5 ms·

TriCorder X-Prize? FDA has done nothing but hobbled it's development. DNA screening for the masses? FDA shut down 23andMe. Terminally ill and willing to try an

TriCorder X-Prize? FDA has done nothing but hobbled it's development. DNA screening for the masses? FDA shut down 23andMe. Terminally ill and willing to try an experimental drug? FDA says, "too bad" (and the Supreme Court agrees).

tim333 11y ago
They should have a principle of maximising the public good which I feel would allow some of that stuff.
kirsebaer 11y ago
The FDA approves requests to use non-approved medications 99% of the time. When you hear about someone unable to access an experimental drug, it is almost always because the pharmaceutical company does not want to make the drug available early (for various reasons). > At the meeting, a senior FDA representative indicated the agency has approved over 99 percent of expanded access requests submitted via single patient or emergency INDs since 2009, suggesting the regulatory agency is not a major barrier to expanded access. As such, provided the access request is reasonably related to the potential benefits of the drug, the biopharmaceutical company is almost solely responsible for the decision and liability regarding whether to grant expanded access to an individual. http://healthaffairs.org/blog/2014/07/31/individual-patient-expanded-access-developing-principles-for-a-structural-and-regulatory-framework/ http://healthaffairs.org/blog/2014/07/31/individual-patient-...
rayiner 11y ago
They didn't "shut down" 23andMe. They stopped them from marketing unproven health diagnoses derived from the DNA tests.
- fedups 11y ago
  I think it went beyond a marketing ban, unless 'marketing' extends to selling and displaying health related information.
  - vitd 11y ago
    You can still use 23 and Me to get your results, but you have to go elsewhere (like to your doctor) to interpret the results. They were basically giving patients a diagnosis without going through the proper legal work to be able to give diagnoses. It would be no different than some random person giving you a medical diagnosis without being an actual licensed doctor. This was not a case of over regulation. It was pretty simple, and the FDA tried repeatedly to work with 23 and Me to bring them into compliance, but the company basically ignored the FDA's requests for meetings and information. They have nobody to blame but themselves, and what happened was good for consumers.
    - ska 11y ago
      Correct. The 23 and Me decision was things working the way that they should.
    - fedups 11y ago
      This does highlight the effort to maintain the historic paradigm of health professionals as gatekeepers in the face of wider and easier access to health information. Fortunately sources like snpedia.com still exist for those wanting to use their 23andme data to do their own exploring without an intermediary, should they choose.
      - rayiner 11y ago
        Nobody is gatekeeping access to health information. You can go online and try and correlate your test results with the information that's out there. What the FDA prevented was a company profiting from selling a diagnostic service that wasn't proven.

tim333 11y ago

They should have a principle of maximising the public good which I feel would allow some of that stuff.

kirsebaer 11y ago

The FDA approves requests to use non-approved medications 99% of the time. When you hear about someone unable to access an experimental drug, it is almost always because the pharmaceutical company does not want to make the drug available early (for various reasons). > At the meeting, a senior FDA representative indicated the agency has approved over 99 percent of expanded access requests submitted via single patient or emergency INDs since 2009, suggesting the regulatory agency is not a major barrier to expanded access. As such, provided the access request is reasonably related to the potential benefits of the drug, the biopharmaceutical company is almost solely responsible for the decision and liability regarding whether to grant expanded access to an individual. http://healthaffairs.org/blog/2014/07/31/individual-patient-expanded-access-developing-principles-for-a-structural-and-regulatory-framework/ http://healthaffairs.org/blog/2014/07/31/individual-patient-...

rayiner 11y ago

They didn't "shut down" 23andMe. They stopped them from marketing unproven health diagnoses derived from the DNA tests.

fedups 11y ago
I think it went beyond a marketing ban, unless 'marketing' extends to selling and displaying health related information.
- vitd 11y ago
  You can still use 23 and Me to get your results, but you have to go elsewhere (like to your doctor) to interpret the results. They were basically giving patients a diagnosis without going through the proper legal work to be able to give diagnoses. It would be no different than some random person giving you a medical diagnosis without being an actual licensed doctor. This was not a case of over regulation. It was pretty simple, and the FDA tried repeatedly to work with 23 and Me to bring them into compliance, but the company basically ignored the FDA's requests for meetings and information. They have nobody to blame but themselves, and what happened was good for consumers.
  - ska 11y ago
    Correct. The 23 and Me decision was things working the way that they should.
  - fedups 11y ago
    This does highlight the effort to maintain the historic paradigm of health professionals as gatekeepers in the face of wider and easier access to health information. Fortunately sources like snpedia.com still exist for those wanting to use their 23andme data to do their own exploring without an intermediary, should they choose.
    - rayiner 11y ago
      Nobody is gatekeeping access to health information. You can go online and try and correlate your test results with the information that's out there. What the FDA prevented was a company profiting from selling a diagnostic service that wasn't proven.