Medicine in the Dark Ages, Part 2. Smartphone Apps Must be FDA-Approved!

SmartphonesIt sounds absurd, but FDA wants to pre-approve simple medical apps—making them impossibly expensive.

Cell phone health apps are a growing industry, as more and more people use them to take ownership over their own health. They could even be the next big thing in the health revolution. Thousands of medical apps are now flooding the market, and they’re doing some amazing things—everything from counting calories or calculating your body mass index to measuring your blood pressure and blood sugar levels and, if desired, sending the readings to your doctor.
Between one-third and one-half of adults in America consult health-related blogs and social networks, visit health product ratings websites, or use health apps. The medical app market is projected to grow 25% annually—more than many other segments of the app market.
But now FDA wants to regulate (i.e., stifle) medical apps. Guidelines, allegedly requested by Congress but really sought by the agency, are expected by the end of the year. Whatever the guidelines say, we already know that:

  • Having to get FDA approval will not only inflate price of individual apps, it will also delay the development of new and potentially crucial apps by months or even years.
  • FDA doesn’t have the technical expertise to regulate mobile phone apps in the first place. Joel White, executive director of Health IT Now Coalition, puts it this way: “The issue here is that they’re really using a process for approval of these mobile apps that was basically created when the 5¼” floppy disk was the latest technology.”
  • Pre-approval interferes with consumers’ ability to become educated about and take a proactive part in their own health, freezing health technology in the “dark ages.”
  • Given the FDA’s bias against alternative medicine, a pre-approval process for apps will very likely ensure that we won’t see many that are focused on natural health. An app, for example, that measures daily recommended intake for vitamins and minerals would adhere to the standards of conventional medicine (such as the ultra-low vitamin D recommendations from the IOM report) rather than the nutrient standards recommended by integrative physicians.
  • FDA could very easily violate First Amendment freedom of speech rights by predetermining what is and is not suitable for viewing. For example, if an app were to cite peer-reviewed science on the benefit of a nutritional supplement for a disease, the FDA will likely, given their track record with food companies, use that citation as the basis for denying approval. We are concerned this may open the door for FDA to regulate online forums and blogs where people share their clinical experiences.
  • New and small businesses that do not have the finances necessary to weather an FDA approval process will be disproportionately hurt.

We will update you once HHS finishes its work and presents its recommendations to Congress at the end of the year. Enjoy your freedom while you can.

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  1. The next thing will be to keep me from checking out a medical book from the library. Oops, did I just say that? What’s the problem? Are they worried I’ll make a medical decision that won’t benefit modern medicine? Are they on they’re way to regulating what we can learn? What’s next?

  2. Why aren’t they concerned about protecting us from the radiation from smart phones?

  3. Anywhere there is money to be made or lost, the big corporate powers will do what they can to stop people from taking responsibility for their own care.

  4. FDA needs to sell shares on the open market,,,The money they are making from the drug makers to pull this one off would be easy mark up on shares,

  5. There is a great sense of freedom when one can choose his/her own remedy for whatever a heart desires. This God given right should not be taken away. Somehow I see this as another way for big business (food industry) to once again find a way to make a profit on something that is a matter of choice.

  6. This is just another example of the Federal Government with too much money and personell.
    Time is start defunding the FDA– starve them of cash. This is Clongress’ responsibility.

  7. I would write my Congressperson–except that the last time I personalized ANH-USA’s form letter, the only Congressperson who responded was my state legislator Mike Michaud, and his response was a form letter that ended in the flat statement, with no explanation, that supplements must be supervised. Why? Free market buyers do a good job of that now–a whole lot better job than FDA ever did on anything–pharmaceuticals, imported olive oil with no olive oil in it, imported wines that could serve as rat poison given their super-high levels of mercury and lead (FDA doesn’t monitor or check up on imports at all, and takes the manufacturer’s word for it on domestic products. So long as they aren’t alternative health or organic healthy products–then out comes FDA’s Big Whip to flog the peasants back into line.
    Point being, nobody intends to do what’s right–only what works. And if we powerless penniless peasants have no bread as a result–FDA says let us eat cake!
    Who ya gonna call? Not even my state legislator’s office lady knew the name of FDA’s oversight committee or its members or their contact data. And even Washington Senators now beg FDA to please play nice–please?–and get ignored. Even Orrin Hatch only got FDA to DELAY the hammer-down deadline–which fits with the six-month extension of patents by trials of adult drugs on children (with the openly stated intent NOT to apply for approval to sell them for use on children, in the case of highly addictive Oxycontin). So Hatch got only what suited FDA’s sugar daddies anyway. And Hatch only got that far because, according to the article I read, Hatch partly holds FDA’s pursestrings.
    I am afraid in a way I never thought anyone in the US would ever have to be afraid.

  8. The FDA is like the State Department. They appear to have an independent agenda completely divergent from the wishes, needs, or safety of the American people. They are “trans-administrational”, if you will. The FDA under Obama, or Bush, or Clinton remains the same–looking out for the welfare of entities (money) that will provide post-agency jobs, not the people who pay they are supposed to protect.

    1. that was supposed to read “not the people they are supposed to protect”.

  9. We need to locate the people who corrupt the FDA.They are heads of billion-dollar conglomerates.That doesn’t make them immune in the eyes of GOD and DIVINE JUSTICE.
    If the US justice department is unable to bring the criminals to justice that run US agencies including the White House, then we need to take them to the international criminal court of The Hague. We k n o w who these people are, and we w o n ‘ t let them run business (DEAATH INDUSTRIES) as usual any longer.The also control NATO , the UN, the IMF the CFR etc. it’s a conglomerate of criminals of the highest degree….EUGENICISTS that want to get rid of billions of people on this planet and control the rest with junkfood and prescription drugs…make us all into zombies and get away with it laughing…

  10. The FDA is largely responsible for our expensive and ineffective medical care system because their bureaucratic delays at every tiny step impede progress. Now they want to do the same thing to the internet. This must be stopped. We would be better off if the FDA was abolished completely.

  11. People need to realize the FDA is only regulating what is safe, not what ensures a person’s HEALTH… they are the FOOD AND DRUG Administration not the FOOD AND HEALTH Administration. They should be focusing on regulations and enforcement of illegal drugs more than touching apps that have to do with improving health.

  12. With all the bellyaching about the FDA, my voice is really the loudest. Am I the only one who wants to stop the yapping and start the recall of each and every one of those dangerous and uncaring, self-interested commissioners? Surely not.
    I was trained in mainstream medicine, but over time, I have realized that almost everything I learned and used in my early years, was wrong. One thing about medicine that is constant: you never stop learning. No need to be self-conscious about changing your views on things you thought were cast in stone. As ideas evolve, observations about disease and how to treat it should evolve also. Curiosity impels medical research, or we would be stuck back in the dark ages.
    There must be a way to start a recall petition of the FDA and stop them from steamrollering the public and depriving us of the ability to take control of our own health.


  13. More regulation from Big Government designed to protect us from ourselves. They have egos as large as the universe and money to burn. They don’t walk on water! They will generate a book of intertwined, convoluted and contradictory regulations that no lawyer in the world will be able to understand. They themselves won’t know what’s in it. At least, not until they pass it. We do not need more regulation, especially from those who are no more intelligent, and not as well informed as the general public.
    Every single statute, agency generated law should have to pass a referendum of the people. Every flawmaker on capital hill should be limited to one bill during their term in office. Any entity that has an income of over, say $100,000 can not lobby Congress or any government agency. The cost of lobbying must be made prohibitive to any but the citizens. Will that happen? No! Our elected representative will not cut off their nose to spite their face. They get too much money from Corporate America for their election funds to allow anything like that to happen. Corporate America owns Congress and all the state legislative bodies.
    Do not vote for the incumbent. Let them know that you are not at all satisfied with their performance. Let Corporate America know that all their contributions did not buy them the representation they thought they had paid for.
    Frightened for years and getting more frightened every day. It has to stop!

  14. Where does the FDA get the authority to regulate telephones or the internet. Truth be known, they do not have the authority. They will write their own regulation that gives them the authority. This is one of the huge problems with any agency or pseudo-agency of the government. They assume authority they do not have. But the problem goes further. No one challenges them. No one can afford to challenge them. We have to sit back and allow them to run rough shod over us.

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