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.
On March 30, 2018, the controversial 2017 Wisconsin Act 165, commonly referred to as the “Right to Try” law, took effect. The Wisconsin Right to Try (“WRTT”) law permits eligible patients to gain access to investigational drugs, devices, or biological products under certain circumstances. Wisconsin is one of 41 states that have enacted a right to try law.
Two months later on May 30, 2018, President Trump signed the Federal Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (“Right to Try Act”) into law. The Right to Try Act amends the Federal Food, Drug, and Cosmetic Act (“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”).
You may be asking yourself, “didn’t the FDA already create a pathway for eligible patients to access investigational drugs and products?” The answer to that question is yes. 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. Under the Expanded Access program, eligible patients can apply to the FDA for approval to access 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. They can now obtain investigational drugs directly from drug manufacturers or sponsors.
Now you may be asking yourself, “Why are there so many laws about this? How do I comply with all of them? What does it mean to me?” These are all good questions. This article aims to answer the third question concerning what these laws might mean for you. For a discussion of the answers to the first and second questions, look for Part II of this article in next month’s blog.
The Role Physicians, Patients, and Manufacturers Play in Facilitating Access to Investigational Drugs under the Laws
Pursuant to the WRTT law and the Right to Try Act, an eligible patient can legally access eligible investigational drugs and certain investigational biological products from a manufacturer or sponsor without prior FDA approval. What does it mean to be an eligible patient and an eligible investigational drug?
To be an eligible patient, an individual must have been diagnosed with a life-threatening disease, he or she must have exhausted approved treatment options, he or she must not be able to participate in clinical trials, and the individual must obtain a recommendation or prescription order from his or her treating physician.[i] The treating physician must be licensed by the State in which he or she practices and must be in good standing with the licensing board. The individual must also give written informed consent to use the investigational drug, the content of which must be consistent with and at least as comprehensive as the consent used in clinical trials for the investigational drug. The individual must be aware of the potential costs that may be associated with or otherwise result from the use of the investigational drug. The laws do not require health insurance plans to cover the investigational products. However, the WRTT law prohibits the manufacturer of the investigational drug from charging more than an amount that is equal to the manufacturer’s actual cost to manufacture the investigational drug.
Finally, an individual must obtain a written verification executed by the individual’s treating physician attesting that the individual is an eligible patient and that the physician is not compensated directly by the manufacturer of the investigational drug for making that attestation.
Eligible patients can access “eligible investigational drugs,” as defined by the FDCA, under both laws.[ii] Both laws require that eligible investigational drugs have successfully completed phase 1 clinical trial and have active and ongoing development or production of the product that has not been discontinued by the manufacturer or placed on clinical hold.[iii] The WRTT law additionally requires the investigational products to be either under investigation in a phase 2 or 3 clinical trial approved by the FDA, or have completed a phase 3 clinical trial and pending approval or licensure by the FDA.
Once the treating physician verifies a patient as eligible, the eligible patient can request the eligible investigational drug from the manufacturer. To encourage prescribers and manufacturers to allow eligible patients access to these products, the laws exempt from liability manufacturers, sponsors, prescribers, distributors, pharmacists, practitioners, or other persons who make investigational drugs available using reasonable care under the conditions specified in the laws. It is important to note that Manufacturers are not required to provide an eligible patient access to an investigational drug. Likewise, any person or entity who determines not to provide access to investigational drugs is exempt from liability for such determination.
If you are a patient, prescriber, manufacturer, or other person or entity involved in providing eligible patients access to investigational drugs, be sure to research the risks and benefits of these options. The passage of these laws was very controversial. Some patients’ rights and physician groups had valid concerns about patient safety, and some manufacturing companies were concerned about how access under these laws might affect research, development, availability, and pricing.[iv]
Finally, it is important to note that this article only focuses on access to investigational drugs as defined by the FDCA. 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. This is an important distinction because of federal preemption. The provisions of the WRTT law that are inconsistent with federal law risk preemption under the Supremacy Clause of the U.S. Constitution. Investigational devices and other investigational biological products conceivably would still be accessible to eligible patients under the Expanded Use program. For a discussion on the differences between the laws, federal preemption, and access to investigational devices and other investigational biological products in light of the right to try laws, look for Part II of this article in next month’s blog.
[ii] See 21 U.S.C. § 360bbb; see also 21 C.F.R. §312.3(b). The FDCA regulations define an investigational new drug as “a new drug or biological drug that is used in a clinical investigation.”Investigational new drug also includes a biological product that is used in vitro for diagnostic purposes. Therefore, the Right to Try Act ostensibly only covers investigational drugs and those investigational biological products included in the definition of investigational drug under the FDCA – it perceivably does not cover all investigational biological products.
[iv] For an informative overview of the controversy surrounding the laws, check out Right-to-try: Patients Lobby for Experimental Drugs by Optum. The sharing of this article should not be construed as an endorsement of Optum.
Latest posts by Lindsey Croasdale (see all)
- The Right to Try in Wisconsin for Patients, Providers & Manufacturers: Part 2 - December 7, 2018
- The Right to Try in Wisconsin for Patients, Providers, and Manufacturers: Part One - November 1, 2018
- McCarty Law Step Up Challenge Winter 2018 - May 3, 2018
- Deadline Alert: Civil Rights Compliance Plan Due - February 15, 2018