President Trump Signs the Right to Try Act to Allow Terminally Ill Patients to More Easily Access Investigational New Drugs and Product

//President Trump Signs the Right to Try Act to Allow Terminally Ill Patients to More Easily Access Investigational New Drugs and Product

President Trump Signs the Right to Try Act to Allow Terminally Ill Patients to More Easily Access Investigational New Drugs and Product

On May 30, 2018 President Trump signed in to law S. 204, the “Right to Try Act,” to allow eligible patients with a life-threatening disease or condition to access experimental treatments that are not yet approved by the U.S. Food and Drug Administration (FDA). The Act establishes national standards and rules by which investigational new drugs may be provided to terminally ill patients and has the potential to result in the first kind of federal authorization for medical marijuana access and use in legal cannabis states.  

The purpose of the Act is to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with state law. Eligible patients must have a life-threatening disease or condition, exhaust approved treatment options and be unable to participate in clinical trials, and receive certification by a physician with patient consent. Notably, there are no specific conditions or illnesses enumerated for qualifying as a “life-threatening disease.” As a result, it is likely that these details will be promulgated on a state-by-state basis.

Eligible investigational drugs (EIDs) are those that: (i) have completed Phase 1 of a clinical trial; (ii) are not approved or licensed; (iii) have a pending New Drug Application (NDA) or that are being investigated in a clinical trial that: (a) will form the basis of approval or license of the drug;  or (b) is the subject of an active Investigational New Drug Application (IND) the purpose of which is to form the primary basis of a claim of effectiveness in support of the approval or licensure; and (iv) for which manufacturer or sponsor  production is still ongoing.

Although the Right to Try Act does not sanction state-authorized medical marijuana programs generally, nor does it provide eligible patients under the Act with access to such programs, eligible patients may now be able to access medical cannabis from investigational new drug trials such as the clinical trial currently being conducted by the Multidisciplinary Association of Psychedelic Sciences (MAPS), provided eligibility requirements for both the patient and the investigational new treatment are satisfied.  The MAPS trial for smoked cannabis in veterans with PTSD is in its second phase of the FDA approval process. Whether PTSD would qualify as a life-threatening condition for the Act has yet to be determined, but arguably satisfies the federally mandated criteria. In addition to cannabis, the Right to Try Act could also pave the way for eligible patients to access other controlled substances such as psilocybin and MDMA, which are also the subject of investigational new drug trials.

While the Federal Food Drug and Cosmetic Act (FFDCA) already includes a Compassionate Use Expanded Access Program which provides a pathway for certain patients to access investigational new products under specific limited conditions, the Right to Try Act removes many regulatory hurdles and FDA oversight which are currently required by the Compassionate Use Program.  

By: Courtney Barnes and Amber Lengacher

The post President Trump Signs the Right to Try Act to Allow Terminally Ill Patients to More Easily Access Investigational New Drugs and Product appeared first on Leafwire.

By | 2018-06-07T10:46:42+00:00 June 7th, 2018|Business|0 Comments