April 29

Ex-Head of F.D.A. Faces Criminal Inquiry

His abrupt departure as FDA Commissioner occurred under a cloud of controversy abut reports of undisclosed stock sales in companies regulated
by the FDA.  Notwithstanding Crawford’s claim that he had decided to retire at age 67, The Times reports "He has since joined a Washington lobbying firm, Policy Directions Inc."

The companies represented by  Policy Directions Inc are regulated by theFDA, raising questions about the propriety of high government officials–particularly those who head regualtory agencies–blithely moving to lobbying firms that represent the same industries.    There are additional accusations of financial conflicts of interest.

Among the long list of food, drug and cosmetics companies that have hired Policy Directions, Inc to lobby the FDA and Congress:

Nestle USA Inc.; Pharmaceutical Research & Manufacturers of America;  Baylor University;  Merck & Co.;  American Feed Industry Association; Altria Group Inc ;  National Association for Biomedical Research;  State University of New York;  Amgen Inc.;  Genzyme Corp.;  Baxter Healthcare Corp.;  U.S. ONCOLOGY;  Society for Neuroscience;  Sanofi-Aventis;  National Renderers Association;  Reckitt Benckiser Pharmaceuticals;  Procter & Gamble Co.; American College of Neuropsychopharmachology;  Grocery Manufacturers of America;  Pharmavite LLC;  Turner Strategies;  Alpharma;  Cellerant Therapeutics;  Depression & Bipolar Support Alliance (DBSA);  Genelabs Technologies, Inc;  Eli Lilly and Co.;  Visx Inc; Millennium Pharmaceuticals, Inc.;  Orphan Medical, Inc.;  Biotech Coalition; Covance Inc.;  Bayer Corp.;  Animal Health Institute;  Cosmetic, Toiletry & Fragrance Association.    

Of note, among Policy Directions’ clients are also several "not-for-profit" organizations and universities that directly and indirectly lobby with the
pharmaceutical industry.

According to Center for the Public Intesest , between 1998-2004 they earned– $6,975,000 in lobbying fees;  In 2004 they earned — $1,320,000
See: http://www.publicintegrity.org/lobby/profile.aspx?act=firms&year=2003&lo=L002522

Contact: Vera Hassner Sharav
April 29, 2006
Ex-Head of F.D.A. Faces Criminal Inquiry

WASHINGTON, April 28 – Dr. Lester M. Crawford, the former commissioner of food and drugs, is under criminal investigation by a federal grand jury over accusations of financial improprieties and false statements to Congress, his lawyer said Friday.

The lawyer, Barbara Van Gelder, would not discuss the accusations further. In a court hearing held by telephone on Thursday, she told a federal
magistrate that she would instruct Dr. Crawford to invoke his Fifth Amendment right against compelled self-incrimination if ordered to answer
questions this week about his actions as head of the Food and Drug Administration, according to a transcript of the hearing.

Dr. Crawford did not reply to messages seeking comment, and Kathleen Quinn, an F.D.A. spokeswoman, declined to comment.

Dr. Crawford resigned in September, fewer than three months after the Senate confirmed him. He said then that it was time for someone else to lead the agency.

The next month, financial disclosure forms released by the Department of Health and Human Services showed that in 2004 either Dr. Crawford or his wife, Catherine, had sold shares in companies regulated by the agency when he was its deputy commissioner and acting commissioner. He has since joined a Washington lobbying firm, Policy Directions Inc.

The criminal investigation was disclosed at a court hearing in a lawsuit over the F.D.A.’s actions on the emergency contraceptive Plan B, a subject
of bitter contention during Dr. Crawford’s tenure as acting commissioner and commissioner. After the pill’s maker, Barr Laboratories, applied three years ago to sell the pill over the counter, the agency repeatedly delayed making a decision on the application.

While many lawmakers, abortion rights advocates and former F.D.A. officials said the delays had resulted from politics, Dr. Crawford and other agency officials said their concerns were scientific and legal.

An advocacy group, the Center for Reproductive Rights, sued the agency in federal court in New York over the delays. Many such suits are quickly
dismissed, but a federal judge allowed the case to proceed, giving the center the right to interview top F.D.A. officials, including Dr. Crawford.

Dr. Crawford was scheduled to be questioned under oath on Thursday, but on Wednesday Ms. Van Gelder, who is his personal lawyer, asked for a delay, saying she would instruct him to invoke his Fifth Amendment rights. Dr. Crawford previously declined to answer questions from the Government Accountability Office about Plan B.

Ms. Van Gelder told Magistrate Judge Viktor V. Pohorelsky of the District Court for the Eastern District of New York on Thursday that Dr. Crawford had been represented by Justice Department lawyers in the reproductive rights center’s suit.

According to the transcript, she said that Dr. Crawford was under criminal investigation and that the issue of his financial disclosures "is within the
grand jury."

Before Dr. Crawford’s confirmation, the secretary of health and human services, Michael O. Leavitt, promised that the F.D.A. would act on the Plan
B application by September 2005, a promise that led two Democratic senators, Hillary Rodham Clinton of New York and Patty Murray of Washington, to relent in their efforts to delay the nomination. But after he was confirmed, Dr. Crawford announced an indefinite delay that has remained in effect.

Simon Heller, a lawyer for the reproductive rights center, noted that the F.D.A. had long insisted that its actions regarding Plan B were not unusual.
"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," Mr. Heller said.

Copyright 2006 The New York Times Company

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