The Right to Try in Wisconsin for Patients, Providers & Manufacturers: Part 2
This blog article presents an overview of the potential application of the Wisconsin Right to Try Law in light of the contemporaneous passage of the Federal Right to Try Act. This article should not be construed as legal advice. Contact an attorney to determine how these laws may affect you.
Introduction and Recap of Part I
Last month in Part I of this article, we discussed the Wisconsin Right to Try (“WRTT”) law and the Federal Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (“Right to Try Act”). In Part I, we discussed how these laws could apply to a patient, provider, or manufacturer when a patient seeks access to an investigational drug. In this Part II, we will try to answer the questions “Why are there so many laws about this? How do I comply with all of them?” with a discussion on the interaction of the WRTT law with federal law and how the federal Right to Try Act impacts the “Expanded Access” program under the Federal Food, Drug, and Cosmetic Act (“FDCA”).
To recap from Part I, the WRTT law permits eligible patients to gain access to investigational drugs, devices, or biological products under certain circumstances.[i] The Right to Try Act amends the FDCA to authorize eligible patients to access investigational drugs directly from the manufacturer or sponsor of eligible investigational drugs without prior permission from the U.S. Food and Drug Administration (“FDA”).[ii] The “Expanded Access” program, commonly referred to as the “Compassionate Use” program, gives eligible patients a way to access investigational drugs, biologics, and medical devices used to diagnose, monitor, or treat patients with serious diseases or conditions for which there are no adequate therapy options available outside of clinical trials.[iii] Under the Expanded Access program, eligible patients could apply to the FDA for approval to access to investigational drugs, biologics, and medical devices. The key difference between the Expanded Access program and the Right to Try Act is that the Right to Try Act excludes the FDA from the process. In other words, eligible patients do not need to apply for review and approval from the FDA to obtain access to certain investigational products under the new law.[iv] They can now obtain investigational drugs directly from drug manufacturers or sponsors.
How the State and Federal Laws Interact
So what’s the deal with all of these laws? Congress enacted the federal law in large part to ensure the state right to try laws would not be preempted. Under the Supremacy Clause of the U.S. Constitution, the U.S. Constitution and the laws of the U.S. are the “supreme Law of the Land,” and they prevail over any conflicting or inconsistent state exercise of power.[v] Congress can expressly preempt state action, but it can also do so impliedly. This means that if Congress expressly preempts state action or if Congress comprehensively regulates or demonstrates intent to regulate a particular field, then the U.S. Constitution and federal law is the law of the Land where state law is inconsistent.
State right to try laws would have likely been preempted in their entirety if Congress did not enact the Right to Try Act because Congress has historically given the FDA comprehensive authority to regulate drugs and investigational products under the FDCA. The FDCA’s legislative history indicates that Congress intended to protect patients with terminal illness from fraudulent cures and to regulate unapproved drugs because of the comprehensive system under the FDCA.[vi] Moreover, certain provisions of the state right to try laws would have made it impossible to comply with both state and federal law.[vii] Therefore, if state right to try laws were challenged before passage of the Right to Try Act, a court would have likely found that the FDCA preempted state right to try laws. This is largely why we now have two right to try laws.
The federal and state laws contain three main provisions. First, they permit eligible patients to access investigational products, as applicable, that have not been approved or licensed for use by the FDA. Second, they limit liability for any manufacturer, distributor, pharmacist, practitioner, or other person who makes applicable investigational products available under the conditions specified in the law. Third, they require the manufacturers or sponsors of the investigational products to submit an annual summary to the FDA regarding the use of the investigational product by eligible patients.
The WRTT law is consistent with federal law in that both cover investigational drugs as defined by the FDCA. However, the state and federal laws differ in an important way. One main difference between the state and federal law is that the WRTT law covers investigational drugs, devices, and biological products. Whereas, the federal Right to Try Act does not expressly cover investigational devices, nor does it expressly cover certain biological products not included in the FDCA’s definition of “investigational drugs.”[viii] This is an important distinction because of federal preemption. Since the WRTT law covers investigational devices and biological products, and the Right to Try Act does not, these provisions risk federal preemption under the Supremacy Clause of the U.S. Constitution because they are inconsistent with federal law.
Unlike state regulation of investigational drugs,[ix] Congress has expressly preempted state regulation of medical devices under the Medical Device Amendments of 1976 (“MDA”).[x] MDA established a comprehensive system for federal regulation of the premarket approval of medical devices and explicitly restricted states’ authority over their regulation.[xi] Moreover, access to investigational devices are regulated under the Expanded Access program, and the requirements for access to investigational devices directly conflict with WRTT law.[xii] For example, because the WRTT law permits manufacturers to provide access to investigational devices to eligible patients in contravention of the FDCA’s requirement not to introduce certain new devices into interstate commerce without prior FDA approval, a court could nullify those WRTT provisions inconsistent with federal law.[xiii] Thus, the manufacturer of an investigational device risks operating in contravention of federal law if it supplies a patient with a device without prior FDA approval pursuant to the Expanded Access program.
Finally, although Congress has not expressly preempted state regulation of biological products,[xiv] there are strong arguments for implied preemption. Therefore, if a manufacturer were to provide an eligible patient with a biological product (not covered by the Right to Try Act)[xv] pursuant to the WRTT law, the manufacturer risks violating federal law.
Consequences of Preemption
However, because of potential federal preemption, it is uncertain how the federal government will treat access to investigational devices and biological products pursuant to WRTT law. As a result, the constitutionality of the WRTT law could be legally challenged as it applies to the aforementioned inconsistencies.
If the FDA disagreed with the WRTT’s inconsistent provisions, it could seek an injunction to prevent a patient’s access to an unapproved investigational device or biological product and to prevent future patient access to such investigational products. An enforcement action could bring rise to a lawsuit, and a litigant with standing, such as a drug manufacturer, could seek declaratory relief in court as to the validity of the inconsistent WRTT provisions.[xvi] If the legally inconsistent provisions were nullified by a court, “the FDA could impose penalties on doctors and manufacturers for marketing or distributing unapproved [devices]. More practically, however, the FDA could impose penalties first with the intent to raise the preemption issue in court.”[xvii] This means that manufacturers and physicians could risk facing FDA enforcement for distributing unapproved investigational devices and certain biological products in contravention of the federal law.
To avoid the risk of operating in contravention with federal law, eligible Wisconsin patients and physicians could apply for FDA approval through the Expanded Use program to access investigational devices and those investigational biological products not covered by the Right to Try Act.[xviii] Also to avoid this risk, manufacturers or sponsors of investigational devices and biological products not covered by the Right to Try Act could require patients and physicians to seek FDA approval from the Expanded Access program before permitting access to such products. Any person or entity who determines not to provide access to such investigational products is exempt from liability for such determination.
The application of the WRTT law and the Federal Right to Try Act is yet to be determined. Because of the discrepancies between these laws, it is possible that we will see further action by the states, by the FDA or in the courts to settle these discrepancies in the months and years to come. Consult with McCarty Law if you have questions about how you can access investigational drugs, devices, and biological products or how you can provide these products to eligible patients.
Please note that this blog article does not discuss access to investigational drugs pursuant to the WRTT law, it only focuses on the potential federal preemption issues concerning access to investigational devices and certain biological products not covered by the Right to Try Act. Although the WRTT law covers investigational drugs, devices, and biological products, the federal Right to Try Act does not expressly cover investigational devices or certain investigational biological products. For a discussion on access to investigational drugs under the WRTT law and the Right to Try Act, please see Part I of this blog article.
[ii] Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017, Pub. L. No. 115-176, 132 Stat. 1374 (May 30, 2018) (codified at 21 U.S.C. § 360bbb-0a).
[iii] Food & Drug Administration Modernization Act of 1997 (“FDAMA”), Pub. L. No. 105–115; Food & Drug Administration Amendments Act of 2007 (“FDAAA”), Pub. L. No. 110–85 (codified at 21 U.S.C. § 360bbb et seq.).
[iv] Jarrow, Lurie, Crowley, et al., Overview of FDA’s Expanded Access Program for Investigational Drugs, 51(2) Therapeutic Innovation & Regulatory Science 177 (Feb. 26, 2017) (available at https://doi.org/10.1177/2168479017694850).
[v] U.S. CONST. art. VI.
[vi] See Ellen A. Black, State “Right to Try” Acts: A Good Start, but a Federal Act Is Necessary, 45 Southwestern L. Rev. 719, footnote 142 (2016) (“United States v. Rutherford, 442 U.S. 544, 552 (1979) ([analyzing] the legislative history of the 1938 [FDCA] and [noting] that Congress desired to shield patients with terminal diseases from fraudulent cures.”); see also Caitlyn Martin, Questioning the “Right” in State Right to Try Laws: Assessing the Legality and Effectiveness of these Laws, 77 Ohio St. L. J. 159, 18 (2016) (concluding that “the FDCA and accompanying FDA regulations provide numerous ways for drug manufacturers to provide, and individual patients to obtain access to, unapproved drugs through the Agency’s expedited drug approval process. This comprehensive system provides strong indication that Congress did not intend for states to provide an alternate route to increased access of unapproved drugs.”)
[vii] See Black, supra note vi, at 740 (concluding “the right to try acts are contrary to the FDA’s approval process, which requires a minimum of three phases of testing, and are also contrary to the FDA’s compassionate use program, which requires permission from the FDA for a terminally ill patient to receive access to investigational drugs.”).
[viii] Under the Right to Try Act, “eligible investigational drug” means an investigational drug (as such term is used in section 561 of the FDCA): 1.) for which a Phase 1 clinical trial has been completed; 2.) that has not been approved or licensed by the FDA; 3.) either a.) for which an application has been filed for FDA license or approval, or b.) that is under investigation in a clinical trial that i.) is intended to form the primary basis of a claim of effectiveness in support of approval or ii.) licensure or is the subject of an active investigational new drug application; and 4.) the active development or production of which is ongoing and has not been discontinued by the manufacturer or placed on clinical hold. The FDCA regulations define an investigational new drug as “a new drug or biological drug that is used in a clinical investigation. The term also includes a biological product that is used in vitro for diagnostic purposes.” “Investigational drug” and “investigational new drug” are deemed to be synonymous under the law and regulations. See 21 U.S.C. § 360bbb; see also 21 C.F.R. §312.3(b).
[ix] See Martin, supra note vi, at 181 (pointing out that the “Kefauver Harris Amendments to the FDCA added a savings clause to the Act, noting that ‘[n]othing in the amendments made by this Act to the [FDCA] shall be construed as invalidating any provision of State law which would be valid in the absence of such amendments unless there is a direct and positive conflict between such amendments and such provision of State law.’” Drug Amendments of 1962, Pub. L. No. 87-781, § 202, 76 Stat. 780, 793 (1962).).
[x] See Medical Device Amendments of 1976, Pub. L. No. 94-295, 90 Stat. 539 (codified as amended at 21 U.S.C. §§ 360c-360k, 379, 379a; 42 U.S.C. § 3512 (2012)); 21 U.S.C. § 360k(a) (“Except as provided in subsection (b) of this section, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement 1.) which is different from, or in addition to, any requirement applicable under this chapter to the device, and 2.) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.”); see also Martin, supra note vi, footnote 142 (“When Congress included this express preemption provision within the MDA of 1976, it could have easily added a parallel provision for prescription drugs, yet declined to do so [in Riegel v. Medtronic, Inc].”); Riegel v. Medtronic, Inc., 552 U.S. 312, 316-17 (2008) (holding that § 521 of the FDCA expressly preempts personal injury lawsuits at common law that challenge the safety or effectiveness of medical devices if the devices enters interstate commerce under the a Premarket Approval application; See also Medtronic, Inc. v. Lohr, 518 U.S. 470, 496 (1996) (holding that § 521 preemption does not apply if the device enters interstate commerce under the “premarket notification” process of § 510(k) of FDCA).
[xi] See Martin, supra note vi, at 167–68.
[xii] See 21 U.S.C. § 360bbb; 21 U.S.C. § 360bbb-0a (Note the absence of the words “investigational device,” “eligible investigational device,” and reference to investigational devices from the statute).
[xiii] Jan Murraya & Lindsey E. Gabrielsena, Right-to-Try Laws: Safe and Effective or Placebo Legislation?, 9 J. Health & Life Sci. L. 54, 67 (June 2016); Certain devices must also receive premarket approval by the FDA. See 21 U.S.C. §§ 360e & 360j.
[xiv] See Abbott v. American Cyanamid Co., 844 F.2d 1108, 1111 (4th Cir. 1988) (finding no express preemption provision applicable to biologics).
[xv] The definition of investigational drugs under the FDCA includes investigational biological products used in vitro for diagnostic purposes. Therefore, access to investigational drugs and those investigational biological products included in the FDCA’s definition of investigational drugs would likely be covered under the WRTT law and the Right to Try Act.
[xvi] See Martin, supra note vi, at 190.
[xvii] See generally Murrarya & Gabrielsena, supra note xiii.
[xviii] U.S. Dept. of Health & Human Servs, U.S. Food & Drug Admin., Expanded Access (last updated Nov. 8, 2018).
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