Washington Editor

Washington - Two members of the U.S. Senate Thursday met at a roundtable with representatives from the Small Business Administration, the Department of Defense and the biotechnology, defense and aerospace industries to discuss concerns about the Small Business Innovation Research (SBIR) grant program.

Over the coming months, Congress will be drafting legislation to reauthorize the SBIR program, which is set to expire Sept. 30, 2008.

Sen. John Kerry (D-Mass.), chairman of the Senate Small Business and Entrepreneurship Committee, this session attached a provision into a DoD authorization bill to extend the SBIR program. However, it is unclear whether that measure will pass this year as part of the DOD bill's final legislation, according to a spokesperson for the Biotechnology Industry Organization (BIO).

The SBIR program was created in 1982 under the Small Business Innovation Development Act to provide competitive grants to small businesses in the U.S. to encourage exploration of new technologies.

The program requires the 11 participating government agencies, including the National Institutes of Health, to set aside a portion of their research and development funds for awards to small businesses.

Of most concern to the biotech industry is a change made in 2003 by the SBA, which oversees the SBIR program, disqualifying for grants any firms with venture-capital investment greater than 50 percent.

The grant restrictions imposed by the SBA have been a detriment to small biotechnology firms' ability to move forward on experimental technologies, the biotech industry has argued.

Biotechnology firms are hoping a bill passed last month by the House, H.R. 3567, will restore the original SBIR eligibility criteria and again permit small firms that are majority backed by venture capital companies to qualify for the grants. A companion bill has yet to be introduced in the Senate.

Alan Eisenberg, BIO's executive vice president for emerging companies and business development, said the roundtable, which was attended by Sens. Kerry and Jon Tester (D-Mont.) and Senate committee staff, was an "open and productive" meeting.

"They are trying to understand what are ways that the program can be improved or adjusted to deal with issues that have been brought up," Eisenberg said. "There were certainly strong desires expressed by many of the participants to try to achieve common ground. We are pleased with that, and look forward to working with the committee."

Also on Thursday, 52 patient advocacy and medical specialty groups sent a letter to lawmakers urging them to restore the original SBIR eligibility criteria in the program's reauthorization legislation.

"The current eligibility guidelines are prohibiting many of the most innovative companies from competing for crucial early state research and development funding, which impacts the future of the research being pursued by universities and the patients that ultimately benefit from new treatments and cures," the groups stated in the letter.

Restrictions On Cold And Cough Medicines Urged

A federal panel of advisors Friday said cold and cough medicines that can be purchased over the counter should not be used in children younger than 6.

Panelists at a joint meeting of the FDA's Pediatric and Nonprescription Drugs Advisory Committees agreed that there is no evidence that the medicines, which are used more than 3.8 billion times a year in children, are safe and effective in the pediatric population. Panelists recommended that more studies of the drugs were needed.

A week before the meeting, the drug industry said it would change the labeling to advise that the drugs should not be used in children younger than 2.

Panelists voted 21 to 1 in favor of banning OTC cold and cough medicines in children younger than 2, and 13 to 9 to prohibit the use of the drugs in children younger than 6.

The panel, however, voted 15 to 7 to allow the drugs in patients older than 6 years.

FDA Letter May Support CMS Anemia Drugs Ruling

Reps. Pete Stark (D-Calif.), chairman of the House Ways and Means Health Subcommittee, and Henry Waxman (D-Calif.), chairman of the House Committee on Oversight and Government Reform, released a letter Oct. 16 from the FDA on the use of erythropoiesis-stimulating agents (ESAs) in the treatment of anemia in cancer patients.

The letter was in response to a request from the two lawmakers seeking an assessment from the FDA about a controversial ruling by the Centers for Medicare & Medicaid Services (CMS) in July on payment for ESAs in cancer therapies.

Under CMS's decision, the government will cover the medications to treat anemia in cancer patients whose hemoglobin levels decrease to less than 10 g/dL.

In March, the FDA issued a black-box warning recommending that practitioners should use the lowest dose necessary to avoid the need for blood transfusions and cautioned against the administration of ESAs to raise patients hemoglobin levels above 12 g/dL.

The letter, signed by Steven Mason, the FDA's acting assistant commissioner for legislation, stated that the agency believes the approved labeling and CMS' National Coverage Decision "are generally consistent in their recommendations regarding the use of ESAs in patients with cancer undergoing chemotherapy."

The FDA letter, Stark said in a statement, "confirms what Amgen and Johnson & Johnson are spending millions of dollars to deny. Medicare's new National Coverage Determination is consistent with the FDA's recommendations and scientific research. Excessive use of ESAs increases the risk of tumor progression in cancer patients. Medicare's action will prevent excessive use and protect patients' lives."

The American Society of Clinical Oncology and the American Society of Hematology are expected to release updated joint guidelines on the use of ESAs shortly.

The groups have urged CMS to reconsider its July decision about payment of ESAs in cancer patients.

Drug-Resistant Staph On The Rise

The federal government Oct. 16 reported that methicillin-resistant Staphylococcus aureus (MRSA) caused more than 94,000 life-threatening infections and nearly 19,000 deaths in the U.S. in 2005.

Most of those infections were associated with health care settings, according to the Centers for Disease Control and Prevention.

About 85 percent of all invasive MRSA infections were associated with health care settings, of which two-thirds surfaced in the community among people who were hospitalized, underwent a medical procedure or resided in a long-term care facility within the previous year. In contrast, about 15 percent of reported infections were considered to be community associated.

However, reports of community-associated MRSA have been on the rise in 2007. Three school-age children recently died of MRSA, and several schools have been closed in the past week while the facilities were disinfected. Maryland's Montgomery County reported at least 14 cases of community-acquired MRSA in school-age children in the past few weeks.

MRSA infections can range from mild skin infections to more severe infections of the bloodstream, lungs and surgical sites.