As Weâ€™re Aging, FDAâ€™s Accelerating
In a regulated industry, the newsmaker is often the regulator. So, at the risk of being predictable, I say the biggest story about the last 10 years is FDA and how it’s changed.
In the March 1994 issue of PMP News, Jim Wagner wrote a feature on FDA’s sluggish product reviews. Wagner was then manager of PMP News’s editorial and marketing and would soon become editor. Also, he wrote, FDA “has tightened up its role as policeman, and it appears it will continue to batten down the hatches in 1994 and beyond.”
I wasn’t at all surprised to find this article during my review of back issues of PMP News. In 1994 I had joined Medical Device & Diagnostic Industry, now PMP News’s sister publication. I would shortly learn about efforts to speed FDA review times.
But, just as I was reading back articles about FDA being a “tough-minded regulator,” one that was described as rejecting applications, “costing months, possibly years,” I recalled how much things have changed. Just before I started work on this issue, I had listened to Commissioner Mark B. McClellan during an industry conference call describe the agency’s progress in modernizing its drug GMPs. FDA wants to ensure that “regulatory review, compliance, and inspection policies are based on state-of-the-art pharmaceutical science and do not impede rapid adoption of new technological advances.” It also “promises to enhance safety and quality in drug manufacturing while increasing efficiencies.”
Could this science-and-efficiency-friendly agency be the same one that Wagner wrote about? It certainly is different from the one under David Kessler, the commissioner in 1994. Wagner had hinted then that Kessler could have been more “industry friendly.”
I recently spoke to Wagner, who now leads another sister book to PMP News, Nutritional Outlook. “During the Kessler years, FDA was more police force than partner,” he says. “FDA was most concerned with enforcement.”
FDA is now certainly more “industry friendly,” at least in terms of considering the challenges manufacturers face. Take the agency’s withdrawal of its guidances on 21 CFR Part 11. It realized its rules for electronic recordkeeping, archiving, and copying were more trouble to industry than the efficiency in using such records was worth in the first place.
Still, FDA expects more from drug and device firms than it did 10 years ago. “Validation protocols are much more involved than they were 10 years ago,” says Rick Sury, vice president, strategic partnerships, for Alcan Packaging—Contract Packaging and Specialty Cartons. “Today, there is more scrutiny, especially when it comes to IQ, OQ, PQ,” he says.
But while FDA has expected more, it has also provided more. Many readers have told us that they’ve appreciated FDA’s guidances on postapproval changes and stability studies, for instance. Readers are also looking forward to PACPAC, which may help them change packaging and related operations after drug approval. Wagner finds the very thought of PACPAC incredible. “It could never have happened during the Kessler years,” he says.
FDA may also require a practice that Wagner had expected would be the norm by now—bar coding. “I had thought that bar coding would be all over the place, with every blister bar coded and every pharmacy automated,” he says. FDA, with its bar coding rule, may make Wagner’s vision a reality.
But FDA’s evolution is just one aspect of our anniversary coverage. You’ll also read about other developments that some readers call even more significant.
We’d also like to thank you for your support. Your interest, perspectives, and contributions have guided us these past 10 years. We look forward to more of your input!