I am Chelsea Kidd, Legislative Liaison for the National Patient Advocate Foundation, and a breast cancer survivor. On behalf of NPAF, I would like to thank you, all, for allowing us to share our views with you on patient use investigational drugs. NPAF is an organization that seeks, through policy and legislative reform, to ensure individuals access to health care. Our advocacy activities are influenced by the information that we receive through the counseling and case management activities of our companion organization, the Patient Advocate Foundation. The Patient Advocate Foundation is a national, non-profit organization that serves as an active liaison between the patients and their insurers, employers, and health care providers to resolve matters related to access to health care. PAF uses the services of professional case managers and attorneys to guarantee that those with serious and life-threatening illnesses, including cancer, receive the care they need. The need for our services is great. In 1999, PAF handled over 29,000 patient calls, and we have on more than one occasion been called upon to assist patients in securing access to investigational drugs. We strongly support the expanded access provision that was included in the Food and Drug Administration Modernization Act of 1997, and recommend that implementation of that provision be made as simple and straightforward as possible. We would like to comment on the basic requirements that must be met before a patient may receive an investigational drug. FDAMA specifies that the patient's physician has to determine that there is no comparable or satisfactory alternative therapy to the investigational drug the patient seeks. In the case of those who are seeking access to an unapproved drug, decisions about the availability of an alternative therapy should be made by a specialist who is properly trained to offer such an opinion. Under the statute, the FDA is required to determine that there is sufficient evidence of safety and efficacy to support the use of the investigational drug. We recommend that this determination should include a consideration of the professional qualifications of the individual's physician, including his or her training to assess the availability of alternatives to the investigational drug. Under FDAMA, the agency is also charged with determining that provision of the investigational drug does not undermine the ongoing clinical investigation. We agree that efforts must be made to ensure that clinical trials are not disrupted and that clinical research enterprise is not hindered in any way. On occasion, our clients need individual access to investigational drugs, however, all of our clients benefit from the clinical research that leads to improvements in medical care. NPAF believes that the agency, relying upon the expert advice of medical specialists, can balance the sometimes competing needs of the individual patient and the need to ensure clinical research is not interrupted. We would like to thank you again for providing this forum for consideration of an issue of great importance to our organization and many others representing those with cancer and other serious and life-threatening diseases. Thank you for the opportunity to address the committee. Remember we are NOT Doctors and have NO medical training. This site is like an Encylopedia - there are many pages, many links on many topics. Support our work with any size DONATION - see left side of any page - for how to donate. You can help raise awareness of CAM.