Is the “Right To Try” Guaranteed?

Five states have approved controversial “right to try” laws, allowing patients access to drugs not yet approved by the Federal Drug Administration ("FDA").

[i] Such laws are commonly referred to as “Dallas Buyer’s Club” laws based on the recent movie of the same title.[ii] Patients and other advocates claim access to these drugs is potentially lifesaving while critics claim it could do more harm than good.[iii] Current FDA regulations do allow for access to these experimental drugs, but patients claim this process is too burdensome.[iv]

So far Arizona, Colorado, Louisiana, Michigan, and Missouri have passed these laws.[v] Arizona is the most recent state to pass this kind of legislation, which quietly passed during the recent midterm elections.[vi] The statutes allow physicians to talk directly to drug manufacturers about medications that have not yet been approved.[vii] The physicians can then discuss trying the medication with their patients.[viii] Generally, medication must have made it through the first phase of FDA trials.[ix] Similar bills are being introduced in ten more states in 2015.[x] Lawmakers in Kansas, Tennessee, Texas, and Wyoming have led the pack with bills either being filed or announced for the upcoming year.[xi]

Patients like Jeff with Duchenne muscular dystrophy argue these laws could help save, or at least prolong, their lives.[xii] Jeff lives in Massachusetts, which does not have a right to try law, so he must rely on a study.[xiii] While this does grant him access to experimental drugs, he was almost kicked out of the study for his failing health.[xiv] Advocates like Jeff claim waiting for these laws to be passed can lead to life-or-death situations for the terminally ill.[xv] Further, patients should have the right to try any drug that has a chance of saving their lives.[xvi] "For people with terminal illness, for whom nothing else has proved effective, they don't have the luxury of waiting four to five months to get through the FDA's compassionate-use program," says Victor Riches, vice president of the group leading the cause for these laws.[xvii]

Critics of these laws are far less hopeful, however. Many claim the law undermines the FDA approval process, allowing patients access to medication that has not been proven safe or effective.[xviii] Patients must be approved by the drug companies, which can lead to heart-wrenching decisions for the companies.[xix] Companies must balance introducing the medication to a larger patient pool and having patients suffer adverse side effects, setting back the drug approval process.[xx] Companies may have limited supplies of these drugs and would also have to worry about potential liability.[xxi] Other critics worry patients may not be fully aware of the potential consequences, such as speeding up death or causing more pain.[xxii] Many companies are worried widespread use of right to try laws will lead to decreases clinical trial participation.[xxiii] Finally, these medications may not be covered by insurance, leading to potentially high costs to the patients seeking them.[xxiv]

Under current FDA regulations, there is a way for patients to gain access to experimental medications.[xxv] Under this “compassionate use” program, patients with terminal illnesses can gain access to unapproved therapies after being rejected from clinical trials.[xxvi] The FDA quickly approves a number of claims this way, approving almost all of the 1,000 claims received between 2009 and 2013.[xxvii] Many patients attack this program, claiming they don’t have time to wait to be approved even through this program.[xxviii] Even with quick approval, the process can take hundreds of hours worth of paperwork and months to navigate for physicians and patients.[xxix] The FDA themselves have taken no stance on the “right to try” issue, instead encouraging patients to use the compassionate use program.[xxx]

At this time it is unclear if right to try laws will become more widespread. What is clear, however, is that policy makers will have a lot to think about in the coming years.

Vaughn Bentley is pursuing his law degree and health law certificate at DePaul University College of Law in Chicago. Vaughn completed his undergraduate degree at the State University of New York, College at Oswego in psychology. He is an active member of the Health Law Institute and has a passion for healthcare law. He would like to focus on transactional healthcare law after graduating in May of 2016.


References:

[i] Kimberly Leonard, Seeking the Right to Try, US News & World Report (Nov. 18, 2014 12:01 AM EST)http://www.usnews.com/news/articles/2014/11/18/right-to-try-laws-allowing-patients-to-try-experimental-drugs-bypass-fda.

[ii] Sam Adriance, Fighting for the “Right to Try” Unapproved Drugs: Law as Persuasion, 124 Yale L.J.F. 148 (2014),http://www.yalelawjournal.org/forum/right-to-try-unapproved-drugs.

[iii] Leonard, supra note 1.

[iv] Brady Dennis & Ariana Eunjung Cha, ‘Right to Try’ Laws Spur Debate Over Dying Patient’s Access to Experimental Drugs, The Washington Post (May 16, 2014), http://www.washingtonpost.com/national/health-science/right-to-try-laws-spur-debate-over-dying-patients-access-to-experimental-drugs/2014/05/16/820e08c8-dcfa-11e3-b745-87d39690c5c0_story.html.

[v] Leonard, supra note 1.

[vi] Id.

[vii] Id.

[viii] Id.

[ix] Michelle Andrews, Laws Spreading That Allow Terminal Patients Access to Experiment Drugs, Kaiser Health News (Nov. 18, 2014), http://kaiserhealthnews.org/news/laws-spreading-that-allow-terminal-patients-access-to-experimental-drugs/.

[x] Julie Turkewitz, Patients Seek ‘Right to Try’ New Drugs, N.Y. Times (Jan. 10, 2015), http://www.nytimes.com/2015/01/11/us/patients-seek-right-to-try-new-drugs.html?_r=0.

[xi] Id.

[xii] Leonard, supra note 1.

[xiii] Id.

[xiv] Id.

[xv] Id.

[xvi] Dennis & Cha, supra note 4.

[xvii] Turkewitz, supra note 12.

[xviii] Dennis & Cha, supra note 4.

[xix] Andrews, supra note 9

[xx] Id.

[xxi] Leonard, supra note 1.

[xxii] Id.

[xxiii] Andrews, supra note 9

[xxiv] Leonard, supra note 1.

[xxv] Turkewitz, supra note 12.

[xxvi] Id.

[xxvii] Leonard, supra note 1.

[xxviii] Turkewitz, supra note 12.

[xxix] Leonard, supra note 1.

[xxx] Turkewitz, supra note 12.