FDA Acting Commissioner Outlines Regulatory Agency’s Four Top Priorities

Acting U.S. Food and Drug Administration (FDA) Commissioner Ned Sharpless emailed agency staff yesterday outlining the FDA’s four main priorities.

The four top priorities are:

1. Assuring public health by using emerging technologies.
2. Investing in the agency’s next-generation workforce and infrastructure.
3. Modernizing frameworks.
4. Promoting and protecting consumer and patient safety.

“We see the promise of technologies like 3D-printed devices, cell-cultured food, cell-based therapeutics and intentional genomic alternations to animals and plants to deliver enormous benefits to public health,” Sharpless wrote. “As these fascinating technologies are developed, however, the FDA will also need to augment its expertise in these areas to afford optimal review and regulation of products derived from cutting-edge technology.”

He did emphasize that hiring more staff is an “immediate priority,” writing, “We will be deploying the 21^st Century Cures hiring authority at much greater scale. Simply put, we need to recruit, develop and retain world-class people, and will be announcing more specific plans in these areas soon.”

The 21st Century Cures Act was passed by Congress in December 2016. Part of the law gives the FDA authority to create its own alternative pay system for specific positions and for the agency’s leadership to set annual salaries up to a maximum of $400,000.

The FDA identified 38 occupations to include in that new pay system, and the new pay structure was based on General Schedule scale and included nine bands.

Part of the problem in this area faced by the FDA was that its average time-to-hire ranged from 150 to 550 days for some positions.

In terms of modernizing frameworks, Sharpless focused on the agency’s efforts to approve generic drugs and biosimilars more quickly in order to lower drug prices. He also said the FDA needed to help the biopharma industry with “the most expensive part of drug discovery and development,” referring to clinical testing.

“To expedite development of effective therapeutics and diagnostics, we will continue to promote the use of innovative clinical trial designs such as platform trials, basket studies, adaptive trials, and pragmatic randomized controlled trials that are more efficient and will lower costs of running trials,” he wrote.

Last week, the FDA held a meeting to discuss real-world data (RWD) and real-world evidence (RWE), which has become something of a priority for the agency.

Back in January, when Scott Gottlieb was still FDA commissioner, he laid out the agency’s new framework for dealing with RWE and RWD. RWD and RWE are collected from electronic health records (EHR), laboratory tests, wearable devices, insurance claims, and potentially even social media.

And not surprisingly, given that it is the primary focus of the FDA, Sharpless said that the agency would strengthen its efforts on patient safety. In particular, he mentioned the FDA’s plans to improve post-market surveillance.

“For instance,” Sharpless wrote, “novel machine learning algorithms can allow us to prioritize international mail inspections to better detect illicit opioid shipments; blockchain can help us track and trace food outbreaks with greater speed; and augmented track and trace technologies can help us improve the safety of drugs, devices, and veterinary products.”