FDA and Congress Must Protect Printed Patient Medication Information 
COMMENTARY

May 14, 2024by Mark Grant, MD, Associate Director of Addiction Services, CODAC Health, Recovery & Wellness
FDA and Congress Must Protect Printed Patient Medication Information 
FILE - A sign for the Food and Drug Administration is displayed outside their offices in Silver Spring, Md., on Dec. 10, 2020 (AP Photo/Manuel Balce Ceneta, File)

Some of the most hotly debated policy conversations happen around health care because it hits so close to home. Almost everyone has either experienced a serious health challenge or has seen someone close to them go through traumatic health issues.

It’s why many Americans feel so strongly about the decisions our government makes on everything from health insurance to treatment standards and prescription drug rules. If there’s one thing we can agree on, government policy on health care issues should always prioritize positive health outcomes for patients.

Unfortunately, the Food and Drug Administration is considering a new rule that would jeopardize the health outcomes of anyone who takes prescription medications. The recently proposed rule would make it much harder for people to access patient medication information, the lifesaving information dispensed at the pharmacy that describes a prescription medication’s purpose, instructions for use and potential side effects.

The rule would shift medication information away from printed paper and replace it with digital-only formats that force patients to scan a QR code.

If enacted, the FDA’s proposed rule would be a dangerous change for anyone who lacks broadband access, smartphone devices or who struggles to use digital technology.

Imagine someone living in a rural area who doesn’t have home internet or consistent cell service. They pick up their prescriptions from a drugstore or receive them in the mail, but instead of receiving paper instructions describing when to take their medication and what the side effects might be, they see a QR code directing them to online instructions.

Anyone living in an area without broadband access would suddenly be unable to access the information they need to take their medication safely.

The same thing could happen to low-income families who don’t own a smartphone device or can’t afford home internet service. According to a Pew Research Center study, one-quarter of adults with household incomes below $30,000 a year say they don’t own a smartphone. About four in 10 adults with lower incomes do not have home broadband services or a desktop or laptop computer.

Low-income families shouldn’t face health risks because they can’t access digital instructions about their medications; they should have reliable, printed paper instructions on hand.

The idea that people will suffer if they can’t follow their medication instructions isn’t a hypothetical — it’s already happening. More than 100,000 people die every year as a result of medication non-adherence.

About 50% of patients with chronic conditions experience medication non-adherence, which, in addition to the health consequences, costs up to $300 billion in avoidable health care costs each year. By cutting off rural, low-income and senior Americans from their medication information, the FDA rule would make this problem even worse.

The proposed FDA rule is a dangerous and costly mistake. Fortunately, there is a bill in Congress that would protect and improve printed patient medication information.

The Patients’ Right to Know Their Medication Act, H.R. 1173, would require drug manufacturers to provide printed, FDA-approved medication info for every American. 

Instead of being left with inaccessible digital PMI, patients would receive their medication info in a one-page, printed, standardized format with FDA-approved content. Both Republicans and Democrats introduced the bill together because they know this isn’t a partisan issue — it’s what’s best for patients’ health.

Americans already face so many daunting health care challenges. The FDA shouldn’t make things harder by limiting access to their medication information.

The agency should reconsider this dangerous rule, and Congress should pass the Patients’ Right to Know Their Medication Act to keep people safe and healthy.


Mark Grant, MD, is the associate director of Addiction Services at CODAC Health, Recovery & Wellness. You can follow their work on Twitter/X.

A+
a-

In The News

Health

Voting

Opinions

Oversight Hearing on Illegal E-Cigarettes Highlights Dire Need for Reform of the FDA

The Senate deserves credit for holding a recent hearing that underscored the failure of the U.S. Food and Drug Administration’s Center for... Read More

The Senate deserves credit for holding a recent hearing that underscored the failure of the U.S. Food and Drug Administration’s Center for Tobacco Products to provide clear and fair regulatory pathways for smoke-free tobacco products that provide Americans with less harmful alternatives to combustible cigarettes. This hearing follows... Read More

E15 Fuel Can Be an Important Tool to Tackle Climate Change

On Earth Day this April, many Americans reflected on what we can do to protect our planet. We are already... Read More

On Earth Day this April, many Americans reflected on what we can do to protect our planet. We are already seeing the effects of climate change, and we know this is not a problem for future generations to solve — it’s up to us. One fact remains clear:... Read More

Latest Cyberattack Is Yet Another Wake-Up Call to Protect the Practice of Independent Medicine

With the rapid increase in drug and labor costs, more administrative burdens from insurance companies, and growing demand for health... Read More

With the rapid increase in drug and labor costs, more administrative burdens from insurance companies, and growing demand for health care, it’s more challenging — yet even more important — for doctors to continue serving their communities. Nevertheless, independent practices in towns across the country have... Read More

June 11, 2024
by Trump Agonistes
Trump Agonistes

One of the intriguing stories in the Bible about the power of vengeance is that of the death of Samson,... Read More

One of the intriguing stories in the Bible about the power of vengeance is that of the death of Samson, which is described in Judges 16.  The strong-man judge of Israel and scourge of the uncircumcised Philistines had finally been betrayed by Delilah and captured by... Read More

The Supreme Court: Term Limits and Mandatory Retirement

Recent Supreme Court decisions have served as reminders of the politicization of the high court. This does not imply that... Read More

Recent Supreme Court decisions have served as reminders of the politicization of the high court. This does not imply that there hasn’t always been a political element to Supreme Court nominations, confirmations and subsequent decisions. However, in recent years, replete with acrimonious Senate hearings, the politicization... Read More

Large Cannabis Companies Spending Millions to Shut Down Hemp 

The year thus far has been enlightening for lawmakers and hemp industry stakeholders. Just as the hemp industry started to... Read More

The year thus far has been enlightening for lawmakers and hemp industry stakeholders. Just as the hemp industry started to recover after a rocky start, a fellow product category took aim — the cannabis industry. And coming out of the House Farm Bill markup, the agenda... Read More

News From The Well
scroll top