LAUSR

e18172 Background: Desperately ill patients who have exhausted treatment options often seek access to therapy through investigational therapies. Participation in a clinical trial may be one option. When a clinical trial is not an option, physicians and patients are left with Expanded Access (EA), and Right to Try (RTT). The 21st Century Cures legislation requires pharmaceutical manufacturers to make information on their EA policy, contact information, and response time readily accessible. RTT became law in 2018, and this path is rarely an option. Methods: To determine best practice in the age of changing legislation of pre-approval access to investigational drugs, we compared pathways by which pharmaceutical companies are providing access to investigational medications. Data has been gathered on presentation of policy, intake of expanded access requests, and education to the public on the company’s internal pathway to access. We conducted a survey of the top 100 Pharma companies to assess compliance with regulations, policy availability, and RTT information. Results: The data has shown that companies show a range of compliance in expanded access. Many companies have published all required aspects outlined in the legislation to be fully adherent to the guidelines with additional education and guidelines for patients and physicians. Others have provided the minimum requirement to be compliant: a policy and contact information. We also see companies that have not established a stance of process in expanded access and therefore provide no public facing information on their policy and pathways toward treatment. Information on RTT remained elusive. Conclusions: While RTT is increasingly requested as a possible path, the mechanism to request RTT remains a barrier and source of confusion to physicians and patients. Companies should take the opportunity to clearly define their policy and process for Expanded Access as well as reevaluate the organization of their current procedure to ensure highest efficiency and full compliance with legislation.