- The Washington Times - Tuesday, September 9, 2003

Despite the sense of national urgency after September 11 and the anthraxmailings, biotechnology companies working on defense and homeland security products are still finding the government funding process cumbersome and slow, with no guarantees that products that work will find a buyer.

“The trouble for small biotech companies is the uncertain commitment and uncertain price,” says Dr. Una Ryan, president and CEO of AVANT Immunotherapeutics, a Needham, Mass.-based biotech company developing biodefense vaccines.

Avant is one of only a handful of biotech companies to have negotiated the multi-agency thicket to win federal funding and contracts over the last two years. Most of the more than 300 companies that reported in the fall of 2001 having products or technologies that could be useful for defense and homeland security, are still waiting. Meanwhile, dozens of experimental drugs, vaccines and other technologies with potential to counter biological and other weapons are stalled between promising lab results and animal or human testing.

This, despite the tremendous need to move forward rapidly on developing biodefense products designed for military use and/or to diagnose, protect against or treat illness resulting from a biological, chemical or nuclear attack.

As President Bush said at the Biotechnology Industry Organization’s convention in June, “The biotechnology industry finds itself on the front lines of some of the great challenges of our time. The first challenge is the need to fight terror.”

The president is not alone in his enthusiasm. Over the past two years, biodefense conferences have been standing-room-only, packed with defense, homeland security and federal health officials eager to bring to the anti-terrorism mission the same technologies that in two decades have brought to market more than 160 new medicines, many of them for previously untreatable disorders.

That’s why Congress needs to pass the $6 billion BioShield initiative this fall. The program would establish new pathways, both for R&D; funding and procurement of products that succeed in testing and earn FDA approval. The legislation also would allow expedited FDA approval during an emergency.

The problem clearly isn’t that that biotech companies can’t see product development through to the finish line. The industry has shown it can deliver vital medical advances if markets support the hundreds of millions of dollars’ worth of investment it takes to develop, test and launch each new medicine or vaccine.

For widespread disorders like depression, high blood pressure and diabetes, the markets work. For rare diseases, the incentives of the Orphan Disease Act — notably, support for clinical trials and extended market exclusivity — have augmented market forces to bring more than 200 new medicines to patients.

As with rare diseases, normal market forces alone clearly won’t work for biodefense products.

The tepid response to the government’s smallpox vaccine initiative showed that, in the absence of an imminent threat or a legal requirement (as with vaccinations for school or military service), a small risk of side effects is enough to deter people from getting an inoculation.

And, as we saw with the run on Cipro two years ago, once the threat arrives, everyone wants a biodefense product in large quantities, right now and at a very low cost.

Biodefense clearly must be treated as an ongoing public health and security matter, not as a component of individual health care. It’s up to the federal government to create a procurement structure — as it does with military aircraft, for example — to make product development and production financially viable.

Dozens of biotech companies will likely step forward to compete for funds if the BioShield legislation becomes law. They aren’t entirely sanguine about the terms — liability protections are less than the industry needs, and funding is barred for biodefense products with non-biodefense uses. But biotech executives like Dr. Ryan are eager for the opportunity to show that the industry that has done so much to improve personal health care can also contribute to public health and national defense.

Congress this fall faces a full agenda that includes passing a final Medicare prescription drug coverage bill, dealing with a raft of issues arising from the Iraq occupation and passing a comprehensive energy bill. Although BioShield is not as alluring at the moment as the electric power grid, it must be a high priority on that agenda. As Mr. Bush said in June, “The message is clear: for the sake of our national security, the United States Congress must pass the BioShield legislation as soon as possible.”

Carl B. Feldbaum is president of the Biotechnology Industry Organization.



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