Washington Editor

WASHINGTON - The National Institutes of Health could get shaken up if a recent reshuffling proposal moves through Congress.

The matter arose last week at a hearing of the House Energy and Commerce Committee, whose chairman, Rep. Joe Barton (R-Texas), said reauthorizing the NIH is a "very high priority for me. We've doubled the agency's budget but have not done anything to improve management."

His proposed legislation, which would amount to the first NIH reauthorization bill since 1993, is designed for better coordinated medical research and streamlined reporting requirements by way of a biennial report that lays out the agency's plans and research activities. The committee has circulated a discussion draft of the proposal, and at the hearing, NIH Director Elias Zerhouni indicated that he would be on board with some of the changes.

"The landscape has changed over the past 12 years and we need to adapt," he said, also endorsing a provision to give the NIH director more power to fund strategic research initiatives or emergency response needs. "The committee concept is a good one."

Also part of the proposal is greater overall fiscal flexibility for the director, allowing him to direct funds among the 27 institutes and centers as opposed to relying on the federal budget process. The bill also would rearrange the NIH's 27 institutes and centers into two categories - mission-specific institutes and science-enabling institutes, and establish a Division of Program Coordination, Planning, and Strategic Initiatives in the Office of the Director.

Natrecor Subject Of Federal Investigation

Scios Inc.'s Natrecor (nesiritide) has caught the attention of U.S. Attorney's office in Boston, which has subpoenaed documents related to the drug's sales and marketing.

Earlier this year, the drug s label was changed to include additional data on mortality, though the FDA acknowledged that such conclusions are difficult. The revision followed the publication of studies on risks related to death and worsened renal function. A recombinant form of B-type natriuretic peptide (BNP), a hormone secreted by the heart in response to heart failure, Natrecor received the agency s approval four years ago for acutely decompensated congestive heart failure patients who have dyspnea at rest or with minimal activity.

Fremont, Calif.-based Scios recently convened a panel of cardiologists and heart failure clinicians, which suggested the company conduct several clinical trials, including a large study of clinical outcomes to further assess Natrecor s benefits and risks. The panel also encouraged the company and outside investigators to continue enrolling patients in current trials and additional planned studies to further add to its body of knowledge.

Notably, panel members also agreed that the drug's use should be strictly limited to patients presenting at the hospital with acutely decompensated congestive heart failure who have dyspnea at rest, as were the patients in the largest trial that led to its approval. Also, they said Natrecor should not be used to replace diuretics, nor for intermittent outpatient infusion, for scheduled repetitive use, to improve renal function or to enhance diuresis.

The FDA said it remains confident that the drug is safe and effective when used as recommended to treat patients indicated in its label. Scios, a Johnson & Johnson company, is cooperating with the subpoena.

Johnson & Johnson, of New Brunswick, N.J., recently acquired European rights to the drug from GlaxoSmithKline plc, of London. Janssen-Cilag, also a Johnson & Johnson company, will market the product in Europe, where it is called Noratak. Financial terms were not disclosed.

FDA Warns On Biologic For Psoriasis

The agency and Genentech Inc. revised Raptiva's label in the warnings and adverse reactions sections, as well as in the patient information sheet, about reports of immune-mediated hemolytic anemia and warnings regarding post-marketing reports of thrombocytopenia and serious infections.

Raptiva (efalizumab) is indicated for adult patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Health care professionals and patients were informed of risks of thrombocytopenia and infections such as necrotizing fasciitis, tuberculous pneumonia, bacterial sepsis with seeding of distant sites, severe pneumonia with neutropenia, and worsening of infection (for example, cellulites and pneumonia) despite antimicrobial treatment.

Genentech, of South San Francisco, received approval for Raptiva early last year. It is partnered with XOMA Ltd., of Berkeley, Calif.

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