Trump Admin Proposes $419 Million Budget Boost for FDA

The Trump Administration has proposed a 7% boost ($419 million) in FDA’s 2020 budget, which includes more than $220 million to continue advancing new initiatives that will promote medical product innovation. An agency release says that the additional resources would “help the agency combat the opioid epidemic; advance new steps to support the production of quality compounded drugs; expand the FDA's capacity to review human food and animal feed ingredients; and continue implementation of the 21st Century Cures Act to advance patient-centered medical innovations.”

To advance medical product safety and innovation, the budget proposes $55 million for an initiative to build an integrated knowledge management system and portal for medical devices to enable safety issues to be monitored, and effectiveness to be evaluated, along devices’ total life cycle. “This capability to better leverage pre-existing and new data in near real time is essential for implementing the FDA's new approaches for digital health technologies, breakthrough devices, use of real-world evidence and cybersecurity,” FDA commissioner Scott Gottlieb says.

The investment in the device portal should make “medical device reviews, post-market surveillance and cybersecurity efforts significantly more efficient and informative,” Gottlieb says. “These efforts could also make medical product review cycles more efficient; allow the agency to more quickly identify and address safety signals and cyber vulnerabilities; and spur the development of innovative, safer, more effective medical devices.”

To strengthen its drug compounding oversight, the budget proposes $76 million to allow FDA to develop new policies for outsourcing facilities, including efforts to improve the quality of outsourcing facilities' compounded products. “We’re also helping address providers’ needs for office stock of compounded medications,” Gottlieb says. “In 2020, for example, we're standing up a Compounding Center of Excellence, to provide training programs on good manufacturing practices for outsourcing facilities, and adding a cadre of inspectors for outsourcing facilities. By engaging with outsourcing facilities and states, we can help the domestic outsourcing facility industry grow and adhere to quality standards to protect patient health, including by finalizing guidance and developing a rule for good manufacturing practices for outsourcing facilities, and evaluating hundreds of nominations for the bulks list.”

According to related budget documents, the increased resources will fund a number of proposals to speed development of generic drugs and eliminate loopholes that have allowed companies to use the regulatory framework to hinder competition. It would:

• Reform the current 180-day exclusivity forfeiture provision for first generics so that first generics do not block subsequent generics from approval.
• Clarify FDA’s approach in determining whether a new drug is a new chemical entity to ensure that only truly innovative new drugs receive an additional five years of exclusivity.
• Enhance FDA authority to address abuse of petition process so FDA has greater flexibility to summarily deny petitions when circumstances indicate that the primary purpose of the petition is to delay FDA approval.
• Enable FDA to tentatively approve a subsequent generic application, which would start the 180-day exclusivity clock, when a first-to-file generic application cannot be approved due to deficiencies.

The Alliance for a Stronger FDA says it is “quite pleased” with the proposed increase in funding for the agency. “The agency will be able to apply new monies to important programs that benefit the American people, as well as hire needed scientific personnel to carry out the FDA’s far-ranging mission,” the group says.