U.S. FDA Eliminating Paper Inserts for Medicines

 

According to an article this past week in The Hill, Washington, D.C., USA, prescription drugs are an integral part of modern life. To ensure the safety and accuracy of the prescribing information provided to the dispenser – your local pharmacist – federal law requires drug manufacturers to accompany all medicines with printed or graphic information. Pharmacists use this information to ensure proper dosages and to avoid conflicts between medications. 

Conventionally, the printed nature of this information is especially important for independent pharmacies and anyone serving small towns and rural areas where Internet service and computer systems are unreliable and expensive. Congress understands this need, which is why they included language to protect the continued use of paper inserts in the Federal Food, Drug, and Cosmetic Act (FDCA) and the Drug Quality and Security bill signed into law this past year. Lawmakers were clear: electronic labeling is perfectly fine, but only in addition to—not in lieu of—paper inserts. The U.S. Food & Drug Administration (FDA), however, does not agree.

On December 18, while Congress was heading home for the holidays, the FDA made notice of a proposed rule that will eliminate professional inserts and force pharmacies onto a cyber-only system.  

This potentially sets into motion a policy confrontation between the FDA and Congress because the House and Senate passed a policy directive in 2014 that instructed the FDA against making any rules mandating a web-only system. The National Community Pharmacists Association opposes the proposed FDA rule because of its many serious, if unintended, consequences such as cyber-threats, cost-shifting from manufacturers to independent pharmacies and the uncertain reliability of high speed internet access, especially in small towns and rural areas.  

"As the president of 3C Packaging, Inc., I also oppose this rule as it impacts my printing and packaging business." said CEO Joe Heplick.

3C Packaging (formerly known as Colonial Carton Company), was formed in the late 1970’s by two entrepreneurs who had $600 and a hand die-cutter from the 1940’s. They were determined to live the American dream and succeeded in expanding the company’s capabilities one step at a time. In 2005 they survived a fire that literally burned the business to the ground. However, they claim they didn’t lose any customers because of the fire – "we rebuilt quickly, put in more modern equipment, and grew exponentially. We were operating out of a new building with new equipment within nine months."

Since reopening, 3C Packaging added insert printing services to their production line and have expanded their operations. "We are very grateful to our community who supported the expansion. Today 3C employs more than 200 employees and our printed insert business entirely serves pharmaceutical firms. The FDA’s proposed rule, entirely contrary to the specific direction of Congress, threatens our livelihood, our community, and our employees."

"We hope Congress will prevail upon the Food & Drug Administration to recede from its position that cyber-labeling is the only solution, at least until such time as the security and reliability of the Internet is assured for all of America’s pharmacists and the communities they serve faithfully. The FDA is accepting comments about this rule online, and it encourages the public to do so. We all want less paper waste in our lives – but not at the expense of life saving patient information and North Carolina jobs," Heplick concluded.