1 mai, 2006 14:29

Ex-Commissioner of FDA under Criminal Investigation

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, Michael 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, Catherine 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.