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# FDA Pushed Into Accelerated Approval Pricing Model
- URL: https://www.fdaweb.com/fda-pushed-into-accelerated-approval-pricing-model/
- Published: 2023-02-15T12:00:00.000Z
- Updated: 2026-09-14T18:16:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153781

While FDA historically stays out of debates about drug prices and it has no legal authority to investigate or control such prices, it is now being tasked to work with CMS’ Innovation Center to test a proposed model that would adjust Medicare payments for accelerated approval program (AAP) drugs. “Working in consultation with FDA, CMS could consider various approaches to adjust payments to the provider for AAP drugs, seeking to balance incentives for developing novel treatments with potential harms of delayed confirmatory clinical trials,” according to a new [HHS report (begins pg. 14).](https://innovation.cms.gov/data-and-reports/2023/eo-rx-drug-cost-response-report?ref=fdaweb.com) The model is intended to incentivize drug manufacturers to expedite and complete confirmatory clinical trials.

The proposed model is in response to a 10/22022 Biden Administration Executive Order entitled “Lowering Prescription Drug Costs for Americans.” The pricing structure would be designed to “avoid penalizing physicians or beneficiaries for choosing (or avoiding) an accelerated approval treatment,” the report says. “By incentivizing timely confirmatory trial completion, CMS could enable improved access to post-market safety and efficacy data.” The model will attempt to answer the following:

- Do targeted adjustments on payments for AAP drugs accelerate confirmatory trial completion?
- Will adjustments help provide timely information on the safety and effectiveness of AAP drugs on the market?
- Will adjustments facilitate earlier withdrawals of AAP drugs when appropriate?
- Will it reduce Medicare spending on drugs that do not have confirmed clinical benefit?

FDA’s accelerated approval program has drawn increased scrutiny in the past few years, particularly over drug makers’ not being as diligent as they should be in completing confirmatory trials. Late last year, the program won FDA-sought legislative reforms in the omnibus spending bill ([see earlier story](https://www.fdaweb.com/fda-reforms-included-in-year-end-omnibus-bill/)).

The HHS report notes that as of 5/2022, 104 out of the 278 accelerated-approved drugs have incomplete confirmatory trials. “From 2018 to 2021, Medicare and Medicaid together spent an estimated $18 billion on AAP therapies that were past their originally scheduled confirmatory trial completion date,” it says. “Given the increasing number of AAP approvals, some experts are concerned the number of past-due trials may continue to increase.

“Although the FDA has authority to issue civil money penalties (CMPs) against sponsors for ‘failure to conduct’ a confirmatory study required under accelerated approval and can withdraw an accelerated approval if a required confirmatory study is not conducted with due diligence or fails to verify clinical benefit,” the report continues, “imposing CMPs and withdrawing approval both involve lengthy procedures. In addition, once a product is on the market and established in clinical practice, physicians and patient groups may oppose the FDA’s recommendation for a withdrawal, even once there is a failure of a confirmatory trial.”

Additionally, the report notes that HHS has directed CMS’ Innovation Center to continue to evaluate potential models in other areas, such as accelerating biosimilar adoption to lower Medicare costs. So far, 40 biosimilar products have received FDA approval, and only 21 products have commercially launched, it says. “As of 2021, only half of the 11 reference products with biosimilar competition have given up over 50% of their market share to biosimilars,” it says, adding that biosimilar acceptance in the U.S. currently lags other comparable countries.