Biden 2022 budget wish list calls for Medicare negotiations on drug prices, new $6.5B NIH agency
President Joe Biden late last week released his FY 2022 budget plan, calling for Medicare to negotiate payment for certain high-cost drugs, in addition to the creation of a new NIH agency to develop next-gen biomedical breakthroughs, and a slight increase in FDA funding.
“The President supports reforms that would bring down drug prices by letting Medicare negotiate payment for certain high-cost drugs and requiring manufacturers to pay rebates when drug prices rise faster than inflation,” the budget says, offering few details on how to accomplish these reforms but noting that they could “yield over half a trillion in Federal savings over 10 years.”
House Energy & Commerce Committee chair Frank Pallone (D-NJ) praised the announcement on reining in drug prices, adding, “The days of Americans paying three to four times more than people in other countries for the same prescription drugs are numbered.”
While the overall plan offers mostly a high-level wish list for Congress to mull over as it decides how to fund the government next year, both FDA and NIH provided details on what they’re looking into.
Chief among the new additions is a request for $6.5 billion to create a new, NIH-based Advanced Research Projects Agency for Health (ARPA-H), tasked with developing new ways to help prevent, detect, and treat diseases like cancer, diabetes, and Alzheimer’s. While there may be some crossover between this agency and other NIH research at the NCI and elsewhere, the new agency will use term-limited program managers and a federal advisory panel for interagency coordination and idea generation.
“Potential areas of transformative research driven by ARPA-H include an ‘innovation funnel’ for accurate, wearable, ambulatory blood pressure technology, preparation of mRNA vaccines against common forms of cancer, or accelerating development of efficient gene/drug delivery systems to target any organ, tissue, or cell type – a zip code for the human body,” NIH said.
Modeled after the Defense Advanced Research Projects Agency (DARPA), the new agency could be a boon for the biopharma industry, as NIH explains most of the funding from ARPA-H will go to industry, universities, and nonprofit researchers.
As the NIH seeks to add this new $6.5 billion agency, the FDA’s FY 2022 total budget request is for $6.5 billion, which would be an increase of $343 million in budget authority (outside of user fees).
An additional $75.9 million will support the FDA’s data modernization work, about $39 million will go to opioids-related efforts, an increase of $18.8 million will help address the FDA inspections delayed by the pandemic, $5.6 million will go for more drug safety surveillance and oversight, and $4.7 million more will go to enhancing FDA’s ability to support and expand health equity and health disparity efforts.
In terms of safety surveillance, the FDA notes that it “currently faces significant challenges to its ability to maintain an efficient and effective postmarket safety surveillance program. Staffing levels have not kept pace with the increasing amount of postmarket work from the growing number and complexities of recent approvals, and the increasing amount of data needing review.”
FDA also says it will assemble a multidisciplinary team of regulatory counsels, project managers, and scientists to craft a risk-based approach to determining what types of scientifically valid information the agency requires industry to submit, and how that information will be used.
“This approach—which will be dynamic—may factor in differential risks including those associated with active pharmaceutical ingredients, excipients, or delivery mechanisms. FDA’s goal with these efforts is to determine which set of information we can both require of industry and utilize internally to maximize the value of data that we receive, while considering the legal, financial, and economic burdens imposed on all stakeholders. This team will evolve into a permanent, cross-discipline function dedicated to post-market safety policy,” the FDA said.
In terms of legislative proposals, the agency seeks to further clarify the FDA’s authority to require information that would improve its ability to assess pharmaceutical critical infrastructure as well as manufacturing quality and capacity.
“For example, FDA is seeking to require detailed drug listings on a quarterly basis for finished drug product or in-process material, regardless of whether they were directly or indirectly imported into the U.S.,” the agency says.
The FDA also notes that it currently has limited authority to request records and other information in advance of or in lieu of drug inspections, and it seeks to expand FDA’s authority in this capacity. The agency also seeks to amend the FD&C Act, to allow for the disclosure of certain non-public information to state, local, and US territorial government agencies.
Meanwhile, as gene and cell-based therapies continue to be submitted to the agency, the FDA’s Center for Biologics Evaluation and Research is requesting $900,000 to accelerate efforts to modernize and streamline the review of these complex biologics. CBER also says it’s developing a regulatory program for individualized therapies and fostering global regulatory convergence for cell and gene therapies.
To help that cause, NIH notes that it’s also working to resolve a production bottleneck for gene-based therapies as wait times to produce vector therapies that meet the manufacturing standards necessary for clinical trials are long, often one to two years.