The Prospects of Dr. Martin Makary and RFK Jr. at HHS, Potential Pharma Tariffs, and EU Guidance on Ethylene Oxide

At a Glance

• Members of the health and life sciences sector are feeling optimistic, generally speaking, that if confirmed as FDA commissioner, Dr. Martin Makary’s role will turn out to be more in the line of a constructor as opposed to a disruptor.
• It is possible the second Trump administration and Congress may support tariffs on Chinese pharmaceutical products.
• Vaccines, fluoride in drinking water, ultra processed foods and more would be focus areas for Robert F. Kennedy, Jr. While some predict destruction and doom, others are more optimistic. One thing is sure: If RFK is confirmed as HHS secretary, he will be a disruptor.
• The European Union recently issued guidance on the use and regulation of ethylene oxide in sterilization of medical products.

With the rapidly evolving regulatory landscape, staying on top of the latest updates is crucial for companies in biopharma and medical devices. In this briefing, we highlight recent regulatory and legislative developments that should be top-of-mind for companies in these industries.

Dr. Martin Makary Announced as Trump Nominee for FDA Commissioner

President-elect Trump recently announced Martin A. Makary, M.D., M.P.H., as his pick to take the Food and Drug Administration reins from Commissioner Califf in January. Makary, a surgeon at the Johns Hopkins Hospital, writer and prolific researcher with 250 peer-reviewed scientific papers, gained attention during the pandemic for his views on public health measures and his emphasis on herd immunity.

Like his fellow nominee and would-be boss, Robert F. Kennedy, Jr., Makary has been a critic of the overprescribing of drugs and the influence of big pharma over the FDA and doctors, as well as the use of pesticides on food. In his most recent of three published books, he conducts a methodical forensic analysis of recent instances where science got it wrong in a big way — for example, with opioids.

According to the health care financing sector, the Makary choice lets some air out of the collective angst balloon that inflated post-nomination of RFK, Jr. Given that Makary’s long-term experience is rooted in the practice of medicine, he has the attendant broad and deep knowledge of what it is to be a practitioner in the sector; and with his experience in business, members of the health and life sciences sector are feeling optimistic, generally speaking, that Dr. Makary’s role will turn out to be more in the line of a constructor as opposed to a disruptor.

Tariffs Under a Second Trump Administration

President Trump has stated that “tariff” is “the most beautiful word in the dictionary,” and proposed many different percentages of tariffs to impose on various countries. His favorite tariff target is, as in his last administration, China. However, he made several statements about imposing tariffs on Mexico while on the campaign trail. Additionally, he proposed a “collar” tariff on all imports into the United States of 10-20%. Most recently, he gave greater clarity on these tariffs in a Truth Social post, stating that on day one of this new administration, he will implement 25% tariffs on Canada and Mexico and 10% tariffs on China “until such time as drugs, in particular Fentanyl, and all illegal aliens stop this invasion of our country!”

Questions have arisen from the business community, such as “can he do this?” and “how will these be implemented?” The first question is easy, while the second is much more nuanced and dependent on the very fluid situation that is the Trump administration.

With respect to the question “can he do this?” the short answer is yes, there are many different avenues through which a president can unilaterally impose tariffs on a single country or targeted countries. However, we think it unlikely those avenues include authorization for a “collar tariff” broadly targeted at all imports from all avenues. A president can use a statute granting the president broad authority in the event of national emergency; the International Emergency Economic Powers Act (IEEPA) would technically allow President Trump to issue them on day one against Canada, Mexico and China.

As to what products will be covered if President Trump does impose tariffs, it is uncertain. Currently, many pharmaceutical products and medical devices are duty-free, even with respect to the Section 301 tariffs currently in place. However, there is currently pending legislation (the BIOSECURE Act) that calls into question the security of pharmaceuticals from China. Therefore, it is possible the administration and Congress may support tariffs on Chinese pharmaceutical products. We are keeping apprised of all proposed tariffs.

Robert F. Kennedy, Jr., as Trump’s Nominee for HHS Secretary

President-elect Donald Trump has selected Robert Francis Kennedy, Jr. (RFK) to serve as secretary of the U.S. Department of Health and Human Services (HHS). RFK is part of a prominent and politically powerful American family. He is the son of former U.S. attorney general and senator Robert F. Kennedy, and a nephew of former U.S. president John F. Kennedy and former U.S. senator Ted Kennedy. Like many in the Kennedy family, RFK is committed to public service. Prior to politics, his career focused on environmental causes, including clean water advocacy, and children’s welfare, addressing childhood chronic disease and toxic exposures.

HHS’s mission is to enhance the health and well-being of all Americans, by providing for effective health and human services and by fostering sound, sustained advances in the sciences underlying medicine, public health, and social services. HHS is comprised of 80,000 employees and 13 supporting agencies, including the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), the Office of the Surgeon General and much more (see HHS Organizational Charts). HHS has an enormous budget. In fiscal year 2024, HHS had $2.86 trillion distributed among its agencies.

The prospect of RFK as HHS secretary has evoked strong reactions. He is viewed as controversial and unqualified by many. He has been outspoken on a wide range of topics, often without strong scientific backing. Vaccines, fluoride in drinking water, ultra processed foods and more will be focus areas for RFK, if confirmed. Many, however, embrace having RFK lead HHS, believing that he will “Make America Healthy Again” by doggedly focusing on excessive bureaucracy in the HHS family of agencies and meaningfully addressing public health problems that most can agree are impactful and real, such as obesity and diet.

There are countless articles analyzing how public health will be impacted by an RFK-led HHS. Some predict destruction and doom, while others are more optimistic. Peter Pitts, former associate commissioner of FDA and now president and cofounder of the nonpartisan Center for Medicine in the Public Interest nonprofit, authored a recent article focusing on the opportunities presented by an RFK HHS. It is a hopeful read.

One thing is for sure: If RFK is confirmed as HHS secretary, he will be a disruptor. Buckle up, America!

EU Guidance on Ethylene Oxide in Device Sterilization

The European Union recently issued guidance on the use and regulation of ethylene oxide (EtO) in sterilization of medical products. The Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) each include provisions which address sterilization of medical products and, more specifically, the use of EtO for such sterilization practices. As such, the use of EtO falls within the scope of the MDR and IVDR as used during the manufacturing and sterilization process of medical products and is outside of the scope of the Biocidal Products Regulation (BPR), since the BPR does not apply to products within the scope of MDR or IVDR.

In view of the above, the use of EtO is controlled only when used as part of a sterilization procedure, which is a process subject to MDR and IVDR conformity.

Health care institutions may also use EtO before first use or in-between use of medical devices in the form of EtO cartridges, which fall under the MDR as a “medical device” or “accessory for a medical device”, placing the EtO cartridges outside of the scope of the BPR as discussed above.