Drug Approval Process A Challenge To Manage

By Rob Wright, Chief Editor, Life Science Leader magazine

In the United States, the drug submission approval, and review process is very complicated, with many facets, including manufacturing, preclinical, clinical, and safety. Dr. Paul Chew should know, as he is the chief science officer (CSO) and chief medical officer (CMO) for Sanofi U.S. "When an application goes to the FDA," Chew explains, "and it's accepted, it's the divided up to be reviewed by different divisions." In essence, the drug's dossier ends up being split up into many pieces which undergo simultaneous review. He continues, "Because of the different review divisions, they go at different speeds, and they may have different questions at different times."

Those questions that come late in the process can be very limiting. Chew would like to see the review process improved and has several suggestions on what could be done. To start, he thinks better coordination and more frequent communication and meetings between the submitting company and the FDA starting prior to the submission of the IND and continuing throughout the clinical trial and submission process, would help both entities through the complexity of a dossier submission.

"The FDA would be the first to admit that it is difficult to meet some of the timelines for review that they set for themselves," he says. So how can you speed up the review process without compromising on patient safety?

"I think what is needed is for a partnership between industry and the FDA," advocates Chew. Greater global connectivity of databases involving millions of lives allows for the possibility of a greater degree of precision when looking at drug safety. Partnering with the FDA would allow for common access and shared methods of analyses to understand the real world safety of products once they have been released. Chew explains that when a dossier is submitted, 90% of the time it involves less than 10,000 patients. A rare safety event that could be serious may not be detectable in 10,000 patients. By collaborating together, the company and the FDA can develop a common language surveillance program on how to evaluate signals, if and when they come up.