Physicians can apply for expanded access to an unapproved investigational drug for their patients to treat a serious or life-threatening disease or condition when there are no other comparable or satisfactory alternative treatment options.
Newly Implemented Expanded Access Principles Support Commitment to Patients.
Biopharmaceutical companies are committed to helping patients gain access to the best possible care, and its researchers are constantly looking for ways to provide more therapeutic options for patients. Clinical trials are one of the primary ways that patients can gain access to investigational medicines before they are approved by the FDA and made available to patients more broadly.
This week, a new chapter of PhRMA’s Principles on the Conduct of Clinical Trials and Communication of Clinical Trial Results goes into effect to facilitate awareness of expanded access programs, which provide investigational medicines for certain patients who are ineligible or unable to participate in a clinical trial. Originally introduced in December of 2014, the Principles on Expanded Access to Investigational Drugs reinforce PhRMA and our members’ commitment to the unmet medical needs and safety of patients.
Physicians can apply for expanded access to an unapproved investigational drug for their patients to treat a serious or life-threatening disease or condition when there are no other comparable or satisfactory alternative treatment options. It is important for the patient’s physician and the medical staff at a biopharmaceutical company to discuss whether it provides the best possible treatment option for the patient before going through the FDA process.
Through these new Principles, PhRMA affirms its commitment to working with all stakeholders to determine ways to help accelerate access to new medicines for the patients who most need them.
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