Drug Safety = New Drug Review

FDA’s “Safety First” initiative imagined a world in which different agency offices (and two in particular) would be able to easily resolve disputes over regulatory policy. So unlike past practice, experts in one area (say, drug safety) would be on equal footing with experts in other areas (say, drug review).

Center for Drugs Evaluation & Research director Janet Woodcock discussed this, among other topics, during a recent interview with The RPM Report. The solution to tension between offices like the Office of New Drugs and the Office of Surveillance & Epidemiology, she said, was ensuring that drug safety was as important—if not more so—than approving new drugs.

More than that, “Safety First” relies on the “expertise model,” Woodcock said. “I want the experts to be advising me or making decisions in the Center on whatever matters they’re expert in”—whether that’s chemists deciding how to make the product, or compliance experts ensuring that people are following the law. And, she said, “I want OSE to be expert in pharmacovigilance and medication errors.”

Given the comments made at a recent public meeting on the brand name approval process, it looks like the implementation of “Safety First” is going quite swimmingly.

FDA called the meeting to consider a new way to review proposed proprietary brand names for new products by transferring the responsibility for testing for potential medication errors over the drug sponsors. (You can check out our earlier blog post on that meeting here.)

Right now, not only is industry facing high rejection rates for proposed names, but last-minute rejections that can lead to the classic “train wreck” scenario. In the worst case, the pre-approval testing process misses problems with look-alike/sound-alike drugs, leading to medication errors. In those circumstances, it’s not uncommon for FDA to ask a manufacturer to change a product’s name after launch—the worst nightmare for marketing execs.

During the meeting, Mike Cohen, the president of the Institute for Safe Medication Practices, expressed concern that disagreements between OSE and OND about the approval of drugs names would continue to hinder the process. Cohen specifically pointed to GSK/Reliant Pharmaceutical’s fish oil Omacor (which went through a post-approval name change to Lovaza) and asked whether that situation could happen again under FDA’s proposed review process for proprietary brand names.

The answer, according to OSE director Gerald Dal Pan, is no. And here's why: “Some of you might have heard that Dr. Woodcock announced a ‘Safety First’ initiative. One of the features of that is that our office, the Office of Surveillance and Epidemiology...will have an equal voice with the Office of New Drugs.”

In the past, Dal Pan acknowledged, the drug safety office had more of a “consultative role where our opinions could be accepted or rejected.” That, he said, “is changing to one of an equal voice and equal role where we will have to work these things out. We’re also working out for our office...to really take the full lead in this area of proprietary name review as well as other aspects of the error prevention review.”

For drug sponsors, it’s something to watch. Under “Safety First,” the rules have changed. No longer is the Office of New Drugs calling all the shots—and the brand name review process is only the latest example. We're on the prowl for other examples of how FDA is implementing “Safety First.” We'd love to hear from you—send them our way.

(Ying/yang photo courtesy of Flickr user Paddl via a creative commons license.)