Washington Editor

WASHINGTON - Newly named acting FDA Commissioner Andrew von Eschenbach temporarily has dropped his post atop the National Cancer Institute as he takes over the reins at the federal regulatory agency. He also has said he would recuse himself from FDA work that could be a conflict of interest.

His decision to depart as NCI director came after high-level criticism surfaced over his initial plan to manage both, with public displeasure voiced by Sens. Edward Kennedy (D-Mass.) and Barbara Mikulski (D-Md.). Both sit on the Senate Committee on Health, Education, Labor and Pensions (HELP), which oversees the FDA. In a letter to the secretary of the Department of Health and Human Services, Michael Leavitt, Mikulski said she had "significant yellow flashing lights about the appointment of an acting commissioner who would only work part time at the FDA."

While she and Kennedy have since said they are encouraged by von Eschenbach's decision to work solely as the FDA's head, they also expressed displeasure with his interim status in that position. Mikulski's letter to Leavitt noted that it "is important to have a full-time, permanent FDA commissioner who is competent and has no conflict of interest."

Similarly, Kennedy issued a statement saying that von Eschenbach's decision "does not go far enough." He added that by taking on the acting commissioner role while temporarily suspending management at the NCI "means that key health priorities important to the American people will lose out - either drug safety or cancer research or both."

Amid such criticism of von Eschenbach, there has been a continued flap over his FDA predecessor, Lester Crawford. Kennedy and Sen. Mike Enzi (R-Wyo.), who heads the HELP committee, have called for a formal government investigation of Crawford's surprise departure of less than two weeks ago. The lawmakers also have questioned the thoroughness of the White House administration's vetting process. (See BioWorld Today, Sept. 27, 2005.)

There have been allegations that Crawford failed to disclose financial conflicts of interest; and of course, his tenure as the FDA's top dog included various controversies such as safety oversight issues, the agency's failure to act on an application for over-the-counter use of the prescription-only Plan B contraceptive product, last year's flu vaccine shortage and even unfounded accusations of an extramarital affair with a female staffer.

But the financial conflict charges are drawing the most attention, though Crawford has publicly denied any such wrongdoing.

Still, a range of questions remain in the wake of his hasty departure, just two months after finally receiving Senate confirmation, prompting the inquiries. (See BioWorld Today, July 20, 2005.)

NIH Metes Out New Research Grants

With the federal government into its new fiscal year, the National Institutes of Health has parceled out fresh funding to a range of research efforts.

Notable among its recent awards is a $16.1 million grant to fund a National Stem Cell Bank over four years. Presented to the WiCell Research Institute in Wisconsin, the site is being established to consolidate many of the federally funded eligible human embryonic stem cell lines in a single location, reduce the costs that researchers have to pay for the cells and maintain quality control over them. In a related grant, the NIH awarded a total of $9.6 million to fund two new Centers of Excellence in Translational Human Stem Cell Research at the University of California, Davis and Northwestern University in Chicago.

Among other grants, the National Heart, Lung, and Blood Institute awarded the first three grants in a new research program on cell-based therapy of heart, lung and blood diseases.

The $6.5 million program will involve both basic and clinical research, but is heavily focused on clinical applications of cell-based therapy. Funding was awarded to Baylor College of Medicine in Houston, Johns Hopkins University in Baltimore, and Massachusetts General Hospital in Boston. The program will be coordinated by Emmes Corp. in Rockville, Md.

In a biodefense-related grant, Dynport Vaccine Co. LLC in Frederick, Md., is one of two recipients of $60 million in total funding for research to identify and evaluate new tularemia vaccine candidates. Trace amounts of the bacterial disease were recently detected on the national mall here, though government officials have said the occurrence was not likely borne of malicious intent but rather of a natural source.

Lastly, Deltagen Inc. in San Carlos, Calif., and Lexicon Genetics Inc. in The Woodlands, Texas, will provide the NIH and its partners with access to extensively characterized lines of knockout mice to provide models for studying human disease and lay the groundwork for a public, genome-wide library of such mice. In the first year of the contract, the NIH said it would spend about $10 million to acquire about 250 lines of knockout mice.

FDA Issues New Drug Safety Alarms

In the past week, the agency has sounded the bell on a couple of products, Menactra (from Sanofi Pasteur) and Strattera (atomoxetine, from Eli Lilly and Co.).

The FDA and Centers for Disease Control and Prevention notified the public of five reports of the neurological disorder Guillain Barre Syndrome following administration of Menactra, a meningococcal conjugate vaccine A, C, Y, and W135. The agencies noted, though, that it remains unclear whether these cases were caused by the vaccine or are coincidental.

The FDA also directed Lilly to add a boxed warning and additional warning statements that alert health care providers of an increased risk of suicidal thinking in children and adolescents being treated with Strattera, a product approved for attention deficit hyperactivity disorder.

$4B Shot In The Arm For Avian Flu

The Senate voted to allocate $4 billion to stockpile antivirals and other medicines in case of an avian flu-caused pandemic, with about three-quarters of the funding tabbed for acquiring Tamiflu (oseltamivir, from F. Hoffmann-La Roche Ltd.). At present, the federal government's supply of that drug is sufficient for only a few million people, far fewer than officials would like to have on hand. The appropriation was attached to a military funding bill, though there is no certainty that the avian flu provision would pass a vote in the House of Representatives.