Axed legal reviews jeopardize regulatory consistency

When it comes to the FDA's recent decision to forgo legal reviews prior to sending warning letters, there's good news and bad news.

The good news is that manufacturers who are in violation of good manufacturing practices will get their warning letters sooner. That's good news because it means they can't go very far down any wrong paths as they attempt to correct the deficiencies discovered by the FDA and documented on a Form 483, says Jim Prutow, a partner in consultancy PRTM's healthcare practice, in a phone interview. A company that thinks it's on the right track in implementing fixes based on its interpretation of a Form 483 could find out that it's not once the warning letter arrives. And that could sometimes be months later.

However, the bad news is that manufacturers stand to lose district-to-district continuity, Prutow says. The legal review ensured a center review, which largely eliminated the problem of one district issuing warnings for something that another district wouldn't. "You want consistency across the country," Prutow says. "Legal reviews gave the FDA the opportunity for that consistency."

Prutow also notes that a warning letter is "a big step up" from a Form 483 inspection observations report. "Districts could overstep their authority," he says.