Opinion: Senator Baldwin should work to protect patient safety and stop harmful FDA proposals

State Representative Jodi Emerson calls on Senator Baldwin to hold RFK Jr. accountable and ensure patient safety.

Newly-confirmed as Secretary of Health and Human Services (HHS), Robert F. Kennedy Jr. (RFK Jr.) represents one of President Donald Trump’s most significant Cabinet appointments, running an agency that oversees large parts of America’s healthcare system, including the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS). Kennedy will wield immense power in this administration, which is why Wisconsin Sen. Tammy Baldwin must work to ensure patient safety remains a top priority and hold him accountable to the millions of Americans who rely on our healthcare system.

As a member of the Senate Committee on Health, Education, Labor, and Pensions (HELP), Senator Baldwin has consistently worked to improve America’s healthcare system. She now has an important opportunity to emphasize the critical role of the Food and Drug Administration (FDA) in protecting patient safety and ensuring that regulatory decisions prioritize public health.

Two proposed FDA rules could have unintended consequences for patient care by limiting access to critical prescribing information. The first would fully digitize Prescribing Information (PI), which doctors and pharmacists rely on to guide patients about their medications. The second would restrict access to the information patients need to take their medications correctly.

Millions of pharmacists provide life-saving advice to patients daily, and millions of Wisconsinites reference printed instructions to take their medications safely. Pharmacists and patients alike must have access to clear, accessible information to ensure proper medication use.

Unfortunately, pharmaceutical companies have been advocating for these FDA proposals, which would transition all PI and Patient Medication Information (PMI) to digital formats. Their motivation? Cutting costs on printing.

Wisconsin’s pharmacists and patients depend on printed materials rather than digital-only access. Pharmacists must be able to reference PI on paper to check for dangerous drug interactions, adjust dosages for specific populations, and review side effects without disrupting workflow.

Additionally, many Wisconsin residents do not have reliable internet access. Around 25% of Wisconsinites lack a dependable internet connection, particularly in rural areas. Furthermore, 10% of Wisconsinites live below the poverty line, and 19% are 65 or older—totaling over 1 million residents. Many of these individuals may not have smartphones or broadband access, yet they are the ones who rely most on prescription medications. Why make it harder for them to obtain crucial information about their prescriptions?

The FDA’s proposed PMI rule would require pharmacies, rather than drug manufacturers, to print PMI upon request. This rule would impose $1.6 billion in costs per year on community pharmacies, worsening the trend of pharmacy closures across Wisconsin. Reduced access to pharmacy care could negatively impact patients who rely on these services.

These proposed rules represent unnecessary regulatory changes that could harm patients. With Senator Baldwin’s leadership, these proposals can be reconsidered to ensure that patient safety remains the top priority. Senator Baldwin should work to rescind the FDA’s proposed rules on Prescribing Information and Patient Medication Information. It’s the right thing to do for Wisconsin.