Right-to-try laws
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Right-to-try laws are state-level reforms that aim to allow terminally ill patients to gain access to experimental drugs without the permission of the Food and Drug Administration (FDA). Under the current model, access to experimental drugs is controlled by the FDA, which must give its approval after it receives an application from a patient's physician. Right-to-try laws allow patients and physicians to approach a drug manufacturer directly to ask for access to the drug.[1]
Since Colorado passed the first right-to-try law in 2014, about half of other states nationwide followed suit, with right-to-try laws on the books in 27 states total as of March 2016. While it's unclear whether any patients have utilized the laws, supporters say the laws will help patients access experimental medications faster and more easily. Critics argue the laws will have little practical effect and may even do more harm than good.
Background
Right-to-try laws are state-level reforms that aim to allow terminally ill patients to gain access to experimental drugs without the permission of the Food and Drug Administration (FDA). Right-to-try laws were developed as a workaround for getting faster and easier access to experimental medicines for terminally ill patients, a process that right-to-try advocates say is slow and burdensome. Colorado was the first state to adopt a right-to-try law in 2014.[2]
As of March 2016, 27 states in total had adopted right-to-try legislation, and the laws received "overwhelming bipartisan support." One state, Arizona, adopted a right-to-try law through a voter-approved ballot measure. Another state, California, passed a right-to-try bill in 2015, but Governor Jerry Brown (D) vetoed the legislation. The state's legislature introduced another bill in 2016. Seventeen other states also considered right-to-try legislation in 2015 and early 2016, and a couple of right-to-try bills have been introduced in the United States Congress.[3][4]
Current process
Under federal law, patients who are seriously or terminally ill can access experimental drugs in one of two ways: they can be enrolled in a clinical research trial conducted by a drug company, or they can apply to the Food and Drug Administration (FDA) for permission to access a drug through its "compassionate use" program (also called "expanded access").[5]
Clinical trials
Clinical trials are tightly controlled experiments conducted by drug companies to determine whether a drug is safe and effective for treating a given condition. They occur in three phases:[5]
- A small trial of less than 100 healthy people that tests the drug's safety;
- A second, larger trial of a few hundred people "to show early evidence of efficacy" of treating the disease it's designed for; and
- A third trial for several hundred to thousands of people that tests effectiveness of the drug against a placebo.
Patients with a disease that a drug is being developed to treat can apply to participate in the second and third phases of clinical trials. Drug companies often limit who is accepted into the trial based on various requirements—e.g., they may require that patients be otherwise healthy, that they be of a certain age, or that they be in an early stage of the disease. Patients who do not meet the requirements are not accepted into the clinical trial. This is meant to ensure the highest possible chance that the drug will successfully pass through the clinical trials without any adverse reactions.[5][6]
A drug must pass through all three trial phases to be approved by the Food and Drug Administration (FDA). If a drug fails at any point in the clinical trial process, the FDA may halt further testing and research and the drug may never make it to market.[5][6]
Compassionate use
If patients are denied acceptance into a clinical trial, they can ask the manufacturer to provide the experimental drug through the FDA's "compassionate use" or "expanded access" program. If the manufacturer agrees, the patient must then apply with the FDA itself for permission to access the experimental drug. The compassionate use program works by allowing the manufacturer either to formally establish a separate clinical trial for the single patient or to modify an existing clinical trial to include the new patient. However, treatment of a patient under compassionate use is not overseen, as is treatment within a clinical trial.[5]
While patients must meet certain eligibility requirements for the program, the FDA approves 99.5 percent of the expanded access applications it receives, according to the Regulatory Affairs Professionals Society, a membership organization for healthcare regulators.[7]
| “ |
Of the 5,849 single-patient expanded access applications (both emergency and nonemergency) made to the FDA between 2010 and 2014, just thirty-three were rejected.[5][8] |
” |
The application is completed and submitted by the patient's physician and formerly took an estimated 100 hours to complete. However, in February 2014, in response to criticism that the form was too burdensome, the FDA announced the introduction of a new compassionate use form that it estimated would reduce completion time to 45 minutes.[7]
Generally, the following conditions must be met for the FDA to approve a compassionate use application:[5]
- The patient must be seriously or terminally ill.
- The patient must have exhausted all other treatment options.
- The patient's physician believes the experimental treatment is the patient's best option.
- The physician agrees to administer the treatment.
- An Institutional Review Board approves the patients use of the treatment.
After receiving the application, the FDA has 30 days to respond. The patient is then monitored over the course of the treatment. Adverse reactions, including death, that occur while a patient is receiving treatment through compassionate use must be reported to the FDA and also, often, to the manufacturer's investors. A drug manufacturer may also charge a patient for the cost of the drug if the FDA allows it to.[5]
A manufacturer may also refuse to allow a patient access to experimental medication through compassionate use. In these cases, the patient has little recourse; the FDA cannot require a drug manufacturer to grant patient access to experimental medication.[5]
Right-to-try reform
The Goldwater Institute developed right-to-try model legislation for adoption by state legislatures and has been the principal advocate for the reform across the country. If enacted as written, the model legislation primarily allows manufacturers to provide terminally ill patients with experimental drugs without patients having to receive additional approval from the Food and Drug Administration.[9][10]
The model legislation also makes a number of other stipulations, many of which are consistent with current federal law. Patients must have "considered all other treatment options" and must give written consent that they understand the risks and wish to use the medication. A patient's physician must formally recommend the experimental medicine and provide documentation that the patient is eligible to receive the treatment. The drug must have successfully passed through the first phase of clinical trials.[10]
At their discretion, drug manufacturers may choose to provide an experimental drug to patients for free or at a reduced cost, or they may require that the patient pay for the cost of manufacturing the drug. Manufacturers are also not required to provide a patient with an experimental drug at all. Under the model legislation, neither insurers nor governmental agencies are required to cover the cost of accessing an experimental drug, although they may do so if they wish. The law also protects providers from having their licenses revoked for recommending an experimental medication.[10]
There are some state-to-state variations in the laws among states that have enacted them. For instance, in Colorado, the law requires that additional information about the treatment be communicated to patients for them to give informed consent, and physicians and manufacturers have limited civil immunity. Arizona excludes primary care physicians from being able to recommend experimental treatment.[5][11]
Support
Advocates of right-to-try legislation say that by removing the Food and Drug Administration (FDA) from the compassionate use process, terminally ill patients can access experimental medications faster and more easily. They say the FDA process can take months—time terminally ill patients may not have. Supporters often assert that the number of compassionate use applications the FDA approves, usually between 900 and 2,000 per year, is too low, taking it as a sign that the current system doesn't work well enough. The Right to Try official website contends that "[f]ewer than 3 percent of terminally ill patients" are accepted into clinical trials and that right-to-try laws help the rest access experimental treatments.[12][13][14]
Supporters also argue that "patients have the right to determine what risks they are willing to undertake to save their own lives." They say the choice of treatment should be between patients and their doctors and that right-to-try laws "return choice and control over treatment options" to them, "where it is most effective."[5][14]
A third argument in support of right-to-try laws is that as more states adopt them, the cause will draw greater public attention and federal policymakers will be pressured to enact nationwide reform. Some supporters would even welcome a legal challenge to the laws for the additional awareness it could bring:[15]
| “ |
(A lawsuit)wouldn't be all bad news because it would further elevate this issue in the public arena and put pressure on Congress and the FDA to make this change and literally save thousands of lives every year.[8] |
” |
| —Frank Burroughs, founder of the Abigail Alliance for Better Access to Developmental Drugs[16] | ||
Criticism
Critics of right-to-try legislation say that the laws will have little practical effect on the ability of patients to access experimental treatments. Because manufacturers are not required to provide the drugs and insurance companies are not required to pay for them, patients will still be limited in their options, critics argue. They assert that there's no evidence that any patients have received experimental treatment through these state laws. Additionally, critics point out that "shipping an investigational drug across state lines is illegal" without Food and Drug Administration (FDA) approval, further limiting the laws' effectiveness.[5][17][18]
Some critics further argue that the laws are ineffective because they don't "address some of the real reasons patients may not receive experimental treatments." They say drug companies are still unlikely to provide experimental treatment to patients under right-to-try laws because of the risks to the drug approval process. If a patient suffers an adverse reaction while taking the drug, a drug's investors may pull out or the FDA may halt the drug's development entirely, preventing the drug from ever reaching the market and hurting the company financially, a particular concern for small companies. Right-to-try laws do not make any changes to a drug company's burden of risk under compassionate use programs.[17][6]
A third argument against right-to-try laws is that they may undermine the clinical trial process. Manufacturers large and small may not be "equipped to handle the extra demands placed on their staff resources or on the limited supply of their investigational product." Some critics also state concerns that fewer people would sign up for clinical trials if they were guaranteed access to experimental treatment under right-to-try laws. Without clinical trials, a drug cannot be approved for treating a larger number of patients with a given disease.[5][17]
Other opponents of right-to-try laws cite ethical concerns. They say terminally ill patients are more likely to be harmed than helped by experimental treatments. Although drugs must have passed the first phase of clinical trials that assess their safety, "serious side effects may not emerge until later stages of research," according to Health Affairs. Critics also question the ability of patients to truly give informed consent, saying they would not have adequate information to accurately assess the risk and that their illness may cause them to have a "reduced ability to understand and retain information on risks."[5][19]
Recent legislation
The following is a list of recent right-to-try bills that have been introduced in or passed by state legislatures around the country. To learn more about each of these bills, click the bill title. This information is provided by BillTrack50 and LegiScan.
Note: Due to the nature of the sorting process used to generate this list, some results may not be relevant to the topic. If no bills are displayed below, then no legislation pertaining to this topic has been introduced in the legislature recently.
Recent news
The link below is to the most recent stories in a Google news search for the terms Right to try. These results are automatically generated from Google. Ballotpedia does not curate or endorse these articles.
See also
External links
- Goldwater Institute, "Right to Try Model Legislation"
- Goldwater Institute
- Right to Try official website
- Regulatory Affairs Professionals Society, "'Right to Try' Legislation Tracker"
- Regulatory Affairs Professionals Society, "Regulatory Explainer: FDA's Expanded Access (Compassionate Use) Program"
- Health Affairs, "Health Policy Briefs: Right-to-Try Laws"
Footnotes
- ↑ National Conference of State Legislatures, "'Right to Try' Experimental Prescription Drugs State Laws and Legislation for 2014 & 2015," March 31, 2015
- ↑ Boulderopolis, "Colorado law gives terminal patients 'right to try' unapproved drugs," accessed March 11, 2016
- ↑ Modern Healthcare, "House lawmakers introduce federal 'right to try' bill," July 15, 2015
- ↑ Los Angeles Times, "'Right-to-try' bill to help terminally ill access experimental drugs falls flat," October 11, 2015
- ↑ 5.00 5.01 5.02 5.03 5.04 5.05 5.06 5.07 5.08 5.09 5.10 5.11 5.12 5.13 Health Affairs, "Health Policy Briefs: Right-to-Try Laws," March 5, 2015
- ↑ 6.0 6.1 6.2 Right to Try, "Dead On Arrival: Federal 'Compassionate Use' Leaves Little Hope for Dying Patients," February 24, 2016
- ↑ 7.0 7.1 Regulatory Affairs Professionals Society, "From 100 Hours to 1: FDA Dramatically Simplifies its Compassionate Use Process," February 4, 2015
- ↑ 8.0 8.1 Note: This text is quoted verbatim from the original source. Any inconsistencies are attributable to the original source.
- ↑ Goldwater Institute, "The Right to Try," accessed March 11, 2016
- ↑ 10.0 10.1 10.2 Goldwater Institute, "Right to Try Model Legislation," accessed March 11, 2016
- ↑ The New England Journal of Medicine, "Table 3. Features of Existing 'Right-to-Try' Laws in Three States," accessed March 20, 2016
- ↑ Regulatory Affairs Professionals Society, "Laws Spreading That Allow Terminal Patients Access to Experimental Drugs," November 19, 2014
- ↑ Regulatory Affairs Professionals Society, "Regulatory Explainer: FDA's Expanded Access (Compassionate Use) Program," February 4, 2014
- ↑ 14.0 14.1 Right to Try, "FAQ," accessed March 20, 2016
- ↑ The Yale Law Journal, "Fighting for the 'Right To Try' Unapproved Drugs: Law as Persuasion," December 4, 2014
- ↑ USA Today, "Right-to-try for the terminally ill," June 19, 2014
- ↑ 17.0 17.1 17.2 Cite error: Invalid
<ref>tag; no text was provided for refs namedrapslawsspreading - ↑ Al Jazeera America, "Don’t give the terminally ill false hope," November 17, 2015
- ↑ The New York Times, "Patients Seek ‘Right to Try’ New Drugs," January 10, 2015
