We hope a common theme emerges from this blog and our public interactions: it is vital when planning 505(b)(2) drug development to look at the entire therapeutic class to learn what studies are needed for approval of the drug . Not including the class in your background of public information can be suicidal.
FDA regulates drugs as a class: drugs for a certain indication get lumped together for regulatory purposes. Maybe it doesn’t always make medical or scientific sense, but this is what industry faces. A case in point is Monday’s (June 2) meeting between FDA and the Epilepsy Study Consortium, a group of pharma companies with drugs for epilepsy. FDA wants to add a warning for suicidal behavior on the labeling for all epilepsy drugs, despite industry saying the warning should be based on each drug.
FDA presented data based on a grouped analysis of 199 clinical studies showing statistically significant difference in suicidal tendencies for patients who have taken one of the 11 epilepsy drugs on the market. The risk for patients taking placebo was 0.23% while those taking an epilepsy drug is was 0.37% – a small difference to be sure.
GlaxoSmithKline, UCB and Pfizer all presented data showing that they had no such signal for their drugs. Each company would prefer to avoid so-called class labeling, where the warning would be on on the label for all epilepsy drugs. Clearly, the market might start to think all of the 11 drugs are the same in other regards.
The FDA is going to hold an advisory committee meeting in July.
Camargo highly recommends that before embarking on a 505(b)(2) drug product development that you examine the entire therapeutic class for the public information used to support safety and efficacy. Examining only the public literature about your drug may cause you to miss ‘signals’ that need to be addressed by your studies for approval. For instance, you might be tempted to rely on ibuprofen-related literature, but in reality, FDA’s DAARP regulates this drug as another NSAID. Thus, you need to look at all NSAIDs for guidance on what studies you need to do.