The Senate unanimously voted to pass the ‘Right to Try’ bill on August 3, which would allow terminally ill patients the ability to try experimental drugs prior to full FDA approval. The bill, which has been subject to strong controversy, has been backed by President Trump and is now set to go to the House for a final vote (1). The bill has been largely championed by the Goldwater Institute, which seeks to ‘preserve and expand constitutional freedoms’ (2).
Such ‘Right to Try’ bills have long been in place on the state level, with 37 states already having passed their own versions of the bill (3). However, because the FDA is a federal institution and supersedes state law, advocates contend that the federal bill in question will protect patients from FDA intervention when seeking treatment (1). The bill will allow patients to receive drugs that have passed only the first stage of FDA approval, provided that the drug has been recommended by a doctor and all other treatment options have be exhausted. The bill also stipulates that the patient cannot be part of any clinical trial while taking the drug (3).
While the bill has been strongly advocated for by families of terminally ill patients, others have argued that the availability of experimental drugs gives patients false hope for recovery. The first stage of FDA approval involves only preliminary drug testing in humans, so experimental drugs may well have harmful effects that have not yet been fully considered or documented (3). Critics of the bill further state that the FDA already has efficient system in place to approve experimental drugs, and that the real limiting factor to patients receiving them is that pharmaceutical companies may decline to make them available even after FDA approval (3). The current bill would put pharmaceutical companies under no legal obligation to provide drugs even when the FDA has approved their experimental use, and offers companies no incentive to provide them, other than a degree of legal protection should they result in harm to the patient (3). Companies often decline to make drugs available in order to continue clinical drug trials, or because they simply haven’t produced enough of it (1).
Under the current FDA experimental drug approval program, known as the expanded access or ‘compassionate use’ program, families may make direct a direct request for experimental drugs to be made available. FDA spokeswoman Sandy Walsh states that “the FDA has authorized more than 99 percent of expanded access requests received in fiscal years 2010-2015. Emergency requests are usually granted immediately over the phone and non-emergencies are processed in a median of four days” (1). However, according to the Goldwater Institute, only 1,000 people have been able to take advantage of the compassionate use program every year.
The bill is likely to face stronger criticism and more deliberation in the House, where similar legislation has seen lengthy debate. The bill ‘will likely [be] subject it to a hearing and markup before bringing it up to a vote’ (4).
References:
(1) “Trump Backs ‘Right to try’ Experimental Drugs, Already Law in 37 States.” The Daily Signal, 7 August 2017. http://dailysignal.com/2017/08/07/trump-backs-federal-right-to-try-law-already-enacted-in-37-states/.
(2) The Goldwater Institute, http://goldwaterinstitute.org/en/.
(3) “Senate passes ‘right to try’ bill to help terminally ill patients get experimental drugs.” The Washington Post, 3 August 2017. https://www.washingtonpost.com/news/to-your-health/wp/2017/08/03/senate-passes-right-to-try-bill-to-help-terminally-ill-patients-get-experimental-drugs/?utm_term=.75edf2ae9cbc
(4) “‘Right to Try’ Bill Could Face Slower Action in House.” Roll Call, 14 August 2017.
https://www.rollcall.com/news/policy/experimental-treatment-bill-face-slower-action-house