Rulemaking Process Flawed, But Making Monograph Rules Still Needs Funding

The federal rulemaking process, FDA officials say, is not an ideal framework for staying on top of OTC drug innovations and emerging safety questions. It is the agency's only choice, though, and additional resources are needed to facilitate rulemakings in its monograph drug program.

The monograph program was "instituted really many, many decades ago. We've been trying to implement it since," said Center for Drug Evaluation and Research Director Janet Woodcock in her opening...