Patients, Industry and Lawmakers Seek to End SBA Bureaucratic Roadblock to New Medical Research
In a letter, delivered to the leaders of Congress, the groups call for passage of (S.1263 and H.R. 2943) "Save America's Biotechnology Innovative Research (SABIR) Act," introduced by Sen. Kit Bond (R-MO) and Rep. Sam Graves (R-MO), which restores the eligibility for Small Business Innovation Research (SBIR) funding grants to biotechnology companies. The letter was released at a Capitol Hill press conference sponsored by the Biotechnology Industry Organization (BIO).
"This letter is the voice of millions of individuals facing devastating and chronic diseases whose best chances for new therapies are associated with the type of research that the SBA bureaucracy has blocked," said Jim Greenwood, BIO's president and CEO.
"This legislation is needed to eliminate the regulatory interpretation that is stifling promising research that could improve the health and lives of people living with many diseases including HIV, lupus, diabetes, leukemia, Alzheimer's and West Nile virus," Greenwood added.
Katy Anderson, a Chevy Chase, Md. mother of three who survived cancer due to Rituxan therapy, shared her story at BIO's press conference. Rituxan was developed by IDEC Pharmaceuticals Corp., once a small biotech firm that received several SBIR grants. (IDEC and Biogen Inc. merged in 2003 to create Biogen Idec, Inc.)
"I'm not a politician, research scientist or physician. I'm a cancer survivor who is alive today because of Rituxan," Anderson said.
Rituxan has roots within a small company that needed SBA funding to validate research in order to attract large investments necessary to fund expensive late-stage development costs.
"I support SBA funding that leads to life-saving drugs," Anderson concluded.
Suzanne R. Pattee, vice president of public policy and patient affairs at the Cystic Fibrosis Foundation, said, "We support this legislation so that all small biotech companies will be eligible to apply for SBIR grants from National Institutes of Health (NIH).
"Patients with rare diseases, such as cystic fibrosis, often rely on small biotech companies to develop new treatments to save their lives. If biotech research that is validated by private equity investors support remains ineligible for SBIR grants, promising research will grind to a halt. Patients, not just companies, would suffer the consequences," said Pattee, herself a 42-year-old cystic fibrosis patient.
More than two years ago, Intronn Inc., a Gaithersburg, Md.-based company had to stop development of a cystic fibrosis RNA therapeutic after the government pulled its SBIR funding on learning that the firm had venture capital backing.
"The current SBIR rules hit hardest at small companies that are developing treatments for disease. The American public is best served by letting the experts decide the most innovative new technologies," Dr. Gerard McGarrity, Intronn's president and CEO, said.
In a June 2005 letter to Hector Barreto, SBA administrator, Elias Zerhouni, NIH director, indicated that the eligibility standards are unduly restricting the ability of the NIH to fund high quality, small companies. "As a result, NIH must turn away many deserving applicants, and the goals of the SBIR program are being underminded," Zerhouni said. The NIH awards and administers SBIR grants, while the SBA maintains general oversight of the SBIR program.
Under the SBA's interpretation of eligibility requirements for SBIR grants, companies that are 51 percent owned by a group of private investors no longer qualify. This interpretation is a departure from the eligibility assessment used in the first 21 years of the program. One-third of biotech companies which have brought drugs to market had received SBIR funding at some point.
Most small and emerging biotechnology companies, which are years away from owning revenue-generating drugs or biologics, must look to private equity firms for investments to fund the very high-cost preclinical and clinical research. These small companies are the ones that take risks and develop breakthrough research that leads to revolutionary treatments and therapies.
In a statement, David Duncan, president and CEO of St. Louis-based Chlorogen Inc., said, "It's ironic that when the news is filled with stories of the flu and pandemics, our firm has had to shelve its bio-defense vaccine program which could potentially deliver massive quantities of vaccines against anthrax, cholera and other afflictions. Why? Because under the current rules of SBA, our firm of only 12 employees is no longer a 'small' business," Duncan said.
To watch a video of the press conference, please click http://www.bio.org/news/video/sbir_patients.asx. For more information on the issue, visit BIO's SBIR webpage at http://www.bio.org/tax/sbir/presskit/.
BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and 31 other nations. BIO members are involved in the research and development of healthcare, agricultural, industrial and environmental biotechnology products.