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Regulatory News | 10 February 2020 | By Zachary Brennan
The Trump administration on Monday unveiled its FY 2021 budget proposal, seeking a 10% reduction in overall funding for the Department of Health and Human Services (HHS), but a slight increase in funding for the US Food and Drug Administration (FDA).
For FDA, the budget requests $6.2 billion overall, including $3.3 billion in discretionary budget authority (BA) and $2.9 billion in user fees.
Steven Grossman, deputy executive director of the Alliance for a Stronger FDA, told Focus that his group’s preliminary analysis is that the proposal includes a $46 million increase in the BA (taxpayer funded) appropriations, which includes $21 million in additional funds for devices, $2 million in additional funds for programs in the FDA commissioner’s office and $24 million in total rent items. Offsetting this are: $1 million in decreases for animal drugs and the National Center for Toxicological Research, the alliance said.
"In relative terms, we are pleased that the Administration’s commitment remains strong, even while many other worthwhile agencies are proposed for cuts. In absolute terms, further increases are going to be needed because the mission and responsibilities of FDA are still growing and the science is becoming more complex," a spokesperson for the Alliance told Focus.
FDA said the BA increase is $25.4 million more than the FY 2020 enacted level and the $2.9 billion for user fees is an increase of $240 million compared to 2020.
On the device side, the HHS budget-in-brief includes an increase of $18 million to continue building a knowledge management system and portal for medical devices, funding for which was also included in last year’s proposal. This increased funding is important as FDA authorizes, on average, 12 new or modified devices every business day. In 2019, FDA also gave the "breakthrough" designation to more than 100 devices, doubling the number of designations in 2018.
“This investment would allow FDA to transform the agency’s premarket review and postmarket surveillance programs, and shorten review cycles without compromising patient safety, quickly identify and address safety signals and cyber vulnerabilities, and spur the development of innovative, safer, more effective devices,” HHS said.
The budget also provides $45 million to increase the enforcement of opioids at international mail facilities. HHS said this investment will enable FDA to inspect 100,000 packages per year.
In addition, the plan seeks a legislative proposal to modernize the over-the-counter drug monograph system and establish a user fee for an estimated $28 million in FY 2021. The Senate passed an OTC monograph bill in December 2019.
Another more than $8 million increase is expected to support an FDA-wide AI strategy to invest in workforce, algorithmic capabilities, data and technical infrastructure. This investment will “advance and promote consumer-friendly AI and digital health medical devices,” HHS said.
FDA also is planning new work to combat drug shortages, including a proposal that would expand FDA’s authority to require, when likely to help prevent or mitigate a shortage, "that an applicant evaluate, submit studies to FDA, and label a product with the longest possible expiration date that FDA agrees is scientifically justified."
In addition, FDA's justification includes a proposal that 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."
On the topic of priority review vouchers (PRVs), FDA is seeking clarification of the novelty standard for a biological product, based on its containing key structural features not contained in a previously licensed biological product, which it says "would help provide a more predictable standard for sponsors seeking PRVs."
And FDA is seeking to allow for expedited access to devices that would otherwise be reviewed under the premarket approval or de novo classifications pathways if they are intended to treat or diagnose a life-threatening or irreversibly debilitating disease or condition and address an unmet medical need using a two-step approval. "These devices would be eligible for provisional approval based on a demonstration of safety and performance plus additional risk mitigations and could remain on the market after an established time period only after a demonstration of reasonable assurance of safety and effectiveness," the justification adds.
Although the numbers or the proposals are not final, and some may stress that the budget plan is nothing more than a political maneuver, the Alliance for a Stronger FDA noted: “The reality: whether Congress accepts or rejects the President’s proposals or adds more money, his numbers will be used as a baseline when the subcommittees mark-up. That matters.”
The budget also proposes to move the Center for Tobacco Products out of FDA to create a new agency within HHS to focus on tobacco regulation.
“This new agency would be led by a Senate-confirmed Director in order to increase direct accountability and more effectively respond to this critical area of public health concern,” the proposal says, noting that it also would allow the FDA commissioner to focus on its traditional mission of ensuring the safety of the nation’s food and medical products supply.
House Appropriations Committee Chairwoman Nita Lowey (D-NY) said in a statement: “The President’s latest budget is a disastrous repeat of the misplaced priorities and callous cuts he has pursued unsuccessfully in past requests. This reckless proposal backtracks on funding levels agreed to in the bipartisan budget agreement and would gut investments in America’s working families with deep cuts to critical programs like medical research, education, and climate science.”
Sen. Lamar Alexander (R-TN) added in a statement: “I appreciate the president’s budget suggestions and will carefully consider his recommendations as Congress begins the process to fund the federal government for the next fiscal year. Under the Constitution, it is Congress’ job to set spending priorities and pass appropriations bills, and as a member of the Senate Appropriations Committee, my priorities will continue to be making sure our national defense, national laboratories, the National Institutes of Health and national parks have the resources they need.”
HHS FY 2021 Budget-in-Brief
Trump Administration Budget FY 2021