Everyone needs to Write To The COMMITTEE >> Rep. Stupak Calls For FDA Commissioner To Resign Amid Recent Prescription Drug Safety Issues ... February 18,2008 >> Posted on Tony's website 2/23/08

[Guest guest]

From our silent sister:-------------------------------

Monday,

February 18, 2008 3:08 PM Rep.

Stupak Calls For FDA Commissioner To Resign Amid Recent Prescription Drug

Safety Issues House

Energy and Commerce Oversight and Investigations Subcommittee

Chair Bart Stupak (D-Mich.) on Thursday called on FDA Commissioner

von Eschenbach to resign, saying that he had lost confidence in officials over

the handling of investigations and oversight by the agency, the AP/Los Angeles

Times reports (, AP/Los Angeles Times, 2/15). Stupak

said his call for von Eschenbach to resign was spurred in part by the recall of

the blood thinner heparin, manufactured by Baxter International, which has been

linked to 350 reports of adverse events since the end of last year. According

to Stupak, Baxter announced the recall on Jan. 25, 2007, but FDA did not send

out its own notice until Monday (Edney, CongressDaily,

2/15). In

addition, Stupak and House Energy and Commerce Committee

Chair Dingell (D-Mich.) this week threatened to hold HHS

Secretary Mike Leavitt in contempt because he refused to turn over subpoenaed

documents that were used to prepare von Eschenbach for a hearing last year.

Stupak alleged that FDA knew that a key safety study of the Sanofi-Aventis antibiotic Ketek contained

faulty data but approved the drug anyway. At the hearing, von Eschenbach

testified that FDA did not use the flawed safety study to approve the drug. Stupak

said von Eschenbach should step down because "it's just a total lack of

leadership" (AP/

Los Angeles Times, 2/15).

He said, "The drug companies know that this administration ... will do

nothing to them," adding, "There is no fear of the FDA." Stupak

said, "With this culture with laissez faire oversight and regulation, I

think they should be gone," adding, "If we get rid of them, it will

put the drug companies on notice." Stupak also called for the resignations

of FDA Medical Officer Janet Woodcock; Deputy Director of FDA's drug center

Kweder; and FDA Associate Commissioner for Regulatory Affairs Margaret

Glavin. Glavin had attempted to close 13 of FDA's food testing labs and

accepted thousands of dollars in bonuses (CongressDaily,

2/15). FDA

spokesperson Heidi Rebello said that "there isn't really anything to say

beyond we've been responsive to the congressman as much as possible." FDA

says there was no intention to deceive anyone of the results of the Ketek study

(AP/ Los

Angeles Times, 2/15). Reprinted

with kind permission from http://www.kaisernetwork.org.

You can view the entire Kaiser Daily Health Policy Report, search the archives,

or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy.

The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a

free service of The Henry J. Kaiser Family

[Guest guest]

From our silent sister:-------------------------------

Monday,

February 18, 2008 3:08 PM Rep.

Stupak Calls For FDA Commissioner To Resign Amid Recent Prescription Drug

Safety Issues House

Energy and Commerce Oversight and Investigations Subcommittee

Chair Bart Stupak (D-Mich.) on Thursday called on FDA Commissioner

von Eschenbach to resign, saying that he had lost confidence in officials over

the handling of investigations and oversight by the agency, the AP/Los Angeles

Times reports (, AP/Los Angeles Times, 2/15). Stupak

said his call for von Eschenbach to resign was spurred in part by the recall of

the blood thinner heparin, manufactured by Baxter International, which has been

linked to 350 reports of adverse events since the end of last year. According

to Stupak, Baxter announced the recall on Jan. 25, 2007, but FDA did not send

out its own notice until Monday (Edney, CongressDaily,

2/15). In

addition, Stupak and House Energy and Commerce Committee

Chair Dingell (D-Mich.) this week threatened to hold HHS

Secretary Mike Leavitt in contempt because he refused to turn over subpoenaed

documents that were used to prepare von Eschenbach for a hearing last year.

Stupak alleged that FDA knew that a key safety study of the Sanofi-Aventis antibiotic Ketek contained

faulty data but approved the drug anyway. At the hearing, von Eschenbach

testified that FDA did not use the flawed safety study to approve the drug. Stupak

said von Eschenbach should step down because "it's just a total lack of

leadership" (AP/

Los Angeles Times, 2/15).

He said, "The drug companies know that this administration ... will do

nothing to them," adding, "There is no fear of the FDA." Stupak

said, "With this culture with laissez faire oversight and regulation, I

think they should be gone," adding, "If we get rid of them, it will

put the drug companies on notice." Stupak also called for the resignations

of FDA Medical Officer Janet Woodcock; Deputy Director of FDA's drug center

Kweder; and FDA Associate Commissioner for Regulatory Affairs Margaret

Glavin. Glavin had attempted to close 13 of FDA's food testing labs and

accepted thousands of dollars in bonuses (CongressDaily,

2/15). FDA

spokesperson Heidi Rebello said that "there isn't really anything to say

beyond we've been responsive to the congressman as much as possible." FDA

says there was no intention to deceive anyone of the results of the Ketek study

(AP/ Los

Angeles Times, 2/15). Reprinted

with kind permission from http://www.kaisernetwork.org.

You can view the entire Kaiser Daily Health Policy Report, search the archives,

or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy.

The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a

free service of The Henry J. Kaiser Family