Re:FDA Warning Letter to 23andMe
by dragonwriter on Monday November 25, 2013 @04:47PM
(#6797298)
> The FDA introduces a bootstrapping problem wherein the proceeds from selling a potential remedy cannot be used to test it
To the extent that approval requirements applied by the FDA under the Food, Drug, and Cosmetics Act do that with remedies (which aren't at issue in this case, as it is about a diagnostic device not a tretment), that isn't what happened here, as demonstrated by the fact that the FDA allowed 23andMe to continue to operate for years after issuing the June 2010 letter in which they first raised the issue that the PGS fell within the FDA's regulatory ambit and that various approvals were needed to continue marketing it the way it was marketed.
The "stop now" letter wasn't set until 23andMe stopped working with the FDA toward meeting the requirements, so 23andMe in fact was able, had it chosen to do so, to use the funds from selling its device to test it.
> and no one other than the inventor can test it, because the product cannot be sold until after it is tested.
The FD&C Act doesn't prevent covered "remedies" (etc.) from being sold before they are tested, it prevents them being sold to prevent, treat, or diagnose disease until they've been tested. Products can be sold for, e.g., research purposes before being approved (and, in fact, often are -- one of the suppliers to 23andMe and other genetic testing services was dinged by the FDA for knowingly selling to 23andMe and other genetic testing services products for diagnostic use which were not yet cleared for such use but which were allowed for research use [1].)
> In any case, the only hurdle to selling should be "does it do harm?", and "does it work as advertised?" can be determined later, if and only if there is any doubt among the consumers.
This approach was tried in the health space for many, many years, and the results were deemed unacceptable. Of course, you may have a different opinion of what is desirable than that which motivated the Food, Drug, and Cosmetics Act, but simply asserting that the rules should be different is unconvincing.
> Elsewhere in consumerland, the product is sold, and independent testing is performed on off-the-shelf samples. Think Consumer Reports or Underwriters' Laboratories.
That's true for some consumer products, and its not true for others, generally driven by perceived risk levels.
To the extent that approval requirements applied by the FDA under the Food, Drug, and Cosmetics Act do that with remedies (which aren't at issue in this case, as it is about a diagnostic device not a tretment), that isn't what happened here, as demonstrated by the fact that the FDA allowed 23andMe to continue to operate for years after issuing the June 2010 letter in which they first raised the issue that the PGS fell within the FDA's regulatory ambit and that various approvals were needed to continue marketing it the way it was marketed.
The "stop now" letter wasn't set until 23andMe stopped working with the FDA toward meeting the requirements, so 23andMe in fact was able, had it chosen to do so, to use the funds from selling its device to test it.
> and no one other than the inventor can test it, because the product cannot be sold until after it is tested.
The FD&C Act doesn't prevent covered "remedies" (etc.) from being sold before they are tested, it prevents them being sold to prevent, treat, or diagnose disease until they've been tested. Products can be sold for, e.g., research purposes before being approved (and, in fact, often are -- one of the suppliers to 23andMe and other genetic testing services was dinged by the FDA for knowingly selling to 23andMe and other genetic testing services products for diagnostic use which were not yet cleared for such use but which were allowed for research use [1].)
> In any case, the only hurdle to selling should be "does it do harm?", and "does it work as advertised?" can be determined later, if and only if there is any doubt among the consumers.
This approach was tried in the health space for many, many years, and the results were deemed unacceptable. Of course, you may have a different opinion of what is desirable than that which motivated the Food, Drug, and Cosmetics Act, but simply asserting that the rules should be different is unconvincing.
> Elsewhere in consumerland, the product is sold, and independent testing is performed on off-the-shelf samples. Think Consumer Reports or Underwriters' Laboratories.
That's true for some consumer products, and its not true for others, generally driven by perceived risk levels.
[1] http://www.fda.gov/downloads/medicaldevices/resourcesforyou/...