New Drug Applications: FDA Increases Focus on Data Integrity
Posted on: Tuesday, 4 March 2008, 12:00 CST
The fact that the New Drug Application for Theravance's antibiotic is being delayed by further investigations into monitoring issues at its study sites shows that the FDA is getting serious about reconsidering its drug approval processes.
The approval of telavancin, an antibiotic in development for the treatment of complicated skin and skin structure infections, has been delayed after the FDA informed manufacturer Theravance that it needs more time to further evaluate the drug.
The agency said that it needs more data with regards to study site monitoring and study conduct to ensure data integrity in telavancin's ATLAS Phase III program. The planned review by the Anti-Infective Drugs Advisory Committee (AIDAC) was cancelled on February 23, only four days before the review was due to take place. The FDA indicated that, due to study monitoring issues at a single study site managed by the primary contract research organization for the ATLAS program, the agency intends to evaluate additional sites, and that more questions could arise after further evaluation.
It is not a coincidence that the FDA now focuses on data integrity issues: the agency's credibility took a serious hit when Sanofi-Aventis's antibiotic Ketek (telithromycin) led to the death of five patients. Although the drug was given a black box warning, many critics questioned whether faulty data and fraud were involved in the FDA's approval process for the drug. Consequently, Iowa Republican Senator Chuck Grassley issued new rules for drug approval processes, stipulating that the FDA cannot continue to consider an approval application where there is even a hint of data integrity problems.
In the case of Theravance, the FDA adopted this new rule unequivocally by informing the company that it was unwilling to review the application after it had removed data from one study site. This decision related directly to a letter sent by Grassley to the FDA on December 19, stating that a sponsor cannot resolve a data integrity issue by simply removing the results from the questioned center or investigator.
Although it is unclear to what extent these new rules may delay or even prevent a drug from reaching the market, other NDA sponsors would be well advised to be more scrupulous with regards to their data integrity issues: judging from its response to the telavancin trials, the FDA is clearly gearing up towards an overall revision of its drug approval processes.
Source: Datamonitor
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