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"The agency has dominion over any part of a vehicle sold in the United States, from the headlamps to the owner’s manual, but can’t regulate the speech of a corp

"The agency has dominion over any part of a vehicle sold in the United States, from the headlamps to the owner’s manual, but can’t regulate the speech of a corporation or its employees." True, but the agency gives legal cover. When there is a question in court as to whether the safety systems performed "as advertised", the NHTSA is free to say that Tesla didn't follow the advertising guidelines, and therefore cannot comment on the performance of the safety system. Drug companies can also advertise drugs outside the FDA guidelines, and would win a court challenge on 1st Amendment grounds. None do it because it would expose them to unbounded liability.

lvs 13y ago
>Drug companies can also advertise drugs outside the FDA guidelines, and would win a court challenge on 1st Amendment grounds. None do it because it would expose them to unbounded liability. No, no, no. This is utterly and confirmably false. It is illegal under the Federal Food, Drug and Cosmetic Act to advertise a prescription drug for a use that is not FDA approved, and it is within the FDA's mandate to recommend investigation to the Department of Justice in such circumstances. The FTC is authorized to oversee advertising for over-the-counter drugs under the Wheeler-Lea Act. As a recent example, Pfizer agreed to settle with the DoJ earlier this summer for half a billion to end an investigation brought under these very circumstances[1]. [1] http://www.newstatesman.com/business/business/2013/07/pfizer-pay-491m-fine-label-marketing-rapamune-us http://www.newstatesman.com/business/business/2013/07/pfizer...
- jcampbell1 13y ago
  Jesus man. You seem awfully certain. Here is a ruling from December that affirms 1st amendment rights to market off label uses: http://www.reedsmith.com/files/uploads/DrugDeviceLawBlog/Caronia.pdf http://www.reedsmith.com/files/uploads/DrugDeviceLawBlog/Car... " Caronia argues that he was convicted for his speech -- for promoting an FDA-approved drug for off-label use -- in violation of his right of free speech under the First Amendment. We agree. Accordingly, -3- we vacate the judgment of conviction and remand the case to the district court. " It is uncertain whether marketing off label is protected by the 1st amendment. The courts don't all agree.
  - lvs 13y ago
    > The courts don't all agree. The one case you cite is very fresh precedent in a single Circuit, and it's highly controversial. No other Federal Circuit has applied First Amendment standards to FDA misbranding regulations before. Even within the Second Circuit (three states), is it still illegal under law to misbrand a drug in marketing materials. The decision in Cariona hinges on the question of whether "misbranding" and "promotion of off-label use" are different narrowly defined legal scenarios. The Second Circuit was concerned that, in the latter scenario, doctors may be legally deterred from promoting off-label use, which is a common practice in medicine and research. You should not take away from this case that drug marketing is now a First Amendment free-for-all. Yes, I am awfully certain.
  - spartango 13y ago
    This is an interesting case, however its important to point out that the legal debate around this is ongoing. This ruling only applies to the 2nd Circuit at this point. It's looking like a Supreme Court case will be necessary to ultimately decided this issue, given the murkiness around it. Until then, however, off-label drug marketing is not something companies get away with without a substantial legal battle (often not worth it), and the FDA has so far collected billions of dollars in settlements and fines through successful off-label drug marketing suits.
  - djjose 13y ago
    I've been out of the industry for a while but I spent 5 years working on regulatory projects in the MD&D sector. We never advertised off-label. Whether it's legal or not, I do recall you'd get slapped by the FDA for lack of controls. We had many cases where doctors would use a product off-label and it'd come back to us in the form of a complaint or defect (product comes back as defective, we investigate and find out the doctor was using the product for an off-label procedure it wasn't designed for and would fail, hence the 'defect'). At which point we'd have to proactively train doctors to not do this and other corrective action measures would have to be put in place. If upon investigating we find this would be a good use of the product, we'd have to go through another round of FDA fun (sometimes clinicals and how much testing depended on some factors, definitely rounds of internal testing and implement new QA tests and procedures to ensure the product can work for the new use and have proper fault tolerances as well as new labeling and training, etc). Now, do companies try to skirt around this? Sure. Part of my job at the time was to make sure we didn't. FDA Warning letters are no joke in this industry, it can literally put you out of business.
will_brown 13y ago
This is an interesting 1st Amendment discussion (relating to the article...I am not touching the separate FDA/drug issue). The most analogous case that comes to mind, is the recent California small claims case against Honda. Facts: According to the EPA (who independently tests vehicles fuel efficiency) the Prius gets an average of 51 MPG. The Plaintiff claimed she only got an average of approximately 30 MPG. The Plaintiff won the lawsuit against Honda for fraudulent misrepresentation winning $10K the small claims limit in the jurisdiction. However, one of the most interesting arguments (and legitimate) was that while Honda does advertise the 51 MPG, that Honda could not be fraudulently misrepresenting the MPG, because Honda had no control over the testing or findings handled by the EPA, and going further Honda does not have a right (1st amendment) to contradict the "EPA sticker". Ergo according to the argument Honda should not be liable, rather the EPA - nevertheless the Court found Honda liable for fraudulent misrepresentation. Assuming this law is on point and controlling, for example, if the Tesla were to under perform in a real crash and Tesla was sued, Tesla may be liable despite having no control over the NHTSA test or findings. Going further, if the dicta from the Honda case is also on point, if Tesla's internal crash tests contradict NHTSA's ratings, Tesla would not have a 1st Amendment right to contradict the NHTSA findings publicly. Note: That SCOTUS makes a distinction between "commercial speech" and other forms of speech, and the government has a lot more power to regulate commercial speech than say political speech.
- tadfisher 13y ago
  Are you referring to a suit against Toyota or a Honda hybrid vehicle? Prius is manufactured by Toyota, not sure why Honda would be involved.
  - will_brown 13y ago
    Nice catch...the suit was against Honda. I must have subconsciously invoked Prius as a matter of bias (not in a negative capacity, simply as the dominate hybrid in my mind subjectively)

lvs 13y ago

>Drug companies can also advertise drugs outside the FDA guidelines, and would win a court challenge on 1st Amendment grounds. None do it because it would expose them to unbounded liability. No, no, no. This is utterly and confirmably false. It is illegal under the Federal Food, Drug and Cosmetic Act to advertise a prescription drug for a use that is not FDA approved, and it is within the FDA's mandate to recommend investigation to the Department of Justice in such circumstances. The FTC is authorized to oversee advertising for over-the-counter drugs under the Wheeler-Lea Act. As a recent example, Pfizer agreed to settle with the DoJ earlier this summer for half a billion to end an investigation brought under these very circumstances[1]. [1] http://www.newstatesman.com/business/business/2013/07/pfizer-pay-491m-fine-label-marketing-rapamune-us http://www.newstatesman.com/business/business/2013/07/pfizer...

jcampbell1 13y ago
Jesus man. You seem awfully certain. Here is a ruling from December that affirms 1st amendment rights to market off label uses: http://www.reedsmith.com/files/uploads/DrugDeviceLawBlog/Caronia.pdf http://www.reedsmith.com/files/uploads/DrugDeviceLawBlog/Car... " Caronia argues that he was convicted for his speech -- for promoting an FDA-approved drug for off-label use -- in violation of his right of free speech under the First Amendment. We agree. Accordingly, -3- we vacate the judgment of conviction and remand the case to the district court. " It is uncertain whether marketing off label is protected by the 1st amendment. The courts don't all agree.
- lvs 13y ago
  > The courts don't all agree. The one case you cite is very fresh precedent in a single Circuit, and it's highly controversial. No other Federal Circuit has applied First Amendment standards to FDA misbranding regulations before. Even within the Second Circuit (three states), is it still illegal under law to misbrand a drug in marketing materials. The decision in Cariona hinges on the question of whether "misbranding" and "promotion of off-label use" are different narrowly defined legal scenarios. The Second Circuit was concerned that, in the latter scenario, doctors may be legally deterred from promoting off-label use, which is a common practice in medicine and research. You should not take away from this case that drug marketing is now a First Amendment free-for-all. Yes, I am awfully certain.
- spartango 13y ago
  This is an interesting case, however its important to point out that the legal debate around this is ongoing. This ruling only applies to the 2nd Circuit at this point. It's looking like a Supreme Court case will be necessary to ultimately decided this issue, given the murkiness around it. Until then, however, off-label drug marketing is not something companies get away with without a substantial legal battle (often not worth it), and the FDA has so far collected billions of dollars in settlements and fines through successful off-label drug marketing suits.
- djjose 13y ago
  I've been out of the industry for a while but I spent 5 years working on regulatory projects in the MD&D sector. We never advertised off-label. Whether it's legal or not, I do recall you'd get slapped by the FDA for lack of controls. We had many cases where doctors would use a product off-label and it'd come back to us in the form of a complaint or defect (product comes back as defective, we investigate and find out the doctor was using the product for an off-label procedure it wasn't designed for and would fail, hence the 'defect'). At which point we'd have to proactively train doctors to not do this and other corrective action measures would have to be put in place. If upon investigating we find this would be a good use of the product, we'd have to go through another round of FDA fun (sometimes clinicals and how much testing depended on some factors, definitely rounds of internal testing and implement new QA tests and procedures to ensure the product can work for the new use and have proper fault tolerances as well as new labeling and training, etc). Now, do companies try to skirt around this? Sure. Part of my job at the time was to make sure we didn't. FDA Warning letters are no joke in this industry, it can literally put you out of business.

will_brown 13y ago

This is an interesting 1st Amendment discussion (relating to the article...I am not touching the separate FDA/drug issue). The most analogous case that comes to mind, is the recent California small claims case against Honda. Facts: According to the EPA (who independently tests vehicles fuel efficiency) the Prius gets an average of 51 MPG. The Plaintiff claimed she only got an average of approximately 30 MPG. The Plaintiff won the lawsuit against Honda for fraudulent misrepresentation winning $10K the small claims limit in the jurisdiction. However, one of the most interesting arguments (and legitimate) was that while Honda does advertise the 51 MPG, that Honda could not be fraudulently misrepresenting the MPG, because Honda had no control over the testing or findings handled by the EPA, and going further Honda does not have a right (1st amendment) to contradict the "EPA sticker". Ergo according to the argument Honda should not be liable, rather the EPA - nevertheless the Court found Honda liable for fraudulent misrepresentation. Assuming this law is on point and controlling, for example, if the Tesla were to under perform in a real crash and Tesla was sued, Tesla may be liable despite having no control over the NHTSA test or findings. Going further, if the dicta from the Honda case is also on point, if Tesla's internal crash tests contradict NHTSA's ratings, Tesla would not have a 1st Amendment right to contradict the NHTSA findings publicly. Note: That SCOTUS makes a distinction between "commercial speech" and other forms of speech, and the government has a lot more power to regulate commercial speech than say political speech.

tadfisher 13y ago
Are you referring to a suit against Toyota or a Honda hybrid vehicle? Prius is manufactured by Toyota, not sure why Honda would be involved.
- will_brown 13y ago
  Nice catch...the suit was against Honda. I must have subconsciously invoked Prius as a matter of bias (not in a negative capacity, simply as the dominate hybrid in my mind subjectively)