FDA’s Second Half: Org Changes, Updating Trial Design and Promotional Regulation, 2020 Budget

July 1, 2019 – Among the issues on the Food and Drug Administration’s (FDA’s) plate for the remainder of 2019 are implementing organizational changes, securing appropriations funding for 2020, modernizing clinical trial design and regulating promotional messaging, according to Nancy Bradish Myers, president, Catalyst Healthcare Consulting, who spoke at the recent Coalition for Healthcare Communication Rising Leaders Conference on Healthcare Policy, held in Washington, D.C.

When Former FDA Commissioner Scott Gottlieb, M.D., took over, he reorganized the Office of the Commissioner to ensure that Center directors and other Offices reported directly to him, Myers stated. Accordingly, Gottlieb left Acting Commissioner Ned Sharpless, M.D., “a more streamlined, tightly organized Office of the Commissioner, with a large number of direct reports.”

Principal Deputy Commissioner Amy Abernathy, M.D., Ph.D., is now the number two at the agency – and with a background in medical research, she is a “very good pick to be at the agency at a time when data is becoming very, very important.” In her current role, Abernethy oversees the day-to-day operations of FDA, handles important cross-center initiatives, and is also acting chief information officer for the agency, Myers explained.

Further, the Center for Drug Evaluation and Research has made some changes that are intended to improve efficiency and accommodate the growing volume and complexity of its workload. First and foremost, CDER created an Office of New Drugs to flatten out the Office and Review divisions, create a more logical grouping of disease states and improve operations so there is more review time and less time spent on paperwork, according to Myers. CDER also created an Office of Drug Evaluation Science, which is charged with creating structured, standardized approaches to data evaluation and is intended to support the transition to a revamped drug review process.

“Gottlieb wanted to have a group inside FDA to take the data packages from sponsors and manipulate that data themselves and to have more authority over the way the data is crunched. That is pretty significant. … FDA really wants this life-cycle approach to drug review, so you have the same people reviewing” – from giving early advice, to applications, to post-marketing data.

The Center for Devices and Radiological Health (CDRH) also has a reorganization underway, Myers told Rising Leaders attendees, which is intended to improve efficiency and create a more team-based approach to regulation. Part of that effort is the recent establishment of the CDRH Office of Product Evaluation & Quality.

When it comes to appropriating funds to the FDA, Myers explained that the Trump administration appears “to recognize the value and expanding scope of the agency.” In fiscal year (FY) 2019, the FDA received the largest appropriations increase in several years. President Trump’s FY 2020 budget request includes a $350 million increase in overall budget versus the prior year, Myers stated.

New initiatives supported by the FY 2020 budget request include:

  • Advancing modern manufacturing technologies for drugs/biologics
  • Advancing use of real-world evidence (RWE) to create near real-time data evaluation capability
  • Facilitating rare disease drug development
  • Addressing opioids
  • Improving IT infrastructure

In the clinical trial design arena, Sharpless and Abernethy plan to build on the FDA’s existing efforts to modernize clinical trials and data generation. According to Myers, Sharpless will likely focus on using RWE as a means to speed clinical trials, and will strive to modernize trial infrastructure and improve efficiency; Abernethy is focused on modernizing/maximizing data generation. “I believe that she was brought in to really help us understand how we can use this data to limit how much patient data we actually need, and how we can mine the data so we have better results,” she said.

On the promotional messaging front, Myers stated that “FDA really has started recognizing that information is developing rapidly and that that information is valuable to patients. [The agency is] trying to wrap their head around how do they stay in the modern era without letting people ride roughshod” over their regulations, she said.

A few of the issues the FDA is looking to address in this area are scientific exchange and labeling considerations to reduce medication errors, Myers stated, adding that these should be coming out in the near future. “They also are looking at the definition of ‘intended use,’” she said. The FDA plans to take new actions to promote appropriate adoption of biosimilars to stop any false or misleading promotion as well, she noted.

“In 2019, FDA will be following [existing] action plans. They are going to deliver on their legislative requirements, because … Congress will hold their feet to the fire, and they are going to deliver on user free requirements, because we are about to go into user free negotiations,” Myers concluded. But surprises, such as political dynamics, global events or staff changes, could emerge to change the agency’s priorities, she said. “You never know.”

To view Myers’ slides, go to the Resources tab above.