FDA Asks Drugmakers: Where Are Those Pediatric Studies?
A decade ago, the Pediatric Research Equity Act was enacted and gave the FDA the authority to require drugmakers to complete studies in children for the same adult indications when existing medicines are expected to be used in a substantial number of youngsters (read more here). And last year, the agency was given the right to shame drugmakers that fail to comply. And so, the FDA has now posted on its web site a batch of letters that were recently sent to drugmakers that have not sought or obtained a deferral extension; submitted a deferred pediatric study by a final due date or requested approval for a required pediatric formulation. An even dozen ‘non-compliance’ letters were sent to nine different drugmakers between April and October. Among those receiving letters was Genzyme, the Sanofi (SNY) unit, which the FDA actually sited in three separate instances. Pfizer (PFE) received two such letters concerning the Protonix proton pump inhibitor. And another was sent to Purdue Pharma, which subsequently wrote the FDA to say that there are plans to reformulate and relaunch Palladone, a narcotic painkiller that was pulled in 2005 over side effects that occurred when taken with alcohol (see this). All but one of the drugmakers has responded to the agency. The exception was Tris Pharma, which was sent a letter on October 3. The other drugmakers generally replied to the FDA within a few weeks of receiving an agency missive. We contacted Tris Pharma for an explanation as to why th...
Source: Pharmalot - Category: Pharma Commentators Authors: esilverman Source Type: blogs
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