The current process for gaining approval for new medications is long and arduous. Patients seeking to use experimental drugs can either wait for the treatments to receive Food and Drug Administration (FDA) approval or go through a lengthy and difficult FDA exemption process, which can take several months. The exemption process requires physicians to complete paperwork that takes almost 100 hours to complete. Even after this lengthy process, the decision lies with FDA.
In order to speed up the approval process and improve access to potentially life-saving drugs for extremely sick people, several states have introduced new laws, commonly called “right-to-try” (RTT) laws, that would allow terminally ill patients to obtain experimental drugs without getting federal approval. Almost half of all U.S. states have implemented right-to-try laws.
Several legislators are determined to make Wisconsin the 31st state to adopt right to try. A bill that would have enacted RTT measures gained significant momentum during the 2016 legislative session, but it failed to pass through the state’s General Assembly, despite receiving bipartisan support. According to Wisconsin Public Radio, right-to-try supporters are undaunted. State Rep. Joel Kleefisch (R-Oconomowoc) plans to introduce another right-to-try bill in the upcoming session, which begins January 4th.
Prior to passage of the 1962 Kefauver-Harris Amendment, which added new requirements for proof of efficacy and safety requirements for approval of new drugs, the average time from the filing of a new drug application to approval was seven months. It now takes an average of 12 years for a drug to travel from the research lab to the patient, according to the California Biomedical Research Association. This is due in large part to delays by FDA.
The Goldwater Institute designed a right-to-try model to address several criticisms of federal policy on experimental drug use. Goldwater’s model pertains only to medications that passed basic safety testing (Phase I), in order to observe reasonable public safety standards for untested drugs. Under the model, access to experimental drugs is limited to use by terminal patients who have exhausted other available treatments. Additionally, the experimental medications would be made available only if the manufacturer chooses to make them available, and the request would require a doctor to diagnose a terminal disease and declare the drug would provide the patient with his or her best chance of survival. Patients would also have to provide informed consent, limiting legal exposure for the drug’s manufacturer.
One challenge state right-to-try laws will have to overcome is barriers put in place by current federal drug-approval laws and regulations. FDA was given jurisdiction over the drug-approval process by Congress and current regulations put into place by FDA makes using experimental drugs very difficult.
Efforts to implement right-to-try legislation nationwide have been slowed by political pressures. A bill was introduced in the U.S. Senate in 2016 to prevent Congress from superseding state right-to-try laws. The Trickett Wendler Right to Try Act of 2016 would give dying patients the right to apply and obtain investigational drugs without requiring a clinical trial, circumventing the need for approval from FDA. The bill was named after Trickett Wendler, a Wisconsin woman who died in 2015 from amyotrophic lateral sclerosis. A companion bill was introduced in 2015 in the U.S. House of Representatives. Sen. Harry Reid (D-NV) recently blocked the Senate version of the bill in a move which appears politically motivated.
Wisconsin legislators should follow the lead of states such as Colorado and pass right-to-try legislation.
The following articles discuss right to try in general and the various RTT proposals now being considered.
The Real Defense of Right to Try
https://heartland.org/news-opinion/news/the-real-defense-of-right-to-try?source=policybot
David S. D’Amato writes in Health Care News about the ongoing and contentious right-to-try debate and argues in favor of reform. “Sick people should not have to supplicate to government bureaucrats to assume certain risks in the desperate attempt to save themselves; such intimately personal health decisions are of no concern to the meddlers in government agencies, to anyone but the patient, his doctors, and his family,” wrote D’Amato.
The Right to Try and the Future of the FDA in the Age of Personalized Medicine
https://heartland.org/publications-resources/publications/the-right-to-try-and-the-future-of-the-fda-in-the-age-of-personalized-medicine
Adam D. Thierer of the Mercatus Center argues right-to-try laws have developed and expanded in recent years in part because technological innovation decentralizes and democratizes medical decisions. “This expansion does not mean that all FDA regulation will fade away, but it will necessitate a move away from the agency’s command-and-control methods of the past and toward a new focus on patient empowerment through enhanced choice, improved risk education, and clearer consent mechanism,” wrote Thierer.
‘Right to Try’ Experimental Prescription Drugs State Laws and Legislation for 2014 & 2015
http://www.ncsl.org/documents/health/RighttoTry2015.pdf
The National Conference of State Legislatures outlines the current state of right-to-try laws and new right-to-try proposals across the country.
Dead on Arrival: Federal ‘Compassionate Use’ Leaves Little Hope for Dying Patients
https://heartland.org/publications-resources/publications/dead-on-arrival-federal-compassionate-use-leaves-little-hope-for-dying-patients?source=policybot
The Goldwater Institute’s report on right to try laws as a possible solution to overcoming the U.S. Food and Drug Administration’s restrictions upon partially tested drugs that could help terminally ill patients.
Federal ‘Right to Try’ Act Would Help States Bypass FDA to Treat Terminally Ill
https://heartland.org/news-opinion/news/federal-right-to-try-act-would-help-states-bypass-fda-to-treat-terminally-ill?source=policybot
Josh Thomas of Health Care News examines new legislation introduced by U.S. Sen. Ron Johnson (R-WI) that would prevent the federal government from superseding state right-to-try laws, making it easier for terminally ill patients in certain states to obtain experimental treatments and devices.
Everyone Deserves the Right to Try: Empowering the Terminally Ill to Take Control of Their Treatment
https://heartland.org/publications-resources/publications/everyone-deserves-the-right-to-try-empowering-the-terminally-ill-to-take-control-of-their-treatment?source=policybot
Christina Corieri outlines the Goldwater Institute’s right-to-try initiative. Corieri argues states should enact right-to-try measures to protect the fundamental right of people to try to save their own lives. Goldwater’s initiative would allow terminal patients access to investigational drugs that have completed basic safety testing, thereby dramatically reducing paperwork, wait times, bureaucracy, and, most importantly, potentially saving lives.
More Choices, Better Health
https://heartland.org/publications-resources/publications/more-choices-better-health?source=policybot
More Choices, Better Health: Free to Choose Experimental Drugs shows the U.S. Food and Drug Administration’s lengthy drug-approval process causes needless pain and suffering. The booklet presents an alternate solution that gives informed patients and their physicians easier access to experimental drugs.
Making Drugs Safe and Available without the FDA
https://heartland.org/publications-resources/publications/making-drugs-safe-and-available-without-the-fda?source=policybot
Noel D. Campbell of the National Center for Policy Analysis argues Americans should be free to choose when selecting drugs and health care treatments. Americans should be able to relieve pain without fear of our safety; “Thus the best reform is the most comprehensive reform. When the 105th Congress undertakes [Food and Drug Administration] reform, the reform should be profound. Congress should abolish the FDA and allow private organizations to certify drugs and medical devices.”
Is the FDA Safe and Effective?
http://www.fdareview.org/
Drawing on the existing body of academic research, Daniel B. Klein and Alexander Tabarrok evaluate the costs and benefits of FDA policy. Their website also presents a detailed history of the FDA, a review of the major plans for FDA reform, a glossary of terms, a collection of quotes from economists who have studied FDA, and a reference section with many links.
The ‘Dallas Buyers Club’ Bill
http://www.thedailybeast.com/articles/2014/03/04/the-dallas-buyers-club-bill.html
Writing in The Daily Beast, Eleanor Clift discusses right-to-try efforts, explaining how they first emerged and how several states are now considering legislation to allow terminal patients greater access to experimental drugs.
Nothing in this Research & Commentary is intended to influence the passage of legislation, and it does not necessarily represent the views of The Heartland Institute. For further information on this and other topics, visit the Health Care News website, The Heartland Institute’s website, and PolicyBot, Heartland’s free online research database.
Whether sending an expert to your state to testify or brief your caucus, hosting an event in your state, or simply sending you further information on the topic, Heartland can assist you. If you have any questions or comments, contact Heartland Institute State Government Relations Manager Nathan Makla at [email protected] or 312/377-4000.
Matthew Glans joined the staff of The Heartland Institute in November 2007 as legislative specialist for insurance and finance.
