- The effects of the 2020 elections on industry are likely to be more incremental than sweeping.
- A “new president, new control of Congress” scenario may have the most impact on industry.
- Regardless of who wins, knowing who industry can work with outside of FDA is a mandate.
Truth be told, I have been a horrible prognosticator regarding elections. Surprise after surprise has come to me over the many decades of my own personal voting history. As we speed toward the pending presidential and congressional elections in November, it is time to predict what is likely to happen when the dust settles. The effects of this election on this industry are likely to be more incremental than sweeping, and overall effects are less driven by the outcome than the potential opportunities that may arise dependent on how things shake out. The wild cards in all of this, of course, will be the ongoing pandemic and the resultant faltering economy.
The realistic scenarios will exert only nuanced effects on the day-to-day operations of the industry. These are: same president, congressional control remains unchanged; new president, congressional control remains unchanged; or new president, congressional control changes. The speculative effects of each of these scenarios only differs in the potential for future influence and action. Historically, this industry has been exclusively reactive to regulatory and legislative activities. Nibbling around the edges of legislative matters is the norm—unless there is a “sky is falling” moment such as occurred in 1976 and again in 1992.
What must be recognized are some critical elements that exist regardless of the outcome of the elections. The reasons for this are pretty simple. FDA is, like any other government agency, influenced less by election outcomes owed to the inertia of the bureaucracy. Unless the commissioner is someone with a particular interest in such products specifically, the likelihood is that “business as usual” will be the outcome regarding the normal course of regulatory activity and enforcement. FDA has consistently been driving deeper into the compliance aspects of the manufacturing of these products particularly, and the testing thereof. Since the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA), the allowances, acceptances and availability for some innovative aspects have been eliminated. This narrowing is likely to continue. Witness, for example, a recent warning letter that noted, among other things, that N-acetyl-L-Cysteine (NAC) is not an acceptable dietary ingredient. This likely came as a shock to those who read this warning letter—especially some of the larger names in the industry offering products that include NAC or are exclusively comprised of this ingredient. The pace at which FDA has conducted this narrowing is not likely to diminish under any of the scenarios presented. Rotating acting commissioners of FDA won’t likely change that unless there is a specific axe to grind coming from the next one. This bureaucratic inertia is a reflection of the industry inertia as well. More on that next.
Of the three scenarios described above, the one that would likely have the greatest potential impact would be the “new president, new control of Congress” presentation. This could mean the new faces and control of both houses by one party presents the chance to take on prospective, if ill-advised, opportunities such as DSHEA 2.0. Finding sympathetic ears may be perceived as a better opportunity under this scenario, but that perception needs tempering. Such a scenario places distinct adversaries to the industry back into political power. These members, particularly in the Senate, have not been advocates of this industry. This is where the inertia of the industry plays a role. Taking on big issues in Congress has only ever occurred when things were at a very critical juncture. If the perception is that this change will only happen after an election, think again. The reality is that things like getting food subsidy programs to cover the purchase of a greater array of dietary supplements is relatively small potatoes. The reality is that working with FDA means knowing who is in charge, and that will be entirely dependent on who wins the presidential election. That individual will have his or her own priorities. When those priorities are defined, they will encounter the inertia of the bureaucracy—and unless the commissioner has a particular, specific interest in these products (please see Commissioner David Kessler in the 1990s), the plodding forward and narrowing of regulatory acceptability will continue.
While it is wonderfully entertaining to speculate on the effects of the upcoming election on our industry, what should be considered are two things. First, who is the commissioner of FDA and what are his or her big interest items—so as to judge the immediacy of need for action (potentially resulting in such action if the sky does start to fall again). Second, if there is no immediate focus from FDA beyond the continued narrowing of the regulations in this industry, then the matter becomes something not performed terribly well. Find alignment with key members of Congress. Help them understand what the issues are, how important the products are and what the government currently is doing to restrict these opportunities. This is a long-game strategy that we, as an industry, have not implemented at all effectively since 1994. The opportunities out of the upcoming election vary slightly in this regard, but knowing who you can work with from outside the regulatory agency is essential regardless of who wins. After the election, gaining knowledge as to who the fresh players are will define what needs to be done next. The effects of the election are less important than an overall strategy as to what the industry truly wants—and then working with the reality of the election results.
As chief operating officer, Jim Lassiter oversees all consulting operations at REJIMUS, formerly Ingredient Identity. He has more than four decades of experience in quality control (QC), and government and regulatory affairs throughout the pharmaceutical, dietary supplement and natural product industries.