By Brandon Schall, Staff Writer
For years, many patients, doctors, healthcare advocates, and families of patients with terminally ill diagnoses have been pushing for a federal law that would allow terminally ill patients the Right to Try experimental drugs that are not yet approved by the Food and Drug Administration (“FDA”).[1]
The Right to Try movement became a national phenomenon after Abigail Burroughs died of cancer in 2001.[2] Burroughs’ physician had advised her that an unapproved drug, Erbitux, might save her life; despite that possibility, she was not able to try.[3] Since Abigail’s death, the Right to Try movement has continued to gain traction when her father started the Abigail Alliance for Better Access to Developmental Drugs (“Abigail Alliance”), to support patients in similar circumstances.[4]
In 2006, the movement again made progress when a three-judge panel of the D.C. Circuit heard the Abigail Alliance lawsuit against the FDA, claiming “a constitutional due process right for terminally ill patients to access unapproved drugs.”[5] The case was reheard en banc and reversed by the panel, holding:
“The right to life, and the asserted corollary right to attempt to preserve life, is not a second derivative species of ‘liberty’ whose protection by the Constitution should be approached with skepticism. Insofar as courts should be skeptical of interfering with the legislative debate and ongoing democratic discussions about fundamental issues of life and death, that skepticism is better applied to the latter portion of the strict scrutiny analysis — the evaluation of the competing government interests and the greater or lesser narrowness of the tailoring required in the face of scientific uncertainty and conflicting opinions. See Abigail Alliance I, 445 F.3d at 478 n.9.”[6]
Despite the movement’s momentum, a federal Right to Try law has not yet been passed by Congress.
In his 2018 State of the Union speech, President Trump reignited the issue, calling on Congress to pass a bill to allow terminally ill patients access to unapproved drugs.[7] He stated that terminally ill Americans should not have to go from country-to-country in search of a cure,[8] a process referred to as “medical tourism,” which has many consequences for patients and the healthcare industry.[9]
In January of 2017, Senator Ron Johnson (R-WI) introduced Senate Bill, S.204, Right to Try Act of 2017.[10] In August 2017, the United States Senate passed S. 204 with an amendment by unanimous consent.[11] The bill was sent to the United States House of Representatives and referred to the House Committee on Energy and Commerce.[12] Additionally, two separate bills were introduced in the 115th Congress, H.R. 878, Right to Try Act of 2017[13] by Andy Biggs (R-AZ) and H.R. 2368, Right to Try Act[14] by Brian Fitzpatrick (R-PA).
Thus, Chairman Greg Walden (R-Ore.) will need to decide which bill to mark-up in committee. Chairman Walden has suggested that he will consider S. 204, but noted that the bill will likely be changed.[15] If the Senate version were changed, the bill would have to be sent back to the Senate before President Trump could consider the measure.[16]
While support for a Right to Try law has continued to grow since Abigail’s death in 2001, there are still many individuals who believe that there should not be a law allowing patients to try. Recently, six academics that work on medical ethics and drug development gathered more than three hundred signatures from people who opposed the Senate bill.[17]
In an open letter, they specifically pointed to the FDA’s compassionate use program allowing physicians to request that the FDA allow patients access to an unapproved drug, which the group claims are granted 99 percent of the time.[18] The letter further notes that in the past three years, thirty-eight states have passed laws allowing terminally ill patients to use drugs that have passed Phase 1 of an FDA clinical trial, but have not been approved by the FDA for market-wide access.[18] Additionally, many who oppose the law believe that a federal Right to Try law could weaken the regulations imposed upon drug makers.[20] On the other hand, supporters of the bill believe that a federal law would help dying patient get access to more potentially life saving drugs.[21]
Both sides of the issue present moral and considered arguments, which have been debated for over a decade. Regardless of any one individual’s stance on a federal Right to Try law, President Trump’s mention of it at the State of the Union Address surely reignited the issue as one worth paying attention to.
Sources
[1] https://www.politico.com/agenda/story/2018/02/02/trump-health-care-right-to-try-000636
[2] https://www.yalelawjournal.org/forum/right-to-try-unapproved-drugs
[3] Id.
[4] Id.
[5] Id.
[6]https://scholar.google.com/scholar_case?case=8342520538153713995&hl=en&as_sdt=6&as_vis=1&oi=scholarr
[7] https://www.politico.com/agenda/story/2018/02/02/trump-health-care-right-to-try-000636
[8] Id.
[9] http://www.medicaltourismassociation.com/en/medical-tourism-faq-s.html
[10] https://www.congress.gov/bill/115th-congress/senate-bill/204
[11] Id.
[12] Id.
[13] https://www.congress.gov/bill/115th-congress/house-bill/878/related-bills
[14] https://www.congress.gov/bill/115th-congress/house-bill/2368/related-bills
[15] http://thehill.com/policy/healthcare/372461-gop-eyes-changes-to-right-to-try-bill
[16] Id.
[17] http://thehill.com/policy/healthcare/372440-hundreds-sign-on-to-letter-opposing-right-to-try-drug-bill
[18] Id.
[19] https://www.cato-unbound.org/2017/07/31/christina-sandefur/track-record-right-try-why-it-matters
[20] https://www.politico.com/agenda/story/2018/02/02/trump-health-care-right-to-try-000636
[21] Id.
