“Within this total, the Committee provides target increases for medical product and food safety activities, including new initiatives to revolutionize the safety of the nation’s blood supply and to enable faster responses to foodborne illness outbreaks,” the House Committee said in a statement. “In addition, the bill includes a strong focus on continuing the FDA’s efforts to advance generic drug reviews and increase medical product manufacturing in the U.S.”
Yesterday the House Appropriations Committee proposed a 2020 draft fiscal year funding bill. Under it, the U.S. Food and Drug Administration (FDA) would receive a 6% increase in discretionary funding over 2019, amounting to a bump of $184 million.
This is a proposed budget. The Trump Administration proposed $6.2 billion for the FDA, but the draft proposal came in a little lower, $5.86 billion, which would include revenue from user fees. The markup for the bill is scheduled for today, including appropriations for agriculture, rural development and related agencies.
“Within this total, the Committee provides target increases for medical product and food safety activities, including new initiatives to revolutionize the safety of the nation’s blood supply and to enable faster responses to foodborne illness outbreaks,” the House Committee said in a statement. “In addition, the bill includes a strong focus on continuing the FDA’s efforts to advance generic drug reviews and increase medical product manufacturing in the U.S.”
The proposed Trump Administration budget included funding for processes related to increasing generic drug competition. As in the proposed 2019 budget, the 2020 budget hoped to save more than $1 billion in Medicare and Medicaid funds by halting some generic drug applicants. The Department of Health and Human Services budget plan stated, “The proposal will trigger an initial generic drug applicant’s 180-day exclusivity when a subsequent application is tentatively approved, subject to specific conditions.”
It wasn’t without its critics, however. Chip Davis, chief executive officer of the Association for Accessible Medicine, stated that the 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 Trump budget proposal also called to close a loophole that is used by companies to avoid forfeiting their 180-day exclusivity by claiming their application was rejected because of a change to the approval requirements or a review that was required after the data when the application is filed.
The budget also called for only new chemical entities to be rewarded with exclusivities. The budget stated, “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 true innovation.”
The Trump budget also called for an amendment to the Public Health Service Act that would make it easier for biological products to be approved, “so that the biological products do not have to meet separate standards issued by the U.S. Pharmacopeia and which are designed specifically for drugs,” writes Regulatory Focus.
The House Appropriations has their hands full as they scour the Trump Administration budget proposal. For example, the committee voted Tuesday to spend $200 million in federal funds to match Florida’s funding for an Everglades restoration project. It passed its version of the defense spending bill, voting along party lines for a budget that is $8 billion below the Trump budget, cutting the use of defense funds for a border wall and ending U.S. military support for the Saudi-led conflict in Yemen.
It’s worth noting that the FDA budget is $5.86 billion compared to the military defense budget of $690.2 billion.
The House Appropriations Committee has added some money, up to $38.6 million to the NOAA Space Weather Follow-on program. NOAA is part of the Department of Commerce. And although the Trump Administration requested $72.5 million for its Space Force, the House only approved $15 million.
