FDA Reviews Drug Development

A new report from FDA, released July 16, 2015, takes a look at the drug-development pipeline to determine what causes some diseases to have an abundance of treatment options while others have few. The report states that while FDA has worked to streamline the drug approval process, drug development has not matched the speed of scientific advancements in the past decade.

“When research does not offer answers to important scientific questions, cures cannot be developed. And when viable cures are not in the pipeline, focusing on regulation will not improve the situation, since FDA can only approve therapies with evidence for safety and effectiveness,” Robert Califf, MD, FDA’s Deputy Commissioner for Medical Products and Tobacco, stated in a blog post on FDA.gov. “Once key scientific questions are answered, we can use a variety of tools to reduce the length and cost of initial clinical trials for drug approval for these disease areas, and we can provide guidance to industry including advice on how to develop additional reliable biomarkers.”

Detailed in the report are FDA’s findings on the state of scientific knowledge in regards to Alzheimer’s disease, diabetes, hepatitis C, and rare diseases.  The report also provides FDA’s plans to accelerate drug development in those specific areas including collaborations with research groups to develop biomarkers, suggesting the use of surrogate and intermediate endpoints, working with drug sponsors, and designing flexible clinical trials. 

Source: FDA