WASHINGTON -- Andrew Perraut has a unique view on the U.S. Food and Drug Administration’s (FDA) rulemaking process, especially when it comes to deeming: asa policy analyst for the White House Office of Information and Regulatory Affairs (OIRA), Perraut was the lead for all regulatory issues for tobacco for six years (pre-dating the FDA’s Center for Tobacco Products) and participated in the redrafting of the deeming regulations before the proposed regs went public in April 2014.
In an exclusive interview with CSP/Tobacco E-News, Perraut (who now works as a consultant at San Francisco-based Radiant Strategies) answered some of the most pressing questions about what’s really going on with deeming.
Q: No flavor ban, no open-system ban—the deeming rules seem fairly retailer-friendly. Am I missing something here?
Perraut said the biggest red flag of the proposed deeming regs has more to do with manufacturers—and the pre-market approval requirement.
“The reality is, the process that the FDA has proposed is not very well fleshed-out,” he said. “They have not published the specific standards that they’re expecting applicants to meet, so a lot of this remains a little bit unknowable.”
Issues Perraut expects will arise from the pre-market requirement include a prohibitive cost to manufacturers (as high as six figures per application), a lack of labs that can prepare the research needed for these applications, the FDA’s less-than-stellar record with the significantly simpler substantial equivalence (SE) applications, and that the cumbersome PMTA process could bring innovation to a grinding halt.
Q: Could SE be an option? And if not SE, what else?
There are varying opinions on whether the grandfather date—which states only products on the market by 2007 can qualify for the SE pathway—could be moved. Though not a lawyer himself, Perraut suspects this might be “a legal heavy lift” due to the clear language in the original statute.
Fortunately, moving the grandfather date is not the only option. The FDA could delay the effective date of the PMTA requirement, giving companies (and the agency) more time to process applications; the agency could simplify or revise the pre-market application, making it more attainable. Alternatively, the FDA could propose a separate, less-complicated PMTA process based on a product’s place on the nicotine risk continuum.
“There are all sorts of strategies to make the process work better,” Perraut said. “So it’s certainly worth engaging in the process.”
Q: I thought the public commenting period ended in August 2014. Isn’t it too late?
Yes, the period to submit comments to the FDA has passed. But the FDA isn’t the only way to engage in the rulemaking process. Interested parties can also share their perspective during the White House review.
“It’s as important, if not more important, to be engaged during the period of White House review than it is to give comments (to the FDA),” Perraut said.
While the FDA must first and foremost consider public health, the White House review takes a much broader approach. This process, led by the aforementioned OIRA, focuses on making sure the regulations align with the president’s agenda and balances the costs and benefits of the proposed regulations.
Though multiple government agencies are involved in the White House/OIRA review, it is not widely known that the public at large has the opportunity to participate as well.
“The OIRA process is very intentionally a little bit under the radar,” said Perraut. “Parties are generally fairly informed on how to submit their comments [to the FDA]; folks are much less informed about how to engage during the White House review.”
According to Perraut, retailers and manufacturers can request a meeting to present their case to OIRA during the review period—a meeting that typically includes OIRA, the FDA and other executive branch agencies directly involved with the rule’s review.
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