The FDA believes it can simplify the process by which companies file applications for combination products by expanding regulatory definitions in that area.
The move toward streamlining many of its regulatory procedures grew out of the 18-month tenure of former Commissioner Mark McClellan, who introduced the critical path initiative, a plan designed to help companies journey through the FDA maze quickly and with few setbacks. McClellan now serves as administrator of the Centers for Medicare and Medicaid Services. (See BioWorld Today, April 16, 2004, and April 19, 2004.)
Meanwhile, the FDA recently published a proposed rule dealing with how it proposes to assign a lead center (for example, center for biologics, drugs or medical devices) with responsibility for premarket review and regulation of a combination product.
The proposal, available on the agency's website at www.fda.gov, recommends codifying the definition of "primary mode of action" (PMOA), the criterion the FDA has used for more than a decade when assigning combination products to a particular center for review. Also the agency believes it can speed the assignment process by giving companies better instructions on defining a PMOA.
Under the proposal, the primary mode of action would be defined as "the single mode of action (drug, device, biological product) of a combination product that provides the most important therapeutic action of the combination product."
The FDA said combination products - those containing a combination of a drug, a device, or a biological product - represent a growing category that incorporates cutting-edge technologies that hold promise for advancing patient care. Products, such as drug-eluting stents (which combine a drug with a medical device) and orthopedic implants with genetically engineered human protein and antibiotic bone cement, often do not fit neatly into traditional categories of FDA-regulated items.
The agency will be accepting comments on the proposal through July 5.
Democrats Introduce Bioterror Bill, Report
Democrats are taking credit for introducing a bill that would reduce the timelines for developing new cures to potential biological threats facing the U.S.
Rep. Jim Turner (D-Texas), a physician and ranking member of the House Select Committee on Homeland Security and Committee Democrats, introduced legislation called the "Rapid Pathogen Identification to the Delivery of Cures" Act (also called Rapid Cures Act) to help the medical and research community quickly turn science into cures, a statement from Turner's office said.
The Rapid Cures Act would require an end-to-end assessment of the drug development process in order to reduce the time from "bug" to "drug" from years to months, and it would require an inventory of existing technologies to determine how they could be used to shorten the process for finding cures for infectious diseases.
Turner's bill was accompanied by a report, "Beyond Anthrax: Confronting the Future Biological Weapons Threat," which describes the existing and future national security challenges posed by biological weapons produced with the application of advanced biotechnologies.
In his statement, Turner said, "We need a Manhattan Project to help win the war on terror."
Meanwhile, word around Washington indicates that the Senate is poised to pass the long-awaited Project BioShield before the Memorial Day recess scheduled to begin later this week.
Project BioShield is the Bush administration's plan to speed development and availability of medical countermeasures in response to current threats. It is designed to streamline government research, create incentives for companies and give the government the ability to make products widely available in a public emergency.
BioShield would guarantee a market for firms that successfully develop countermeasures.
The House version, which passed last summer in a 421-2 vote, allocates $5.6 billion over 10 years for the project. While the Senate version has yet to pass, this year's budget has allocated $890 million. (See BioWorld Today, July 23, 2003.)
Bill Encourages Growth In Biotech Industry
Sen. Kit Bond (R-Mo.) introduced legislation that would help more of the biotechnology industry gain access to Small Business Innovation Research (SBIR) grants.
The legislation would allow biotechnology companies that are majority owned by venture capitalists to win SBIR grants.
Traditionally, to qualify for an SBIR grant, 51 percent of the business had to be owned by one or more "individuals," and the company could employ no more than 500 people.
At issue is the definition of "individuals." The Small Business Administration recently determined that "individuals" are "natural persons," therefore the law excluded firms that were mostly owned by venture capital companies.
Rep. Samuel Graves (R-Mo.) in April introduced similar legislation in the House. (See BioWorld Today, April 12, 2004.)