Every day, millions of patients and families do their best to make the right health care decisions for themselves and their loved ones. This cannot happen without the freedom to choose from a wide array of treatments. However, recent changes to the Food and Drug Administration’s (FDA) vaccine policies have significantly limited access for patients across the country. Deliberations by a key Centers for Disease Control and Prevention (CDC) vaccine panel have restored some degree of patient choice. This move still fell woefully short of the mark. Bolstering vaccine access will require bureaucrats at the federal and state level to take a step back from interfering with patients and providers.
Until recently, Americans could easily walk into the pharmacy of their choosing and get the latest version of the COVID-19 booster. Patients convinced of the efficacy of a fifth booster were free to get a jab without a doctor’s note. Their more skeptical neighbors were free to abstain. The FDA abruptly changed that when it announced that, while it approved the latest iteration of COVID-19 vaccines, that approval came with new restrictions. Approval is now limited to seniors and younger Americans with at least one underlying health condition that increases risk of severe infection. Because of these limits, millions of Americans now require prescriptions to get boosters. This costly and time-consuming hurdle will almost certainly hamper access, especially when it can take weeks to get a doctor’s appointment.
The FDA is also demanding that every new iteration of a COVID shot “use a true placebo control (salt water) so we will learn the side-effect profile.” Experts, such as Northeastern University pharmaceutical sciences professor Mansoor Amiji, note that “placebo trials can last for months or years” and are thus immensely costly.
These costs aren’t just a concern for vaccine manufacturers. The history of drug approvals — including vaccines — shows unnecessary requirements imposed by the FDA are ultimately passed along to consumers. It’s no coincidence that median list prices for new drugs are high and rising as regulations impose many millions of dollars of cost just to get approval. Taxpayers also foot this bill through pricey government health care programs, such as Medicaid, which costs nearly $1 trillion annually.
New government guidance is likely to increase costs and confusion over vaccine access. The Advisory Committee on Immunization Practices (ACIP) — a CDC vaccine panel — laudably rejected a motion that “state and local jurisdictions should require a prescription for the administration of a COVID-19 vaccination.” Instead, it recommended COVID-19 vaccination based on a confusing concept called “shared clinical decision-making” (SCDM).
As University of California law professor Dorit Reiss notes, SCDM “usually leads to less uptake, partly because nobody is sure what it requires.” In the best-case scenario, residents of states such as Minnesota, Wisconsin, New Mexico and Hawaii are probably once again allowed to get boosters at pharmacies. That’s because these states allow pharmacists broad discretion to give vaccines based on ACIP recommendations. However, in about half of states, ACIP’s recommendations are not enough. Pharmacists need some kind of sign-off from physicians, whether that is a prescription or a previously agreed-upon vaccination protocol. Such approval was never needed back when the FDA explicitly allowed pharmacists to give boosters. Given the incoming avalanche of vaccine lawsuits, physicians will likely be reluctant to give this sign-off. The result is a predictable one for patients: less choice.
Fortunately, a few simple reforms can dramatically increase health care access. At the federal level, the FDA should reverse course and allow patients to get the vaccinations they desire at the pharmacy without a doctor’s note. ACIP can likewise abandon its confusing “shared clinical decision-making” framework and make clear that providers are not required to dissuade patients from taking vaccines.
States need not stand by and wait for the FDA and ACIP to rewrite their rules. Cato Institute scholars Marc Joffe and Jeffrey A. Singer said it best: “Let pharmacists prescribe.” States can and should grant pharmacists broad and independent prescribing authority, including for off-label drug use. Even if the FDA decides to limit an approved drug’s availability, a pharmacist can still quickly sign off on a patient’s desired vaccination — no other doctor’s visit or protocol needed. States such as Colorado and New York have implemented quick measures to allow pharmacists to prescribe boosters, but these (mostly) executive actions are no substitute for real reform and will inevitably encounter legal challenges unless replaced by legislation.
Patients deserve choice and flexibility in their health care decisions. Overreaching bureaucracy and regulation are not what the doctor ordered.
Ross Marchand is a senior fellow at the Taxpayers Protection Alliance.
