Since Congress has returned from its July 4th recess, there has been a flurry of activity on rare disease-related policy issues. We want to update you on important developments relating to key discussions that we’re following closely.
User Fee Reauthorization
The House passed the Food and Drug Amendments of 2022 Act in June, while the Senate version of the combined FDA user fee reauthorization legislation, the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022, appears to have stalled after being advanced out of the HELP Committee on June 14th. This week, user fee activity picked back up as HELP Ranking Member, Senator Burr (NC), introduced a “clean” user fee reauthorization bill that is stripped of most policy reforms included in the original House and Senate bills.
The introduction of this pared down version could mean there are deeper disagreements in the Senate over high profile policy changes included in the original FDASLA bill, but it is unlikely that the years of negotiation, thorough policy vetting and community advocacy that went into forming the user fee bills will be tossed out in favor of a bill that simply establishes the user fee amounts, timeline commitments and necessary program reauthorizations. Already, leaders within the House of Representatives have indicated that key provisions reflecting the broader package must be considered before this process is finalized.
The user fee legislation is must-pass legislation and activity on Capitol Hill is intensifying. We anticipate that there will be much more activity over the coming days and weeks. We will alert you to key windows of opportunity to engage and make our voices heard.
Orphan Drug Tax Credit and Reconciliation
Last year, as part of the efforts to pass a budget reconciliation bill, a policy proposal emerged that will negatively impact the rare disease community. While the reconciliation efforts did not advance, Congress is now discussing a revitalized reconciliation bill that could contain major changes to the Orphan Drug Tax Credit (ODTC).
While we have not yet seen a revised version of the reconciliation bill under consideration, the time to make your voices heard is now. The changes previously proposed in late 2021 would limit the ODTC to apply only for clinical testing expenses for the first approval of a rare disease drug. This provision would fundamentally alter the rare disease pipeline and discourage companies from pursuing further clinical programs to test approved therapies in new disease areas. Investment in further research improves the lives of the most vulnerable rare disease patients and offers clinicians and insurers the evidence needed to guide treatment recommendations.
As an advocate for patients with rare diseases, your voice can make a difference. As the Congress continues to debate the reconciliation bill, we urge you to speak up and let our elected representatives know the rare disease community does not want changes to the ODTC.
