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# Reps. Question FDA Pace for New Covid Therapeutics
- URL: https://www.fdaweb.com/reps-question-fda-pace-for-new-covid-therapeutics/
- Published: 2023-05-03T12:00:00.000Z
- Updated: 2026-09-14T18:29:16.000Z
- Author: David McFarland
- Tags: Biologics, Drugs, #legacy-id-D5154363

Reps. **Lori Trahan** (D-MA) and **Dan Crenshaw** (R-TX) say they are concerned about FDA’s pace for authorizing and approving updated Covid-19 therapeutics. In a 5/3 [letter](https://trahan.house.gov/uploadedfiles/final-final-crenshaw-trahan-letter-to-fda-re-covid-19-therapeutic-platform-approval-pdf.pdf?ref=fdaweb.com) to FDA commissioner **Robert Califf**, the two say that while FDA has modernized its process in the past for flu vaccines and pioneered the Operation Warp Speed public/private partnership for Covid vaccines, “we fear it has not provided the same attention to other interventions. Of particular interest are therapies that do not rely on the health of a patient’s immune system to provide benefit, such as oral antivirals, IV antivirals, and monoclonal antibody therapies.”

Trahan and Crenshaw say their greatest fear is that new variants are developing faster than current FDA emergency use authorization reviews can be completed, all despite the continued innovation to update drugs and biologics for a changing virus.

The members ask for answers to these questions:

- whether FDA will consider a platform approach for authorizing and approving updated monoclonal antibodies or antivirals;
- whether FDA is open to using language from the 117th Congress creating a platform designation program for technologies reviewed by FDA for the review of products that treat and prevent Covid-19;
- the steps FDA is taking to work with healthcare providers and identify supply chain and delivery barriers and resolve them to increase the availability of monoclonal antibodies and antivirals;
- whether streamlining the clinical data package makes sense for updated treatment and prevention options, particularly for targeted populations with unmet medical need and a high risk of poor outcomes; and
- the recent changes that have been made to the authorization process, recognizing that many of the therapeutics are aimed at a high-risk population with the highest likelihood of benefits.