Source: https://www.yalelawjournal.org/forum/right-to-try-unapproved-drugs
Timestamp: 2019-04-19 12:31:16+00:00

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The reality of Right to Try laws, however, is very different. Media descriptions often do not even mention one of the most pressing questions surrounding these laws: do state laws on drug access meaningfully alter the legal regime governing experimental drugs?5 Regardless of the substantive merits of allowing terminally ill patients to use experimental drugs, FDA regulations require drugs to be approved before they can be sold to consumers, and Right to Try laws do nothing to change that. So what is the purpose of these laws?
I suggest that Right to Try laws do not themselves meaningfully alter substantive law but instead serve a different function. By advocating for these reforms, the movement’s leaders6 are seeking to persuade policy makers at other levels of government. Their aim is either to promote federal policy reform through the FDA or Congress, or to convince federal courts to recognize a Right to Try under the Constitution. The laws’ supporters are using state legislatures as forums to draw attention to and legitimate their cause. The Right to Try saga therefore demonstrates an important feature of American federalism: even when federal law ensures that states lack legal power to alter substantive law meaningfully, state actors can still use their legislative processes to promote their desired policies and constitutional interpretations at the federal level.
I proceed in three parts. Part I describes the content of the Right to Try laws and the context surrounding their passage. Part II argues that state Right to Try laws are unlikely to lead directly to wider access to drugs. Finally, Part III argues that Right to Try laws instead serve the purpose of persuading federal decision makers to reform federal law.
Existing Right to Try laws share several common characteristics. Most generally, they codify a position that the state government will not interfere with a terminally ill patient’s attempt to save her life.7 The laws enact this general policy in two ways. First, they permit doctors to prescribe and drug companies to provide any drug, biological product, or medical device that might save an otherwise terminal patient, as long as it has passed the FDA’s Phase 1 testing and some minimal procedures are followed.8 Under FDA regulations, such drugs would not otherwise be available to the general public for several years (though they are sometimes made available to terminal patients through the Administration’s “expanded access” program).9 Second, Right to Try laws shield, at least to some extent, doctors and drug companies from state tort liability for providing experimental drugs.10 However, these laws do not create any requirement or incentive for drug companies to provide the drugs or for insurance companies to cover them.
Right to Try’s supporters have successfully framed the laws as both a boon to personal liberty and a remedy for bureaucratic failure.24 They state that the laws enshrine “the fundamental right of people to try to save their own lives”25 and describe them as “Dallas Buyers Club laws”—that is, laws that might have prevented some of the horrors of the AIDS crisis as portrayed by the 2013 film.26 The fact that laws have been passed in multiple states suggests that these efforts have been by and large successful; it may be unpopular to argue that terminal patients shouldn’t be allowed to try whatever drug their doctor thinks might work.
Access to experimental drugs, however, differs from marijuana legalization in at least one important respect. Marijuana producers have an obvious financial incentive to sell the drug to consumers.38 In contrast, for Right to Try laws to help anyone, the drug companies must risk FDA enforcement and other issues for financial returns that are likely to be marginal. The number of patients seeking access to experimental drugs is necessarily small,39 since participants must be terminally ill, unable to get into a nearby clinical trial, and unable to find a reasonable alternative—while also desiring to use a drug the FDA has not yet deemed effective. This would limit the financial upside of providing unapproved drugs. Given that it takes, on average, ten years and roughly $1 billion to complete the FDA approval process,40 the money a company might make from such experimental sales would likely be nominal compared to the costs of development. Moreover, even without fear of FDA enforcement, drug companies are often reluctant to provide access to experimental drugs, reasoning that a bad outcome might damage a drug’s chances of being approved,41 or that a company should focus its resources on the approval process.42 While Right to Try laws shield pharmaceutical companies from state tort liability, limiting their exposure significantly, a careful lawyer would still almost certainly advise her client to go through the FDA process.
If this analysis is correct, do Right to Try laws simply lack a purpose? Some commentators have suggested this is the case,44 but I don’t think so. As toothless as the current laws may be, their passage can support a campaign of persuasion that may ultimately lead to meaningful federal reform.
However, within our federal system, with its multiple sources of law and separate legislative bodies, a state law can also serve to persuade federal decision makers. This is one of the assumptions behind the famous “laboratories of democracy” theory of federalism, which celebrates the way in which state-level legal experiments can become models for nationwide reforms.45 Indeed, it is common for a policy movement to begin by seeking changes to state law on the road to its ultimate aim of changing federal law.46 Such a strategy can have two benefits from a movement’s perspective: first, it can bring the desired policy to a segment of the population before the whole country is prepared to accept it (though not in the case of Right to Try). Second, and more relevant here, it draws greater national attention to the issue47 and conveys the point that respectable public figures believe in the policy. In this sense, state laws can serve to legitimate a policy and help to develop its constituency, even if the laws themselves do not alter the current legal regime in a meaningful way.
Therefore, while the current Right to Try laws do not create new rights, they are not necessarily futile. The movement behind them is leveraging a facet of American federalism: that state laws can be used to persuade federal actors. In the future, the Right to Try may become an entrenched legal right, and these laws, currently toothless, may very well have made the difference.
Sam Adriance is a member of the Yale Law School Class of 2015. He would like to thank Mike Labson for his helpful suggestions and Zach Arnold and editors of the Yale Law Journal for their thoughtful feedback.
Preferred Citation: Sam Adriance, Fighting for the “Right To Try” Unapproved Drugs: Law as Persuasion, 124 Yale L.J. F. 148 (2014), http://www.yalelawjournal.org/forum/right-to-try-unapproved-drugs.
By “experimental drugs,” I mean drugs as-yet unapproved for general sale by the FDA.
See Our Story, supra note 12.
See Bellamy, supra note 11.
Abigail Alliance, 495 F.3d 695.
See supra notes 1, 3.
See Tozzi, supra note 5.
See Servick, supra note 39.
Such laws have been passed in Colorado, Louisiana, Missouri, Michigan and Arizona. Right To Try Act, Colo. Rev. Stat. Ann. § 25-45-101-06 (West 2014); Right To Try Act, 2014 La. Sess. Law Serv. Act 346 (West); Mo. Ann. Stat. § 191.480 (West 2014); Right To Try Act, Mich. Comp. Laws Ann. § 333.26451 (West 2014); Terminal Patients’ Right To Try Act, Ariz. Rev. Stat. Ann. § 36-1311 (West 2014).
See, e.g., Patti Parson, Colorado First State to Pass ‘Right To Try,’ or the ‘Dallas Buyers’ Club’ Law, PBS Newshour (May 19, 2014), http://www.pbs.org/newshour/rundown/colorado-first-state-pass-right-try-dallas-buyers-club-law/ [http://perma.cc/NU67-VQZ5].
Christina Corieri, Everyone Deserves the Right To Try: Empowering the Terminally Ill To Take Control of Their Treatment, Goldwater Inst. 1-2 (Feb. 11, 2014), http://goldwaterinstitute.org/sites/default/files/Right%20To%20Try_1.pdf [http://perma.cc/LS5M-4Y5S].
Many news reports assume these laws will allow greater access to the relevant drugs, even though the assumption is dubious. See, e.g., John Tozzi, Do Dying Patients Have a Right To Try Experimental Drugs? Libertarians Say Yes, Bloomberg Businessweek (Aug. 21, 2014), http://www.businessweek.com/articles/2014-08-21/do-dying-patients-have-a-right-to-try-experimental-drugs-libertarians-say-yes [http://perma.cc/HEE2-QXYW]; ‘Right To Try’ Law Gives Terminal Patients Access to Drugs Not Approved by FDA, PBS Newshour (June 21, 2014), http://www.pbs.org/newshour/bb/right-try-law-gives-terminal-patients-access-non -fda-approved-drugs [http://perma.cc/3QJ9-RKQE].
The organization at the forefront of the movement is the Goldwater Institute, a libertarian think tank that has recently begun pushing for these laws after unsuccessful litigation on the issue in the D.C. Circuit. See infra notes 16-23 and accompanying text.
See Colo. Rev. Stat. Ann. § 25-45-104 (West 2014) (providing that manufacturers may sell experimental drugs to terminally ill patients, and insurers may cover such purchases); 2014 La. Sess. Law Serv. Act 346 § 1300.384 (West) (same); Mo. Ann. Stat. § 191.480 (West 2014) (same); Mich. Comp. Laws Ann. § 333.26452-53 (West 2014) (same); Ariz. Rev. Stat. Ann. § 36-1311 (West 2014) (same).
See Colo. Rev. Stat. Ann. § 25-45-104-05 (West 2014); 2014 La. Sess. Law Serv. Act 346 § 1300.384 (West); Mo. Ann. Stat. § 191.480 (West 2014); Mich. Comp. Laws Ann. § 333.26452-53 (West 2014); Ariz. Rev. Stat. Ann. § 36-1311 (West 2014).
See IDE Early/Expanded Access, Food & Drug Admin (Jun. 27, 2014), http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/ucm051345.htm [http://perma.cc/ZYE-9739].
The statutes vary on the extent of the shield. The Colorado statute, for example, shields manufacturers and doctors unless “there was a failure to exercise reasonable care.” Colo. Rev. Stat. Ann. § 25-45-107 (West 2014). In contrast, the Missouri law shields providers “[e]xcept in the case of gross negligence or willful misconduct.” Mo. Ann. Stat. § 191.480 (West 2014).
See Jann Bellamy, The Illusions of “Right To Try” Laws, Sci.-Based Med. (Mar. 6 2014), http://www.sciencebasedmedicine.org/the-illusions-of-right-to-try-laws [http://perma.cc/9JTU-AWKW].
See Our Story, Abigail Alliance, http://www.abigail-alliance.org/story.php [http://perma.cc/XJV4-K7FG].
Peter Hart, Abigail Alliance Case Discussed: Balancing Study Drugs, Safety, Univ. Times. Feb. 19, 2009; http://www.utimes.pitt.edu/?p=8605 [http://perma.cc/Y58C-DLWV] (noting that the FDA denied Burroughs’s request for the drug).
Abigail Alliance for Better Access to Developmental Drugs v. Von Eschenbach, 445 F.3d 470 (D.C. Cir. 2006), rev’d en banc, 495 F.3d 695 (D.C. Cir. 2007).
There is at least one important difference between what the plaintiffs asked for in Abigail Alliance and what the new laws aim to achieve: the litigation would have allowed for some continued oversight of the process by the FDA, while the new laws, at least superficially, cut out the FDA altogether. See Bellamy, supra note 11.
See Mary Lou Byrd, The Right to Try, Wash. Free Beacon (Feb. 21, 2014), http://freebeacon.com/issues/the-right-to-try [http://perma.cc/WU8F-4HD4]; David Gorski, “Right To Try” Laws and Dallas Buyers’ Club: Great Movie, Terrible for Patients and Terrible Policy, Sci.-Based Med. (Mar. 08, 2014), http://www.sciencebasedmedicine.org/right-to-try-laws-and-dallas-buyers-club-great-movie-terrible-public-policy/#more-30518 [http://perma.cc/EZD2-FV3E].
Dallas Buyers Club, a popular film based on true events for which Matthew McConaughey won the Academy Award for Best Actor, portrayed an AIDS patient’s struggle to gain access to promising drugs that the FDA refused to approve. See Kyle Smith, How the Oscar-Winning Libertarian Favorite “Dallas Buyers Club” Exposes the FDA, Forbes (Mar. 05, 2014), http://www.forbes.com/sites/kylesmith/2014/03/05/how-the-oscar-winning-libertarian-favorite-dallas-buyers-club-exposes-the-fda [http://perma.cc/R49U-8TRK]. Backers of Right to Try laws see their project as allowing patients similarly situated to McConaughey’s character get access to the drugs they need without interference from the FDA. See Eleanor Clift, The “Dallas Buyers Club” Bill, Daily Beast (Mar. 4, 2014), http://www.thedailybeast.com/articles/2014/03/04/the-dallas-buyers-club-bill.html [http://perma.cc/V8GH-MMSX]; Kristen Wyatt, Colorado’s ‘Right To Try’ Law Will Give Some Patients Access to Experimental Drugs, Huffington Post (May 18, 2014), http://www.huffingtonpost.com/2014/05/18/colorado-right-to-try-law-experimental-drugs _n_5347490.html [http://perma.cc/J56E-DQ4F].
There are also significant substantive debates over the movement’s goals. One issue is that the Right to Try laws do little to motivate drug companies—which are arguably more difficult to convince than the FDA—to provide access to the drugs. See, e.g., Wyatt, supra note 26 (“Gorski [a surgical oncologist and editor of the blog Science-Based Medicine] said a drug company ‘wouldn’t do anything to endanger a drug they’re potentially spending hundreds of millions of dollars to bring to market’ through elaborate FDA trials.”).
The expanded access program was actually largely created in response to the FDA’s errors during the AIDS crisis. See Expanded Access and Expedited Approval of New Therapies Related to HIV/AIDS, Food & Drug Admin., http://www.fda.gov/ForPatients/Illness/HIVAIDS/Treatment/ucm134331.htm [http://perma.cc/M3TB-66B8] (“FDA has taken significant steps, primarily in response to the HIV/AIDS crises, toward making experimental drugs intended to treat life-threatening diseases more widely available to severely ill patients, as well as toward speeding the review and approval of the applications for these products.”).
See Understanding Expanded Access/Compassionate Use, Food & Drug Admin., http://www.fda.gov/ForPatients/Other/ExpandedAccess/default.htm [http://perma.cc/EEY8-YF3U] (To grant access to the drug to a patient, the “FDA must . . . determine that: there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition[;] the potential patient benefit justifies the potential risks of the treatment use and those potential risks are not unreasonable in the context of the disease or condition to be treated[;] providing the investigational drug will not interfere with the initiation, conduct, or completion of clinical investigations that could support marketing approval of the expanded access use or otherwise compromise the potential development of the expanded access use[;] that the patient cannot obtain the drug under another . . . protocol.”).
See Darkshak M. Sanghavi, The Pills of Last Resort: How Dying Patients Get Access to Experimental Drugs, N.Y. Times Mag., Oct. 31, 2013, http://www.nytimes.com/2013/11/03/magazine/how-dying-patients-get-access-to-experimental-drugs.html [http://perma.cc/8ZT4-DZ87] (describing how the author’s terminally ill father petitioned his insurance company for off-label use of a drug, only for at-the-time unknown side effects to worsen his condition and hasten his death); Understanding Expanded Access/Compassionate Use, supra note 29 (“It is important to remember that the drug/device may have unexpected serious side effects and that patients need to consider all the possible risks when seeking access to an investigational drug or device.”).
See IDE Early/Expanded Access, U.S. Food & Drug Admin., http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/ucm051345.htm [http://perma.cc/GUU7-JSRE] (“An unapproved medical device may normally only be used on human subjects through an approved clinical study in which the subjects meet certain criteria and the device is only used in accordance with the approved protocol by a clinical investigator participating in the clinical trial.”). Similarly, drugs the FDA has not approved may not be marketed. See Unapproved Prescription Drugs: Drugs Marketed in the United States That Do Not Have Required FDA Approval, Food & Drug Admin., http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/enforcementactivitiesbyfda/selectedenforcementactionsonunapproveddrugs/default.htm [http://perma.cc/JCW4-4CDY] (describing drugs sold without FDA approval as being “marketed illegally”); How Can I Get Access to a Drug That Is in Testing but Has Not Yet Been Approved?, Food & Drug Admin., http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194958.htm [http://perma.cc/8TMV-6NQY] (describing exceptions to FDA approval requirements).
See, e.g., Wyatt, supra note 26; ‘Right To Try’ Law Gives Terminal Patients Access to Drugs Not Approved by FDA, PBS NewsHour (June 21, 2014), http://www.pbs.org/newshour/bb/right-try-law-gives-terminal-patients-access-non-fda-approved-drugs [http://perma.cc/ALF6-MGPX].
It is well accepted that federal law trumps state law when they conflict. Gibbons v. Ogden, 22 U.S. (9 Wheat.) 1, 41 (1824); Erwin Chemerinsky, Constitutional Law 402 (3d ed. 2013).
See Wyatt, supra note 26 (“‘The FDA regulates drug development, and this doesn’t do anything to change that,’ said Dr. David Gorski, a surgical oncologist and editor of the blog Science Based Medicine.”).
In all likelihood, a straightforward announcement that companies were still not permitted to provide drugs without the FDA’s consent would be sufficient to guarantee no rational company would do so: even the chair of Goldwater’s Right to Try National Advisory Council has acknowledged it would be a bad idea to disregard the clear statement of the FDA on this issue. Neuralstem: CEO Blog (Jun. 6, 2014), http://www.neuralstem.com/neuralstem-ceo-blog/216-fda-has-demonstrated-its-commitment-to-supporting-access-to-experimental-therapies-for-patients-living-with-serious-diseases#sthash.n1rnqlls.dpuf [http://perma.cc/HTX2-K98J] (“No one is suggesting that this process take the place of the existing clinical trial process. And no company (though I can only speak for Neuralstem) will offer a drug if the FDA tells it not to.”). Neuralstem’s CEO chairs the Goldwater Institute’s Right to Try National Advisory Council. Neuralstem Flirting with Stem Cell Noncompliance in Colorado via Right To Try Law?, Knoepfler Lab Stem Cell Blog (Jun. 11, 2014), http://www.ipscell.com/2014/06/neuralstem-flirting-with-stem-cell-noncompliance-in-colorado-via-right-to-try-law [http://perma.cc/FY8Z-5ZU9].
See Ryan J Reilly & Ryan Grim, Eric Holder Says DOJ Will Let Washington, Colorado Marijuana Laws Go Into Effect, Huff. Post (Aug. 29, 2013), http://www.huffingtonpost.com/2013/08/29/eric-holder-marijuana-washington-colorado-doj_n_3837034.html [http://perma.cc/7ZP9-FMXE]. Alaska, Oregon and Washington, D.C. also recently legalized marijuana in their territory. See Dan Merica, Oregon, Alaska and Washington, D.C. Legalize Marijuana, CNN (Nov. 5, 2014), http://www.cnn.com/2014/11/04/politics/marijuana-2014 [http://perma.cc/F794-U3U8].
See Christopher Ingraham, Colorado Marijuana Tax Revenues Surge as Recreational Sales Surpass Medical, Wash. Post: Wonkblog (Sep. 11, 2014), http://www.washingtonpost.com/blogs/wonkblog/wp/2014/09/11/colorado-marijuana-tax-revenues-surge-as-recreational-sales-surpass-medical-for-the-first-time [http://perma.cc/7VRB-9L7C] (describing recreational marijuana sales of nearly $30 million in Colorado between January and July 2014).
For example, in 2013, the FDA received fewer than 1,000 total requests for expanded access across all unapproved drugs. Kelly Servick, ‘Right To Try’ Laws Bypass FDA for Last-Ditch Treatments, Sci. (June 20, 2014), http://www.sciencemag.org/content/344/6190/1329.full [http://perma.cc/898D-F38D].
See Servick, supra note 39; see also Brady Dennis & Ariana Eunjung Cha, ‘Right To Try’ Laws Spur Debate over Dying Patients’ Access to Experimental Drugs, Wash. Post, May 16, 2014, http://www.washingtonpost.com/national/health-science/right-to-try-laws-spur-debate-over-dying-patients-access-to-experimental-drugs/2014/05/16/820e08c8-dcfa-11e3-b745-87d39690c5c0_story.html [http://perma.cc/A6XH-SD67] (“Granting unwarranted expanded access requests not only places ‘an individual’s health ahead of the public’s health,’ [Sascha Haverfield, vice president of scientific and regulatory affairs at the Pharmaceutical Research and Manufacturers of America,] said, but it also could undermine the regulatory process and hinder a company’s ability to make new drugs available to a broader patient population.”).
As far as I am aware, the only drug company that has indicated it might provide its unapproved drugs as a result of these laws is Neuralstem, which is developing an ALS drug, and whose CEO chairs the Goldwater Institute’s Right to Try Advisory Council. Neuralstem Flirting with Stem Cell Noncompliance in Colorado via Right To Try Law?, Knoepfler Lab Stem Cell Blog , supra note 36. However, even Neuralstem announced it would ultimately defer to the FDA. Neuralstem: CEO Blog, supra note 36.
See, e.g., Bellamy, supra note 11; Joan Korber-Walker, HCR 2005—”Right To Try” Won’t Benefit Patients, Ariz. Bioindustry Assoc. (Mar. 24, 2014), http://www.azbio.org/hcr2005 [http://perma.cc/RLQ2-WC5F] (arguing against the passage of the Arizona law in part because of its ineffectiveness in the face of FDA regulations, and recommending advocating for changes to Congress and the FDA instead of passing state laws).
See New State Ice Co. v. Liebmann, 285 U.S. 262, 311 (1932) (Brandeis, J., dissenting) (“It is one of the happy incidents of the federal system that a single courageous State may, if its citizens choose, serve as a laboratory; and try novel social and economic experiments without risk to the rest of the country.”); see also Cruzan ex rel. Cruzan v. Dir., Mo. Dep’t of Health, 497 U.S. 261, 292 (1990) (O’Connor, J., concurring); Kristin Madison, Building a Better Laboratory: The Federal Role in Promoting Health System Experimentation, 41 Pepp. L. Rev. 765, 771 (2014) (describing the Patient Protection and Affordable Care Act as the product of such a “laboratory” in Massachusetts).
The gay rights movement can be interpreted to provide an example of this strategy. It began by achieving marriage equality in a small number of states, and has since moved on to great success in various state and federal courts, with the ultimate aim of convincing the U.S. Supreme Court to enshrine marriage equality as a constitutional principle. See George Chauncey, The Long Road to Marriage Equality, N.Y. Times, June 26, 2013, http://www.nytimes.com/2013/06/27/opinion/the-long-road-to-marriage-equality.html [http://perma.cc/87TG-LBKG].
For example, according to Google Trends, news headlines containing the “Right to Try” spiked dramatically in May 2014, when Colorado passed the first law of its kind. Interest in Search Term “Right to Try” Over Time, Google Trends, http://www.google.com/trends/explore#q=%22right%20to%20try%22 [http://perma.cc/YU66-BHKV].
There is a Right to Try bill in Committee in the House even now, though there is no indication as yet that it will get a vote on the floor. See Compassionate Freedom of Choice Act of 2014, H.R. 4475, 113th Cong. (2014).
See Jack M. Balkin, From Off the Wall to On the Wall: How the Mandate Challenge Went Mainstream, Atlantic, June 4, 2012, http://www.theatlantic.com/national/archive/2012/06/from-off-the-wall-to-on-the-wall-how-the-mandate-challenge-went-mainstream/258040 [http://perma.cc/T449-4S97].
See Michael Ollove, Right-To-Try for the Terminally Ill, USA Today, June 19, 2014, http://www.usatoday.com/story/news/nation/2014/06/19/stateline-fda-terminal-illness-drugs/10836705 [http://perma.cc/8ED2-4LCF].

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