Pharma Blog Watch

Approvable Letter for Wyeth's Pristiq (Eye on FDA)
In his blog, Mark Senak writes about the FDA's approvable letter for Wyeth's depression drug Pristiq. "While no new studies are required preapproval, there are postapproval studies to which the company will have to commit in order to gain approval. The FDA currently has no authority to enforce postmarketing studies."

"The studies outlined are certainly admirable, but it is interesting to note the length to which the FDA is asking for specific studies in postmarketing commitments — from long-term use to pediatric studies," he writes. "Should the agency actually get such authority from this reform-minded Congress, it will be interesting to see how these commitments are enforced, and this approvable letter serves as insight on how the agency might approach the issue."

Assessing Drug Development (DrugWonks)
Fresh from the Med Ad News Drug Development Summit, Robert Goldberg discusses the current state of drug development. Companies are "refilling their pipelines with new drugs that will hit new targets for unmet medical needs in areas like Alzheimer's, cancer, schizophrenia, Parkinson's, respiratory infections and stroke" and "doing a better job of weeding out medicines that won't work or would 'fail' because of toxicity issues." Additionally, drugmakers are "interested in doing more collaborative work to identify biomarkers, both efficacy and safety."

"The takeaway: This is an industry furiously seeking to change," he writes. "The question is, why do so many people still believe that drug companies are sitting on cures for diseases so they can make money?"