By Helen Guo (PO ’20)
In recent years, “right-to-try” laws, which aim to grant terminally-ill patients access to experimental drugs or devices, have become a contentious policy issue and have gained speed throughout the U.S. In the latter months of 2014 alone, five states—olorado, Louisiana, Michigan, Missouri, and Arizona—passed right-to-try legislation.[1] As of September 2016, California has joined the growing ranks of states that have approved right-to-try bills.[2] This article will examine the issues surrounding California’s recently-passed right-to-try bill, California Assembly Bill 1668.[3] It must be noted that although each state’s right-to-try legislation has its own complexities in terminology and implementation, most of these bills passed across the nation are similar to California’s.[4] Moreover, the unconstitutional nature of right-to-try legislation is applicable to all states. Thus, the arguments in this article may be extrapolated to state right-to-try laws that are similar.
Since Governor Brown signed California Assembly Bill 1668 in September 2016, the Health and Safety Code in California has been revised to allow the terminally ill the right to try investigational medications and treatments.[5] On the surface, the state’s newly-approved right-to-try bill seems to grant individuals access to treatment that may save their life. However, state right-to-try laws directly challenge the federal Food and Drug Administration’s regulations concerning access to investigational treatments, which means they are preempted by federal law (per the Supremacy Clause of the Constitution). Beyond the power clash between state right-to-try legislation and federal laws, Californiaight-to-try law requires less scrutiny in granting access to experimental drugs than the latter, endangering public health.
This article argues that California’s right-to-try law should not be implemented because it is unconstitutional and poses a threat to public health. The next section details how state right-to-try laws are preempted by federal law and are therefore unconstitutional. The subsequent section will analyze the flaws in California’s right-to-try law that lead to public health issues.
State vs. Federal Jurisdiction
The FDA certifies specific drugs or treatments that have passed the full round of clinical trials, banning pharmaceutical companies from selling non-certified drugs or treatments.[6] State right-to-try laws thus conflict with federal law in granting access to experimental treatment, breaching the Supremacy Clause of the U.S. Constitution, which deems federal law the “supreme law of the land.”[7] State laws are preempted by federal law, rendering right-to-try laws necessarily unconstitutional.
Still, proponents of state right-to-try legislation argue that barring access to investigational drugs is considered the deprivation of life without due process of law for terminally-ill patients, violating the Fourteenth Amendment. However, in the 1979 case United States v. Rutherford, the Supreme Court did not find any legislative justification for terminally-ill cancer patients to have access to the drug Amygdalin, a now-detracted treatment that was pending before the FDA at the time.[8] The case affirmed, although only on statutory grounds, that “nothing in the legislative history suggests that Congress intended protection only for persons suffering from curable diseases… The FDA has never exempted drugs used by the terminally ill.”[9] In other words, the terminally ill must abide by federal regulations.
Although United States v. Rutherford was only resolved on statutory grounds, the recent 2008 case, Abigail Alliance v. von Eschenbach, established that access to experimental treatments is not a constitutional right. In this case, the Abigail Alliance for Better Access to Developmental Drugs sued the FDA for the patient’s right to due process under the Fourteenth Amendment. The U.S. District Court for the District of Columbia first ruled in favor of Abigail Alliance, then reheard the case en banc and reversed the panel in favor of the FDA. The U.S. Supreme Court declined to review the case further, again upholding the decision that the “right-to-try” experimental drugs are not guaranteed within the Constitution.[10]
In justification of state right-to-try laws, some scholars have noted that the laws serve to persuade federal lawmakers by creating constitutional conflict and drawing national attention to the issue.[11] So while state right-to-try laws are technically unconstitutional, they are a method of inciting changes within federal law. States may pass right-to-try laws to critique the time required to access treatment under the FDA regulations.[12] FDA regulations and programs provide patients with the access to experimental treatments within a necessary time frame. State right-to-try laws, which point out a need for changes in federal law, may incite lawmakers to quicken and de-regulate access to investigational drugs on the federal level.
To allow for more flexibility in terms of access to experimental treatment, the FDA has set the federal Expanded Access Program in place.[13] Although the provisions of the Expanded Access Program and California’s right-to-try legislation achieve the same purpose, the former adopts stricter and more consistent standards of treatment access.[14] As a consequence of federal oversight and stricter standards, the argument of right-to-try legislation sympathizers still holds; the time required to approve individuals for treatment under the Expanded Access Program may justify state right-to-try laws.[15] However, the restrictions under the Expanded Access Program are set in place to ensure a higher level of inspection than that of state right-to-try laws in determining the health risks of experimental drug access for patients. Expanded Access attempts to establish treatment safety and effectiveness, so that patients are not trying investigational drugs with a blind eye to unreasonable risk. The differences between Expanded Access and state right-to-try laws will be discussed in the following section.
A Danger to Public Health
Under California Assembly Bill 1668, those who have an “immediately life-threatening disease or condition” are allowed access to treatment that has undergone at least the first stage of clinical trials.[16] The patient would require a physician’s recommendation, consistent with the protocol of an accredited institution’s review board. Any physician recommending investigational treatments would be exempt from disciplinary action by medical boards.[17] To the uninformed eye, California’s right-to-try law seems justified, necessary for the terminally ill, and safe.
Under scrutiny, however, the language of the bill reveals alarming flaws of California’s right-to-try legislation. The bill states that a terminally-ill patient may be given access to an “investigational drug, biological product, or device that has successfully completed phase one of a clinical trial approved by the United States Food and Drug Administration.”[18] Treatments open to the terminally ill will have undergone the lowest level of inspection, phase one of clinical trials, which, as defined by the FDA, “determine[s] what the drug’s most frequent side effects are and, often, how the drug is metabolized and excreted.”[19] Stage one does not require controlled trials and demands a sample size too small (20 to 80 patients) to determine safety or effectiveness; it is only in the second stage of clinical trials that drug effectiveness is tested in controlled trials.[20]
The Expanded Access Program, in contrast to California’s right-to-try law, ensures scrutiny when giving the terminally ill access to experimental treatments. The FDA not only must determine that the treatment in question does not pose a greater risk than an individual’s disease, but it must also find sufficient evidence of “safety and effectiveness” before it permits an expanded-access protocol involving large numbers of patients with serious disease.[21] To determine “safety and effectiveness” before permitting large numbers of people to access a treatment, Expanded Access would study larger samples of individuals in comparison to those of controlled trials.[22] Expanded Access is more likely to procure positive health outcomes than California’s right-to-try law. The low level of scrutiny to which the medical treatments are subject to under California’s right-to-try law pose serious health risks for the state’s residents as it fails to ensure treatment safety and effectiveness.
Beyond issues involving inadequate scientific investigation and its effects on drug safety, the ethical dilemmas surrounding a singular physician recommendation for an investigational treatment may exacerbate public health issues. California’s right-to-try law allows for access to treatment “based on [a] physician’s recommendation to an eligible patient…if the recommendation or prescription is consistent with protocol approved by the physician’s institutional review board or an accredited institutional review board.”[23] While the physician’s recommendation or prescription would have to be consistent with the protocol of an accredited institution review board, medical review boards vary from institution to institution. A physician’s recommendation under one set of institutional protocols may not pass under another’s, calling into question the reliability of various independent physicians motivated by profit and the reliability of varying institutional protocols in general. While the standards of treatment recommendation for California’s right-to-try law vary, those of the Expanded Access Program are consistent and overseen by the FDA. Although the Expanded Access Program also requires that “the patient’s physician determines that there is no comparable or satisfactory therapy available to diagnose, monitor, or treat the patient’s disease or condition,” the FDA is involved as a second party that establishes that the potential benefits of expanded access justify the potential harms.[24] Federal oversight provides more reliability than the standards provided by California’s right-to-try law.
Review: Beyond the Superficial
From a cursory glance, legislation like California Assembly Bill 1668 seems to provide citizens with the inalienable right to attempt saving their own lives through investigational treatments not yet offered on the market. Underneath the surface, however, California’s right-to-try law is apt to result in negative health outcomes and is unconstitutional. Legal precedent would dictate that terminally-ill patients do not have a constitutional right to access experimental treatment and state right-to-try laws cannot bypass federal law.
The interests of constitutionality and public health go hand-in-hand as the federal Expanded Access Program ensures a higher level of scrutiny than state legislation like California’s newly-passed right-to-try law. As most of state right-to-try bills passed across the nation only require that investigational treatments undergo phase one of clinical trials, the legislation may prove more harmful than helpful to the health of the patients involved.[25] Before similar laws continue to be passed throughout the nation, legislators should look beyond the falsely-philanthropic surface of proposed right-to-try bills. However, for the time being, state right-to-try laws will likely continue to sweep across the nation until they are challenged in federal court or until legislators hold themselves to higher standards of accountability for the public health.
[1]Sam Adriance, “Fighting for the ‘Right To Try’ Unapproved Drugs: Law as Persuasion,” Yale Law Journal Forum 124 (2014): 148-157. Online at: http://www.yalelawjournal.org/pdf/AdriancePDF_vdkbnz4m.pdf
[2] “California AB1668 | 2015-2016 | Regular Session.” LegiScan. Online at https://legiscan.com/CA/text/AB1668/id/1431020.
[3] Ibid.
[4] “Right to Try Experimental Prescription Drugs State Laws and Legislation for 2014 & 2015.” National Conference of State Legislatures, March 31, 2015, Online at: http://www.ncsl.org/documents/health/RighttoTry2015.pdf.
[5] Ibid.
[6] Center for Drug Evaluation and Research. “Development & Approval Process (Drugs).” U S Food and Drug Administration Home Page. Online at: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/default.htm.
[7] David Carlson. “Preemption.” LII / Legal Information Institute. June 10, 2009. Online at: https://www.law.cornell.edu/wex/preemption.
[8] United States Court of Appeals, Tenth Circuit. “616 F. 2d 455 – Rutherford v. United States.” 616 F2d 455 Rutherford v. United States a | OpenJurist. Online at: http://openjurist.org/616/f2d/455/rutherford-v-united-states-a.
[9] Ibid.
[10] “Abigail Alliance For Better Access To Developmental Drugs v. Eschenbach.” Findlaw. Online at: http://caselaw.findlaw.com/us-dc-circuit/1098828.html.
[11] Sam Adriance.
[12] John J. Darrow et al., “Practical, Legal, and Ethical Issues in Expanded Access to Investigational Drugs — NEJM.” New England Journal of Medicine. January 15, 2015. Online at: http://www.nejm.org/doi/full/10.1056/NEJMhle1409465.
[13] Office of the Health and Constituent Affairs’ Expanded Access Team. “Expanded Access (Compassionate Use).” U S Food and Drug Administration Home Page. Online at: https://www.fda.gov/NewsEvents/PublicHealthFocus/ExpandedAccessCompassionateUse/default.htm.
[14] Ibid.
[15] John J. Darrow et al.
[16] “California AB1668 | 2015-2016 | Regular Session.”
[17] Ibid.
[18] Ibid.
[19] “U.S. Food and Drug Administration Drug Approval Process.”
[20] Ibid.
[21] Office of the Health and Constituent Affairs’ Expanded Access Team.
[22] “U.S. Food and Drug Administration Drug Approval Process.”
[23] “California AB1668 | 2015-2016 | Regular Session.”
[24] Office of the Health and Constituent Affairs’ Expanded Access Team.
[25] “Right to Try Experimental Prescription Drugs State Laws and Legislation for 2014 & 2015.”
