FDA reports lack of interest, high rejection rate for its STAR program

The US Food and Drug Administration (FDA) said there is "minimal industry interest" from companies to participate in its Split Real Time Application Review (STAR) pilot program for drugs and biologics. Companies that have sought to participate have witnessed a high rate of rejections.

“Despite several FDA presentations on STAR, and the program's availability across all therapeutic areas and review disciplines in CDER and CBER, FDA observed minimal industry interest in the program during the assessment period, as evidenced by the limited number of STAR Entry requests received. Additionally, none of the requests received met the criteria for acceptance into the pilot program. As a result, FDA received no applications in the pilot program as of the end of FY2025,” FDA said.

Nevertheless, the program will continue until 30 September 2027, the agency said in an update on the program.

Since its inception in October 2022 until 30 September 2025, FDA said it received just six requests to participate in the program, all of which for products to be reviewed by its Center for Drug Evaluation and Research (CDER). There were no requests made for products regulated by the Center for Biologics Evaluation and Research (CBER) during the same time period.

Of those requests, one was voluntarily withdrawn by the sponsor and the other five were rejected because they did not meet at least one of the established eligibility criteria for the program.

All of the requests received were for efficacy supplements; there were no submissions for original new drug applications (NDAs) or new biologics license applications (BLAs).

The program is meant to expedite patient access to therapies addressing an unmet medical need by allowing a “split” submission and earlier review of data. This program was established by the seventh iteration of the Prescription Drug User Fee Act. (PDUFA VII).

The program was first announced in October 2022 and was initially available only for specific efficacy supplements related to existing drugs and biologics that addressed unmet medical needs. Later, in November 2024, the program was expanded to include original applications. (RELATED: FDA offers details on PDUFA VII STAR review pilot, Regulatory Focus 4 October 2022; RELATED: FDA to test STAR pilot for original applications, Regulatory Focus 5 November 2024)

Applications were denied for the following reasons: a lack of clinical evidence from adequate and well-controlled investigations showing substantial improvement on a clinically relevant endpoint compared to available therapies; failure to address a serious condition with an unmet medical need; and the presence of one or more aspects of the proposed marketing application that would necessitate longer review timelines.

FDA noted that its efforts to expand the program to include NDAs and BLAs have not been successful, as the agency did not receive any formal requests to participate in the STAR-like initiative for original marketing applications. The agency said that “this outcome further reinforces the limited industry interest in the STAR pilot program and suggests that barriers to participation or lack of perceived value extend beyond the scope of efficacy supplements alone.”

A survey conducted during a February 2024 webinar by the FDA, with 39 respondents, provided “valuable insights” into industry perspectives on the program.

A majority of respondents (65%) expressed interest in applying to the STAR pilot program. However, participants also reported facing significant barriers that hindered their participation. Additionally, 67% of respondents indicated a preference for the Real Time Oncology Review (RTOR) program over STAR for oncologic drug development programs.

FDA announced that “given the lack of applications entering the STAR pilot program, FDA is unable to conduct a comprehensive assessment of the program's experiences, internal operational impacts, and clinical or regulatory outcomes.”

Despite the lack of interest, the FDA has announced that the STAR program will continue to be available for efficacy supplements throughout the remainder of the PDUFA VII commitment period, as outlined in the PDUFA VII commitment letter. The agency plans to evaluate the future of the pilot program during the negotiations for PDUFA VIII.

STAR program

FDA reports lack of interest, high rejection rate for its STAR program

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