With midterm elections looming, Republicans rush to confirm key health officials
As many polls show Democrats gaining momentum entering the November midterm elections, Senate Republicans are working diligently to confirm key health care nominees at FDA and CMS before the end of the year. Key appointments include Dr. Heidi Overton to lead FDA as commissioner and Chris Klomp to fill the #2 spot under HHS Secretary Robert F. Kennedy, Jr. Overton made her appearance before the Senate Health, Education, Labor and Pensions (HELP) Committee on September 24, fielding pointed questions from both Republicans and Democrats on issues ranging from vaccine safety, vaping, abortion and her willingness to stand up to President Trump if she disagrees. The hearing wasn’t nearly as headline-generating as it could have been, with Overton staying on script and navigating any potential political landmines. Key Republicans to watch on the Overton nomination include HELP Chairman Dr. Bill Cassidy (R-LA), who is frustrated with the Trump Administration’s positioning on vaccines, Sen. Susan Collins (R-ME), who is in a tough re-election fight and moderate Sen. Lisa Murkowski (R-AK), who remains skeptical of Overton’s qualifications to lead such a large, important government agency. All three are officially noncommittal. A reminder that Republicans control the Senate 53-47, so if all three of these Republicans vote “no” on Overton, Vice President J.D. Vance would cast the tie-breaking vote. With the lack of committee action on the Overton nomination this week, it’s likely it will have to wait until after the November midterms. Klomp currently serves as Medicare chief at CMS. His nomination passed through the Senate Finance Committee with the support of one Democrat on September 24. In August, the full Senate approved Dr. Erica Schwartz to lead the Centers for Disease Control and Prevention (CDC) and the Senate HELP Committee voted in favor of Trump’s Surgeon General nominee, Dr. Nicole Saphier, along party lines on September 30. Her nomination awaits a full Senate vote.
Trump Administration rolls out pharmaceutical tariff guidance at the last minute, raising confusion and concern
The Department of Commerce’s Bureau of Industry and Security published long-awaited guidance on pharmaceutical tariffs in the Federal Register on September 23, less than a week before the 100% tariff went into effect for many prescription drugs. The biopharmaceutical tariffs were originally announced in April, and Commerce was expected to release formal implementation guidance earlier this summer. As a result of negotiations and agreements with many larger biopharmaceutical companies, many drugs are exempted from the tariffs. However, it’s estimated that more than 100 biotech/biopharma companies are impacted by the new tariffs. The guidance released last week has caused confusion and concern that the tariff exemptions for certain drugs are not as broad and clear as they need to be. While the guidance again references that rare disease drugs (orphan drugs), nuclear medicines and cell and gene therapies are technically exempt, the 0% tariff rate is only for drugs where every approved or licensed indication is for a rare disease with orphan designation under the Orphan Drug Act. All indications must be orphan. A drug approved for a rare disease plus a common one doesn’t qualify. On top of that, the exemption isn’t automatic. The product also has to meet one of two conditions: 1) It comes from an eligible jurisdiction. These are Argentina, Bangladesh, Cambodia, Ecuador, El Salvador, the EU, Guatemala, India, Indonesia, Japan, Jordan, Malaysia, North Macedonia, South Korea, Switzerland and Liechtenstein, Taiwan, Thailand, the UK, and Vietnam; and 2) The Commerce Department approves the drug as meeting an “urgent U.S. health need”. BIO CEO John Crowley has warned that tariffs penalizing U.S. innovators are counterproductive and could slow investment. His broader point: large drugmakers got out from under the tariffs through MFN pricing deals and onshoring agreements. That leaves the full rate on small and mid-sized biotechs, where much of the innovation in hard-to-treat diseases resides. BIO has also complained that the late rollout of guidance doesn’t allow enough time to implement the tariffs properly. Crowley’s concerns were echoed by the Wall Street Journal editorial board on September 28, which argued that the tariffs are an “attack on American biotechnology.” The editorial board argued the new tariffs amount to a gift to Chinese leader Xi Jinping, since they would hurt the U.S. biotech industry and work against American interests to remain the global leader in discovery of new medicines. CNN reported this week that patients with conditions larger biopharma manufacturers don’t treat could feel the most impact, because they depend on drugs from smaller companies. As companies try to wade through compliance and assess the impact of the tariffs, there is also discussion of potential legal challenges. Stay tuned for more updates on that front.
Election Watch: What Senate and governors’ races are “up for grabs” as we head into October?
We are almost a month away from crucial midterm elections, and as we mentioned earlier, Democrats appear to be positioned for a positive night. This isn’t surprising since the party in control of the White House (not to mention the House and Senate) often struggles in midterm elections, as voters tend to seek more balance in governing. It is a very high likelihood that Democrats reclaim control of the U.S. House, although their margin of control will likely be thin. For many months, observers expected Republicans to retain control the Senate. However, polling (and general voter concerns about affordability and the war in Iran) have put several races in the spotlight.
- Here are a few U.S. Senate races to watch closely on November 3: OHIO (Republican incumbent John Husted vs. former Senator Sherrod Brown (D)); MICHIGAN (Republican congressman Mike Rogers vs. Abdul El-Sayed (D)): ALASKA (Republican Incumbent Dan Sullivan vs. Democrat congresswoman Mary Peltola); MAINE (Republican incumbent Susan Collins vs. former state legislative leader Troy Jackson (D)); TEXAS (Republican Attorney General Ken Paxton (R) vs. James Talarico (D)). These states will likely determine control of the Senate (although keep an eye on New Hampshire, Iowa and Georgia as well!).
- At the state level, we’re watching three governors’ races very closely. GEORGIA (open, R-held). Keisha Lance Bottoms (D) vs. Rick Jackson (R), running to succeed the term-limited Brian Kemp. Georgia last elected a Democratic governor in 1998. NEVADA (R incumbent). Gov. Joe Lombardo (R) vs. Aaron Ford (D). Democrats are close to a supermajority in the Nevada legislature, and Lombardo has vetoed a record-number of bills during this term (including some anti-pharma bills). OHIO (open, R-held). Vivek Ramaswamy (R) vs. Amy Acton (D). We’re also closely watching races in Wisconsin, Iowa and Alaska.
Health Policy Snippets
- Majority of Americans don’t credit Trump for lowering prescription drug prices. As the Trump administration continues its efforts to focus on lowering the cost of prescription drugs in the U.S., a new poll from the Kaiser Family Foundation shows that only four in 10 U.S. adults (41%) say it is likely the Trump administration’s policies will lower prescription drug costs for people like them, with Republicans making up the vast majority of respondents who believe drug prices are lower thanks to the Trump Administration’s actions. 79% of Republicans and 88% of Make America Great Again (MAGA) supporters credit Trump for lowering prescription drug costs, while much fewer independents (35%) and Democrats (11%) say the policies are working. However, public support for increased government control of drug prices remains strong, with at least two-thirds of Republicans, Democrats, and independents saying there is not as much government regulation as there should be in this area.
- Forthcoming Medicaid “work requirements” and the medically frail; CMS issues new guidance. On September 8, the Centers for Medicare & Medicaid Services (CMS) released new information to states on the implementation of the medical frailty exclusion from the new Medicaid work/community engagement requirements. The new requirements were included in the 2025 “One Big Beautiful Act (OBBA)”, which contained a plethora of Medicaid reforms. CMS’ new direction to states on medical frailty verification comes three months after CMS issued its June Interim Final Rule (IFR), which significantly departed from the common understanding of medical frailty statutory language, by requiring states to assess whether an individual’s condition “significantly impairs” their ability to meet work reporting requirements. Litigation challenging the IFR remains pending, with a ruling on whether CMS’ medical frailty definition conforms to the statute potentially coming in November or December.
