FDA SAYS PDUFA PROPOSAL MAKES DRUG REVIEWS MORE THOROUGH, TRANSPARENT
Recommendations in the latest installment of the Prescription Drug User Fee Act (PDUFA) seek to bulk up the premarket drug approval process, stabilize financing and expedite drug development, FDA officials said at a public hearing last week.
The hearing was called to obtain comments and remarks from industry representatives and other interested parties regarding the federal government's proposed legislation authorizing it to collect user fees from drug manufacturers for the expansion of FDA services and drug reviews.
Enhanced premarket review goals under the PDUFA IV proposal focus on achieving objectives outlined in the agency's guidance for good review management principles/practices. According to John Jenkins, director of the Office of New Drugs, a key goal under the proposed plan calls for the early completion of such primary review activities as:
Labeling discussions with sponsors;
Agreements on any postmarketing study commitments; and
The review of and agreement on any necessary risk management plans, a newly added step to the premarket review process.
Drawing on resources obtained from PDUFA IV, the FDA would further enhance the premarket review process by maintaining current review goals for drug applications and developing a review plan for each application. The plans would include specific target dates for completion of various review activities, Jenkins said.
The agency is proposing to draft new guidance to clarify how the FDA looks at certain critical design issues such as clinical hepatotoxicity, noninferiority trials and adaptive trial designs.
"We need to communicate FDA's guidances and its ideas for best practices in these areas," Jenkins said. For example, new guidance on enriching trial designs would help the drug industry select human subjects better suited for certain clinical trials, he said.
PDUFA must be reauthorized by Oct. 1.