CDER Deputy Director Bob Temple is a confirmed skeptic of the value of observational trial data to FDA’s regulatory decisions. A recent Medicare study on the bleeding risks associated with Boehringer-Ingelheim’s Pradaxa, however, confirmed an earlier position on the drug by FDA and meets with Temple’s approbation.

Pfizer’s long-term safety outcome study comparing Celebrex, ibuprofen and naproxen has its flaws, but FDA advisory committee says its data will be far superior to meta-analyses or observational studies.

FDA’s Arthritis and Drug Safety and Risk Management advisory committees on Feb. 10-11 will examine cardiovascular risk data for non-steroidal anti-inflammatory drugs, including meta-analyses indicating naproxen could have a better safety profile than other OTC ingredients ibuprofen and ketoprofen.