United States: National Right To Try Legislation Passes Congress

On May 22, 2018, the United States House of Representatives passed 250-169 the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Mathew Bellina Right to Try Act of 2017 (S. 204), intended to expand access by terminal patients to investigational drugs.1 Passage of this bill, first approved by the Senate on August 3, 2017, is the culmination of a national campaign, led by the Goldwater Institute, a libertarian public policy think tank, that has galvanized 40 states to pass their own right to try (RTT) laws. While clearly an important political and policy statement, the extent to which this legislation will have a practical impact on expanded access remains to be seen. This Advisory summarizes the existing framework for expanded access to experimental treatments, key aspects of the RTT legislation, and potential implications for stakeholders.

Expanded Access Under Current FDA Rules

State and federal RTT legislation purports to provide terminally ill patients with an alternative to obtaining investigational drugs through FDA's expanded access program.2 FDA's current regulations and guidance permit administration of an investigational drug to eligible individual patients3 under a single-patient, compassionate use investigational new drug application (IND) outside of the context of broader clinical trials. Eligible patients are limited to certain criteria, including that they have a serious or immediately life-threatening disease or condition.4

Under current regulations, the first step in obtaining an investigational drug for expanded access use is for the patient's treating physician to determine that the patient meets the eligibility criteria for expanded access, including that the "probable risk" to the patient from the investigational drug "is not greater than the probable risk from the disease or condition."5 Next, the physician must ask the drug manufacturer to provide the investigational drug for expanded access use.6 In order for the physician to proceed, the company developing the product in question must agree to provide the investigational drug and, typically, a limited right of reference to their IND. However, companies are under no legal obligation to support such INDs through provision of the drug or otherwise, and there are many reasons why companies may decline such access, including potential liability, cost, safety or other medical concerns about the particular proposed use, and other factors. If the company agrees, and the patient's physician is assuming responsibility for operating as both the sponsor and the investigator for the expanded access use,7 the physician must then submit the IND to FDA, which may include use of forms that FDA has recently streamlined to expedite expanded access requests.8 To grant access to an investigational treatment, FDA must find that there is no comparable or satisfactory alternative therapy, the patient cannot obtain the drug under another IND or protocol, the benefit to the patient justifies the potential risks of the treatment and those potential risks are not unreasonable, and providing the investigational drug will not interfere with clinical investigations that could support approval of the use or otherwise compromise development of the use.9 FDA authorizes more than 99% of the single-patient IND requests that it receives.10 If access is granted, then the physician must also obtain the patient's written informed consent, and obtain, at a minimum, concurrence by the institutional review board (IRB) chairperson or designated member prior to starting treatment.11

Path to RTT Legislation at the State and Federal Levels

As noted, to date, 40 states have passed RTT legislation, and RTT bills have been introduced in 9 additional states.12 Such legislation has largely been based on a model RTT law proposed by the Goldwater Institute, which purported to create a patient right to an alternative pathway bypassing FDA-expanded access requirements. However, because the Goldwater model law and subsequently enacted state RTT laws were widely thought to be at least impliedly preempted by the Federal Food, Drug, and Cosmetic Act (the FDCA), implementing a federal RTT law was viewed as instrumental to preserving an alternative, expedited pathway to investigational drug access for terminal patients. The FDCA, among other things, prohibits the introduction or distribution of an unapproved drug into interstate commerce.13 It also sets forth the framework that provides access to and authorizes distribution of investigational drugs.14 Therefore, state laws that circumvented FDA's authority by permitting distribution of an unapproved investigational drug from a manufacturer to a physician would directly conflict with the FDCA, and could be preempted due to the impossibility of complying with state and federal law.

At the federal level, RTT legislation faced considerable pushback by a variety of stakeholders as well as lawmakers in both chambers. Senator Ron Johnson (R-WI) led the push for federal RTT legislation, having introduced S. 204 on January 24, 2017. Under Senator Johnson's threat of holding up passage of the FDA Reauthorization Act of 2017, the Senate passed the bill under unanimous consent. S. 204 was subsequently referred to the House Subcommittee on Health. The House Energy & Commerce Committee held a hearing in October 2017, at which FDA Commissioner Scott Gottlieb testified, providing FDA input on S. 204. Progress in the House stalled until the President called for passage of RTT legislation during his 2018 State of the Union address. The House subsequently released its own RTT bill (H.R. 5247) that addressed FDA and other stakeholder concerns raised by S. 204 on March 10, 2018. On April 9, 2018, after an initial failed attempt at passage under suspension of the rules, the House passed H.R. 5247. An attempt by the Senate to pass H.R. 5247 on unanimous consent collapsed under Democratic pressure, at which movement forward on the legislation slowed. President Trump again re-ignited the RTT issue in his May 11, 2018, speech announcing the Administration's Blueprint for Lowering Drug Prices.15 Now that S. 204 has passed both the House and Senate, the bill will be sent to President Trump, who is expected to sign the bill into law.

S. 204: An Act to Authorize the Use of Unapproved Medical Products by Patients Diagnosed with a Terminal Illness in Accordance with State Law, and for Other Purposes

S. 204 amends the FDCA by inserting after section 561A (FDA's expanded access program), section 561B, "Investigational Drugs For Use By Eligible Patients."16 The bill authorizes "eligible patients" to use unapproved drugs and biological products in accordance with state law. Specifically, the bill "establishes national standards and rules by which investigational drugs may be provided to terminally ill patients" and "is consistent with, and will act as an alternative pathway alongside, existing expanded access policies of the Food and Drug Administration."17 Significant features of this bill include the parameters for who may access investigational drugs and how such terms are defined, the use of clinical outcomes, reporting, liability, and provision of investigational drugs.

Access to Eligible Investigational Drugs

Under this alternative program, to access an "eligible investigational drug," a patient must meet the following criteria to be considered an "eligible patient":

  1. The patient must be diagnosed with a life-threatening disease or condition, meaning a disease or condition where the "likelihood of death is high unless the course of the disease is interrupted" or the disease or condition has a "potentially fatal outcome, where the end point of clinical trial analysis is survival."18
  2. A physician must certify that the patient has exhausted their approved treatment options and is unable to participate in a clinical trial involving the investigational drug.19 The physician must be in good standing with the physician's licensing organization or board, and must not be compensated directly by the manufacturer for providing such a certification.
  3. The patient or his legally authorized representative must provide written informed consent to the treating physician.20

Patients who meet the above criteria may request that a manufacturer provide them with access to an "eligible investigational drug," defined as an investigational drug (1) for which a Phase 1 clinical trial has been completed, (2) that has not been approved or licensed by FDA for any use, (3) that is either the subject of a pending new drug application (NDA) or biologics license application (BLA) or that is under investigation in a clinical trial that is the subject of an IND and that is intended to form the primary basis of a claim of effectiveness in support of approval or licensure, and (4) for which development or production of the drug is ongoing and has not been discontinued by the manufacturer or placed on a clinical hold.21 Manufacturers are not obligated to provide access to any investigational drug. However, if a patient is granted access to an eligible investigational drug, there is no obligation on behalf of the sponsor or physician to notify FDA that such drug will be administered to an eligible patient, subject to more general annual report requirements noted below.

Exemptions from Certain Statutory and Regulatory Provisions

Subject to fulfilling certain conditions described below, eligible investigational drugs provided to eligible patients are exempt from the following statutory and regulatory requirements:

  • Section 502(f) of the FD&C Act - Directions for Use, Warnings on Labels
  • Section 503(b)(4) of the FD&C Act - Misbranding
  • Section 505(a) of the FD&C Act - Application Approval
  • Section 505(i) of the FD&C Act - Research Exemption
  • Section 351(a) of the PHS Act - Biologics License
  • 21 C.F.R. part 50 - Protection of Human Subjects
  • 21 C.F.R. part 56 - Institutional Review Boards
  • 21 C.F.R. part 312 - Investigational New Drug Application

To qualify for exemptions from the above list of statutory requirements, the investigational drug sponsor or any person who "manufactures, distributes, prescribes, dispenses, introduces or delivers for introduction into interstate commerce, or provides to an eligible patient an eligible investigational drug" must:

  • Label the drug as an investigational drug in accordance with 21 C.F.R. § 312.6;
  • Comply with the regulations prohibiting promotion of investigational drugs at 21 C.F.R. § 312.7; and
  • Comply with FDA regulations governing costs recoverable for an investigational drug, which provides that a sponsor may only recover the direct costs of making its investigational drug available as provided in 21 C.F.R. § 312.8(d)(1).22 Any sponsor or person that provides an investigational drug to an eligible patient under the RTT legislation pathway need not seek prior written authorization from FDA to charge such direct costs for an investigational drug, as the bill exempts such sponsor or person from complying with the requirements of 21 C.F.R. part 312, except with regard to charging for direct costs only.

Use of Clinical Outcomes

Generally speaking, the bill prevents FDA from using a clinical outcome associated with the use of an eligible investigational drug to delay or adversely affect the review or marketing approval of such drug or biological product, unless one of two scenarios occurs.23 First, FDA may, at the sponsor's request, consider a clinical outcome from a use of an investigational drug under this pathway.24 Second, FDA may consider such a clinical outcome if the Agency determines that the clinical outcome is "critical to determining the safety of the eligible investigational drug" and provides written notice of the determination to the sponsor, includes a public health justification for the determination, and makes the notice part of the administrative record.25

Reporting

The bill establishes reporting requirements for a manufacturer or sponsor who provides an investigational drug, and requires the Secretary to publicly post summary information about use of the program. Specifically, a manufacturer or sponsor must submit to the Secretary an annual summary of the use of their investigational drug under this alternative pathway, including the "number of doses supplied, the number of patients treated, the uses for which the drug was made available, and any known serious adverse events."26 FDA will publish an annual summary report on the use of this program on FDA's website.27 The report will contain the number of drugs for which clinical outcomes associated with the use of an eligible investigational drug were used in delaying or adversely affecting the review or approval of a drug or biological product based on a sponsor's request or the Secretary's determination that the clinical outcome is critical, as described above, and the number of drugs for which clinical outcomes were not used in the review of a product application.28

Liability

The RTT legislation purports to provide protection against liability for alleged acts or omissions related to providing an eligible patient with an eligible drug under this section to (1) manufacturers and sponsors, and (2) prescribers, dispensers, and other individual entities, provided that the relevant conduct does not rise to the level of reckless or willful misconduct, gross negligence, or an intentional tort under applicable state law.29 The legislation also provides that sponsors, manufacturers, prescribers, dispensers, or other individual entities would also not be held liable for determining not to provide access to an investigational drug.30 Except for the exclusions from liability based on acts or omissions, and a determination not to provide a drug, nothing in section 561B should be construed to modify or otherwise affect the right of a person to bring a private action under state or federal product liability, tort, consumer protection, or warranty law.31

Potential Implications

The Federal RTT law, once signed by the President, will provide an alternative pathway for patients seeking access to experimental treatments outside of participating in a clinical trial. Whether this alternative pathway will actually significantly expand access to investigational treatments remains to be seen. Although Commissioner Gottlieb now supports the bill and has expressed a willingness to implement the legislation, he previously speculated about the efficacy of RTT legislation.32 In October 2017, he testified, "[t]here is a perception that certain products that aren't being offered under FDA expanded access . . . will be offered under right to try . . . I don't see that."33 As noted, similar to FDA's current expanded access program, the legislation does not require manufacturers to provide patients with access to their investigational drugs. Under the auspices of a program that is incorporated into the FDCA and that contains some liability protection, however, manufacturers—who will undoubtedly continue to be under public pressure from certain patient groups, the Goldwater Institute, and other stakeholders—may be more willing to grant access to investigational drugs than they were under the state RTT framework. Still, manufacturer participation will in many cases be constrained by various factors, including concerns about safety and the de facto impact of outcomes on the prospects of the investigational product, ethical and legal concerns, costs, and adequacy of supply.

If patients do obtain greater access to experimental treatments, concerns about patient safety and the ethics of administering experimental treatments in this manner will remain a focus. Because eligible investigational drugs available under this pathway need only have completed Phase 1 clinical trials, only preliminary evidence of safety will be available about many such treatments. Without FDA's input as provided under the current expanded access program, patients and their physicians will not have access to the Agency insights that could improve patient safety or outcomes. The Commissioner has noted, however, that there is a pathway for incorporating additional patient protections "administratively and still remain consistent with both the letter and the spirit of the law."34

* * *

After years of debate at the state and federal levels, national RTT legislation is now expected to become law. While the legislation does provide a new pathway for terminal patients seeking access to experimental therapies, it does not fully address the many valid practical, legal, and ethical concerns associated with providing such access, and manufacturers remain under no legal obligation to provide drug supplies for such patients where such concerns cannot be resolved. Indeed, while terminally ill patients certainly should have the opportunity to seek consideration of their request for investigational product access—whether under the traditional expanded access or newly framed RTT pathway—physicians and manufacturers will continue to play a critical role in denying such access where unethical or presenting other serious concerns.

Footnotes

1 Trickett Wendler, Frank Mongiello, Jordan McLinn, and Mathew Bellina Right to Try Act of 2017, S. 204.

2 21 C.F.R. part 312, subpart I, "Expanded Access to Investigational Drugs for Treatment Use for Individual Patients."

3 Our analysis is limited to the individual patient expanded access criteria (21 C.F.R. § 312.310) and does not assess expanded access to intermediate-size patient populations (21 C.F.R. § 312.315) or for widespread treatment use, under a treatment IND or treatment protocol (21 C.F.R. § 312.320), because RTT legislation focuses on individual patient access to experimental drugs.

4 21 C.F.R. § 312.305(a)(1). A serious disease or condition is one that is "associated with morbidity that has a substantial impact on day-to-day functioning" while an immediately life-threatening disease or condition "means a stage of disease in which there is reasonable likelihood that death will occur within a matter of months or in which premature death is likely without early treatment." 21 C.F.R. § 312.300(b).

5 21 C.F.R. § 312.310(a)(1); Expanded Access: Information for Physicians (last updated Apr. 12, 2018).

6 FDA Guidance for Industry, Individual Patient Expanded Access Applications: Form FDA 3926, at 5, Oct. 2017.

7 The drug or biologic manufacturer may also serve as the sponsor of the expanded access use, and in such case, could submit an expanded access protocol as a protocol amendment to an existing IND. See 21 C.F.R. § 312.310(b)(2).

8 FDA Guidance for Industry, Individual Patient Expanded Access Applications: Form FDA 3926, at 5, Oct. 2017. Form 3926 is FDA's streamlined method for physicians to submit an IND for individual patient expanded access; FDA estimates that completion of this form takes 45 minutes. Id. at 7.

9 Id. at 3; 21 C.F.R. § 312.305(a)(1)-(3); 21 C.F.R. § 312.310(a)(2).

10 Expanded Access: Information for Physicians (last updated Apr. 12, 2018).

11 FDA Guidance for Industry, Individual Patient Expanded Access Applications: Form FDA 3926, at 6, Oct. 2017. For emergency requests, treatment may begin as soon as 5 days after FDA provides authorization, and for non-emergency requests, 30 days after FDA receives the IND, unless the Agency provides earlier notice to the treating physician that treatment may commence. Id. at 6-7.

12 Right To Try In Your State (accessed May 18, 2018).

13 21 U.S.C. § 355(a).

14 21 U.S.C. § 360bbb-0. See also Expanded Access to Investigational Drugs for Treatment Use regulations at 21 C.F.R. part 312, subpart I.

15 Remarks by President Trump on Lowering Drug Prices, May 11, 2018.

16 21 U.S.C. 360bbb-0.

17 S. 204 at 9.

18 Id. at 2. See also 21 C.F.R. § 312.81

19 S. 204 at 2-3.

20 Id. at 3.

21 Id. at 3-4.

22 Id. at 4-5. Direct costs are "costs incurred by a sponsor that can be specifically and exclusively attributed to providing the drug for the investigational use for which FDA has authorized cost recovery. Direct costs include costs per unit to manufacture the drug (e.g., raw materials, labor, and nonreusable supplies and equipment used to manufacture the quantity of drug needed for the use for which charging is authorized) or costs to acquire the drug from another manufacturing source, and direct costs to ship and handle (e.g., store) the drug." 21 C.F.R. § 312.8(d)(1)(i).

23 S. 204 at 5-6.

24 Id. at 5.

25 Id. at 5-6.

26 Id. at 6.

27 Id. at 6-7.

28 Id.

29 Id. at 7.

30 Id. at 8.

31 Id.

32 Right-To-Try Bill Headed for Vote Puts Bigger Burden on FDA to Protect Patients, Gottlieb Says, May 17, 2018.

33 Statement of FDA Commissioner Scott Gottlieb, Examining Patient Access to Investigational Drugs, Oct. 3, 2017.

34 Id.

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