Omnibus Spending Package Makes FDA Diversity Plans, Confirmatory Trials Mandatory
With President Joe Biden signing into law a massive $1.7 trillion omnibus spending package last week, a number of clinical trial-related changes — including new trial diversity provisions and updates to the accelerated approval pathway — and increased FDA funding come into play in the new year.
Most significantly, the spending bill’s passage means the FDA will make mandatory its current recommendation that sponsors file diversity action plans alongside phase 3 trials submitted to the agency. The new law does give the FDA some flexibility to exempt certain trials from this requirement, such as trials of rare diseases for which diversity plans may be unrealistic.
The law also directs the FDA to issue final guidance on trial diversity, an effort the agency began last April with a 12-page draft guidance explaining how it would assess diversity plans as significant components of development programs (CenterWatch Weekly, April 18, 2022).
Updated guidances on decentralized trials and digital health tools are now also on the FDA’s agenda as a result of the bill’s passage.
Also included in the package are the first-ever legislative reforms to the accelerated approval (AA) program. These reforms allow the FDA to insist that drugmakers have confirmatory trials underway before it agrees to grant approval. The agency now also has expedited procedures for withdrawing an AA, though sponsors are still allowed to request an advisory committee meeting when withdrawal is being considered.
Sponsors will need to submit reports on the progress of their confirmatory trials six months after earning AA that include information on “progress toward enrollment targets, milestones and other information as required.” And the FDA must assemble an intra-agency coordinating council that will be tasked with ensuring “the consistent and appropriate use of accelerated approval.”
The FDA itself will receive $3.5 billion in appropriations, a marked boost of $226 million, or 6.5 percent, over fiscal 2022 funding.