On November 22, 2013, the Inquisition collided with the Internet.  On that date, the Food and Drug Administration issued a Warning Letter threatening 23andMe, Inc. with seizure of product, injunctions and civil monetary penalties based on allegations that 23andMe – which provides customers with information about their personal genomes – is selling misbranded and adulterated medical devices.  In plain terms, FDA has sought to restrict dissemination of this information for no other reason than an undocumented fear people might misuse it.  If FDA follows through on its threats of regulatory action, this dispute could provide the forum for defining the First Amendment limits of the FDA’s power to regulate public health by restricting dissemination of information.

By way of brief background, for $99, 23andMe provides a receptacle for a saliva sample and a mailer.  Upon receipt, 23andMe extracts selected genetic information from the sample and provides on-line access to the results, including information about genealogy and a short synopsis of selected publically-available, non-patient specific research on medical conditions associated with those genes.  The company’s terms of service caution that:

You should not change your health behaviors solely on the basis of information from 23andMe. Make sure to discuss your Genetic Information with a physician or other health care provider before you act upon the Genetic Information resulting from 23andMe Services. For most common diseases, the genes we know about are only responsible for a small fraction of the risk. There may be unknown genes, environmental factors, or lifestyle choices that are far more important predictors. If your data indicate that you are not at elevated genetic risk for a particular disease or condition, you should not feel that you are protected. The opposite is also true; if your data indicate you are at an elevated genetic risk for a particular disease or condition, it does not mean you will definitively develop the disease or condition. In either case, if you have concerns or questions about what you learn through 23andMe, you should contact your physician or other health care provider. ^[1]

23andMe thus makes clear the information it provides is not intended as a diagnostic tool or for use in making medical decisions, but merely as a starting point for dialog and investigation with health care professionals.

FDA’s pretext for regulation is a self-serving classification, first articulated in a June 2010 letter, of thisservice as a device.  The only tangible item that comes in contact with the customer is the saliva collector, which poses no threat to human health and is substantially equivalent to collectors in common use.  The only other possible “instrument, apparatus, implement, machine, contrivance, in vitro reagent or other similar or related article” within the meaning of 21 U.S.C. §321(h)’s definition of “device” is the “chip” used to identify the selected genetic information.  Since the chip does not come into contact with the customer and is not “intended to affect the structure or any function of the body”see 21 U.S.C. §321(h)(3), the “hook” FDA relies on to ban this service is 21 U.S.C. §321(h)(2), which classifies as a device an instrument, apparatus etc. “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease[.]”  (emphasis added).  The statutory interpretation FDA relies upon to ban 23andMe’s service thus depends entirely on FDA’s view of the intent of the service as a diagnostic tool, an intent directly contrary to 23andMe’s clear disclaimer.

In the Warning Letter, FDA makes clear that its intent is to censor dissemination of information.  It gives as one example of the need to keep consumers in the dark the possibility that a false positive for BRCA-related risk assessment “could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negativecould result in a failure to recognize an actual risk that may exist.” (emphasis added).  The key word “could” simply glosses over the various intervening, superseding events necessary to create even the potential for harm.  It also overlooks the fact that none of the false positive risks are possible without a physician’s intervention and the informed consent of that physician’s patient.  It also ignores that the “false negative” risk of failing to recognize a risk exists not only always exists, but is also specifically addressed in 23andMe’s disclaimer, which warns, in no uncertain terms, “[t]here may be unknown genes, environmental factors, or lifestyle choices that are far more important predictors. If your data indicate that you are not at elevated genetic risk for a particular disease or condition, you should not feel that you are protected.”

The Warning Letter thus reflects an assertion by FDA of the right to ban dissemination of information based on fear that it might be misused.  Courts, however, have been painfully clear that, as much as FDA desires this power, its exercise would violate the First Amendment.  In 2002, for example, the Supreme Court struck down an effort by FDA to bar advertising of compounded drugs out of fear that advertising might lead to excessive demand for compounding, observing that “[t]he First Amendment directs us to be especially skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good[,]” noting the preferred alternative “is to assume that this information is not in itself harmful, that people will perceive their own best interests if only they are well enough informed[.]”^[2]   The Court recently made a similar statement striking down Vermont’s efforts to ban dissemination of prescribing information as a means of limiting marketing of brand-name drugs, noting that “fear that people would make bad decisions if given truthful information cannot justify content-based burdens on speech.”^[3] Lower federal courts have repeatedly found FDA cannot rely on fear of misuse to justify restricting speech, at least without proof that the risk of misuse is significant and cannot be controlled by disclaimers similar to those 23andMe has already provided.^[4]

It is possible that nothing will come of the Warning Letter.  Such communications, by their nature and FDA regulations, do not represent formal agency findings and do not commit the agency to enforcement action.  Given the tone of the letter and the publicity it has received, however, follow-up action would not be surprising.  If the FDA attempts to pursue enforcement, however, 23andMe may prove to be a different kind of opponent than FDA is used to dealing with.  For decades, FDA has actively sought to insulate its regulatory actions from First Amendment scrutiny by using Warning Letters threatening misbranding actions – or when that fails, misbranding actions themselves – to raise the stakes of judicial review so high no regulated entity can afford the risk of losing.^[5]  Where it has not been able to deter litigation on the merits, FDA has made concessions to moot adverse determinations on appeal^[6] or not pursued further appeals of adverse decisions that might result in more-broadly binding precedent.^[7]

Unlike a pharmaceutical company that cannot afford to risk its ability to make money selling a drug on the outcome of litigation over the ancillary issue of what it can say to market the drug, here the product 23andMe is selling is information, making FDA’s efforts a direct threat to its core business.  Second, 23andMe is not a traditional drug or device company with other products subject to FDA regulation, but an internet start-up with backing from Google.  It is not vulnerable to the need to placate FDA over regulation of other product lines, and may be more likely to make a legal stand on principle.  In 23andMe, FDA may have picked on an adversary it can’t intimidate.

_{[1] https://www.23andme.com/about/tos/}

_{[2] Thompson v. Western States Medical Center, 535 U.S. 357, 375 (2002), citing 44 Liquormart, Inc. v. Rhode Island, 517 U.S. 484, 503 (1996);  Virginia Bd. Of Pharmacy v. Virginia Citizens Consumer Council, Inc., 425 U.S. 748, 769-70 (1976)).}

_{[3] Sorrell v. IMS Health, Inc., 131 S. Ct. 2653, 2670-71 (2011) (internal citations omitted).}

_{[4] Pearson v. Shalala, 164 F.3d 650, 659 (D.C. Cir. 1999);  Alliance for Natural Health, US, v. Sebelius,786 Supp.2d 1 (D. D.C. 2011).}

_{[5] See, e.g., Washington Legal Foundation v. Kessler, 880 F. Supp. 26, 36 (D. D.C. 1995).  This process was also apparently at play in FDA conditioning settlement of a misbranding action on Allergan Inc.’s dismissal of a declaratory judgment action seeking clarification of FDA’s power to restrict off-label promotion.}

_{[6] Washington Legal Foundation v. Henney, 202 F.3d 331 (D.C. Cir. 2000).}

_{[7] United States v. Caronia, 703 F.3d 149 (2nd Cir. 2012)}.