Science  14 Nov 1997:
Vol. 278, Issue 5341, pp. 1215

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  1. Ministers Approve EU Research Overhaul

    Although observers had expected a battle, a meeting this week in Brussels to consider streamlining the European Union's (EU's) flagship research program was a picture of harmony. Science ministers from 15 member states endorsed proposed changes to the Framework 5 program, to be launched in 1999.

    The proposed $18.6 billion budget for the 4-year program means countries will chip in 3% more than they do for the ongoing Framework 4. An “intensification of the research effort at the European level is essential,” says EU research commissioner Edith Cresson. But while the current program focuses on 15 topics, the next one will back projects in just six (Science, 18 April, p. 343): biology and the environment; information technology; sustainable growth; and three topics to improve research coordination among EU scientists and industry.

    Ministers also endorsed the idea of revamping the program's bureaucracy. For example, the EU wants to put decisions about funding individual proposals in the hands of managers rather than program committees and set time limits on the grant review process. Given rumblings of dissent before the meeting, says a British science official, “I was surprised by the level of agreement.” The final plan is expected next spring.

  2. Landmark FDA Reform Bill Passed

    Drug and biotech companies tasted sweet victory this week when Congress put its stamp of approval on a bill to overhaul the Food and Drug Administration (FDA). President Clinton is expected to sign the bill as early as next week.

    The bill will speed FDA's review of potential drugs by requiring the agency to work closely with industry to design clinical trials—a step that could allow a candidate drug to be tested in just one trial. The measure also mandates that FDA give an expedited review to applications for potential life-saving drugs. And it extends for 5 years a popular program that allows FDA to hire additional review staff from fees that accompany a new drug application; these “user fees” have helped shave the time for new drug approvals since 1992.

    At the height of the Republican revolution 2 years ago, some critics wanted FDA to farm out drug reviews and abolish most of its in-house research. The bill that finally emerged, however, leaves FDA's research structure untouched (Science, 19 September, p. 1751), and third-party reviews are an option only for relatively innocuous medical devices. As long as the new policies are “not delaying drugs,” says Biotechnology Industry Organization executive director Carl Feldbaum, “there's no argument here.”

  3. Suit Threatens Internet Upgrade

    The National Science Foundation's (NSF's) plans to spend a windfall in Internet fees on improving the Net have hit a roadblock: a class-action lawsuit arguing that NSF had no right to levy the fees.

    The suit, filed last month by the Washington, D.C., law firm of Bode & Beckman, argues that NSF had no authority in 1995 to allow a contractor—Network Solutions Inc.—to collect an annual $50 registration fee from organizations holding Internet addresses ending with .org, .com, or .net. (E-mail addresses end in these “domain names.”) This fall, Congress decided to use $23 million from these fees to pay NSF's share of the multiagency, $100-million-a-year Next Generation Internet initiative (Science, 3 October, p. 23). The suit—brought on behalf of any person or group that has paid the registration fee—claims that the money represents “an unconstitutional tax” on Internet users and should be returned.

    William Bode says he may seek a preliminary injunction from the federal district court to block NSF's use of the money. But meanwhile, say NSF officials, the Justice Department has reviewed the suit and given them the green light to solicit proposals on ways to upgrade the Internet.

  4. Clinical Research Panel Advises Fine-Tuning

    Clinical researchers hoping for a blue-ribbon panel to deliver them from a litany of problems they say they face at the National Institutes of Health (NIH) shouldn't hold their breath: According to a preview last week of the panel's report, NIH already gives clinical research a pretty fair shake.

    NIH director Harold Varmus convened the panel 2 years ago after a similar group had found much amiss at NIH, including a perceived bias against clinical proposals in peer review (Science, 27 January 1995, p. 448). The panel, chaired by David Nathan of the Dana-Farber Cancer Institute in Boston, came to different conclusions. At a 7 November meeting, the panel stated that funding for clinical research amounts to almost 40% of NIH's pot—a sum that's “not unreasonable,” said panelist Judith Swain of Stanford University.

    Moreover, Swain said, the odds of winning a grant are about equal for M.D.s and Ph.D.s. What bias there is, says Nathan, can be remedied with “minor adjustments,” such as routing proposals to NIH panels that review clinical proposals regularly. The real problem, Nathan says, is that fewer M.D.s are applying for grants: only about 550 last year, down from 800 or so 4 years ago.

    To boost those numbers, the committee plans to recommend that NIH set aside grant funds specifically for young and midcareer clinical researchers and bring more med students to its campus for research stints.

    But clinical research advocates aren't appeased. They're pinning their hopes on bills introduced last week in Congress that endorse the more aggressive recommendations from the earlier panel's report—such as having NIH set up separate review sections for clinical proposals. Legislators won't take up the bills until next year. In the meantime, the Nathan panel plans to deliver its report to Varmus next month.

  5. Congress Keeps Brookhaven in Limbo

    Department of Energy (DOE) managers were hoping to choose a new contractor to run Brookhaven National Lab this month, but Congress has littered DOE's path with red tape that may postpone the award until next year. That, in turn, could delay a decision to restart the lab's High-Flux Beam Reactor (HFBR), a machine used by neutron researchers that remains closed due to a tritium leak.

    DOE fired Brookhaven's longtime manager, Associated Universities Inc., in May due to the leak and other problems at the Upton, New York, facility. DOE wants another nonprofit with good academic ties to be the new operator. But buried in DOE's 1998 funding law is a provision requiring the agency, if it restricts the competition to nonprofits, to give Congress 60 days' notice before making an award, estimated at $400 million a year.

    Energy Secretary Federico Peña complained to lawmakers in a 4 November letter that DOE could have made its mid-November target date for the award, adding that a contractor should be selected “as soon as possible” to tackle the lab's problems. DOE officials hope Congress will let them bypass the 60-day requirement.

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