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FDA Establishes New Rules For Experimental Drugs
The U. S. Food and Drug Administration (FDA) has established two new regulations that are geared toward increasing access to experimental drugs for patients who have life-threatening conditions and have already utilized all other available treatment options.
The new rules have been posted to the FDA Web site, www.fda.gov, and focus on the fact that many individuals who might benefit from experimental drugs may not qualify for the trials that are being conducted for those drugs. While the FDA has permitted access to experimental drugs since the 1970s, the new rules assist with defining and facilitating expanded-access programs.
The expanded-access programs allow the FDA to review and authorize requests from patients to utilize an experimental drug even though they did not qualify for a related clinical trial program. Anothersignificant change in the regulation is the provision which permits drug companies and researchers to now charge patients who are taking the experimental drug; typically the trials cover the drug costs.
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Keeping Current
Your source of information about the Keenan Pharmacy Purchasing Coalition (KPPC). In this and upcoming issues, we will be providing you with:
- solutions for improving pharmacy benefit performance
- items that may be of interest to your employees to pass along
- information on trends and innovations in pharmacy benefits
We hope you enjoy Keeping Current and we invite you to send us your comments and suggestions on what you'd like to see. You can reach us at kppc@keenan.com
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Contact:
Keenan & Associates
P.O. Box 4328
Torrance, CA 90510
800.654.8109
www.keenan.com
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