Public Often in the Dark About Why FDA Rejects Drugs
Drugmakers typically do not publicly disclose the reasons why some medications are not approved by FDA, even though the treatments often are rejected because of concerns about the their safety and effectiveness, according to a study published last week in BMJ. The study found drugmakers often did not make any announcements about rejections or omitted a majority of the reasons why FDA denied approval. Peter Lurie -- FDA's associate commissioner for public health strategy and analysis and the study's lead author -- said sharing more details about complete response letters would help to bolster transparency and stave off misconceptions about why new drugs are rejected.
- "Public Rarely Knows Full Reason FDA Rejects New Drugs" (Rapaport, Reuters, 6/16).