Legislators in Rhode Island are considering increasing access to experimental drugs for terminally ill patients, thus bypassing the draconian federal approval process, through a policy known as “right to try” (RTT).
Presently, the federal procedure to approve new medications and medical devices is protracted and expensive. Under current regulations, patients in desperate need of potentially life-saving drugs must either wait for the treatments to receive Food and Drug Administration (FDA) approval or apply for an FDA exemption. The exemption process can take several months and requires extensive paperwork to be completed by physicians. Ultimately, the decision to approve an exemption is made exclusively by FDA bureaucrats.
In 1962, the Kefauver-Harris amendment increased the number of barriers and requirements placed on manufacturers to create and bring new drugs to the marketplace in the United States. Prior to the passage, “the average time from the filing of an [Investigation New Drug application] to approval was seven months.” Because of the “stringent regulations” put in place by Kefauver-Harris, it is projected the approval process now takes approximately “12 years, and the estimated average cost of taking a new drug from concept to market exceeds $1 billion.”
Due to the burdensome nature of many of these rules, states have bypassed federal regulations and enacted legislation expanding patients’ access to experimental medications. Colorado became the first state to pass RTT legislation in 2014 under the Right To Try Act. Currently, 38 states have some form of RTT laws in place.
The Goldwater Institute, a free-market think tank based in Arizona, has been a leading advocate of RTT legislation. Goldwater’s model legislation addresses the issues in federal policy that decrease patients’ access to experimental drugs and treatments. The model only includes medications that have passed FDA safety testing (Phase I). Access is also limited to patients who are terminally ill and have exhausted all available treatment options.
Darcy Olsen, former CEO of the Goldwater Institute, said Americans should not be required to seek permission by government for access to treatments that could save their lives. Rather, Olsen believes these individuals “should be able to work with their doctors directly to decide what potentially life-saving treatments they are willing to try. This is exactly what Right To Try does.”
Under the Rhode Island bill being considered, developmental drugs and devices must have successfully completed Phase I of clinical trials to be eligible. Further, the proposal requires written consent by the physician acknowledging that all available treatments have been tried. Physicians must also provide details on the potential use of an experimental drug or device, explaining the realistic outcomes. The model legislation affords health care providers immunity from sanctions by licensing boards or disciplinary subcommittees, and patients’ access cannot be blocked by state agencies.
More than expanding access to life-saving treatments, RTT laws are a move toward reestablishing federalism. The Tenth Amendment Center believes these laws “provide a clear model that demonstrates how to nullify federal statutes that violate the Constitution. The strategy narrows the influence of nullification to limited aspects of the law itself, which has proven to be very effective.”
Right to try would give Ocean State residents access to life-saving drugs and medical devices for those that are terminally ill, as well as help to reassert states’ constitutional powers.
The following articles provide more information on right to try.
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.
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.
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.
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 subject, visit The Heartland Institute’s website and PolicyBot, Heartland’s free online research database.
If you have any questions about this issue or The Heartland Institute’s website, contact Charlie Katebi, The Heartland Institute’s state government relations manager, at [email protected] or 978/855-2992.
