In the run up to an evaluation of a new drug review process at the US Food and Drug Administration (FDA), pharmaceutical industry trade groups are calling on the federal agency to vouch for the independence of the third party contractor conducting the audit. The independent contractor will evaluate the agency's New Molecular Entity (NME) Review Program—a model enacted by the latest version of the Prescription Drug User Fee Act (PDUFA V) meant to speed the approval of drugs and get them onto the market quicker. While the industry is largely in favor of the new program, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Industry Organization (BIO), trade groups representing thousands of drugmakers, worry that the FDA will have too much leeway to edit or revise the contractor's report.
In an open letter to the FDA, BIO cited several mentions in the PDUFA V commitment letter...
According to FDANews, both BIO and PhRMA worry that the potential back and forth between the contractor and the FDA will effectively shut out other key stakeholders from the NME evaluation, tarnishing the independence of the audit.
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