THE BIOTECH BOTTLENECK
December 28, 2007
The United States has the world's strongest biotech industry. But research breakthroughs and drugs in the pipeline are not getting through to the market fast enough, says Dr. Richard Miller, president and CEO of Pharmacyclics and adjunct professor of oncology at Stanford University Medical Center.
Take pancreatic cancer, for example:
- Only two drugs have ever been approved to treat this deadly condition, and only one new drug has been approved in the last 11 years.
- Yet it is one of the most lethal forms of cancer, and the nation's fourth most common cause of death from cancer.
- This year, 37,000 Americans will be diagnosed, and three-fourths of them will die from the disease within 12 months of their diagnosis; only 5 percent are alive at five years.
One of the main problems is that the Food and Drug Administration (FDA) is stifling, rather than encouraging, investments in innovation through cumbersome and overly restrictive policies. To crack through this pessimism, we need focused collaboration between government, business and academia, says Miller:
- For starters, the FDA should utilize the Accelerated Approval regulations as they were originally intended when they came into effect in 1992.
- This will allow for conditional approval of promising drugs based on the use of surrogate endpoints, which are endpoints requiring shorter-term patient follow-up but are reasonably likely to predict clinical benefit.
- Faster approvals from smaller, earlier-stage trials will provide an incentive for both the private sector and academia to test more ideas and products while larger confirmatory trials are conducted.
We should also ramp up the newly created Reagan-Udall Foundation, authorized by Congress as part of the FDA Amendments Act of 2007 to develop new research tools and techniques that will be available to the entire scientific community, address gross inefficiencies in our drug-development process, modernize product evaluation, and streamline the "critical path" drugs travel from discovery to market.
Source: Richard Miller, "The Biotech Bottleneck," Wall Street Journal, December 28, 2007.
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