Drug makers want a more digital future, but the paper industry is lobbying to keep printed drug information around.
Because matter: The conflict has been raging for nearly a decade, but could come to a head this year.
- For the first time since 2014, the 2024 House appropriations text does not include a clause that prevents the FDA from allowing drug companies to use only electronic formats to distribute prescribing information.
Where is it: Pharmaceutical companies currently have to send printed information with every prescription, even if they send the same information digitally.
- Prescription information labels typically for use by pharmacists can run up to 45 pages, according to the GAO.
- A coalition of drugmakers says eliminating paper would improve patient safety by enabling real-time updates to drug labels, as well as reduce paper waste.
- Paper labeling also comes with substantial costs, said Allan Coukell, senior vice president of public policy at Civica Rx.
- The drug company pays the cost of printing them and attaching them to the package, but of course, ultimately, this is built into the price we all pay for drugs, Coukell said.
The backstory: In late 2014, the FDA proposed a rule that would have required drug companies to send prescribing information to healthcare providers electronically, instead of on paper.
- The proposal has received significant pushback from lawmakers, especially those representing areas with large logging industries.
- Since then, appropriation runners have prevented the agency from implementing the rule, an agency spokesman said. The FDA withdrew the proposal in 2019.
What were they looking at: The Prescription Information Modernization Act, reintroduced in March by Congressmen Diana Harshbarger and Mikie Sherrill, would also eliminate appropriations bypass and allow, but not require, electronic prescription information.
- It’s not that we’re against the newspaper lobby, but for us, the patient is most important, said Zac Rutherford, Harshbarger’s chief of staff.
- We hate that it affects bottom line, but frankly, if patients are going to benefit, well, then we’ll side with patients, he said.
Other side: The Pharmaceutical Printed Literature Association, whose members include paper, labeling and printing companies, wants to keep prescription information in print format.
- We vehemently oppose electronic instead of paper in prescribing information, said Richard Scholz, strategic advisor to the PPLA board.
- PPLA points to a 2013 GAO report that notes that there is no consensus that eliminating paper labeling for both providers and patients would improve patient safety and public health.
- Allowing suppliers to opt out of paper information isn’t going to work either, said PPLA board chairman Dave Joesten, vice president of labeling company CCL Industries.
- “We’ve developed a system to ensure pharmacists and professionals have the information they need. It’s a proven system. It’s been in place for a long time,” said Joesten.
PPLA also supports the law on patients’ right to know their medicines.
- The bill focuses on improving communication to patients about their outpatient medications by requiring drug manufacturers to distribute hard-copy information in a standard FDA-approved format to patients. The FDA proposed a rule similar to the bill on Tuesday.
- Representatives 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.
- People assume that everyone in the world has high-speed internet, Golden told Axios in a hallway interview. I still have places [in my district] which barely have the slowest services. When people are bothered by things like that, they go ahead and take the medicine.
But Golden acknowledges openly that the problem is deeper than patient safety. Its district, Maines 2nd, is home to the Madawaska mill of Twin Rivers Paper Co.s.
- Those are 200 something high-paying, unionized, fantastic Cadillac health care jobs in a city that would literally fall apart without those jobs, he said.
- They’re building a product that gives people easy access to important safety information, so I don’t really care about the profit margins of pharmaceutical companies.
The intrigue: A similar conflict exists around health insurance. Payers must also send paper communications to subscribers.
- As federal interest in switching these policies grows, insurance industry stakeholders are no doubt anticipating strong opposition from the paper industry, said an insurance industry lobbyist.
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