FDA to sponsor Twitter chat on proposed guidelines for health-related apps

SILVER SPRING, Md. — The Food and Drug Administration will sponsor a chat session via Twitter concerning proposed guidelines for health-related apps, the agency said Tuesday.

The chat session will begin at 3 p.m. on Twitter.com/US_FDA.

A wide variety of health apps have become available for smartphones in recent years, and the FDA is responding by proposing guidelines affecting medical apps that the agency said could present a risk to patients if they don’t work as intended. The guidelines are scheduled to be posted on the Federal Register website and to appear in print on Wednesday.

Comments

More fiscally irresponsible

More fiscally irresponsible regulation from the FDA. Big surprise.

Medical apps are a small proportion of our medical devices. 50% of our medical devices and 80% of our pharmaceuticals are imported according to the FDA themselves in their report Pathway to Global Product Safety and Quality. They also said themselves that “The safety of America’s food and medical products remains under serious threat… it would take 9 years just to inspect every high-priority pharmaceutical facility alone, let alone those of lower priority.” The FDA is lacking in resources and manpower. The FDA’s budget was slashed recently by 258 million. This new set of regulations is only one instance of new regulations that are taking away resources from more important areas. This lack of resources has made the 2011 Food Safety and Modernization Act reactionary instead of preventative as the FDA will need to establish a myriad of partnerships, coalitions and improved intelligence-gathering techniques. Even then, resources will still be deployed on “data-driven risk analytics.” Hardly all-inclusive, hardly preventative. By overregulating this new field of technology and handing over monopolies to big pharma, we crush innovation. Many companies, especially small tech startups cannot afford the increased research. For example since 1968 about 41 less new pharmaceuticals have been approved each year according to the Independent Institute and even more aren’t even researched due to the costs associated.

Initially, for the first 86 years of FDA's existence, from 1906-1992the U.S. treasury department funded the FDA. In 1992 a law passed allowing pharmaceutical companies to provide funding for their own research that smaller companies could not put forth.

Once again the FDA kills growth and initiative in favor of Big Pharma.