Behind the Numbers: FDA Offers Budget Specifics, New Proposals

Regulatory NewsRegulatory News | 18 March 2019 |  By 

Further modernizing generic drug and new drug reviews and development, improving medical device safety and additional efforts to support the opioid crisis will all see additional funding next year, according to the FY 2020 budget justification from the US Food and Drug Administration (FDA).

The 384-page justification breaks down where all the newly requested funding is expected to go, with $3.8 billion slated for medical product safety and availability, which is an increase of $428 million above the FY 2019 annualized continuing resolution.

For generic drug reviews, the budget allocates $27 million, and includes a proposal to expand current efforts to streamline and automate the review of the drug quality section of abbreviated new drug applications to include other disciplines engaged in such application assessments.

Another $55 million to support ongoing efforts to address the opioids crisis, as well as support existing investments and to increase field and mail center operational capacity to review up to 100,000 packages annually.

Another $50 million is set for building a knowledge management system and portal to advance new drug development and review, as well as to support a new model for team-based product review and collaboration within the FDA Oncology Center of Excellence (OCE).

In addition, the budget includes $60 million to advance the use of real-world evidence to better inform patient care and provide potentially lower-cost ways to develop clinical data to inform product reviews. “This capability will allow FDA to conduct near-real-time evidence evaluation down to the level of individual electronic health records for at least 10 million individuals in U.S. healthcare settings,” the budget justification says.

On the device side, the budget includes $55 million to build an “integrated knowledge management system and portal for medical devices using modern, agile information technology systems with secure cloud-based data storage” to better track safety issues. The justification says such a system could shorten review cycles, and quickly identify and address safety signals and cyber vulnerabilities.

New Proposals

In addition to proposals spotlighted in the HHS budget on drug pricing, the FDA budget justification also includes several new proposals to help relieve medical device shortages, improve cybersecurity abilities at FDA and deal with other shortcomings related to old generic drug labeling and post-approval agreements.

For instance, currently no law requires medical device manufacturers to notify FDA when they become aware of a circumstance that could lead to a device shortage. Such circumstances may include discontinuation of a device, a manufacturing interruption or loss of or damage to a manufacturing facility.

“This proposal would ensure FDA has timely and accurate information about likely or confirmed national shortages of essential devices to enable FDA to take steps to promote the continued availability of devices of public health importance. Specifically, FDA is seeking authority to: require firms to notify FDA of an anticipated significant interruption in the supply of an essential device; require all manufacturers of devices determined to be essential to periodically provide FDA with information about the manufacturing capacity of the essential device(s) they manufacture; and authorize the temporary importation of devices whose risks presented when patients and healthcare providers lack access to critically important medical devices outweigh compliance with U.S. regulatory standards,” FDA says.

Cybersecurity is another area where FDA is seeking additional authority and proactive responses to vulnerabilities. Specifically, FDA seeks to require that devices can be updated and patched in a timely manner; that premarket submissions to FDA include evidence demonstrating that capability; the possible creation of a list that includes software and hardware components that could become susceptible to vulnerabilities; and that device firms publicly disclose when they learn of a cybersecurity vulnerability.

On the pharmaceutical end, FDA explains how generic drug labeling can become outdated after approval of the reference listed drug (RLD) is withdrawn at the request of its sponsor.

“This proposal would give FDA explicit authority to update the labeling of generic drugs with withdrawn new drug application (NDA) or new animal drug application (NADA) RLDs when the generic labeling becomes outdated, including to update the uses to reflect the current state of the science. This would ensure that labeling of generic drugs continues to provide healthcare professionals and consumers with the most up-to-date information about the use of the drugs even after the NDA or NADA RLD is no longer on the market,” the justification says.

The proposal comes as OCE began helping companies update their generic labels as part of work known as Project Renewal. The plan is to help companies update about 40 generic chemotherapy labels that are still used in clinical practice but no longer have brand name reference products.

Another new proposal seeks to address post-approval agreements, which unlike post-marketing requirement studies are not legally enforceable requirements.

“FDA, therefore, has limited ability to take enforcement action if an applicant does not submit the agreed-upon information, short of proposing to withdraw approval of the application. This proposal would grant FDA authority to require NDA, biologics license application (BLA), or abbreviated new drug application (ANDA) applicants to submit a post-approval quality update to provide information or implement changes needed to ensure ongoing quality and, therefore, safety and efficacy of the product once approved and marketed,” FDA adds.

FDA Fiscal Year 2020 Justification of Estimates for Appropriations Committees


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