Negotiations over the fifth reauthorization of the Prescription Drug User Fee Act haven’t formally begun, but one item is sure to be discussed: a process for allowing the Food & Drug Administration to release more information about a sponsor’s pending application—including the contents of a “complete response” letter when FDA declines to approve a new product.

Career officials have long wanted greater transparency, and FDA Commissioner Margaret Hamburg agrees that change is inevitable. Recommendations from FDA’s Transparency Task Force are due out early this year, and it’s quite likely that making regulatory letters public will be on the list.

That’s where the PDUFA reauthorization process comes in. All things being equal, biopharma companies would probably prefer the status quo. But if the letters are going to be made public, they want to make sure it is on their terms: as part of a process that allows for redaction of genuine trade secrets, one that treats all sponsors equally.

The reauthorization of the user fee act in 2012 presents a perfect opportunity to talk about transparency. That leaves plenty of time for stakeholders to prepare.