Manhattan Project analogies come cheap in Washington, but none is more apt or better deserved than Senate Majority Leader Bill Frist’s call for a “Manhattan Project for the 21st Century” to bolster the nation’s biodefenses.
Terrorist attacks with biological or chemical agents are among the nation’s most dangerous vulnerabilities, to say nothing of possible natural catastrophes like an Avian Flu outbreak. Potentially millions of lives are at stake. In many respects, the federal government should be doing more to encourage biotechs to create the vaccines and countermeasures we need.
That’s why legislation sponsored by Sen. Judd Gregg, New Hampshire Republican, and co-sponsored by Mr. Frist and six Republican colleagues is so urgently needed. The bill, the Biopreparedness Act of 2005, aims to eliminate barriers and build incentives for biotech companies to create better and more vaccines and countermeasures, reduce waste and unnecessary delays in regulatory processes, strengthen government-private sector partnerships and enhance public-health preparedness efforts at the Department of Health and Human Services, the Centers for Disease Control and Prevention and elsewhere.
Many of the proposals seek to eliminate or make less perilous what one Hill staffer calls the “Valley of Death”: the period of time after basic research but before the end of clinical trials, during which the vast majority of failed compounds do their failing. Problems like investor non-confidence and lengthy delays can be lessened by sending clear signals to biotech firms that federal money and support are available for viable products, and that unnecessary thickets of government rules can be cut. In some cases a few changes in HHS and the Department of Homeland Security can accomplish what is needed.
Among the specific proposals: Strengthen patent guarantees to give biotechs greater assurance that products will be profitable; limit liability exposure to lessen investor fears of huge damages; create a limited antitrust exemption for biotechs and pharmaceutical firms cooperating on compounds of critical importance; create a Food and Drug Administration “rapid-action team” to work with manufacturers to solve problems; ensure fast-track reviews for “second generation” vaccines and countermeasures; and enhance disease surveillance and communications with a “biointelligence unit” at the CDC and other efforts. Some of these will be controversial, but Mr. Frist and his cosponsors are to be commended for making them.
The backdrop to all this is the 2004 bioshield law, which has shaped up to be a good (if tardy) start for biodefenses, but one which did little to improve the incentives and reduce the disincentives biotechs face as they prepare vaccines and compounds the country needs. This is in large part what Mr. Frist and his colleagues are setting out to fix.
The alternatives are grim. As Mr. Frist put the question in a speech at Harvard Medical School a month ago to call for the new Manhattan Project: “We will not be able to look away from what could be coming soon — a front of unchecked and virulent epidemics, the potential of which should rise above your every other concern … susceptible of either purposeful or accidental combination, in which case they could be devastating almost beyond imagination.” It’s time to start acting to prevent the dark possibilities Mr. Frist envisions.
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