Opioids, Old Initiatives Dominate FY 2020 US FDA Funding Increase
Executive Summary
The agency requested a funding increase in part to implement 2018 legislation intended to combat the opioid crisis, but also to support many initiatives in last year's budget request.
The US FDA intends to dedicate a substantial amount of its requested fiscal year 2020 Human Drugs program budget increase for new congressional mandates to fight the opioid crisis, but also wants increased funding for several other familiar areas.
In its congressional justification for its budget request, the agency asked for $55m for new opioids initiatives, which includes funds to implement the 2018 Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act. Signed into law in October, the legislation gave FDA several mandates related to the opioid crisis.
About 21% of the total increase requested for FDA's Human Drugs program is go to the new opioids related activities.
FDA said it wants to use the proposed increase to establish a surveillance program to help the agency "assess the impact of its regulatory actions and treatment guidelines on opioid use, misuse and abuse," which will help it develop regulatory policy and compliance and enforcement activities.
The agency also wants to create "a comprehensive systems model of the opioid crisis," according to the document, which accompanies the FY 2020 budget request from President Trump and the Health and Human Services Department.
"This model is critical to harness the best available data to assess the potential effects and interdependences of various interventions," FDA said. The agency offered no additional details on what the model would entail.
In addition, funding would support collection and analysis of preclinical, clinical and real-world data needed to determine "safer analgesic packaging and rational prescribing through evidence-based treatment guidelines," as well as support studies to improve generic abuse-deterrent opioid formulation evaluation and "mechanistic models of social and behavioral science research to help foster the same use of opioids," the agency wrote.
FDA also intends to strengthen its presence at international mail facilities (IMFs) to be able to review 100,000 packages per year, compared to its present capability of reviewing 15,000 packages per year. FDA said an additional 12 full time equivalent positions for field staff will help screenings at IMFs and enhance support lab work.
The agency also plans to use data from IMFs to increase surveillance for illicit opioids entering the country. The agency said its Office of Regulatory Affairs will create a database of violative products and firms, and the Center for Drug Evaluation and Research will review the products and associated websites to determine if warnings letters or other enforcement action is necessary.
Curtailing opioid abuse and misuse has been a top priority for FDA for several years and several initiatives are underway. The agency already intends to launch randomized withdrawal studies to determine whether opioid efficacy diminishes with chronic use over time, as well as create evidence-based prescribing guidelines to include in labeling. (Also see "Long-Term Opioid Efficacy Studies Will Take Years, Gottlieb Says" - Pink Sheet, 28 Feb, 2019.)
New opioid packaging standards also may be released soon, which are intended to help curb prescribing. (Also see "Opioid Packaging: Is Non-Inferiority Enough For A New Claim?" - Pink Sheet, 12 Dec, 2017.)
Several 'Novel' Projects Recycled From FY 2019 Request
FDA described several other initiatives requiring new funds as "novel," but they are actually recycled from the agency's FY 2019 budget request. Many of the repeated projects had different funding amounts attached to them in the new request.
The agency used much of the same language in its FY 2019 budget request when describing its intent to modernize generic drug development and review, which includes creation of a Knowledge-aided Assessment and Structured Application (KASA) platform to capture and manage "all the required information about a drug product, facilitate risk identification, mitigation and communication, and provide a structured template that would completely replace an unstructured text-based narrative review."
FDA also called it a "one-time platform investment" in both budget justifications, although the cost now appears to be cheaper. The agency allocated $27m to the project in the FY 2020 budget justification, compared to $37.6m in the FY 2019 budget justification.
A new drug innovation platform reappeared in the request following inclusion in FY 2019, which is intended to be a system for easily accessing regulatory precedent and other data submitted to the agency. The knowledge management system would improve consistency in responses to regulatory questions and enhance safety monitoring, FDA wrote. The agency also requested fewer dollars in FY 2020 for the project, $45m, compared to the previous year, $57.5m.
In addition, the agency requested that $20m of the Human Drugs program increase go toward stimulating medical product development for rare diseases, just as in FY 2019. The asks were mostly identical, indicating the money would support natural history studies and clinical trial networks.
A review of orphan drug incentives also was included in the request again. (Also see "Orphan Drug Policy Changes To Be Considered Under US FDA's FY 2019 Budget Proposal" - Pink Sheet, 4 Apr, 2018.)
Request Largely A Wish-List
The presidential and FDA budget requests mainly serve as a starting point for negotiations on Capitol Hill and have little chance of enactment as written as Democrats already have said they are dead on arrival.
Trump allocated $6.14bn overall for FDA, a $643.1m increase from the level in the annualized FY 2019 continuing resolution. (Also see "Trump FY 2020 Budget Renews Push To Reform 180-Day Exclusivity " - Pink Sheet, 11 Mar, 2019.)
About $266.4m of the increase is intended for the Human Drugs program, FDA wrote in the justification document. About $218.5m of the increase would be budget authority, along with $47.9m in user fees.
The FY 2020 budget process will be the last for Commissioner Scott Gottlieb, and is another example of his good relationship with the White House. He is expected to depart in early April and be replaced by National Cancer Institute Director Norman Sharpless. (Also see "US FDA 2020 Budget Request Is Parting Gift From Commissioner Gottlieb" - Pink Sheet, 15 Mar, 2019.)