Forecasts For PDUFA, FDA "Improvement" Bill

Money is the key to future US Food and Drug Administration activities,Center for Drug Evaluation and Research director Janet Woodcock told the Food and Drug Law Institute's annual Pharmaceutical Update. Publication of rules, policies, guidances, etc, plus further FDA improvement (new buzzword instead of "reform") will depend on the outcome of talks on the budget as well the Prescription Drug User Fee Act extension and FDA reform.

One of the FDA's four goals is streamlining the regulatory system; the other three goals are supportive of this, she said. With drug industry globalization, the FDA has had to take a world view, and the international arena will grow in importance for it. Many topics are now completed due to the lead-up to July's International Conference on Harmonization, and the FDA's new adverse reaction reporting system, starting this fall, is built on ICH's reporting system. Expedited and periodic ADRs will be harmonized, as will formats for regulatory transmissions. Data will be available under the Freedom of Information Act, she said, with the public able to search the database by computer rather than having to make written requests. Terminology for international ADR reporting and maintenance is still up in the air.

Possible new ICH topics include a Commercial Technical Dossier, and also of interest are Good Manufacturing Practice agreements, but the FDA's ability to support this effort will be driven by resources. The Mutual Recognition Agreements with the European Union on GMP inspections are still under discussion, with any agreement probably leading to a phase of validation to understand worldwide practices, said Dr Woodcock.