There’s still a small window to make the FDA listen to reason. Action Alert!
“Medical foods,” by the federal government’s definition, aren’t simply a diet plan prescribed by a doctor. They are foods that are specifically formulated and processed for a sick patient. They are intended to meet specific nutritional requirements for the management of a disease or condition. Please read our new white paper on medical foods for more information.
As we reported recently, the FDA has recently issued an updated draft guidance that drastically limits the number of conditions that medical foods can be used to manage.
Under the new guidance, producers of medical foods will either have to reformulate their products to go through the drug approval process (which can cost billions of dollars) or market them as dietary supplements (which would severely limit the claims their products could make, depriving practitioners and consumers of valuable health information). By making the “buy-in” for the medical industry affordable only to Big Pharma , small businesses and start-up innovators will be kicked out of the industry, drug companies will reap the rewards of yet another FDA-sponsored monopoly, and consumers will be left to deal with the ramifications of limited, more expensive options.
Medical foods can be an integral tool of an in-patient hospital treatment plan, and can reduce the length of hospital stays by speeding recovery. In-patient visits are extremely expensive—on average, one day as an in-patient costs $4,000. The medical food draft guidance could limit the availability of medical foods, thus making treatment plans less effective and hospital stays longer.
For example: in America, the average hospital stay of discharged patients (meaning those who don’t “live” in a hospital) is 4.8 days. If reducing access to medical foods, as a result of the new guidance, raises the average hospital stay even a tiny bit—to 5 days—it could have a huge effect on the economy. That extra 0.2 day may not seem like a significant jump until you realize that there are 35.1 million in-patients a year, so this would raise the cost of healthcare by over $28 billion!
And let’s not forget that hospital-acquired infections come at the annual expense of 99,000 deaths and $20 billion—healthcare mistakes are the leading cause of death in the US. Using medical foods to keep hospital stays as short as possible, thereby reducing the risk of patient exposure to infections and medical errors, could save billions of lives and dollars.
Right now the use of medical foods is in the hands of the doctor and patient. Isn’t that exactly where it should be?
With its “Big Brother knows best” mentality and its attempts to limit consumer access to dietary supplements, direct-to-consumer genetic testing, and medical foods, the FDA is supporting the needs of special interests—not the needs of our country or our economy. Individual freedoms are, to put it bluntly, being trampled.
Action Alert! First, read our latest white paper on medical foods, and share what you’ve learned with your family and friends. Then tell the FDA they need to broaden their list of diseases and conditions for which medical foods may be administered, not restrict it! The comment period for the draft guidance on medical foods has been extended until December 16. Send the FDA your comments today!
