Paper industry, drugmakers spar over requirement to print prescribing information

Drugmakers are resuming their annual lobbying battle with the paper industry over an obscure clause slipped into a key spending bill.    

The House Appropriations Committee’s legislation to fund the Food and Drug Administration (FDA), advanced last week, includes a provision preventing the agency from digitizing prescribing information. 

Congress has passed a similar rider every year since 2015 in response to an FDA proposal that would require drug manufacturers to deliver certain prescribing information to pharmacists digitally rather than on paper. Paper industry groups successfully lobbied Congress to block the agency’s proposed rule. 

The Alliance to Modernize Prescribing Information, a group of pharmaceutical companies, is lobbying lawmakers to remove the provision when the bill goes to the House floor. 

A spokesperson for the Alliance called the measure “essentially an earmark for the multi-million dollar paper lobby,” arguing that Congress’s rule mandates paper waste and that paper labels provide pharmacists with outdated information.

“The continuation of this backwards and harmful policy runs counter to what the FDA itself has sought since 2014, which is to modernize pharmaceutical prescribing information labels by no longer requiring the printing of 90 billion unnecessary sheets of paper each year,” the spokesperson told The Hill.

The FDA proposal only applied to prescribing information delivered to pharmacists, not patient labels. 

The Sierra Club, an environmental advocacy group, estimates that Congress’s prohibition of digital labeling has led to the destruction of nearly 30 million trees. The Alliance has underscored the environmental impact of Congress’ rule in letters to key Democrats. 

The Pharmaceutical Printed Literature Association, which represents companies involved in the printed prescribing information (PI) supply chain, is the leading paper industry group backing Congress’s rule. 

The association told The Hill that health care professionals prefer printed PI, and that rural communities lacking broadband internet cannot reliably access the information online. 

“The printed PI has been the gold standard communication form relied upon by health care professionals across practice settings independent of internet connectivity and internet security challenges,” the group said in a statement. “Patient safety and prescription drug therapy success is best served by retaining printed PI.”

The paper industry has a bipartisan group of allies in Congress led by Maine lawmakers. Rep. Jared Golden (D-Maine), a leading opponent of efforts to digitize prescribing information, represents paper mill workers who manufacture printed inserts for prescription drugs.

Golden is one of the few remaining Democrats representing a conservative district, making his reelection campaign key to Democrats’ hopes of keeping the House. Golden won reelection last year by 6 points, even as former President Trump carried his district by 7 points. 

Another bipartisan group of lawmakers is pushing back. Reps. Adam Kinzinger (R-Ill.) and Mikie Sherrill (D-N.J.), along with 18 other lawmakers, wrote a letter to appropriators in May urging them to reject language that prevents the digitization of PI. 

“Providers are already very familiar with electronic labeling information,” the lawmakers said in a statement. “Common sense modernization of the PI requirements will not only avoid a negative impact to patients but may actually improve patient care by allowing labeling updates to be shared more readily than updates made in paper form would permit.”

The pharmaceutical industry alliance is hoping to secure an amendment on the House floor to remove the FDA provision. The House is expected to vote on spending bills when lawmakers return from their Fourth of July recess.