Trump’s 2020 Budget Seeks FDA Tweaks to Increase Generic Competition

Regulatory NewsRegulatory News | 11 March 2019 |  By 

With Democrats controlling the House, the specifics of President Donald Trump’s Fiscal 2020 budget, released on Monday, may not matter much, but it does feature new attempts to alter US Food and Drug Administration (FDA) processes in order to increase generic drug competition.

Similarly to last year’s budget, the 2020 budget looks to save more than $1 billion in Medicare and Medicaid funds by stopping some generic drug applicants, who file first and win tentative approval, from limiting competition by intentionally delaying seeking final approval in order to not trigger their 180-day exclusivity.

“The proposal will trigger an initial generic drug applicant’s 180-day exclusivity when a subsequent application is tentatively approved, subject to specific conditions,” the Department of Health and Human Services (HHS) budget plan says.

But Chip Davis, CEO of the Association for Accessible Medicines, said this proposed change on 180-day exclusivity would "only weaken this critical incentive for competition and ensure that more non-innovative brand-name drug patents remain in place, delaying the availability of generic medicines for patients."

The budget plan also calls to close a loophole whereby companies avoid forfeiting their 180-day exclusivity by claiming the failure of their application is caused by a change in or a review of the requirements for approval imposed after the date on which the application is filed.

“Some first applicants have taken advantage of ambiguities of this provision, avoiding forfeiture and delaying generic competition,” the proposal says.

The budget also seeks to ensure that only new chemical entities can be rewarded with exclusivities.

“Five-year new chemical entity exclusivity will apply only to drugs with significant changes to their chemical structure compared to current drugs. This proposal codifies a narrow definition to avoid awarding exclusivity to products that do not represent a true innovation,” the plan says.

And new to 2020, the budget calls to address citizen petition abuse and provide FDA with greater flexibility to deny these petitions. It also calls to eliminate the mandatory 150-day response timeframe for FDA, which the agency believes “is unnecessary because all generic drug applications have goal dates under law and language is no longer needed to prevent delay of approval.”

As for increasing biosimilar competition, the budget also calls to amend the Public Health Service Act so that the biological products do not have to meet separate standards issued by the US Pharmacopeia and which are designed specifically for drugs.

Medical Devices, Opioids

Overall, the budget includes $6.1 billion in total resources for FDA, which is an increase over last year in user fees by $281 million and budget authority by $362 million.

For medical devices, the budget proposes $55 million for an initiative, presumably the National Evaluation System for health Technology (NEST), to enable safety issues to be monitored throughout the total lifecycle of each device, from bench testing to premarket clinical trials to postmarket adverse events and real-world evidence.

Another $55 million would be devoted to FDA's work on opioids, which includes efforts to decrease exposure to opioids, supporting treatment for those with opioid use disorder, encouraging the development of novel pain treatments and increasing enforcement activities around illicit opioid sales.

HHS 2020 Budget in Brief

FY 2020 Administration Budget

FDA Comments


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