Current Controversies in Food and Drug Law
January 18, 2011
I recently attended a panel on “Current Controversies in Food and Drug Law” and thought I’d jot down a few notes to share with those of you back home (who, obviously, are dying to learn more about the strage exciting world of food and drug law.)
Panelists
Peter Hutt - Current HLS Professor (former FDA general counsel, teaches a Food and Drug Law course every winter)
Mark Raza - Senior Counsel at FDA’s Office of the Chief Counsel
Kirsten Mayer - Ropes and Gray counsel with all sorts of medical and science-related clients
Each panelist had a chance to stand up and discuss in a few minutes what they took to be some of the biggest challenges the FDA currently faces, and while I am not mean an expert I’ll try and lay out a few of the concerns raised:
- Hutt brought up some economic incentive difficulties based on the duration of patents coupled with the significant amount of time it takes to get through FDA approvals. [from my understanding the issue is: patents run for either 14 or 20 years. You file for a patent fairly early in the game (long before you’ve even gone through clinical trials, let alone gotten approval to actually market and sell. So, by the time you get through all the FDA hurdles for approval, you typically only have 11 or 12 years left on the patent — which for a lot of companies isn’t enough time to fully recoup costs and make the sort of profit that incentives companies to invest in the R&D to begin with. So, unless you have a blockbuster, it isn’t worth it for a lot of companies.)
- Raz, changing gears, talked about biosimilars and the regulatory difficulties there (a topic on which the FDA had a two-day meeting back in September). As a bit of background, biosimilars are what they sound like — they are (if I understand correctly — and I’m sure Chris will read this and correct me if I’m wrong) basically molecularly identical to some drug that was already approved, but they are created by another lab, under non-identical conditions, at a time after the original patent has expired. One of the big questions is what sort of testing should these biosimilars have to go through before getting FDA approval. On one hand, they’re basically the same as something already on the market (think of a certain active ingredient in both a name brand drug and some generic) so it seems redundant. On the other hand, we don’t know how much other factors come into how that drug will actually perform. So for instance, with different manufacturing processes they might have different impurities or slight differences at some level — and that in turn may have a profound effect on how that drug is digested in the body.
- Mayer went last and it turns out her issues ended up dominating the rest of the discussion: Off-label marketing. So, in a few sentences what is that all about? Well, from what I understand it goes like this: The FDA approves a drug for a specific use. The manufacture of that drug is then allowed to promote (market) the use of that drug to doctors and the like for just that use. However, it turns out that a drug might be approved to deal with one condition but actually is really great to use in another as well. How do we know this? Well, the drug company might be sponsoring studies to explore that or doctors have recognized relationship in underlying pathology between the condition it was approved for and another condition and then decided to conduct trials of their own (this sometimes happens at university hospitals for people who are basically out of options and are willing to try anything), etc. The issue is: even if it turns out the drug is really useful for another condition, the manufacturer cannot promote/market the use of the drug for that other condition. It is criminal to do so. But, notwithstanding the serious criminal penalties (let alone the absolutely enormous fines companies have paid for doing so) they still do promote off-label use in some cases. Mayer brought up the argument that such off-label marketing prosecution may (1) have some pragmatic issues but more interestingly (to me) (2) may run afoul of Free Speech protection.
So, having not taken ConLaw I will say just a few sentences and see if others have thoughts on all this. The argument seems to be as follows: It’s granted that while we have freedom of speech not all speech is protected (can’t yell “fire” in theatre, can’t slander someone and expect that to be protected, etc.) The government argues that there is no First Amendment issue because 1) the regulations prohibit the promotion by manufacturers of off-label marketing, so for the manufacturer to do so would be an unlawful activity and 2) the speech (which I guess is just the marketing tactics) are just used to establish intent — the intent to commit the unlawful activity. [I think that’s right… though it is a bit confusing to me]
The issue with that line of arguments however is that the promotion of off-label use isn’t prohibited, period. In fact, anyone but the manufacturer can promote the use of the drug in an off-label way. As Mayer points out, if the NYtimes wants to write a bit piece on the virtues of the off-label use of x drug, it can do so under the law. So, it cannot be that the speech itself is an illegal activity; it’s only the speech itself coming from the manufacturer that’s prohibited — and that seems to be a First Amendment issue.
What this made me think of was the Citizens United case. The more we think of companies through the personhood metaphor, the more these free speech for the company issues come up.
Anyway, I must run and do actual class readings but just thought I’d lay out a few of the things I heard. If I can better clarify the last argument in the future, I’ll be sure and do so… and soon!
23andMe Sends People The Wrong DNA Results [and what is (and is not) interesting about it]
June 9, 2010
As reported Monday (TechCrunch article here), 23andMe recently sent the wrong DNA results to up to 96 customers. Long story short, it appears the lab they farm the sequencing out to (LabCorp) mixed up the labeling on one of their 96-well trays (a standard sized plate) and, well, that meant that when some people logged on to see their results, they ended up seeing the results of someone else.
Beyond the obvious privacy and data security questions this raises, I think it’s the response from 23andMe customers that’s most interesting and illuminating. I will paste their feedback in below since, unless you have an account, you won’t be able to see it (if you do have one, see it here.)
Title: Results in, my son is not my son?
Yesterday I received a message that my son and my daughter’s results were in. I rushed to carrier status and checked, she was negative for all the diseases. I checked my son’s it stated that he was a carrier for hemochromatosis, I was upset. How could he be a carrier and we weren’t. Well my husband’s result’s weren’t in yet so I would wait and see. Still upset I checked family inheritance and noticed my daughter shared with me, and then I checked my son’s. He was not a match for any of us. I checked his haplogroup’s and they were different from ours. I started screaming. A month before my son was born two local hospitals had baby switches. I panicked and I checked over and over. My kid’s were sitting at the computer because we all wanted to see the results. My son laughed but he looked upset. I called my sister in tears. She being the pragmatic one instantly told me to stop crying. She reminded me we took a thousand pictures of his birth and every breath he took the first few months. She told me to check the traits. When I checked for eye color I noticed he was GG (blue eyes) we are AG. My son does not have blue eyes. I compared genes and I noticed he did not compare with any African Americans. His closest results were European. Then I read a post from another person who had wrong results. I realized these results were wrong. I sent an e-mail to 23andme. I received the standard 3-5 days response.Upset, I sent Shirley Wu an e-mail, she said she would forward it to customer service. That’s it. So far I haven’t heard a word from 23andme.
Later I found my son in my bed asleep and hugging my pillow. He did not go to school today, he said he was sick. I told him it’s a mistake.
Someone out there has new results maternal L2c2, paternal E1b1b1a, and those are my son’s results. I looked at relative finder my son has 56 relatives. My son’s Ancestry painting came up today, it says 99% European. I share with 3 of the relatives. I hope they don’t send an invite. Thank god the results were totally off or I would have been in linbo for days. I hesitated before I sent this post, I wanted to give 23andme time to get back to me with some explanation. I am still waiting. I am still screaming inside………
In the comments section another user wrote,
23andme has just sent my son’s girlfriend a notice about a mistake in her processing and took down her results. She was just about to write in and ask how they determined she was Asian. She has spent the day in shock.
I don’t know if she yet called her mother, but I know she was wondering what to ask. She came back 100% Asian. We talked about all possibilities..and some of them were odd and disturbing.
We have spent the entire day discussing her 100% Asian ancestry painting and taking a new look at her pics. Even the high risk breast cancer results were less disturbing to her than what the ancestry meant.
23andme…time for some mea culpas here…
So why does this matter?
Well, before that, I think there’s an important point to be made: the root problem here is not a direct-to-consumer (DTC) specific one - any lab using 96-well plates could have confused labels (or whatever exactly happened here.)
So what’s this “96-well plate” business, you ask? Basically, when a lab is running the same test on a lot of samples, it’s much easier to have one big plate with a lot of wells than it is to have a bunch of individual test tubes. Think about it — would you rather carry around 96 individual test tubes or one plate with 96 wells in it? Since it’s easier and faster, this plate method also contributes to scalability, which then helps bring down costs. So, not only would a lab sequencing for 23andMe use this, but any lab working with a lot of samples that require the same procedures.
Non-DTC examples:
- BRCA1 and BRCA2 genetic testing (which is ordered through a doctor)
- Hepatitis B immunity (checking to see if you have it, that is)
Point being: this mistake didn’t happen because these tests were offered DTC.
Now, what I do think important here is the responses from 23andMe users. DTC companies have long stressed that they aren’t providing medical testing but genetic information (and thus shouldn’t be regulated in certain ways)– but what does all that mean? The first user’s experience (above) shows that the first thing she does when she gets her son’s results is check for carrier status. It’s true that whether or not I’m a carrier for, say, a SNP associated with hemochromatosis, is genetic information — but is getting that information also the result of a medical test? Given the intensity and speed with which she checked for those things, it sounds a lot more like she viewed it as a test than as just “genetic information.” [Maybe I feel this way because “information” sounds so neutral, but “medical test” more closely captures the way we respond to our testing “results.”
To be honest though, I don’t have enough experience with how regulations view the difference to say, but I think the distinction is not so obvious — and the non-obviousness isn’t just a function of how our policies and regulations view the difference. How do people truly view the information they’re given through these tests? An interesting study would be to take people who are told they are a carrier for something and see if they act differently — see if, upon telling their family, if their family treats them differently. How do we process that sort of information?
Why is HIV testing a medical test but the results of a DTC genetic test not? Because an HIV test tells you whether or not you will actually develop certain ailments? The BRCA tests don’t tell you definitely that you will or will not get breast and/or ovarian cancer, but they’re considered medical. Difficult…
Other food for thought:
-The community feedback and advice given to users who wrote about confusing or upsetting results was strong and helpful — I think it shows that, if you’re willing to engage with a community of active and interested participants, you can get constructive information without a doctor middleman. On the flip side, it sounds like users didn’t hear back from 23andMe for days — and thinking you were adopted for a few days doesn’t sound so great.
- DTC genetic testing results aren’t just “for fun.” There were unquestionably traumatic identity crises going on with some of these people. And why? Because when they first clicked through and got their results they were ready to accept those results as telling them deep truths about themselves. They weren’t rapid-fire clicking to carrier status or ethnic background to take a glance, eat some popcorn, and then go out with friends and forget about it. No, this information meant something to people.
It will be interesting to see what comes of this… I’m willing to bet Walgreens is counting its blessings right now, though.
New FTC Guidelines for Endorsements and Testimonials in Advertising
December 4, 2009
Slightly behind the times but I just had to mention this - on December 1st the new FTC regulations [announcement here, actual guideline legalese here] went into effect.
All in all I think it’s a fantastic move by the FTC. These guidelines, which give interpretational direction regarding the FTC Act, are a big step in the direction of dealing with novel (well, novel since 1980, which is the last time these guidelines were updated) ways endorsements and testimonials are used in advertising.
And I for one am happy to hear there might be an end to the following:
- those annoying “Lose 50 pounds in a month with SlimQuick” ads where at the bottom, in teeny tiny font, you see “results not typical.”
- Bloggers who appear to be writing for fun (i.e. people like me) who you later find out were paid to write that glowing review of that new restaurant you were thinking about trying out.
- Facial potion and lotion ads where you get a “doctor” saying that “clinical trials” show that the product reduces wrinkles in 6 weeks. (Where the “doctor” is really a PhD in creative writing and the clinical trials consisted of a completely shit-ily designed experiment on rats.)
- And, yes, “shit-ily” is a technical term.
- An ad where a doctor says he always recommends X for cholesterol (where it turns out the doctor is a co-founder of the company producing X).
Ugh ugh ugh! Even writing out those examples gets me all flustered! It’s so ridiculous I have a hard time understanding why on earth it was allowed to persist for as long as it was. I’m no lawyer (yet!), but I have a seriously difficult time understanding how some of this isn’t tantamount to fraud.
But, anyway, a few highlights from the actual guidelines:
Definitions:
- endorsement = “any advertising message that consumers are likely to believe reflects the opinions, beliefs, findings, or experiences of a party other than the sponsoring advertisers, even if the views expressed by that party are identical to those of the sponsoring advertiser”
- endorser = “The party whose opinions, beliefs, findings, or experience the message appears to reflect” [this can be an individual, group, institution, etc.]
- expert = “individual, group, or institution possessing, as a result of experience, study, or training, knowledge of a particular subject” that’s superior to what your average Joe would know or acquire.
More Interesting Stuff:
- An endorser cannot represent the product in a way that, if the advertiser represented it that way, would be deceptive. (Think of Britney Spears saying “I used SlimQuick and lost 20 pounds in a week! This product is a wonder drug!” where the average weight loss from the product is a pound a month)
- The following footnote on the whole “results not typical” debacle, “The Commission tested the communication of advertisements containing testimonials that clearly and prominently disclosed either “Results not typical” or the stronger “These testimonials are based on the experiences of a few people and you are not likely to have similar results.” Neither disclosure adequately reduced the communication that the experiences depicted are generally representative. Based upon this research, the Commission believes that similar disclaimers regarding the limited applicability of an endorser’s experience to what consumers may generally expect to achieve are unlikely to be effective…”
- Yes!
- If you lost 100 pounds in 6 months using SlimQuick while also only eating “raw vegetables and exercising vigorously for six hours at the gym” then an ad that says “Betty lost 100 pounds in 6 months on SlimQuick together with diet and exercise” would be misleading because it does not “adequately alert consumers to the truly remarkable circumstances leading to her weight loss".
- (aka: Betty went nuts, pretty much stopped eating, and dropped a bunch of weight, and 99.99999% of people aren’t going to think that’s what it means to say “lose 100 pounds in 6 months on SlimQuick.”)
- When a connection between the endorser and advertised product isn’t obvious and might materially affect the credibility of that endorsement, it has to be disclosed.
- Think of a blogger where you’d never know she was being sent the products to review or a celebrity on a talk show who casually mentions how much she loves Soda X, where she gets paid every time she mentions the product during publicity events.)
- If you are getting paid to tweet or post status updates on Facebook and the like, you’ve got to disclose it.
- If you write on a message board about a topic but you are employed by a company who makes that product (or is a competitor of that product, etc.), you’ve got to disclose that to.
- I wonder if that means both if you are writing in your capacity as an employee or agent of that company and if you’re writing on your own free time.
- How you are paid to endorse something matters
- The credibility of your endorsement might change based on if you’re paid one lump sum to endorse the product, if you’re given 10% of all gross profits off that product for the next year, or if you are a shareholder in that company and, accordingly, consumers should be given that information.
Short version: “don’t go around trying to deceive people with wild claims or by trying to make it look like someone is endorsing your product out of love (and not money) – it’s messed up.”
Shorter version: “don’t be a slime ball”
Sounds good to me!
New Doodles and Zittrain’s “Minds for Sale” part one!
November 19, 2009
I’ve added two more doodles to the Artsy Stuff > Computer Doodles section. I’ll add them here, too!
I’m also hoping to send out my write up about the really interesting talk I went to last night. Jonathan Zittrain from Harvard’s Berkman Center gave his “Minds for Sale” talk. Info here.
Long story short – I think most of the problems he expressed aren’t unique to cloud computing (or technology at all). Generally speaking, there’s a danger when people agree to do work when they don’t understand the overarching goal of the project or even who they’re working for.
Simple example: Someone puts an ad in the paper: “Will hire someone to flier cars in x shopping center.” You know that’s a heavily Persian area and so you aren’t surprised that the ads are in Farsi. You accept the job, get your $20 and continue on your merry way.
Turns out those little fliers were actually filled with hate speech, threatening to kill Muslims and Muslim supporters.
You didn’t really care (or perhaps better said, you didn’t really think to care) when you took the job what the flier said. And, especially because it was in Farsi, you didn’t have ready access to figuring it out for yourself. But, if the ad would have said “Will pay someone to distribute Muslim hate speech on cars!” you certainly would have declined.
Now taking that to the land “o” the Internets, things like Amazon’s Mechanical Turk allows people to post simple jobs (like, “what words best describe this picture”) for something like $.01/job. The “turks” have no idea what the larger scope of the project might be and it’s possible if they did, they’d never support it.
So the worry seems to be that things like Mechanical Turk at least have the potential to make people complicit in activities they never would have supported otherwise. But, because you’re just turning one little cog, you might be.
Food for thought…
My little animation
October 6, 2009
I’m at the Adobe MAX 2009 conference and had the chance to make this little guy in my character animation in flash and illustrator hour session. It’s amazing how a few little tricks make the character come to life!