FDA’s FY 2019 Justification: How Extra Funds Will be Used
An increase of more than $400 million for the US Food and Drug Administration (FDA) in fiscal year 2019 would help the agency advance drug, biologic and device manufacturing tech, better regulate drug compounders and over-the-counter medicines, among other initiatives unveiled in FDA’s 346-page fiscal year 2019 justification of estimates for appropriations committees.On the manufacturing front, FDA says an additional $35 million and two full time employees will help to advance manufacturing technologies like continuous manufacturing, in addition to other means of enhancing product quality and avoiding shortages. An additional $12 million also could help FDA establish a voluntary program for device manufacturers to receive certification for meeting certain manufacturing and product quality criteria.
As part of the voluntary device plan, the budget justification says FDA “will recognize third-party certifiers and offer regulatory incentives for those manufacturers who receive certification demonstrating their quality capability.”
The budget request also includes $37.6 million to create a new review platform for generic drugs and support efforts to update generic drug labeling, with an initial focus on oncology products.
FDA also said it’s working to push new legislation to enable the collection of $22 million in user fees to better regulate over-the-counter drugs.
As discussed earlier, FDA’s Office of Regulatory Affairs is also looking to establish a “Center of Excellence on Compounding for Outsourcing Facilities,” to provide education and training, conduct research to help inform regulatory decision-making, and implement programs to harmonize and strengthen state oversight of drug compounding facilities.
Cures Highlights
The budget justification also discussed how FDA is implementing the 21st Century Cures Act, noting the agency is establishing a qualification process for drug development tools (DDTs) (i.e., biomarkers, clinical outcome assessments (COAs), and animal models) for proposed contexts of use for drugs and biologics.
“Once a DDT is qualified under the new process, it can be used for its qualified context of use to support regulatory decisions. In 2017, the first COA from the COA Drug Development Tool Qualification program was accepted for review under these updated provisions —the Symptoms of Major Depressive Disorder Scale—and the Agency expects to act on that submission soon,” the agency said.
FDA also held two recent multi-stakeholder collaborations to help inform future guidance on the criteria to support biomarker qualifications.
In addition, the Cures Act supports the FDA’s “evaluation of the potential use or utility of real world evidence (RWE) to support the approval of new indications of approved medical products or to satisfy post-approval study requirements for marketed products.”
Last June, the agency noted that it became the first regulator in the world to approve the most recent iteration of the Sapien valve, the Sapien 3, to treat high-risk patients whose surgically-placed aortic or mitral bioprosthetic valves were old and worn out.
“This approval was based in part on data from the Transcatheter Valve Therapy (TVT) Registry, a partnership of the American College of Cardiology and the Society of Thoracic Surgeons,” FDA said.
Also in June 2017, FDA partnered with the American Society of Clinical Oncology’s big data initiative known as CancerLinQ, which will be using real world, aggregate, de-identified patient care data from oncology practices to understand a variety of issues related to the appropriate use of newly approved therapies.
“FDA is establishing a program to evaluate the potential use of RWE to support regulatory decisions. The draft framework is due in December 2018, but the Agency is already gathering stakeholder input to move this field forward,” FDA said.
US Food and Drug Administration Justification of Estimates for Appropriations Committees