Issues to Watch

Patients Can Try Experimental Treatments Before They Are Approved by the Federal Drug Administration (FDA) . . . What Could Possibly Go Wrong?: Maryland’s Right to Try Law and the Potential for Federal Preemption.


* Alana Glover

Establishing “Right to Try” legislation throughout the country has been a concept that proponents of the law have been working toward for years.  What Is Right To Try?, Right To Try, http://righttotry.org/about-right-to-try/, (last visited Nov. 8, 2018).  Many proponents of this legislation support the concept of creating alternative options for terminally ill patients who have exhausted government approved treatment options and cannot secure a position in a clinical trial.  See id.  As of today, forty-one states, and recently Congress, have passed Right to Try laws, which allow terminally ill patients to try an experimental drug or treatment that has only completed a Phase 1 trial of the Federal Drug Administration’s (FDA) multi-phased process.  Id.  Although, on its face, providing terminally ill patients with access to use an experimental drug at their choice seems ideal, there may also be many complications.

Ethicists, doctors, former FDA commissioners, and patient advocates have vehemently expressed opposition to Right to Try legislation.  James Hamblin, The Disingenuousness of ‘Right to Try’, Atlantic (June 2, 2018), https://www.theatlantic.com/health/archive/2018/06/right-to-try/561770/.  The American Society of Clinical Oncology is among nearly forty health organizations that have publicly expressed opposition to the bill.  Id.  Three phases are required in a clinical trial before an experimental drug can be considered safe.  Id.  Phase 1 only establishes whether the drug is toxic or unfit for basic safety testing.  Id.  To put it into perspective, approximately ten percent of drugs that pass Phase 1 trials go on to be considered safe for patients to try.  Id.  Opponents typically believe that giving these individuals access to these drugs without proper FDA approval makes the patient more vulnerable to experiencing negative side effects, which are not worth the risk.  Id.  Although Maryland has enacted the Right to Try law throughout the state, it seems that the state legislature has attempted to address these potential issues with the requirements that are included in the written informed consent form.  See generally, H.B. 584, 2017 Leg., 437th Sess. (Md. 2017).

I.  Maryland’s Right to Try Legislation

Maryland’s House Bill 584 was passed on May 25, 2017, and was set to take effect on October 1, 2017.  H.B. 584, 2017 Leg., 437th Sess. (Md. 2017).  The bill authorized that eligible patients have the right to try a manufacturer’s investigational drug, biological product, or device without full approval from the FDA.  Id.  The bill, which has now been enacted, established an eligible patient as a terminally ill individual, based off the diagnosis of his or her treating physician, who has exhausted all options and has signed an informed consent form drafted by the Maryland Attorney General’s Office.  Id. at 2.  In addition, House Bill 584 required a manufacturer of an investigational drug, biological product, or device to notify patients and health care providers of the side effects and risks of the experimental drug and required the Maryland Office of the Attorney General to develop an informed consent form, which meets specified requirements outlined in the bill.  Id.  The form must explain the products currently approved by the FDA, state that the patient concurs with the physician that all approved treatments are unlikely to prolong the patient’s life, and inform the provider and eligible patient of known or anticipated side effects of the investigational drug or treatment.  Id.

II.  Federal Right to Try Act

On May 30, 2018, President Donald Trump signed Federal Right to Try legislation into law, which was established as an amendment to the Federal Food, Drug, and Cosmetic Act (FDCA).  Right To Try, supra;  Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017, § 561.A, 21 U.S.C.A. § 301 (2018).  The Act authorizes an eligible patient to have access to an eligible investigational drug or treatment pursuant to federal guidelines.  Id.  Pursuant to Section 561B, an “eligible patient,” is defined as someone who has been diagnosed with a life-threatening disease, exhausted eligible treatment options, and has provided their physician with a written informed consent form regarding the investigational drug.  Id. § 561.B.  The Federal Right to Try Act makes no other mention of requirements that must be included with the informed consent document.  Cf. id.  The law also establishes the national standards in which investigational drugs may be provided to terminally ill patients.  Id.

III.  Where Does Federal Preemption Come In?

Based on the language of the two laws, the possibility may exist that certain sections of Maryland’s Right to Try may be rendered null and void by federal preemption.  One of the most notable differences between the two laws is Maryland’s consent form requirement, which will likely be reviewed if federal preemption becomes an issue.  See H.B. 584, 2017 Leg., 437th Sess. (Md. 2017); see also Right to Try Act of 2017, § 561.A, 21 U.S.C.A. § 301 (2018).  Maryland’s consent form requires that the patient agrees with the physician that all approved treatments are unlikely to prolong the patient’s life and informs the provider and eligible patient of known or anticipated side effects of the investigational drug or treatment.  Id.  In comparison, the only requirement of the Federal Law is the signed written consent form.  Cf. id.  Although there is a possibility that an argument for preemption based on Maryland’s requirements for the written consent form will arise, it is not likely it will be upheld in court.  Cf. Chateau Foghorn LP v. Hosford, 168 A.3d 824 (Md. 2017) (holding that federal preemption standards did not apply to landlord-tenant laws because states traditionally have the power to that area of the law).  However, the possibility of federal preemption is important to watch because this would be an issue of first impression, and it would be difficult to determine how courts would rule.  See generally Jennifer Piel, Informed Consent in Right-To-Try Cases, 44 J. Am. Acad. Psychiatry & L. 290 (2016), http://jaapl.org/content/44/3/290.

When assessing the possibility of preemption, one must recognize that there are two main types of preemption that exist when analyzing federal and state law.  Erin Smith, Federal and State Pre-emption Basics: What Every Drafter Ought to Know, Nat’l Conf. St. Legislators (July 19, 2016), http://www.ncsl.org/legislators-staff/legislative-staff/research-editorial-legal-and-committee-staff/webinar-federal-and-state-preemption-basics.aspx.  The two different types are express and implied preemption.  Id.  Express preemption exists in circumstances where Congress has established preemptive intent through expressed language of the law.  Id.  Congress establishes implied preemption when the federal law preempts the state law through the law’s purpose and structure.  Id.; see also Worton Creek Marina, LLC v. Claggett, 850 A.2d 1169 (2004).  In accordance with established precedent on this issue, neither of these forms of preemption may exist here.  Prior case law has established that when the intent of congress is unclear, the courts typically favor an opinion that rules against federal preemption as a rule of law.  Smith, supra.

When analyzing the federal Right to Try law through the lens of express preemption, there is no clear and explicit language surrounding the requirement of the consent form other than the provision which states that it must be written and signed.  See Right to Try Act of 2017, § 561.A, 21 U.S.C.A. § 301 (2018).  Because the signature requirement is the only additional component of the federal law, the weight of authority indicates that a court reviewing the federal Right to Try legislation will likely hold that the federal law does not preempt the informed consent requirement of the Maryland legislation established in House Bill 584.  Compare H.B. 584, 2017 Leg., 437th Sess. (Md. 2017) with Right to Try Act of 2017, § 561.A, 21 U.S.C.A. § 301 (2018).  The “informed consent” requirements seem to only expound upon the federal legislation, rather than contradict with the standard established, therefore there is no means for standing for an expressed preemption claim.  See Smith, supra.

There may, however, exist a stronger argument for federal preemption of the informed consent form, through the use of implied preemption.  See id.  As stated above, implied preemption looks to a law’s purpose and structure.  Id.  An individual may argue that when the federal government passed the legislation, they did so with the intent that all states follow their law as written, since federal laws are universally viewed as the law of the land.  U.S. Const. art. I, § 2.  However, in Chateau Foghorn LP, the Court of Appeals of Maryland addressed an issue surrounding the landlord of a federally-subsidized apartment building who brought eviction action against a tenant.  Chateau Foghorn LP v. Hosford, 168 A.3d 824 (Md. 2017).  The holding in this case was that “major damage” federal preemption standard did not apply because landlord-tenant law was a traditional domain of state law.  Id. at 835.  Although this case has material factual differences, it is synonymous to the issue surrounding the federal Right to Try Act and Maryland’s House Bill 584, in that health matters have typically been left to the states to govern.  Id.  Since state Right to Try legislation has been recently established as law, we must wait to see how a court eventually interprets this issue.

IV.  Conclusion

In the future, there may be a case reviewing the Maryland Right to Try law and the newly established Federal law that involves the question of whether Maryland’s written consent form requirement is overly burdensome.  If this issue is litigated, it will establish precedent on how the Right to Try legislation in Maryland will be enforced, and how it will affect terminally ill patients, pharmaceuticals, and healthcare providers.

*Alana is a second-year law student at the University of Baltimore School of Law, where she serves as a staff editor for Law Review and a member of the Royal Graham Shannonhouse III Honor Society. Alana Glover is also a member of the National Mock Trial Team, Co-President of If/When/How: Lawyering for Reproductive Justice, Vice President of the Family Law Association, and Director of Community Service for the Black Law Student’s Association. In the spring, Alana will continue serving as a student attorney practicing pursuant to Maryland Rule 19-217 in the school’s Innocence Project clinic as well as serving as the Law Scholar for Professor Michael F. Higginbotham. This past summer, Alana was chosen to be a part of the Thurgood Marshall Clerkship Program hosted at the Maryland Attorney General’s Office where she was placed in the Health, Education, and Advocacy Unit of the Consumer Protection Division. Next summer, Alana will serve as a summer associate at Pessin Katz Law, P.A.

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