Enforcement likely to continue under Trump, with state AGs waiting in wings if it falters

Building on remarks she made at a recent industry event, Susan Winckler, chief risk management officer at the Leavitt Partners law firm, said it’s important to remember that whoever the Trump Administration eventually nominates to head the Food and Drug Administration, and whatever the Administration might say in the meantime, most of FDA’s organizational DNA remains intact.  Winckler spoke on the subject of what the Trump Administration might mean for the dietary supplement industry at an event focused on New Dietary Ingredients put on by the United Natural Products Alliance recently in Salt Lake City. Winckler, who is an attorney and a pharmacist by training, served as FDA chief of staff from 2007 into 2009.

“​The vast majority of FDA employees are not political appointees and will continue to be there. The vast majority of the staff will not change their jobs based on who is going to be commissioner,​” ​she said.

Reality overrides marching orders

Winckler said new commissioners often comes in with an agenda and a set of goals from the Administration. Then reality sets in and those marching orders have to be rewritten.

“​Part of what I talked about in Salt Lake City is that there is a dynamic that any commissioner comes in with their agenda and what they​’​d like to accomplish. And then there are those realities about the scope of FDA​’​s authority,​”​ she said.

“​I think you go in thinking you​’​ve taken one job and the majority of your tenure will be taken up with firefighting product safety issues,​”​ Winckler said.

Winckler said the biggest issue on a new commissioner’s plate will be to renegotiate a wide swath of user fees on prescription drugs and medical devices that are due to expire in September. That focus, and messages from the White House, could mean that dietary supplement issues will fly under the radar for the time being.

“​The direction from the President himself has been a goal to get drugs to market faster,​”​ she said.

Regulation curtailment

The recent executive order from the Administration meant to restrict the the growth of regulation, the so-called “2 for 1” order, will have a bigger impact than a political appointment, Winckler said. Under that order, two rules or regulations of equal monetary impact on a given regulated industry must be removed for a new regulation to take effect. This stricture applies to guidances as well.

The impact of that order on the updated draft New Dietary Ingredients Guidance has yet to be determined.  It’s unclear if the order would apply to this document, as it was first put out before the order was signed on Jan. 30 of this year. What’s unclear, too, is where the calculation of the financial burden the guidance will impose will come in.  The way Trump’s administrative order is written, the Office of Management and Budget will play a crucial referee-type role in resolving cost calculation discrepancies. At the moment, FDA’s calculation of the cost of implementation (relatively modest) and the consensus among industry stakeholders about what’s it’s going to cost are not even close to being on the same page. One thing is clear, though;  new initiatives on the rule making front from FDA or from any regulatory agency are highly unlikely in the short term.

“​It​’​s a blunt instrument, but the idea of looking at the cumulative burden of regulation on industry has merit,​” ​Winckler said.

Players ready to take the field

Winckler said that the pace of inspections, the issuing of warning letters and so forth is likely to continue as before. But if there are issues that come to the fore that FDA might find difficult to address in the new, less friendly environment for regulatory agencies, there are other authorities ready to step in, such as state attorneys general. Doug Gansler, the former Maryland Attorney General and now a partner in the Buckley Sandler law firm, said that’s a tide that has been rising and will continue to do so. And he’s less sanguine than Winckler is that the Trump Administration will leave well enough alone when it comes to enforcement.

“​While the FDA is an enforcement agency and will continue to enforce the law, there is a notion that the Trump Administration will significantly curtail enforcement. The notion is that the state AGs will pick up that slack and I think that is correct. With the entry of state AGs into this space over the past couple of years, one would think that they were planning to increase their enforcement anyway,​”​he said.