FDA 'Path' to streamline drug development could improve quality

May 1, 2006

NATIONAL REPORTS-As part of its Critical Path initiative, FDAhas released a list of 76 high-priority research projects designedto modernize and advance medical product development. Thisprogram's goal is to bring medical innovations to patients quickerand at a lower cost.

NATIONAL REPORTS-As part of its Critical Path initiative, FDA has released a list of 76 high-priority research projects designed to modernize and advance medical product development. This program's goal is to bring medical innovations to patients quicker and at a lower cost.

"The goal of the initiative is to facilitate and catalyze a national effort to improve the scientific evaluative tests used to assess investigational medical products," an FDA spokesperson tells MHE.

According to an http://fdanews.com/ report, FDA is seeking $5.9 million in federal funding to fully support the Critical Path, with negotiations in Congress expected to pick up this month or in June. FDA also hopes to stimulate industry and others to make their own investments in modernizing the product development sciences.

This report demonstrated FDA's commitment to modernize the drug/device development and approval process, says Anthony Staresinic, clinical coordinator of drug information for Navitus Health Solutions, a Wisconsin-based pharmacy benefits management company. "The success of this vision relies on the close collaboration among academia, industry and government. If successful in all aspects, the Critical Path innovations could help control rising healthcare costs. The impact on insurers is uncertain because their viewpoint was not documented in the current report."

This effort to streamline drug development comes at a time when more than nine out of 10 experimental drugs tested on humans have failed, says Staresinic. "Many of the proposed innovations have yet to be developed," he says. "The time-line for many of the listed proposals is five, 10 or even 20 years away. For example, the FDA emphasizes greater reliance on surrogate markers for product approval; the science behind many of these is in the infancy stage and is technically complex."

MEDICAL SCIENTIFIC ASPECTS

Managed care executives may need to consider bolstering their medical scientific departments through training or hiring talent that is able to interpret these new outcome measures and place the results in relative context to comparative therapies, advises Staresinic.

"The major deficiency of the report is a lack of specification of alternatives to cost-benefit analyses," he says. "Formulary decision making and plan benefit design is complicated by the fact that new products using the surrogate markers of safety and efficacy will be compared with drugs and products already on the market that do not possess such data. There may be little financial incentive to pharmaceutical companies to invest in drugs approaching the end of their product life cycle."