001 to
accept a different job, said that Senate confirmation could
prove difficult. Woosley said that the appointment of an FDA
commissioner "really should be taken out of the realm of
politics," adding, "It's a public health job. The head of the
CDC isn't a political appointment, and it's in the same
realm." Alaistair Wood, a Vanderbilt University
pharmacologist, said, "The issue is, once you've involved
politics in the drug approval process, there's no way to put
that genie back in the bottle." Steven Burrill, CEO of a
California-based biotechnology investment company, said that
Bush might not nominate a new FDA commissioner for 18 months
(Rubin, USA Today,
9/25).
Reaction Sen. Chuck Grassley (R-Iowa) praised the Crawford
resignation, adding, "FDA scientists and employees are by and
large hardworking and committed to fulfilling the agency's
mission. They deserve a commissioner who will reinvigorate the
agency" (Kaufman, Washington Post, 9/24). Grassley said, "In
recent years, the FDA has demonstrated a too-cozy relationship
with the pharmaceutical industry and an attitude of shielding
rather than disclosing information. The opportunity to name a
new commissioner is a chance to take the agency in a necessary
new direction" (CQ HealthBeat, 9/23). Sen. Hillary Rodham
Clinton (D-N.Y.) said, "With the resignation of Dr. Crawford,
the FDA has a real opportunity to restore its battered
reputation and nominate a leader with vision and drive to
ensure that the FDA upholds its gold standard of drug
regulation" (Kaufman, Washington Post, 9/24). Sen. Barbara
Mikulski (D-Md.) criticized the leadership of Crawford as
"tepid and passive," adding, "Every day, I have grown more
concerned about what's going on." She said that she hopes the
Crawford resignation will serve as a "move toward reforming
FDA." Peter Lurie of Public Citizen said, "In his watch, some
of the worst drug disasters in the last decade took place"
(Rockoff, Baltimore Sun, 9/24). However, Peter Pitts, a former
associate FDA commissioner under Crawford, said that Crawford
"started to lift the veil on how the FDA does business, which
was long overdue" (New York Times, 9/24).
Editorial FDA has lacked a permanent commissioner for more
than half of the Bush presidency, which is "not a healthy
situation for any agency, and certainly not for one whose
jurisdiction covers one-quarter of the nation's economy and
touches on so many critical issues of public health,"
according to a Post editorial. The editorial adds, "Also
unhealthy are the suspicions -- which increasingly appear to
have some grounding -- that the supposedly independent agency
has been relentlessly politicized." The editorial concludes
that Bush "should move quickly to nominate -- and the Senate
should, after careful consideration, confirm -- a
commissioner with staying power: someone with scientific
expertise, management abilities and strength of character to
do one of the most important jobs in government" (Washington
Post, 9/24).
****
Here is a bit about Crawford:
Lester M. Crawford, Ph.D., D.V.M., Director, Center for Food
and Nutrition Policy (CERES Forum) at Georgetown University.
That center formed a partnership with the Grocery
Manufacturers of America in 1998 (http://www.gmabrands.com,
9-15-00); the Center also receives funding from the Sugar
Association (see Maureen Storey, below). Previously: Research
and development at American Cyanamid; Director, Center for
Veterinary Medicine at FDA; Administrator, USDA Food Safety
and Inspection Service; Executive Director, Association of
American Veterinary Medical Colleges; VP, National Food
Processors Asso. (http://www.ceresnet.org, September 15, 2000)
Member, FDA Food Advisory Committee that reviewed olestra
(1995). Foodfit.com advisory board
(http://www.foodfit.com/about/advisoryBoard.asp; November 11,
2000) (see also Corporate Funding Database, CSPI, under
Georgetown Center for Food and Nutrition Policy)
****
I think it is time to get someone with impeccable credentials
and independence from industry into this office and thoroughly
clean up this rats nest of corruption that is called the FDA.
TC