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The following was received 12/23/2009 @ 1 PM EST along with a 10-PAGE PDF RESPONSE.
Click here to download the PDF.
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Dear Fabio and the FDASM Community,
Thank you for submitting your questions. We found them to be useful in identifying general issues for policy development. However, please note that we are unable to provide additional comments on some of the questions in this forum as we need to adhere to FDA's Good Guidance Practices (GGP's).
FDA welcomes research, data, and comments from its stakeholders and the public on any current issues related to Internet and social media promotion and adverse event reporting of FDA-regulated medical products and encourages submissions of written and electronic comments to this docket, which closes on February 28, 2010. We are committed to getting the best information as possible in helping inform our policy. Once the docket closes and we review all the comments, we will be able to determine next steps.
Again, we appreciate your continue support of this important endeavor, which we believe will aid FDA in achieving its objective of ensuring that consumers and healthcare professionals have access to accurate, balanced, and timely information about medical products.
Kind regards,
Thomas Abrams, Director, Division of Drug Marketing, Advertising, and Communications (DDMAC)
Kristin Davis, Deputy Director, DDMAC
Mark Askine, Associate Director, DDMAC
Jean-Ah Kang, Special Assitant to the Director, DDMAC
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Written by Jaimy Lee
December 10 2009
Source: PR Week
Media reports are questioning a coalition of health insurance trade groups that is offering Facebook users "virtual currency" if they send letters protesting healthcare legislation to members of Congress.
"Virtual currency" can be used to purchase virtual products in social networking games like Mafia Wars.
The Get Health Reform Right coalition includes America's Health Insurance Plans, the BlueCross BlueShield Association, the Healthcare Leadership Council, and the National Retail Association.
Privacy-enhanced search technology addresses privacy concerns to increase patient participation
Source:Pfizer Media Room
Published on August 19, 2009
NEW YORK--(BUSINESS WIRE)--Recognizing that patient participation in clinical trials is the key to progress in medical research, Pfizer Inc announced today that it has entered into a collaboration with Private Access, the innovator in privacy-enhanced search technology, to create a new online community aimed at increasing clinical trial awareness and participation. The site will be the first to focus on patient privacy rights to connect patients, physicians and researchers with tailored information, tools and technology that will lead to more informed decisions about patient care, including clinical trial participation industry-wide.
Pfizer’s collaboration with Private Access will help address patients’ and physicians’ top concerns regarding research and clinical trials. The companies will work toward reducing the time needed to develop new and improved treatments by making it possible for researchers and investigators -- based on express private access rights granted by the patient -- to conduct more focused searches for clinical trial candidates.
Private Access’ patented technology allows patients to control to whom, and for what purposes, they grant access to see all or selected portions of their personal health information. By granting “private access” only to researchers focused on the conditions that interest them, patients can be more quickly and precisely matched to appropriate clinical trials while simultaneously protecting their confidential personal health information.
Nearly 85 percent of patients in a recent survey stated they were unaware that clinical trials were a possible treatment option, and 31 percent of physicians surveyed did not refer patients to trials due to, among other things, lack of information. According to a study commissioned by the Institute of Medicine (IOM), the number one reason patients who were aware of trials were not willing to participate was fear that their health information would not remain confidential.
“Many patients who could benefit from participation in clinical trials don’t enroll in them because they are not aware that potentially relevant research is under way or they cannot find a specific trial to meet their needs; others worry that they will lose control of their health information,” said Freda Lewis-Hall, M.D., Pfizer’s chief medical officer. “With unprecedented collaboration among key groups, Pfizer and Private Access believe we can build the preeminent online clinical trial community to be used industry-wide to share knowledge while giving patients the confidence and control to share their health information.”
The costs to find and enroll patients into clinical trials more than doubled between 2000 and 2005, and continue to climb. With study protocols becoming more complex, the number of clinical research studies increasing to more than 35,000 and patient participation in clinical trials declining, effective patient recruitment is a critical factor in successfully bringing new treatments to patients.
“A privacy-enhanced search engine for personal health information enables patients to simultaneously address their privacy concerns and improve access to care,” said Robert Shelton, founder and CEO of Private Access. “It is great that the Internet can be used today to find publicly available information for free in seconds or to locate potential employees for a small fee in minutes, yet it still takes months or years and often thousands of dollars per patient to locate individuals for clinical trials that might save or improve lives.
“By introducing technology that honors each patient’s privacy needs, we can leverage the efficiency of Internet-based search for clinical trial patients – speeding up the recruitment process and the discovery of new treatments,” Mr. Shelton continued.
Pfizer and Private Access will work together to bring a wide range of partners to the online community, including additional clinical trial sponsors, patient advocacy groups, technology providers, and other key public and private stakeholders. The portal will also encourage social networking on the clinical trial experience. The new platform and online community will be rolled out in phases, starting in late 2009.
"Patients are the most important stakeholders in medical research. By merging respect for their privacy with access to relevant and actionable medical information, we are giving patients more control over their destinies," said Greg Simon, senior vice president for worldwide policy at Pfizer. "This collaboration has the potential to accelerate medical progress by putting patients' needs front and center."
About Private Access, Inc.
Private Access, Inc. is making it safe for sensitive personal information such as medical records to be accessible over the Internet. We accomplish this with technology that allows each person to grant private access to all or selected parts of their confidential personal information to doctors, family members, researchers and others based on their particular needs and interests. Our people and technology platform, as well as the applications we build, are all dedicated to empowering individuals to improve the care they receive, accelerate the discovery of new treatments for diseases and chronic illnesses that affect them or others they care about, and reduce health care costs for their families and the nation. Founded in late 2006 upon issuance of its core patent, Private Access is headquartered in Irvine, California.
Pfizer Inc: Working together for a healthier world™
Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with health care providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.
Mobile Phone Technology May Address Unmet Needs of Parents of Children With Diabetes, Sending Blood Sugar Readings Via Text, to Help Manage Child's Illness
According to new study conducted by the Center for Connected Health, parents most concerned about access to their child's healthcare provider
Source: Pr Newswire
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Extracted from Day 2 (Nov 13, 2009) transcript of part 15 Public Hearing "PROMOTION OF FDA-REGULATED MEDICAL PRODUCTS USING THE INTERNET AND SOCIAL MEDIA TOOLS"
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