Industry Fears FDA May Monkey With ‘Independent’ Audit of Reviews

September 21, 2012
Drugmakers worry that the FDA doesn’t plan to conduct an honest review of its new drug review program in an upcoming audit. To head off a whitewashing of the review, PhRMA and BIO are calling on the FDA to confirm the independence of the third-party contractor it will use to audit the new drug review process under the Prescription Drug User Fee Act (PDUFA).

The new review process adds 60 days to the review clock for new molecular entity (NME) NDAs and original BLAs and is supposed to result in more first-cycle decisions for drugmakers.

But the trade groups are worried they won’t get an accurate picture of the program’s success. The FDA’s draft work plan allows it too much wiggle room to influence the outcome of a required independent assessment of the program, PhRMA and BIO said in comments to the draft.

The agency’s intention to require the appraiser to share draft outputs and “revise based on FDA feedback” will effectively close off communication from other key stakeholders, the groups said. Instead, the contractor should have discretion to incorporate FDA revisions on a case-by-case basis, BIO suggested.

It would take weeks to read and digest the regulatory changes drugmakers face under the new PDUFA law —  changes that may upend the way you do business. With some of the changes going into effect this year, you won’t want to wait that long.

Don’t waste countless hours researching all the changes PDUFA has in store for your business. Order your copy of FDAnews’ PDUFA V: A Drugmaker’s Guide to Provisions in the New Law.