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Author: ClinEdge Staff

May 31, 2018 •

"Right to Try Act" Signed Into Law

On Wednesday, May 30th, President Trump signed the “Right to Try Act” into law. ”Right to Try” allows terminally ill patients to access experimental drug treatments that "have passed Phase 1 of the [FDA’s] approval process" (CNN) but have not yet passed through the subsequent rounds of trials needed to go to market.

When a new drug is developed, it must go through at least three phases of clinical trials, or in some cases, four. This process typically takes many years to complete. After the trials have concluded, there is another waiting period during which the drug receives final approval and is developed for commercial sale and widespread use. “Right to Try” authorizes patients who have been diagnosed with life ending illnesses to side-step this prolonged waiting period, so long as the drugs are under continual evaluation in phase II, III, and potentially IV trials. The Act also stipulates that patients need to have attempted other treatment options before opting to take unapproved medicines.

Opponents to the law are worried about the effects that providing such preliminary drugs could have on the FDA’s ability to manage public health concerns, as well as the safety of those patients who choose to use the early-stage medications.

Proponents of “Right to Try” argue that, while this new opportunity presents some risks, many patients’ lives could be saved, or their suffering alleviated, now that access to previously denied medications will be made available. Advocates also argue that Phase 1 passage “demonstrate[s a certain] level of safety” (FOX News) in any given drug, as it will have been already proven that the drug will not poison humans when given in a reasonable dose.

It is in the later phases of trials that a drug is proven effective or ineffective in treating specific indications without significant side effects – therein lies a risk of opting to take a drug not yet approved by the FDA.

The Act’s very name grants no rights to patients. It simply gives them permission to ask pharmaceutical companies to supply their “in development” medications to them. Pharmaceutical companies have no obligation to comply with such requests.

It is unclear what kind of effect this bill will have on the clinical trial industry, as it opens the door to previously uncharted waters for patients, sponsors and healthcare providers. Some say that “little will change,” (CBS News) but only time will tell.




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