New FDA rule should make experimental drugs more widely available


The FDA just made it easier for patients to get access to investigational drugs outside of clinical trials. For patients who are not eligible for clinical trials and who don't have other treatment options, the agency released updated regulations today that are meant to broaden and clarify how to get an experimental drug.Here's a snapshot from the FDA: "The final rule establishes eligibility criteria, submission requirements, and safeguards for the expanded access use of investigational drugs by individual patients, including in emergencies; intermediate-size patient populations; and larger populations under a treatment protocol or treatment IND. The proposal is also intended to increase public knowledge and awareness of expanded access and, thus, to make investigational drugs more widely available. In addition, by establishing clear eligibility criteria and submission requirements, the final rule will ease administrative burdens on physicians seeking investigational drugs for their patients and on sponsors who are willing to make promising unapproved therapies available for treatment use."A second rule will allow drug makers to charge patients for investigational drugs obtained through an expanded access program. Direct costs only, though. The drug company would not be allowed to make a profit.Douglas W. Blayney, MD, president of the American Society of Clinical Oncology, said in a statement that ASCO will be developing tools to ensure that oncologists understand the new rules and can help their patients benefit.The expanded access and charging rules take effect on October 12. Get all the details on the FDA's website. And check out information for patients on the agency's consumer page.

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