Illustration: Aïda Amer/Axios
Drugmakers want a more digital future — but the paper industry is lobbying to keep printed pharmaceutical information around.
Why it matters: The conflict has been playing out for nearly a decade, but it could come to a head this year.
- For the first time since 2014, the fiscal year 2024 House appropriations text doesn’t include a rider that prevents the FDA from letting drug companies use only electronic formats to distribute their prescribing information.
Where it stands: Pharmaceutical companies currently have to send printed information with each prescription, even if they transmit the same information digitally.
- Prescription information labels — generally for pharmacists’ use — can run as long as 45 pages, according to the GAO.
- A coalition of drugmakers says getting rid of the paper requirement would improve patient safety by enabling real-time updates to drug labels, as well as cut down on paper waste.
- Paper labeling also poses substantial costs, said Allan Coukell, senior vice president of public policy at Civica Rx.
- “The pharmaceutical company pays the cost of printing them and attaching them to the package, but of course, ultimately, that gets built into the price that we all pay for drugs,” Coukell said.
The backstory: In late 2014, the FDA proposed a rule that would have required drugmakers to send prescribing information to health care providers electronically, instead of via paper.
- The proposal received significant pushback from lawmakers, particularly those representing areas with big timber industries.
- Since then, appropriations riders have prevented the agency from implementing the rule, an agency spokesperson said. FDA withdrew the proposal in 2019.
What we’re watching: The Prescription Information Modernization Act, reintroduced in March by Reps. Diana Harshbarger and Mikie Sherrill, would also remove the appropriations rider and allow, but not require, electronic prescription information.
- “It's not that we're against the paper lobby, but for us, the patient's the most important,” said Zac Rutherford, chief of staff for Harshbarger.
- “We hate that this might affect the bottom line, but quite frankly, if patients stand to benefit, well then we're going to side with the patients,” he said.
The other side: The Pharmaceutical Printed Literature Association — whose members include paper, labeling and printing companies — wants to preserve paper-format prescription information.
- “We vehemently oppose electronic in lieu of paper” in the prescription information, said Richard Scholz, strategic adviser to the PPLA board of directors.
- PPLA points to a 2013 GAO report that notes there isn't consensus that eliminating paper labeling for both providers and patients would improve patient safety and public health.
- Allowing providers to opt into paper information won't work either, said PPLA board president Dave Joesten, a vice president at labeling company CCL Industries.
- "We've developed a system to ensure that pharmacists and professionals have information that they need. It's a proven system. It's been in place for a long time," Joesten said.
PPLA also backs the Patients’ Right to Know Their Medications Act.
- The bill focuses on improving communication to patients about their outpatient drugs by requiring drugmakers to distribute standardized-format, FDA-approved paper information to patients. FDA proposed a rule similar to the bill Tuesday.
- Reps. Buddy Carter, Jared Golden, Bruce Westerman and Dutch Ruppersberger are co-sponsoring the legislation. They say not providing physical information to patients is the real safety concern.
- “Folks assume everyone in the world has high-speed internet,” Golden told Axios in a hallway interview. “I’ve still got places [in my district] that barely have the slowest of services. When people are inconvenienced by stuff like that, they just go ahead and take the meds.”
But Golden openly acknowledges that the issue runs deeper than patient safety. His district, Maine’s 2nd, is home to Twin Rivers Paper Co.’s Madawaska Paper Mill.
- “Those are 200-something good-paying, union, awesome-Cadillac-health care jobs in a town that would literally fall apart without those jobs,” he said.
- “They're making a product that is about giving people easy access to important safety information, so I don't really worry about the pharmaceutical companies’ profit margins.”
The intrigue: A similar conflict exists around health insurance. Payers also have to send paper communications to enrollees.
- As interest grows on the federal level to change these policies, insurance stakeholders are “definitely anticipating a very strong opposition from the paper industry,” an insurance industry lobbyist said.
