In their 15-year data analysis, authors Sana Mostaghim, Joshua Gagne and Aaron Kesselheim of the Regulatory, Therapeutic and Legal (PORTAL) Program at Brigham and Women's Hospital and Harvard Medical School found that the fastest drug approvals had a higher percentage of tag changes related to safety than those approved for non-accelerated routes.
"More research is needed to understand the underlying factors of the process that contribute to the differential rates in the safety changes that were observed in this analysis," the authors added. "Policymakers are likely to need to ensure that these channels are not overused, that there is sufficient oversight of post-approval compliance approved by these channels, and that patients and clinicians are fully exposed to the risks associated with the widespread use of accelerated development and channels of regulatory review in the approval of new drugs. "
With the implementation of 21st Century Curative legislation, more treatments are expected to receive rapid approvals, especially regenerative medications.
The authors point out that increasing safety tag changes underscore the importance of accelerated follow-up of approved drugs "to help identify emerging problems that require a change in the safety tag as soon as possible," write the authors.
And while drugs that accelerate approval usually include a statement about "clinical benefit ... not established" because of "dependence on an incomplete validated measure," the authors suggest that there must also be formal requirements for manufacturers warn patients about the higher rate of subsequent changes in the safety labeling of drugs approved by channels of accelerated adoption, fast path or priority.
The authors also point out several limitations to their research, including that the rate of safety changes "does not provide a qualitative assessment of the clinical relevance of a particular change.
"For example, adding the" risk of serious cardiovascular events "to the boxed warning of a label in which already had cardiovascular outcomes mentioned could have less clinical impact than the addition of new psychiatric secondary effects that were not included in this section the label, "they write. "Such a qualitative analysis of label changes is complicated by the fact that in some cases the FDA only indicates that a change has been made, but it presents the whole section of the label and in others it emphasizes or italicizes the text but does not indicates what has been changed The FDA's clarity about the exact nature of each label change and the number of changes each month would be helpful in resolving these issues.
