To: Scott Jenkins,
Subject: "Right to Try" Experimental Drug Laws
Date: Mon Jun 09 15:20:13 MDT 2014
The current process for pharmaceutical firms seeking Food and Drug Administration (FDA) approval for new medications is long and arduous. And patients seeking to use experimental drugs before FDA approval must go through an exemption process that can take several months, requiring physicians to file paperwork that takes almost 100 hours to complete. Even after this lengthy process, the decision to grant an exemption for the patient’s use of the experimental drug lies solely with the FDA.
To speed up this process and improve the access of terminally ill patients to potentially beneficial drugs, several states have introduced “Right to Try” laws that would allow patients to obtain experimental drugs without getting federal approval. Three states—Colorado, Louisiana, and Missouri—are on track to become the first to pass such laws. Arizona voters will consider a similar measure in November.
The Right to Try model was designed by the Goldwater Institute to address several concerns about patients’ use of experimental drugs. First, the model allows access only to medications that have passed basic safety testing (FDA Phase I). Second, access is limited to use by terminally ill patients who have exhausted other available treatments. Finally, a medication is made available only if the company manufacturing it chooses to do so. A patient’s request for access to an experimental drug 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 manufacturer of the drug.
Critics of Right to Try claim providing experimental drugs to terminally ill patients creates a false hope. Supporters say any hope is better than the alternative of no hope, which is inevitable when no treatments are made available for terminal patients. Milton Friedman once noted the FDA drug approval process, done in the name of safety, has harmful consequences for both the health of the public and the economy: “The FDA has done enormous harm to the health of the American public by greatly increasing the costs of pharmaceutical research, thereby reducing the supply of new and effective drugs, and by delaying the approval of such drugs as survive the tortuous FDA process.”
According to the California Biomedical Research Association (CBRA), it takes an average of 12 years for a drug to travel from the research lab through the FDA to the patient. In addition, the FDA allows only five in 5,000, or .1 percent, of the drugs that begin preclinical testing ever to make it to human testing, and of those five, only one is ultimately approved for human use. Prior to passage of the 1962 Kefauver Harris Amendment, which added new requirements for proof of efficacy in addition to safety for approval of new drugs, the average time from the filing of an investigational new drug application to approval was seven months.
Right to Try laws allow patients, with the advice of their doctors, to choose what treatments to try. These laws take reasonable steps to ensure the drugs are reasonably safe and that drug manufacturers and patients work to manage legal risk. Legislators in other states should consider passing such laws.
The following documents provide additional information about Right to Try laws.
Everyone Deserves the Right to Try: Empowering the Terminally Ill to Take Control of Their Treatment http://heartland.org/policy-documents/everyone-deserves-right-try-empowering-terminally-ill-take-control-their-treatment
Free to Choose Medicine http://freetochoosemedicine.org/
Making Drugs Safe and Available without the FDA http://heartland.org/policy-documents/making-drugs-safe-and-available-without-fda
A Clinical Trial for the FDA’s Clinical Trial Process http://heartland.org/policy-documents/clinical-trial-fdas-clinical-trial-process
Is the FDA Safe and Effective? http://www.fdareview.org/
The ‘Dallas Buyers Club’ Bill http://www.thedailybeast.com/articles/2014/03/04/the-dallas-buyers-club-bill.html
‘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
Every Patient Deserves a “Right to Try” http://townhall.com/tipsheet/townhallmagazine/2014/04/10/every-patient-deserves-a-right-to-try-n1822217
The Right to Try http://freebeacon.com/issues/the-right-to-try/
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 athttp://news.heartland.org/health, The Heartland Institute’s website at http://heartland.org, and PolicyBot, Heartland’s free online research database at www.policybot.org.
If you have any questions about this issue or the Heartland Institute Web site, contact Heartland Institute Government Relations Director John Nothdurft at firstname.lastname@example.org or 312/377-4000.
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