The Alliance to Modernize Prescribing Information (AMPI), an alliance of pharmaceutical manufacturers and other stakeholders, has advocated strongly for the elimination of paper prescribing information from pharmaceutical packaging, most recently with a 30-second ad alleging that US Congressional appropriators have blocked a proposed regulatory rule designed to shift prescribing information from paper to digital media.
The Washington, DC-based television and digital advocacy campaign, dubbed “Senseless Waste,” calls on House Appropriations Committee Democrats to support greater sustainability in pharmaceutical practices.
At the center of AMPI’s advocacy rhetoric is a rule proposed by the US Food and Drug Administration (FDA) and published in the Federal Register in 2014. This rule, “Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products,” proposes that prescribing information no longer be distributed in paper form with the product’s package. The prescribing information, which is directed at healthcare professionals (not patients) would be required to be distributed electronically.
The FDA, in a summary of the proposed rule, stated: “We are proposing these actions to help ensure that the most current prescribing information is publicly accessible for the safe and effective use of human prescription drugs.” According to AMPI, the rule would modernize pharmaceutical labeling and speed information updates, in addition to saving millions of trees and reducing paper waste.
A rider that prevents the FDA from finalizing the proposed rule “has been included in each appropriations bill since the proposed rule was published,” an FDA spokesperson explains.
He adds, “The rider states as follows: Sec. 730. None of the funds made available by this Act may be used to propose, promulgate, or implement any rule, or take any other action with respect to, allowing or requiring information intended for a prescribing health care professional, in the case of a drug or biological product subject to section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)(1)), to be distributed to such professional electronically (in lieu of in paper form) unless and until a Federal law is enacted to allow or require such distribution.”
The rider stayed in place on the appropriations bill that will fund the FDA in the coming year. The Fiscal Year (FY) 2022 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies funding bill passed in the House on July 29, 2021, as part of a package of seven appropriations bills. It was approved by the US Senate Committee on Appropriations the following week.
AMPI’s advocacy campaign targeted two US Representatives, both Democrats, for allegedly obstructing finalization of the rule and siding with “the paper lobby.”
One of the two Representatives is Chellie Pingree. Representing Maine’s First Congressional District, Pingree is a member of the House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies. She is also a proponent of boosting broadband coverage in rural communities. Effective electronic distribution of prescribing information clearly requires reliable, widespread broadband service.
The other Congressman targeted in AMPI’s ad is Jared Golden, who represents Maine’s Second Congressional District. Golden, together with a bipartisan group of nine additional Representatives, sent the chairman and ranking member of the House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies a letter in April 2021, asking for the rider language to be included in the FY 2022 FDA appropriations bill.
That letter stated, “This rule would jeopardize the health of the American people by eliminating hard copies of critical medicine prescribing information, upon which physicians, pharmacists, and other health care professionals rely.” It went on to cite a government study from 2013 that indicated “an absence of printed labels is particularly problematic for prescribers and patients in rural practice settings, deployed military practice settings, and in all areas in the event of a severe weather or man-made disaster.”
In a prepared statement released in July 2021, Golden touted his work to include the rider language in the FDA appropriations bill and highlighted the paper-industry jobs saved as a result. “I was proud to lead my colleagues to choose hundreds of good-paying, union jobs in a rural community that needs them over the priorities of pharmaceutical companies,” Golden said.
He added, “I came here to represent my constituents and stand up for their jobs and I’m proud to get this done for the workers in Madawaska.” That Maine town, which is in Golden’s Congressional district, is home to a paper mill operated by Twin Rivers Paper, a leading supplier of pharmaceutical insert paper.