For years, pharmaceutical industry officials have argued that splitting the FDA into two agencies — one that regulates medical products, and one that regulates food — would improve efficiency. And while the agency’s recently announced proposal to restructure its Human Foods Program is a far cry from those more drastic reforms, it could pose some upsides for pharma.
The proposal, announced on Feb. 1, came after the Reagan-Udall Foundation, a nonprofit FDA oversight group created by Congress, recommended a slew of structural changes to the food program in December amid ongoing controversy over the agency’s handling of baby formula shortages. Among the most notable concerns raised by the group’s report was the “lack of a single clearly identified person to lead the Human Foods Program,” which it argued “has adversely impacted the organizational culture and led to overlapping roles and competing priorities that result in what is perceived as constant turmoil” at the agency.
While Steven Grossman, executive director of the Alliance for a Stronger FDA and a former deputy assistant secretary for health at the HHS, said it might be difficult to imagine, the FDA’s food program has historically lacked clear lines of authority and is chiefly managed by the commissioner.
“Government is organized in hierarchies to prevent a vacuum in leadership. There is always some person or office accountable for every specific decision and action. You never see — nor should see —situations where no one is in charge,” Grossman said. “For those who work with government every day, including medical products stakeholders, it requires some imagination to understand what happened in FDA’s food programs.”
Under the FDA’s proposal, a new deputy commissioner for human foods would be charged with overseeing all policy, strategy and regulatory activities related to food and nutrition. The agency’s Office of Regulatory Affairs (ORA), which is responsible for the inspection of all FDA-regulated products and manufacturers, would also be reconfigured and “transformed into an enterprise-wide organization.”
“When medical products are being questioned, there is a secondary impact on foods. Vice versa, when foods are being questioned there is a secondary impact on medical products.”
Steven Grossman
Executive director, Alliance for a Stronger FDA
On the surface, these changes might appear unrelated to the agency’s drug industry activities, but they’re likely to have far-ranging impacts across the agency. Here’s a look at a few of the ways they could affect pharma.
A reputational boost
The FDA has faced myriad challenges over the last few years, and with them, has made a number of controversial decisions in both its food and drug divisions that have led to rising public concern over its ability to effectively regulate both industries. Chief among these scrutinized missteps was its 2021 accelerated approval of the Alzheimer’s treatment Aduhelm that at the time showed iffy efficacy data. On the food side, a massive infant formula recall drew the agency’s inability to respond timely to consumer crisis into sharp focus last year. Both of these incidents sparked investigations into the agency’s practices.
With the reputation of the FDA hanging in the balance, Grossman said any reform efforts that decrease dysfunction at the agency are likely to improve confidence in its food and drug work, at a time when trust in science is on the decline.
“The public views (the) FDA as one organization that maintains world-class standards for both food and drugs.” Grossman said. “When medical products are being questioned, there is a secondary impact on foods. Vice versa, when foods are being questioned there is a secondary impact on medical products.”
If the agency’s latest revamp of its food safety program addresses consumer concerns and improves its ability to effectively regulate, that could have positive reputational impacts on its drug division as well.
Increased agency efficiency
Under its proposed Human Foods restructuring plan, the FDA also announced it would strengthen its “enterprise information technology and analytical capabilities,” across the agency to “facile communication, more efficient operations and enhanced empirical risk algorithm.”
These improvements are likely to be focused on the food safety division but any upgrades to the agency’s IT infrastructure could have trickle effects on its drug and biologics divisions that could enhance operational speeds for drug reviews.
In the past, the FDA has outlined priorities to improve technology in its 2019 Technology Modernization Action Plan, 2021 Digital Modernization Action Plan and 2022 Enterprise Modernization Plan but, as the Reagan-Udall report said, the vision of these plans “has not been realized.” If its latest commitment to enhancing IT capabilities resembles those past action plans, the FDA could seek to streamline data sharing for its inspection processes, create an inventory of FDA-regulated firms and “solve shared, cross-agency issues.”
A new look for the inspection office
A realignment of the ORA could also spell big changes for how the FDA handles drug facility inspections. The agency said it will consolidate some of the offices functions, including state and local food safety partnership functions, under the Human Foods Program and will take a more prevention-based approach to inspections.
Currently, food-safety related activities encompass the “largest portion of ORA’s budget, representing 62% of total FY 2021 ORA funding,” according to the Reagan-Udall report. But because of coordination issues across the Human Food Program, much of this funding isn’t allocated effectively.
The movement of food-safety related activities is bound to change these dynamics at ORA, which also supports the FDA’s drugs and biologics divisions, according to lawyers at the law firm Akin Gump Strauss Hauer & Feld.
“These proposed changes will be closely watched by a much broader range of stakeholders than just those focused specifically on food and nutrition,” they said in a blog post.
So far, however, FDA has revealed little about what the ORA restructuring might actually entail. As the agency looks for public comments on the proposal and releases finalized plans, pharma companies should stay tuned for details on how the newly imagined ORA might meet their specific needs and priorities.
