In its comments—available here—Consumers for Paper Options makes the following main points:
- The FDA has not established that the rule is necessary and has made no attempt to demonstrate the current system is qualitatively or quantitatively inadequate.
- The FDA's Preliminary Regulatory Impact Analysis (PRIA) fails to consider the potential negative public health outcomes resulting from cyber-security risks and pharmacist workflow interruptions which all might result from this ruling.
- The FDA erroneously assumes all pharmacies have equal or adequate Internet access without contemplating emergency events, such as natural disasters, which can cause power outages and loss of Internet. Even in blue-sky scenarios many pharmacists do not have reliable Internet connection or web-browsing capabilities. The Federal Communications Commission reports that 55 million Americans lack advanced Internet access and more than half of the Americans in rural areas lack it. The comments also quote a 2015 national survey in which 27 percent of pharmacists indicated that their pharmacy "either does not have Internet access or that they cannot browse the Internet."
About Consumers for Paper Options
Consumers for Paper Options is organized by the American Forest & Paper Association (AF&PA) and the Envelope Manufacturers Association (EMA) to bring together industry, non-profits and consumers in an effort to address the transition to Internet-only resources at the exclusion of millions of citizens. Consumers for Paper Options is united in the belief that paper-based communications are critically important for millions of Americans, especially seniors and the 25 percent of households without Internet access. While regulated entities and governments at every level need to streamline services, cut costs and improve efficiencies, the goal of Consumers for Paper Options is to preserve access in a way that neither hinders the natural evolution of technology nor discriminates against those who may not, or cannot, use it. For more information, visit http://paperoptions.org.
Consumers for Paper Options Urges FDA to Rescind Switch to Electronic Drug Labeling
In its comments—available here—Consumers for Paper Options makes the following main points:
About Consumers for Paper Options
Consumers for Paper Options is organized by the American Forest & Paper Association (AF&PA) and the Envelope Manufacturers Association (EMA) to bring together industry, non-profits and consumers in an effort to address the transition to Internet-only resources at the exclusion of millions of citizens. Consumers for Paper Options is united in the belief that paper-based communications are critically important for millions of Americans, especially seniors and the 25 percent of households without Internet access. While regulated entities and governments at every level need to streamline services, cut costs and improve efficiencies, the goal of Consumers for Paper Options is to preserve access in a way that neither hinders the natural evolution of technology nor discriminates against those who may not, or cannot, use it. For more information, visit http://paperoptions.org.