Gottlieb Challenges Manufacturers to Make Processes More Efficient

Each year, the pharmaceutical industry spends about $120 billion dollars on research and development. This spending has resulted in the discovery of many new and innovative drug molecules. “That’s the good news,” said Scott Gottlieb, deputy commissioner for medical and scientific affairs at the US Food and Drug Administration (Rockville, MD, www.fda.gov) in his keynote address on the final day of Interphex. “The bad news is that the molecules aren’t coming out of the pipeline fast enough….For the amount of money we’re spending, it’s not flowing out the other end.”

There are “significant bottlenecks” in the drug pipeline, said Gottlieb. Holdups in the process include no framework for incorporating new science tools into the drug regulatory process; risks that FDA and industry sponsors are required to take to implement new tools; and approaches to regulation based on tradition, which doesn’t allow for innovation.

To help drugs come to market quicker, FDA recently announced updates to its Critical Path Initiative, which included a list of 75 methods to improve clinical trials and a new consortium of eight pharmaceutical companies that will work with FDA to improve the drug development processes.

Gottlieb also pointed out that the manufacturing industry has not received a lot of attention to facilitate advances in new technologies, though innovation in this area has the potential to help lower drug costs, eliminate drug impurities, and help bring new treatments to market faster. To improve manufacturing processes, he suggested that the relationship between quality, safety, and efficiency must be better understood. In addition, processes must be modernized with analytical tools, particularly process analytical technology. Hand-in-hand with these issues, the industry must overcome regulatory hesitancy and uncertainty and ask the questions that must be asked. 

Questions were raised about the tradeoff between speed to market and consumer safety if drugs are discovered, developed, manufactured, and brought to market faster. Gottlieb suggested that we need to focus efforts on obtaining postmarket data to get information about side effects before they become catastrophic. He suggested that a more active monitoring system that closely tracks patients taking new drugs would be a good way to collect data. Gottlieb admitted, though, that such a system would be difficult to implement.