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Drugmakers Question FDA's Integrity

Pharmaceutical and biotech companies ask the US Food and Drug Administration to ensure the independence of a third-party audit of its new drug program.

By | September 26, 2012

image: Drugmakers Question FDA's Integrity Flickr Creative Commons, .v1ctor.

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 that seem to give the agency the ability to revise the independent contractors review, or workplan. The trade group implored the agency to assure drugmakers that the independent contractor conducting the review would in fact remain independent. "We request that FDA clarify in the final statement of work that as an independent entity, the Contractor is not required to adopt FDA’s proposed revisions to the workplan, proposed data collection and analysis methodologies, interim and final assessments, or presentations to the public," BIO wrote. "In order to maintain the independence, autonomy, and credibility of the Contractor, the statement of work should explicitly acknowledge that FDA does not have authority to overrule the decisions of the Contractor regarding the conduct and outcomes of the assessment."

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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