The FDA said it intends to work with drug, biologics and medical device stakeholders to create a new generation of performance standards and predictive tools aimed at providing better and quicker results regarding the safety and effectiveness of investigational products.
In a report released Wednesday, the agency said that despite advances in fields such as genomics, proteomics and nanotechnology, "there has been a downward trend in recent years in the number of innovative medical product applications to the FDA and its counterpart agencies throughout the world."
Indeed, even though the number of new product applications and approvals was somewhat higher in 2003, most new scientific fields have not had a fundamental impact on patient care, the agency said.
The industry has been heavily criticized around Washington for those failings. In an era in which the price of overall health care, including the costs of prescription drugs, is increasing, lawmakers have charged that the industry fails to spend research and development money on breakthrough medicines, instead investing the dollars on sure bets, such as improvements on existing drugs.
Meanwhile, the industry often complains that it is bogged down in regulatory matters and must invest in products that will net a financial return for shareholders.
Whatever the case, FDA Commissioner Mark McClellan and Deputy Commissioner Lester Crawford requested the report, prepared under the leadership of Janet Woodcock, director of the Cross Center Initiatives Taskforce. The Senate last week confirmed McClellan's nomination as administrator of the Centers for Medicare and Medicaid Services. Crawford has been tapped to temporarily run the FDA once McClellan is sworn in to his new post. (See BioWorld Today, March 15, 2004.)
The FDA said the report, titled "Innovation or Stagnation? - Challenge and Opportunity on the Critical Path to New Medical Products," examines medical product development. In other words, it looks at the steps that determine whether and how quickly a medical discovery becomes a reliable treatment for patients. It is available on the agency's website at www.fda.gov.
In conjunction with the industry, academia and other government agencies, the FDA said it will develop the "Critical Path Opportunities List" designed to identify areas that would benefit the most from a modernized path of medical product testing and manufacture.
The agency also says it will make internal changes to help realize some of those opportunities, cautioning that the initiative is not meant as a departure from its proven "best practices" programs.
However, a possible example of new efforts would include developing new animal models for speeding the assessment of safety and effectiveness of next-generation medicines against anthrax, smallpox and other bioterrorist threats.
Under the leadership of Crawford, the agency will hold public workshops and meetings to generate a list of priorities.