Key Take Away:
This webinar will provide an overview of the federal and state laws that are designed to allow terminally ill patients access to investigational products.
The webinar will review the legal framework of FDA’s expanded access regulations and the recent initiative to pass ‘Right to Try’ laws at the state level, which are designed to allow patients access to investigational treatments without the need for FDA approval.
The webinar will provide the historical context of challenges to FDA’s authority to regulate access to investigational drugs by seriously ill patients who do not qualify for an ongoing clinical and for whom there is no approved therapy, and the ensuing development of the ‘Right to Try’ initiative.
An update on the number of states that have passed ‘Right to Try’ laws will be provided and the similarities and differences between the various state laws will be reviewed.
The webinar will explore legal tension between the FDA regulations and the state ‘Right to Try’ laws, and the latest efforts to pass a National ‘Right to Try’ Law.
Why Should You Attend:
Personal autonomy is at the heart of the tension between the FDA’s expanded access regulations and the ‘Right to Try’ initiative.
FDA’s expanded access regulations seek to provide seriously ill patients with access to investigational new drugs in a manner that is designed to ensure the potential benefit to the individual patient justifies the potential risks posed by the use of the investigational drug outside the context of an ongoing clinical trial and which preserves the integrity of the clinical trial system for the development of new drugs.
But for seriously ill patients, the prospect of trying to comply with government regulations while fighting to save their lives can be viewed as an unreasonable burden established by an over reaching and paternalistic government. Clinicians, hospitals, and institutional review boards (IRBs) need to understand both the federal and state laws and the tension between them, so they are prepared to address requests from seriously ill patients for access to investigational drugs. Members of the pharmaceutical industry need to understand the potential legal, business, and financial risks of providing, or not providing, access to their investigational drugs to an individual patient.
Areas Covered In This Webinar:
The webinar will review FDA’s current legal framework for providing seriously ill patients access to investigational new drugs outside the context of an ongoing clinical trial. The legal challenges to FDA’s authority will be reviewed.
The advent of the recent ‘Right to Try’ initiative to pass state laws providing patients access to investigational drugs without FDA oversight will be discussed. An update on the number of states that have passed ‘Right To Try’ laws will be provided along with an analysis of the similarities and differences in the individual state laws.
The implications for companies in providing access to their investigational products will be outlined and will include a review of the policy considerations that must be made in determining whether to provide access to an investigational product outside the context of a clinical trial.
The impact and implications of the use of broadcast and social media by individuals seeking access to an investigational drug on companies and FDA will be reviewed.
Understanding FDA’s current legal framework for gaining access to investigational drugs outside the context of a clinical trial and the advent of state laws designed to remove FDA from the process
To understand the implications for members of the pharmaceutical industry in responding to individual requests for access to their investigational products
Explore the policy considerations involved in developing a legal framework for providing individuals access to investigational products outside the context of the clinical trials
Executives in the Pharmaceutical Industry
Institutional Review Boards
Kate Duffy Mazan
Kate Duffy Mazan is an attorney in private practice in McLean, VA. She is the founding member of The Clinical Technology Transfer Group (CTTG). CTTG is a law firm concentrating in technology transfer and regulatory compliance in the clinical setting.
Kate has extensive experience in the negotiation of Cooperative Research and Development Agreements (CRADAs). Prior to entering private practice, Kate worked for nine years at the National Cancer Institute (NCI) within the National Institutes of Health. As a technology transfer professional at NIH she managed the intellectual property portfolio of NCI’s Natural Products Branch, negotiating CRADAs and international agreements with countries in Africa, Central and South America, and the Pacific rim.
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