MessageFrom: Cunningham, Rose E Sent: Tuesday, October 25, 2005 9:22 AM To: 'Brad Bednarz'; Dockets, FDA Subject: Testifying at Nov. 1 DTC Mtg - Docket 2005N-0354 Mr. Bednarz, I am terribly sorry, but we cannot add you to the list of speakers. The registration to speak at the DTC Part 15 Hearing closed on October 11, 2005. We have had others request to speak after that date that we had to turn down also. Please remember that although you will not be allowed to testify, the docket remains open until the end of February and you can submit any information you would like FDA to consider to docket number 2005N-0354. We will be looking carefully at all information received, whether it is in the form of written comment to the docket or oral presentation at the meeting. Since you are registered to attend the meeting, I will put your name on a list of people interested in speaking if there is time to take comments from the floor. Since there are 40 people testifying, the schedule is very full and there may not be time to take comments from the floor. If there is time for comments from the floor, the time will be limited to under 2 minutes each - depending on the number of people and time available. Once again, I am terrible sorry that we cannot accommodate your request. Rose Cunningham Regulatory Health Project Manager Executive Operations Staff Office of Executive Programs Center for Drug Evaluation and Research 301-443-5595 -----Original Message----- From: Brad Bednarz [mailto:bednarz@dlife.com] Sent: Monday, October 24, 2005 5:44 PM To: fdadockets@oc.fda.gov; cunninghamr@cder.fda.gov Subject: Re: Testifying at Nov. 1 DTC Mtg Dear Sirs and Madam, I am requesting permission to testify at the upcoming CDER Meeting: Public Hearing on Direct-to-Consumer Promotion of Medical Products on November 1 and 2, 2005. Currently I am registered as an attendee: FDA Registration Number: EAPE-188 and wish to register as a presenter to provide pertinent testimony on Direct To Consumer Advertising. As Background My company, LifeMed Media has built a community of individuals and their families who suffer from diabetes. We have accumulated a significant body of evidence that DTC advertising benefits patients. We reach over 2.5 million diabetic households. We have created of a network of media channels and a membership dedicated to improving the lives of diabetic patients. Our objective is to provide our members with health and wellness information – including drug and medical device information - that helps them cope and successfully manage their disease. We provide drug information and advertising through our network of communication channels: dLifeTV, the first weekly diabetes TV Show (airing on CNBC with 430,000 viewers per week); a web site, dLife.com that provides medical and emotional support for 280,000 individuals per month; a nationwide diabetes radio program to educate patients to new diabetes information; a membership roster with over 60,000 people suffering from diabetes; and a direct mail educational newsletter program reaching 2.5 million diabetes households. Reason for Testifying We have gathered a large body of information showing how DTC advertising can have a positive effect on patients. Our objective in testifying is to demonstrate that under proper circumstances, providing timely and objective drug and medical device information can be of enormous benefit to patients. Through targeted niche media directed at the patient, drug and device information can be successfully disseminated quickly and safely becoming an essential part of a patient’s treatment. We have accumulated a large body of evidence that shows where this has worked and this information will be the core of our testimony. We believe that by sharing this information with the FDA, it will provide the perspective of a successful approach to the dissemination of drug and device information through targeted Direct To Patient advertising as well as patient education. My information is as follows: Bradley Bednarz Executive Vice President LifeMed Media Company 101 Franklin Street Westport, CT 06880 Ph: 203-221-3449 Fax: 203-454-6975 E-mail: Bednarz@dLife.com Please let us know if we can be put on the Docket to testify. Cordially, Brad Bednarz Bradley Bednarz Executive Vice President LifeMed Media Company 101 Franklin Street Westport, CT 06880 Ph: 203-221-3449 Fax: 203-454-6986 Watch dLifeTV - Sunday night, 7:00 PM, CNBC The information contained in this transmission is for the sole use of the intended recipient(s) and may contain confidential and privileged information. Any unauthorized review, use, disclosure or distribution of this communication is strictly prohibited. If you have received this e-mail in error, please contact the sender by reply e-mail and destroy all paper and electronic copies of the original message.