Re: Ex-Commissioner of FDA under Criminal Investigation

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UGh. Does it ever end with the FDA corruption? Rogene S <saxony01@...> wrote: 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.

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