Examination of the relationship between oncology drug labeling revision frequency and FDA product categorization.

University of Minnesota, Minneapolis, USA.
American Journal of Public Health (Impact Factor: 4.23). 05/2009; 99(9):1693-8. DOI: 10.2105/AJPH.2008.141010
Source: PubMed

ABSTRACT I examined the relationship between the Food and Drug Administration's (FDA's) use of special regulatory designations and the frequency with which labels of oncology drugs are revised to explore how the FDA's designation of products relates to product development and refinement.
One hundred oncology drugs, designated by the FDA as accelerated approval, priority review, orphan drug, or traditional review, were identified from publicly available information. Drug information for each product was evaluated to assess the rate at which manufacturers revised product labeling. Rates were compared between specially categorized products and traditional review products (e.g., orphan vs nonorphan drugs) to produce revision rate ratios for each special category.
Labeling for accelerated approval and priority review products are revised significantly more frequently than are labels for traditional products.
Accelerated approval products are approved based on surrogate endpoints; this approval process anticipates subsequent labeling refinement. Priority review products, however, are approved through a process that is ostensibly as rigorous as traditional review. Their higher than expected label revision rate may suggest deficiencies in the FDA's current priority review evaluation processes.

  • Source
    Archives of internal medicine 10/2012; 172(21):1-2. DOI:10.1001/archinternmed.2012.4444 · 13.25 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: We compared, and determined the reasons for any differences in, the review and approval times of tyrosine kinase inhibitors (TKI) by the FDA and the EMA/CHMP. Applications for these novel cancer drugs were submitted to them within a mean of 31.2 days of each other, providing a fair basis for comparison. The FDA had granted priority review to 12 TKIs but the EMA/CHMP did not grant the equivalent accelerated assessment to any. The FDA granted accelerated approvals to 6 (38%) and CHMP granted (the equivalent) conditional approvals to 4 (29%) of these agents. On average, the review and approval times were 205.3 days in the US compared to 409.6 days in the EU. The active 225.4 days in the EU and 205.3 days in the US). Since oncology drug development lasts about 7 years, the 20-days difference in review times between the two agencies is inconsequential. Clock stops during review and the time required to issue an approval had added the extra 184.2 days to review times, however were comparable (review time in the EU. We suggest possible solutions to expedite the EU review and approval processes. However, post-marketing emergence of adverse efficacy and safety data on gefitinib and lapatinib, respectively, indicate potential risks of expedited approvals. We challenge the widely prevalent myth that early approval translates into early access or beneficial impact on public health. Both the agencies collaborate closely but conduct independent assessments and make decisions based on distinct legislation, procedures, precedents, and societal expectations.
    British Journal of Clinical Pharmacology 01/2013; 76(3). DOI:10.1111/bcp.12085 · 3.69 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Studying drugs withdrawn from the market for safety reasons can help in evaluating the strengths and weaknesses of the pre- and post-market safety evaluation systems. This study considered 2 questions: Has there been a change over time in the percentage of new drugs that are eventually withdrawn because of safety reasons? How long are new drugs on the market before their serious safety problems are recognized?
Show more


Available from