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Packaging company CEO slams FDA over drug labeling

Eliminating printed professional inserts would put pharmacies at risk, the CEO believes.

The CEO of 3C Packaging, Inc. is urging the FDA to not "eliminate professional inserts and force pharmacies onto a cyber-only system."

In a blog post published on The Hill, Joe Elphick explains that Congress has previously addressed the issue when they signed the Federal Food, Drug and Cosmetic Act (FDCA) and the Drug Quality and Security bill into law last year, which had language that continued to the use of paper inserts, "in addition to—not in lieu of—paper inserts."

However, "on Dec 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."

"The FDA’s proposed rule contains too many potential negative implications on public health and addresses no public health crisis," he wrote in the post. "It’s a cumbersome and risky solution that may well create more problems than it prevents."

Acknowledging the fact his company prints, among other things, those professional inserts, he also points to cyber security threats as a major reason why the pharmacies around the country cannot solely rely on sensitive drug information being delivered, and stored solely in cyberspace, even mentioning the National Community Pharmacists Association as an opponent of the move.

"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," he wrote.

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