The House Appropriations Committee approved a spending bill Wednesday for FY 2019 on a vote of 31-20, with a budget authority for the US Food and Drug Administration (FDA) of $3.1 billion—up from $2.8 billion in fiscal 2018.
The bill includes a committee recommendation for a net increase in the amount allocated for medical product safety and effectiveness of about $300 million, and hikes for FDA initiatives.
As part of the $400 million in additional FDA funding requested under President Trump’s budget proposal
, FDA Commissioner Scott Gottlieb highlighted
in February most of the initiatives included in the committee’s recommendation, such as promoting domestic manufacturing of drugs and medical technologies, creating a new medical data enterprise through greater use of real-world evidence (RWE), and fostering growth and transformation in the digital health space.
The senate is set to begin marking up their version of the federal budget proposal next week.
The initiatives are expected to lower healthcare costs for patients, with improved options for treatment and diagnostics, increase US-based jobs in developing new industries and advancing approaches to manufacturing that are less costly, but of higher quality and predictability.
“Of particular interest to the committee, is the opportunity for FDA to facilitate advancements in the manufacturing of safe and effective therapeutics, including continuous manufacturing of drugs and biological products,” the appropriators wrote in the 114-page bill.
Under the approved spending bill, FDA is set to receive a total of $10,000,000 in support of a continuous manufacturing initiative for drugs and biological products. The committee was authorized to provide this FDA funding under the 21st Century Cures Act of 2016
The committee’s expectations for this initiative involve agency staff partnering with nonprofits that have “a demonstrated capacity and experience on advanced manufacturing technologies to lower pharmaceutical costs and where limited federal funds will be matched by non-federal resources.” FDA has previously indicated it intends to promote this manufacturing technique—a modernized approach to keep pace with innovations—for devices and technologies as well.
In addition, FDA is directed to submit a report to the committee on its plans for addressing the many remaining challenges regarding medical device cybersecurity vulnerabilities as the US healthcare industry becomes increasingly connected through the Internet of Things.
The agency’s cybersecurity plans to address vulnerabilities “should describe potential solutions and list compensating controls such as continuous inventory, log monitoring, data protection, micro segmentation, and patching on legacy devices to prevent cyber threats from spreading across hospital systems,” according to the appropriators.
On genomic editing, the committee expressed concerns with the framework drafted in guidance issued in October 2014 for regulatory oversight of laboratory developed tests (LDTs).
The drafted framework is “a significant shift in the way LDTs are regulated” and it “circumvents the normal rulemaking process and changes expectations for patients, doctors, and laboratories for the first time since the Clinical Laboratory Improvement Amendments Act was passed in 1988,” the committee wrote.
Yet several FDA actions on drug compounding were praised, including the recent withdrawal
of a 2015 draft memorandum of understanding (MOU) in response to stakeholder feedback.
On digital technologies, the committee members called on FDA to expand on the use of virtual clinical trials and provide an annual report on the actions pursued as part of this effort.
“Through the use of telemedicine, connected sensors, patient engagement applications and direct data capture tools, virtual trials are conducted geographically near the patient,” the members wrote in the spending bill. “Reducing or eliminating on-site visits has the potential to increase patient convenience and lower study costs, while the implementation of new technologies is expected to increase data quality.”
The committee also recommended $30,000,000 for continued efforts to combat the opioid crisis in addition to the $94,000,000 provided to FDA under the 2018 Consolidated Appropriations Act
—which is set to expire in September.
“With this level of funding on the Federal side and billions more invested by the private sector, Congress and the American people need to see results in terms of reduced illnesses, hospitalizations and deaths,” the committee members added.
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Bill, 2019