Haste Makes Waste: Merck Serono May Have Rushed Cladribine NDA

In an effort to market the first FDA-approved oral treatment for multiple sclerosis, Merck Serono may have submitted an incomplete NDA for cladribine. The suggestion is provided by the consistently informative and entertaining* In Vivo Blog.

Although the FDA has not publicly addressed its refusal to file Merck Serono's cladribine NDA, the agency's John Jenkins, director of the Office of New Drugs, provides a hint, according to the blog. Yesterday, during the FDA/CMS Summit, Jenkins addressed the agency's refuse-to-file notifications and a primary reason for drawing them up.

Jenkins implicitly chastised pharma for submitting incomplete NDAs and then providing additional information during the drug-review process—which may require an extension owing to the lack of necessary data.** Jenkins reportedly said that pharma execs who delay the submission of an NDA to ensure its completeness will ultimately save themselves time.

NDA = new drug application; PDUFA = Prescription Drug User Free Act.

* Hey, In Vivo Blog, you can quote the flattery.

** And thereby violates the 6-month "PDUFA clock."