As we enter a new era in which executive agencies are headed by President Trump, we are also faced with many other transformative changes that will affect FDA-regulated entities in a significant and lasting way. This post will outline some of our thoughts related to what could face FDA and its various stakeholders as we go forward into the great unknown.
First, since being signed into law by former President Obama on December 13th, we’ve been writing and speaking about the myriad provisions of the 21st Century Cures Act. This wide-ranging law has many mandates for agency actions and new guidance documents, which FDA will be working on beginning this year, but far beyond 2017 as well. Drug, biologic, and medical device stakeholders are also awaiting the outcome of the upcoming reauthorization of all the major User Fee Acts that are “must-pass” legislation before the end of the current fiscal year (FY17 ends on September 30th), in order to ensure FDA’s continuing operations. Many other policy changes that are expected to result from the switch from a Democratic-led to a Republican-led Executive Branch, the latter also being supported by a GOP-controlled Congress, will likely have major impacts on medical product developers.
A Disclaimer: Although as of today, without a definitive announcement from President-elect Trump about his pick to lead the Agency, it is somewhat difficult to make detailed predictions about what lies in store for FDA this year (or, for that matter, the next four years), we thought describing some trends and our general thoughts could be valuable. Some of these areas could be affected by the next FDA Commissioner, but it takes time and not an inconsiderable amount of buy-in from career Agency staff to make major changes in longstanding programs and initiatives, so less politically controversial issues are unlikely to be revisited in the short-term.
Regulations: When it comes to new regulations, it remains to be seen what steps Congress will take under the Congressional Review Act (see here and here) to roll back Final Rules promulgated since last May. But for any FDA regulations that remain in proposed rule form, don’t lose sleep waiting for them to be finalized – one thing the incoming Administration has made clear is its disdain for “government regulation” writ large, and we expect that to translate into new leadership taking a hard look at everything that’s currently in the pipeline. Thus, some of the rules listed in the Agency’s Fall 2016 Unified Regulatory Agenda as pending a proposed regulation are likely to be taken off the table altogether.
Guidance: For FDA guidance documents, which everyone refers to in order to understand the Agency’s “thinking” even though technically they are non-binding on all parties, it is a simple matter for the next Commissioner to order individual centers and offices to withdraw either a Final Guidance or a Draft Guidance by providing written notice to affected parties in the Federal Register. Unlike final regulations, these documents are not subject to the notice-and-comment provisions of administrative law that require the same public consultation process to be undertaken for the rescission of regulations currently in effect.
Therefore, several of the more controversial or legally questionable guidance documents may be withdrawn by FDA following the change in leadership. One good example here would be the recent draft guidance that creates a quality metrics reporting program for pharmaceutical manufacturers, as that guidance was not well-received by industry. At the same time, however, we could see relatively fast action by the new FDA to issue guidance on certain subjects that current Agency leadership has delayed or been hesitant to act upon even with significant and diverse stakeholder pressure. The prime example being guidance on the permissible scope of off-label communications by medical product manufacturers. Indeed, off-label communications and related enforcement are one area where we expect a significant policy change to be implemented by the Trump Administration.
Enforcement: Finally, some enforcement priorities and initiatives are likely to change in the near term as well. Although it is unlikely that the next Administration will alter FDA’s enforcement activities and policing of serious public safety issues – examples would be issuing safety communications when illegal drug residues are found in dietary supplement products, or sending Warning Letters when a compounding pharmacy is found to have insanitary operations – there may enter a more laissez-faire climate when it comes to enforcement of “victimless” regulatory violations. One area where this is likely would be in the enforcement of cosmetic labeling rules that do not allow cosmetic products to be labeled with claims that they can alter the structure or function of the skin or other parts of the body such claims would make the product a “drug” under the law. Over the past two years, FDA has markedly and aggressively increased its policing of these claims by issuing regulatory letters to manufacturers and requiring them to undertake corrective actions. In our view, those cosmetic enforcement actions are likely to be history, at least for now or until the political pendulum swings again.
There are some areas where we don’t anticipate any changes, at least not noticeably for those of us outside of the Agency and looking in. For example, FDA has been busy implementing the Biologics Price Competition and Innovation Act and its new pathway for biosimilar products, as well as working with biosimilar developers and reviewing their marketing applications. This program is unlikely to see much attention from the Trump Administration, except perhaps to urge regulators to work more quickly and to help get more biosimilars to market. Similarly, the Agency as well as State regulators and affected industry alike have been working for years towards a food safety system for a modern, globalized supply chain in response to the Food Safety Modernization Act of 2011. So unraveling the complex and interlocking regulations that emerged from that food safety modernization process may be politically unpopular (assuming such an activity would not be administratively impossible, for all intents and purposes); only one of the seven major foundational Final Rules issued under FSMA falls within the window that would allow it to be considered for rescission under the Congressional Review Act. In general, therefore, we are not expecting a sea change in the area of foods.
It is also possible that President Trump’s seeming disdain for the outsourcing of drug manufacturing operations to countries like India and China will impact whether he would have his FDA Commissioner continue the high level of inspection activity of those facilities. On one hand, a large number of foreign manufacturing sites have been the subject of regulatory action (including some Import Alerts) due to their failure to comply with cGMPs and, in some cases, their use of outright fraudulent data in their quality systems. However, on the other hand, ramping down inspections and regulatory actions makes it more difficult for those facilities to be given a clean bill of health by the Agency so that they can export products to the U.S., which would be equivalent to implementing a new regulatory policy through administrative inaction.