Ex-Commissioner of FDA under Criminal Investigation

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From foodconsumer.org

L.AWS & REG.

Ex-Commissioner of FDA under Criminal Investigation

http://www.foodconsumer.org/777/8/Ex-Commissioner_of_FDA_under_Criminal_Investig\

ation_.shtml

By Kathy

Apr 29, 2006, 16:17

Lester M. Crawford, D.V.M., Ph.D. FDA Commissioner

7/18/2005 - 9/23/2005

April 29 (foodconsumer.org) - Dr. Lester Crawford,

ex-commissioner of the Food and Drug Administration is

under criminal investigation by a federal grand jury

over suspicions of financial skullduggery and for

making false statements to the Congress. His lawyer,

Barbara Van Gelder, confirmed that Dr Crawford was the

target of the investigation, but declined to go into

the details of the charges.

According to a transcript, Ms Van Gelder told a

federal magistrate in a telephone hearing that she

would instruct her client to invoke his Fifth

Amendment right against compelled self-incrimination

if he was asked to describe the decisions taken by the

FDA in his tenure.

Dr. Crawford was due to be questioned under oath on

Thursday, but Ms Van Gelder asked for a delay on

Wednesday and said that he would invoke his Fifth

Amendment rights, The New York Times reported.

Dr Crawford resigned from his post in September, less

than three months after the Senate confirmed him. He

had said at that time that it was time for someone

else to lead the agency. One of the most controversial

issues during Dr Crawford's tenure was the application

by Barr Laboratory to market the emergency

contraceptive Plan B as an over-the-counter drug.

Barr had applied for giving Plan B an OTC status three

years ago and despite secretary of health and human

services, O. Leavitt's assurances that FDA

would decide on the Plan B application by September

2005, the issue was allowed to slide.

A month after Dr Crawford resigned, financial

disclosure forms released by the Department of Health

and Human Services revealed that in 2004 either Dr.

Crawford or his wife, had dealt in shares of

a company, which was under the agency's regulation. Dr

Crawford was the deputy commissioner and acting

commissioner of the FDA when these transactions took

place.

The criminal investigation report was confirmed during

a court hearing in a lawsuit over the F.D.A.'s

inaction on Plan B. The Center for Reproductive

Rights, an advocacy group had brought the suit against

the FDA alleging that the repeated delays were

politically motivated.

Such suits are generally quickly dismissed, but a

federal judge allowed the case to proceed. He also

granted permission to the center to interview top

F.D.A. officials, including Dr. Crawford. Many

abortion rights activists and lawmakers felt that the

delay in Plan B's approval was political, but Dr

Crawford and other FDA officials have maintained that

the reasons were " scientific and legal. "

Now Ms. Van Gelder has told Magistrate Judge Viktor V.

Pohorelsky of the District Court for the Eastern

District of New York that Justice Department lawyers

would represent Dr Crawford in the reproductive rights

suit.

According to the aforementioned transcript, she added

that the " issue of his financial disclosures is within

the grand jury. "

Commenting on the involvement of the Justice

Department lawyers, Simon Heller, a lawyer for the

reproductive rights center, said " It would be

remarkable if the Justice Department was conducting a

criminal investigation of Plan B and at the same time

asserting in a civil case that everything done was

normal. "

Dr. Crawford did not respond to The Times' messages

for comments, while FDA spokeswoman Kathleen Quinn

chose not to comment on the issue.

Plan B is an emergency contraception pill that is

designed to prevent pregnancy if a woman has forgotten

to take more than 2 pills in a month. It can also

reduce the chances of pregnancy after unprotected sex.

It is a valuable backup in case of a condom breaking

or forced assault.

Plan B is not related to the abortion pill RU-486 and

does not work in already pregnant women. The pill

works by stopping the release of an egg from the

ovary, or preventing the fertilization of the egg. It

is made up of the hormone levonorgestrel, which has

been used for birth control methods over the last 35

years. However, Plan B has a larger dose of

levonorgestrel than found in an ordinary birth control

pill.

The FDA approved Plan B for use as an emergency

contraceptive, which has very few side effects. When

present, these manifest themselves as nausea,

abdominal pain, tiredness, headache, dizziness, or

breast tenderness. It must be stressed that Plan B is

just that - a second plan if your regular birth

control methods fail.

© 2004-2005 by foodconsumer.org unless otherwise

specified.

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Ex-Commissioner of FDA under Criminal Investigation

From foodconsumer.orgL.AWS & REG.Ex-Commissioner of FDA under Criminal Investigationhttp://www.foodconsumer.org/777/8/Ex-Commissioner_of_FDA_under_Criminal_Investigation_.shtmlBy Kathy Apr 29, 2006, 16:17Lester M. Crawford, D.V.M., Ph.D. FDA Commissioner7/18/2005 - 9/23/2005 April 29 (foodconsumer.org) - Dr. Lester Crawford,ex-commissioner of the Food and Drug Administration isunder criminal investigation by a federal grand juryover suspicions of financial skullduggery and formaking false statements to the Congress. His lawyer,Barbara Van Gelder, confirmed that Dr Crawford was thetarget of the investigation, but declined to go intothe details of the charges. According to a transcript, Ms Van Gelder told afederal magistrate in a telephone hearing that shewould instruct her client to invoke his FifthAmendment right against compelled self-incriminationif he was asked to describe the decisions taken by theFDA in his tenure. Dr. Crawford was due to be questioned under oath onThursday, but Ms Van Gelder asked for a delay onWednesday and said that he would invoke his FifthAmendment rights, The New York Times reported.Dr Crawford resigned from his post in September, lessthan three months after the Senate confirmed him. Hehad said at that time that it was time for someoneelse to lead the agency. One of the most controversialissues during Dr Crawford's tenure was the applicationby Barr Laboratory to market the emergencycontraceptive Plan B as an over-the-counter drug. Barr had applied for giving Plan B an OTC status threeyears ago and despite secretary of health and humanservices, O. Leavitt's assurances that FDAwould decide on the Plan B application by September2005, the issue was allowed to slide. A month after Dr Crawford resigned, financialdisclosure forms released by the Department of Healthand Human Services revealed that in 2004 either Dr.Crawford or his wife, had dealt in shares ofa company, which was under the agency's regulation. DrCrawford was the deputy commissioner and actingcommissioner of the FDA when these transactions tookplace. The criminal investigation report was confirmed duringa court hearing in a lawsuit over the F.D.A.'sinaction on Plan B. The Center for ReproductiveRights, an advocacy group had brought the suit againstthe FDA alleging that the repeated delays werepolitically motivated. Such suits are generally quickly dismissed, but afederal judge allowed the case to proceed. He alsogranted permission to the center to interview topF.D.A. officials, including Dr. Crawford. Manyabortion rights activists and lawmakers felt that thedelay in Plan B's approval was political, but DrCrawford and other FDA officials have maintained thatthe reasons were "scientific and legal." Now Ms. Van Gelder has told Magistrate Judge Viktor V.Pohorelsky of the District Court for the EasternDistrict of New York that Justice Department lawyerswould represent Dr Crawford in the reproductive rightssuit. According to the aforementioned transcript, she addedthat the "issue of his financial disclosures is withinthe grand jury."Commenting on the involvement of the JusticeDepartment lawyers, Simon Heller, a lawyer for thereproductive rights center, said "It would beremarkable if the Justice Department was conducting acriminal investigation of Plan B and at the same timeasserting in a civil case that everything done wasnormal."Dr. Crawford did not respond to The Times' messagesfor comments, while FDA spokeswoman Kathleen Quinnchose not to comment on the issue. Plan B is an emergency contraception pill that isdesigned to prevent pregnancy if a woman has forgottento take more than 2 pills in a month. It can alsoreduce the chances of pregnancy after unprotected sex.It is a valuable backup in case of a condom breakingor forced assault. Plan B is not related to the abortion pill RU-486 anddoes not work in already pregnant women. The pillworks by stopping the release of an egg from theovary, or preventing the fertilization of the egg. Itis made up of the hormone levonorgestrel, which hasbeen used for birth control methods over the last 35years. However, Plan B has a larger dose oflevonorgestrel than found in an ordinary birth controlpill. The FDA approved Plan B for use as an emergencycontraceptive, which has very few side effects. Whenpresent, these manifest themselves as nausea,abdominal pain, tiredness, headache, dizziness, orbreast tenderness. It must be stressed that Plan B isjust that - a second plan if your regular birthcontrol methods fail. © 2004-2005 by foodconsumer.org unless otherwisespecified.