By Nicole D. Prysby, J.D.
The GAO released a report identifying factors that may contribute to the approval of generic drugs in the first review cycle and suggesting steps that the FDA should take to increase the approval rate.
The U.S. Government Accountability Office (GAO) has released a report to Congressional Committees on factors that may contribute whether a generic drug application is approved in the first review cycle. The report also recommends steps the FDA should take to improve the approval rate. Factors found to be contributing to the approval rate were the sufficiency of the application, deficiencies in drug quality, the type of drug reviewed, the application’s priority status, and the type of drug. While the FDA has taken some steps to increase approval rates, it should take additional steps such as improving consistency among generic drug application reviewers and assessing the effects of the timing of brand-name companies’ changes to labeling (GAO Report, GAO-19-565, August 2019).
The GAO undertook the study pursuant to a directive in the FDA Reauthorization Act of 2017 that it study issues regarding the approval of generic drug applications in the first review cycle. The study (using data from 2015-2017) examined the first review cycle approval rate of generic drug applications and factors that may have contributed to approvals, as well as changes FDA has made to increase the first review cycle approval rate.
The GAO discovered that 12 percent of the 2,030 generic drug applications FDA received in 2015-2017 received approval in the first review cycle. Several factors contributed to this approval rate, including the sufficiency of the application, deficiencies in drug quality, the type of drug reviewed, and the application’s priority status. The sufficiency of the application may reflect the experience of the applicant and applications that were previously refused were slightly less likely to be approved in the first review cycle than those that had not. The most common deficiency remaining at the end of the first review cycle was drug quality, such as issues relating to the manufacturing facility. The rate of approval also differed based on the type of drug. For example, drugs that are dispensed through a delivery device (such as an asthma inhaler) are less likely to be approved in the first review cycle. Topical drugs were more likely to be approved in the first review cycle, possibly as a result of FDA product-specific guidance for those products. A generic drug application’s priority review status may affect the rate of approval in the first review cycle.
The FDA has taken some steps to increase the rates of approval for generic drugs in the first review cycle, including providing product-specific guidance, regulatory guidance, outreach to industry, and assistance with applications for complex drugs. The GAO recommended that the FDA take additional steps to address inconsistency in its written comments to generic drug application sponsors and assess the extent to which the timing of brand-name drug companies’ drug labeling changes affects the approval of generic drugs and take action, as appropriate, to limit the effect. HHS concurred with the recommendations.
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