US FDA Wins Big In Shutdown-Averting Approps Bill
Executive Summary
Agency would receive more than $268m in additional dollars for medical product and food safety as part of substantial FY 2019 increase.
Medical product safety dollars would dominate the substantial budget authority increase that the US FDA would receive in fiscal year 2019 appropriations legislation.
FDA is slated $257.6m in additional discretionary funds for medical product safety, according congressional summaries of the legislation released Feb. 14. Another $13.8m is intended for food safety activities.
The legislation would fund FDA and several other federal departments through the end of FY 2019. Funding will lapse Feb. 16 if the bill is not passed and signed by President Trump, forcing another government shutdown.
FDA would receive $5.58bn overall in the bill, which is 8.7% more than was allocated in the FY 2018 appropriations bill. More than half the total increase was in budget authority. FDA received $268.8m in additional budget authority and $178.3m in additional user fee funds.
Compared to the FY 2018 funding level, the Center for Drug Evaluation and Research would receive the largest increase, about $262m. The Center for Biologics Evaluation and Research would see a $42.5m increase and the Center for Devices and Radiological Health would gain about another $69m. The only line item with a funding cut (about $18m) is within what are known as "other activities," such as Office of the Commissioner. (See charts at end of story.)
The Alliance for a Stronger FDA, a group advocating for agency appropriations, was "very pleased" with the bill. The group said the increase in budget authority is the largest in number and percentage in several years.
House and Senate appropriators "saw the needs and the opportunities for the agency to better serve the American public and they backed that with a considerable increase for the agency," the Alliance said.
Congress is expected to swiftly pass the bill and President Trump likely will sign it, although he left some doubt when the initial deal was announced.
A disagreement between Trump and congressional Democrats over border security funds forced the government to shutter from Dec. 21-Jan. 25. FDA funding was caught up in the shutdown, although the agency maintained many of its drug review and other operations using carryover user fee funding. (Also see "Shutdown Deal Avoids Further US FDA Service Cuts, But Damage May Linger" - Pink Sheet, 26 Jan, 2019.)
Opioid Data Warehouse, Drug Manufacturing Increases Allocated
The increase for medical product safety includes $47m devoted to combating the opioid epidemic, which will be used for "regulatory science, enforcement and innovation activities," according to the explanatory report accompanying the bill. Twenty million dollars would be allocated "to create a large-scale data warehouse and perform data analytics to better assess vulnerability points in the population, anticipate changes in the crisis, and target regulatory changes required," according to the report.
FDA has a multi-faceted opioid effort under way. The agency recently launched an effort along with the National Academies of Sciences, Engineering and Medicine to develop evidence-based opioid prescribing guidelines, which could be used to adjust labeling and packaging. (Also see "Opioid Prescribing Guidelines Will Be More Template Than Commandment" - Pink Sheet, 14 Nov, 2018.)
FDA also would receive a $38.5m increase to promote domestic manufacturing, which was among FDA's asks in its FY 2019 budget request. Another $12m would be allocated for "new domestic drug industry," along with $6m for medtech manufacturing, appropriators said in the report.
Commissioner Scott Gottlieb wants to encourage more adoption of advanced manufacturing systems, which he believes will attract more drug manufacturing to the US. (Also see "FDA Highlights Advanced Drug Manufacturing Approaches In Budget Plan" - Pink Sheet, 13 Feb, 2018.)
Generic Drug Development, OCE Funding Increases Authorized
The bill also would provide an increase of $25.1m for "modernizing generic drug development and review" along with $43.3m for a "new platform for drug development," including $5m to ensure the Oncology Center of Excellence is fully funded.
Gottlieb has indicated that the agency may ask for additional appropriations to update outdated generic drug labels. Often when the brand sponsor exits a genericized market, there is no way to add new information to the labels. The controversial generic labeling rule was intended to allow those changes, but was pulled amid widespread opposition. FDA continues to look for alternatives that would further the goals. (Also see "US FDA May Ask Congress For More Resources After Withdrawing Generic Label Reg" - Pink Sheet, 13 Dec, 2018.) Oncology drug labels are expected to be the first to be updated. (Also see "Project Renewal: US FDA's Plan To Update Generic Cancer Drug Labels Depends On NDA Holders" - Pink Sheet, 28 Nov, 2018.)
The initiative may be among the early priorities for New Office of Generic Drugs Director Sally Choe, who will take over for outgoing director Kathleen Uhl in March. (Also see "Generic Industry Once Again Must Get To Know New US FDA Office Director" - Pink Sheet, 13 Feb, 2019.)
FDA also is restructuring its review processes within the Office of New Drugs as part of a reorganization that will create many new divisions and offices. The agency plans to implement new templates and other systems to help streamline reviews. (Also see "Office Of New Drugs Reorg Is Bigger Than Expected: US FDA Adds 11 Review Divisions " - Pink Sheet, 4 Jun, 2018.)
Another $10m of the product safety increase was allocated for "investment and innovation for rare diseases," according to the report.
FDA recently issued new draft guidance with additional recommendations for safety assessment. (Also see "Rare Diseases: US FDA Gives More Guidance On Premarket Safety Evaluation, Historical Controls" - Pink Sheet, 11 Feb, 2019.)
Genetically-Modifed Embyro, Electronic Labeling Provisions Return
The bill also includes a now familiar provision that would continue barring FDA from accepting or evaluating research or clinical applications for a drug or biologic where a human embryo is intentionally created or modified to include a heritable genetic modification. The prohibition has particular salience this year following news of the birth of gene-edited twin babies in China. (Also see "How One Rogue Scientist Could Sink Global Gene Therapy Progress" - Pink Sheet, 30 Nov, 2018.)
The Senate Appropriations Committee highlighted the provision, which also appeared in FY 2018 appropriations legislation, in its summary of the FDA section of the bill.
Agency funds also would continue to be barred from using funds to implement regulations allowing prescribing information to be distributed electronically in lieu of paper "unless and until" a federal law allowing it is enacted.
House appropriators were concerned that the agency continued to work on the electronic labeling rule while working on FY 2019 appropriations last year, saying its actions subvert congressional intent. (Also see "House Appropriators Warn US FDA: Stop Working On Electronic Labeling Rule" - Pink Sheet, 18 May, 2018.)
FDA still has not nixed the rule, however. It remains among its long-term actions in the unified regulatory agenda. A date for issuing a final rule remains to be determined. The agency upgraded the rule from "inactive" to "long-term action" in 2017. (Also see "Generic Labeling Rule Dies In Latest Reg Agenda, But Electronic Labeling Is Reborn" - Pink Sheet, 14 Dec, 2017.)