Ohio is considering becoming the 31st state to allow terminally ill patients to obtain experimental drugs without getting federal approval, a policy commonly called “right to try.” Ohio’s right-to-try law would allow for the distribution and use of “investigational drugs” alone – drugs that have passed the first phase of the Food and Drug Administration’s (FDA) clinical trials. The proposal would also mandate physician approval before a patient can access one of these products. To add needed protections for patients, doctors, and insurance companies, several additions were made to the Ohio proposal. They include requiring individuals seeking treatment to receive an opinion from a second physician.
Proponents of right-to-try laws say the current process to gain approval for new medications is long and arduous, with many patients desiring to use experimental drugs being forced to wait for years to receive FDA approval. Others face a lengthy and difficult FDA exemption process, which may or may not result in approval. The Ohio right-to-try bill is designed to improve on FDA’s flawed Compassionate Use Program, which is both slow and unavailable for many patients.
State Rep. Robert Sprague (R-Findlay), a co-sponsor of the bill, told the Columbus Dispatch too few Ohioans seeking experimental treatments have been approved for clinical trials, and only about 1,000 individuals nationwide have been approved for compassionate use. “By the time the FDA gets back to you three or four months later to allow you into the program, in many cases these individuals have passed,” Sprague said.
The Goldwater Institute designed its right-to-try model to address several criticisms of federal policy on experimental drug use. First, the model pertains only to medications that passed basic safety testing (Phase I) in order to observe reasonable public safety standards for untested drugs. Second, access to these drugs is limited to use by terminal patients who have exhausted other available treatments. Finally, the experimental medications are made available only if the manufacturer chooses to make them available. The request would require a doctor to diagnose a terminal disease and declare the drug represents the patient’s best chance at survival with the patient providing informed consent, limiting the legal exposure of the drug’s manufacturer.
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 7 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 U.S. government agency responsible for drug approval.
One challenge state right-to-try laws will have to overcome is current federal drug approval laws; the FDA has jurisdiction over the drug approval process through Congress’s authority to regulate interstate commerce. A new bill recently introduced in Congress would prevent Congress from superseding state “right to try” laws, but its chances of being passed by Congress are uncertain.
Right-to-try laws would give patients the ability, with the advice of their doctors, to choose what treatments work for them. These laws take appropriate steps to ensure the drugs are reasonably safe and drug manufacturers and patients take necessary steps to manage legal risk. Ohio legislators should follow the lead of states like Colorado and seriously consider right-to-try legislation.
The following articles discuss right to try, how it would work, and the various proposals now being considered.
‘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.
‘Right to Try’: States Move to Expand Access to Experimental Drugs
http://www.nbcnews.com/health/health-news/right-try-states-move-expand-access-experimental-drugs-n108316
NBC News covers the Colorado right-to-try bill and its passage through the state’s legislature: “The ‘Right to Try’ law allows terminally ill patients to obtain experimental drugs without getting federal approval. It’s a proposal being advanced in several states by patient advocates who are frustrated by the years-long federal approval process for experimental drugs in the pipeline.”
Every Patient Deserves a ‘Right to Try’
http://townhall.com/tipsheet/townhallmagazine/2014/04/10/every-patient-deserves-a-right-to-try-n1822217
The federal government is allowing terminally ill patients to suffer while the Food and Drug Administration (FDA) drags out the approval process. Some states are fighting back. In the April issue of Townhall Magazine, where this article originally appeared, HotAir’s Mary Katharine Ham discusses one mother’s battle with FDA to save her terminally ill sons.
The Right to Try
http://freebeacon.com/issues/the-right-to-try/
Mary Lou Byrd of the Free Beacon discusses the Arizona right-to-try bill, which would allow the terminally ill to use experimental drugs not yet approved by the Food and Drug Administration. “Arizona lawmakers passed the bill out of committee and in the next three weeks both chambers of the legislature could vote on it. It would then need to be approved by voters in November.”
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 Health Care News at https://heartland.org/publications-resources/newsletters/health-care-news, The Heartland Institute’s website at http://heartland.org, and PolicyBot, Heartland’s free online research database at www.policybot.org.
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Matthew Glans joined the staff of The Heartland Institute in November 2007 as legislative specialist for insurance and finance.
