FDA reforms to speed drug approval

Challenging what he termed "the popular and incorrect notion" that speed in approving new products and ensuring drug safety are opposite virtues, Scott Gottlieb, Deputy Commissioner for Medical and Scientific Affairs at the US Food and Drug Administration, told those attending the BIO CEO meeting (see also pages 24-25) that new processes and new science can make the system more compact and increase the ability to assess safety, while shortening development time and saving money all around.

The drug development process is in a bottleneck, he said, noting that the goals that Prescription Drug User Fee Act sets for review time are usually met, but it is the lengthy and expensive development process prevents drugs from getting to patients. The development process, scientific tools, and benchmarks that are being used were developed years ago, with new tools not being incorporated.

Stagnating drug development