Lester M. Crawford

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

GARDINER HARRIS / New York Times 29apr2006

[More below, including bio]

Mindfully.org note:  That Crawford is being prosecuted should come as no surprise because the FDA is not much more than a corporate shill. However, it is disheartening that so few of these criminals are sent to prison for the damage they do to us all. This one would look especially good in stripes.

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.

source: http://www.nytimes.com/2006/04/29/washington/29fda.html?_r=1&oref=slogin&pagewanted=print 1may2006

Former FDA Chief Faces Probe 

JOHN WILKE / Wall Street Journal 1may2006

WASHINGTON — Lester Crawford, former chief of the Food and Drug Administration, faces a grand-jury investigation of his financial holdings, his lawyer said in a separate civil case.

Dr. Crawford resigned in September 2005 after questions were raised about his financial holdings. The Wall Street Journal reported at the time that he held stock in companies regulated by the agency as recently as 2004 when he held a top position at the FDA, according to his financial disclosure forms. (See related article.)

Dr. Crawford's lawyer, Barbara Van Gelder, said Friday that Dr. Crawford "fully disclosed everything and we are prepared to defend that."

The grand jury's examination of Dr. Crawford emerged in a telephone hearing before a magistrate judge April 27 on procedural matters in a civil suit filed against the FDA over its handling of the emergency contraceptive Plan B. An FDA spokeswoman declined to comment Friday on Dr. Crawford's case.

p.A4

Bush Is Set to Nominate Acting Chief as Head of FDA 

ANNA WILDE MATHEWS & JENNIFER CORBETT DOOREN
Wall Street Journal 10mar2006

WASHINGTON — The White House is expected to nominate the acting commissioner of the Food and Drug Administration to formally head the agency.

Andrew von Eschenbach, 64 years old, is likely to be named in the next several weeks, people with knowledge of the matter say. But that could still stall over questions about whether Dr. von Eschenbach would have to give up his other job, as director of the National Cancer Institute, upon being nominated. He would likely face a tough confirmation process, tangled with controversial issues such as the Plan B emergency contraceptive and stem-cell research.

The last FDA commissioner, Lester Crawford, won confirmation only to resign last September after two months, a move likely tied to questions about his finances. Mark McClellan, the previous FDA leader, stepped down in March 2004 after about 16 months to run the Medicare program.

Dr. von Eschenbach, a urologic surgeon and cancer survivor who previously was executive vice president of the M.D. Anderson Cancer Center at the University of Texas in Houston, is identified with an aggressive goal of ending suffering and death because of cancer by 2015. Seen as an advocate of speeding approval of promising drugs, he will win support from industry but likely face opposition from lawmakers focused on drug safety, such as Iowa Republican Sen. Charles Grassley.

"He'd be a great FDA commissioner," said James Greenwood, chief executive of the Biotechnology Industry Organization. But "we've learned that it's easier to confirm a Supreme Court justice than it is an FDA commissioner."

Any FDA nominee will come under sharp pressure from both ends of the political spectrum. Democrats have attacked the agency's handling of a bid to sell the emergency contraceptive known as Plan B without a prescription, which stalled under Dr. Crawford. Republicans may want to grill Dr. von Eschenbach about the FDA's plans for condom labeling and the abortion pill mifepristone, which has been potentially tied to a handful of deaths. The agency has scheduled a scientific meeting that would address that and other infection-related issues.

A spokesman for Senator Michael Enzi, chairman of the committee that oversees the FDA, said the Wyoming Republican "continues to believe it is critical that the FDA have a Senate-confirmed leader at the agency's helm," though he said Mr. Enzi has told the White House he "believes it's essential that the Plan B issue be resolved before the Senate votes on an FDA nominee." A spokeswoman for Sen. Edward Kennedy of Massachusetts, the ranking Democrat on the committee and a fulcrum vote on any FDA nominee, said he believes the "next commissioner must have the capacity to see that FDA once again sets the standard for quality, sound science and integrity."

Aside from the highly charged reproductive-rights matters, Dr. von Eschenbach likely will face difficult questions over a range of FDA-related issues, including the possibility of copies of biotech medicines. He may also be asked about his unusual dual job at the FDA and the cancer institute, which he has headed since 2002.

—John D. McKinnon and Sarah Lueck contributed to this article.

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BIO — Dr. Lester M. Crawford

Dr. Crawford was confirmed by the Senate to be FDA Commissioner on July 18, 2005.

Previously, Dr. Crawford was Chair of the Department of Physiology-Pharmacology at the University of Georgia, Administrator of the Food Safety and Inspection Service (USDA) and Deputy Commissioner of FDA. From 1997-2002, he was Director of the Center for Food and Nutrition Policy at Georgetown University and at Virginia Tech, where it moved in 2001.

Dr. Crawford has played major roles in mandatory nutrition labeling, the formation of the World Trade Organization and the control of chemical and microbiological contaminants of food. He has been an advisor to the World Health Organization of the United Nations for much of his career.

Dr. Crawford is a Member of the National Academy of Sciences Institute of Medicine. He is a Fellow of the Royal Society of Medicine (UK) and a Fellow of the International Society of Food Science and Technology. In 1984, he was inducted into the French Academy of Veterinary Medicine. In 1991, he received the Wooldridge Award, the British Veterinary Association's highest award.

Dr. Crawford received his Doctor of Veterinary Medicine (DVM) from Auburn University, his PhD in pharmacology from the University of Georgia, and his Honorary Doctorate (MDV) from Budapest University.

He has been married since 1963 to Catherine Walker of Birmingham, Alabama. They have two daughters, Leigh and Mary, and four grandchildren.

source: http://www.fda.gov/oc/crawford/bio.html 1may2006

FDA Chief Chosen Amid Troubles

President Bush taps acting commissioner Lester Crawford,
as the agency faces criticism for handling of popular drugs

GREGORY M LAMB / Christian Science Monitor 16feb2005

With the heat turned up on the Food and Drug Administration regarding its failings as a consumer watchdog, the Bush administration has decided that the man already in place is the one to battle the blaze.

The White House announced it was nominating Lester Crawford, who has served as acting commissioner of the FDA since March 2004, for the post.

Critics were quick to express disappointment that the administration hadn't turned to an outsider to show it was serious about addressing the agency's shortcomings. Though Dr. Crawford is expected to be confirmed by the Senate, the process will undoubtedly provide yet another forum for critiquing the embattled agency.

"I was hoping for someone who could actually redirect the agency to what its legal and legislative mission is: to protect the public from unsafe drugs," says Vera Hassner Sharav, president of the Alliance for Human Research Protection and a longtime FDA critic. "Instead, the agency is in the business of fast-tracking the approval of drugs even before they've been found to be safe."

Drug safety and the clamor for change

In recent months, a simmering stew of issues has kept the FDA under constant scrutiny. Concerns that antidepressant drug use among children could increase their risk of suicide in turn raised cries for a more open policy on publication of clinical trials by drug companies, and spurred questions on the FDA's role in promoting that openness.

Last fall, the FDA seemed to be caught by surprise when half of the annual supply of flu vaccine, about 40 million doses, was declared tainted and unsafe for use. As the public fretted and waited in long lines for the existing doses, the government scrambled to find new supplies. In the end, a mild flu season has left the nation with an oversupply of doses.

Wednesday an advisory panel to the FDA begins three days of hearings on heavily marketed and highly popular painkillers known as Cox-2 inhibitors. One, with the brand name Vioxx, has been voluntarily removed from the market by its manufacturer, Merck. Two others, Celebrex and Bextra, made by Pfizer, remain on the market. In a number of studies, the drugs have been implicated in higher incidences of fatal heart attacks and other cardiovascular problems.

Critics have questioned why the FDA has taken so long to recognize the problem and take action. The agency could ask for strong warnings on the products or demand their removal from the market. David Graham, a whistle-blower within the FDA, will be allowed to testify, but has said he does not feel free to present new unpublished data about the drugs.

In an editorial released Wednesday, accompanying three more studies linking Cox-2 drugs to heart problems, Jeffrey Drazen, editor of the New England Journal of Medicine, wrote that "It is reasonable to ask whether the use of the drugs can now be justified" and said that the same zeal that had suggested the drugs offered new benefits to patients had not been applied to ensuring that they were safe.

A changing science

The press reports have sent patients and doctors fleeing from the drugs. Sales of Cox-2 drugs dropped 43 percent in December from a year earlier, according data released by IMS Health in Plymouth Meeting, Pa. "I've been in practice for 30 years, and I've never seen such a mess," Michel Dubois, director of the New York University Pain Management Center, told the Associated Press.

Tuesday, the FDA announced it would be establishing an independent drug-safety oversight board to help ensure the safety of drugs already in the marketplace. A number of critics had been calling for such a step as part of revamping the FDA.

"Dr. Lester Crawford is an outstanding choice for Commissioner of the Food and Drug Administration," said Mike Leavitt, Secretary of Health and Human Services, in announcing the nomination Monday. "Dr. Crawford has dedicated his career to advancing the nation's public health and will lead the way as we enter a new era of individualized medicine and rapidly developing science. With Dr. Crawford's leadership, the FDA will provide the world's safest drugs and empower citizens with the tools they need to make informed choices about their health."

Crawford's background is in veterinary medicine and pharmacology. Before joining the FDA he worked in the food industry for the National Food Processors Association.

Among the topics likely to be discussed at his Senate hearing is the FDA's proposed budget. Though overall funding would increase about 4.5 percent under the president's budget proposal, the plan also calls for the FDA to cut the number of inspections of food-processing plants, blood banks, and foreign drug plants, USA Today reported Tuesday. New funding would be put into fighting bioterrorism and establishing the drug-safety office.

Material from wire services was used in this report.

source: http://www.csmonitor.com/2005/0216/p02s01-uspo.htm 1may2006