PhRMA Seeks Route To Prevention Therapies Along FDA’s “Critical Path”

Development of prevention therapies should be included in FDA's Critical Path initiative, the Pharmaceutical Research & Manufacturers of America said.

PhRMA recommends FDA create a task force with members from industry to advocate the development of prevention therapies in comments on FDA's Critical Path initiative.

"Encouraging the development of medicines for use in primary prevention of disease is an important public health objective," ¹ PhRMA's comments say.

"A joint industry-FDA task force could both recommend policies to accelerate the development of new prevention-oriented drugs and also suggest means to harmonize review center practices specific to prevention therapies."

FDA created the Critical Path initiative in response to a slowing pharmaceutical pipeline across the industry. The goal of the program is to foster drug development by creating tools to simplify drug discovery (² (Also see "FDA Will Fund Research On “Critical Path” Of Drug Development" - Pink Sheet, 22 Mar, 2004.), p. 30).

FDA established a docket to collect comments on the Critical Path initiative in April; the comment period ended July 30.

The agency, however, said that comments submitted after the deadline likely will be reviewed before it assembles a critical path opportunity list, which is due in the fall.

PhRMA's comments also touch on consistency between FDA review divisions and the Division of Drug Marketing, Advertising & Communications on labeling language and promotion.

"Particular attention should go to maintaining consistency between FDA review division and...DDMAC product promotion policies to encourage development of new drugs and exploration of new indications," PhRMA's comments state.

DDMAC's position on the promotion of prevention therapies was the impetus for the comment, PhRMA said. DDMAC has set a high standard for promotion of prevention indications.

PhRMA and BIO suggested the critical path initiative be secondary to FDA's regulatory responsibilities.

"Critical Path initiatives will undoubtedly yield efficiencies; however this work should not distract FDA staff from their core mission to review new products," PhRMA comments say.

"Regulatory efficiency, quality systems, and GMP initiative goals should not be compromised in pursuit of Critical Path objectives, nor should staff and reviewer training programs," PhRMA said.

BIO agreed: "We urge FDA to place the highest priority on meeting its obligations under the Prescription Drug User Fee Act and the Food & Drug Administration Modernization Act."

"FDA's fulfillment of its user fee goals is crucial in the short-term, to ensure access to new products that are being developed now," ³ BIO's comments say. "We see activities discussed as part of the Critical Path as being valuable over the longer term."

Effective pursuit of the Critical Path would require re-organization of the agency, BIO added.

"More must be done in the area of restructuring, to prepare FDA for a new role as a driver of innovation in addition to its existing regulatory role," BIO's comments state.

BIO and PhRMA also suggested FDA pare down unnecessary Phase IV commitments. "One area in which FDA currently seems to be trading positive movement with negative change is in the area of increasing level and number of required post-marketing commitments," BIO said.

"For every post-marketing commitment a sponsor takes on, there will be a commensurate reduction in the number of early-development projects that can be undertaken. We ask FDA to look closely from a science-based and risk-based perspective at these kinds of trade-offs," BIO stated.

PhRMA suggested the agency develop a process for determining necessary post-marketing studies. "A process for ongoing review by therapeutic area to distinguish necessary Phase IV studies from those that are informative but not required for the safe use of a drug should be considered."

"Absent this process, sponsors can be faced with escalating Phase IV programs with little or no offsetting reduction in the Phase III testing requirements."