Raise Your Voice: Letters

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Your article provided lots of great insight from pharmaceutical industry leaders about their individual quests to achieve a return on their investments in IT solutions. It is quite clear that the industry will continue to embrace IT solutions that address key priorities like accel erating and enhancing R&D efforts, increas ing the sales pipeline, and fostering better relationships with physicians and providers. One of the issues that is going to “rock” the healthcare industry is HIPAA, particularly the physicians and providers that deliver the care, as well as the retail pharmacies. This is very much an IT issue. Physicians and providers will need to achieve compliance before the end of 2002, or they will face strict penalties, and none of the contributors to the article shed light on how they plan to assist physicians and providers with tacking the complexities and challenges of HIPAA compliance. Perhaps some of their IT investments should be focused in this area to help their customers and supply chain partici pants to achieve HIPAA compliance? Recently, it was made public that a major pharmaceutical company inadvertently released the emails of more than 600 patients taking an antidepres sant medication. By exposing the names of the subscribing users, people are able to trace their real names and other private information about them, including medical history. The Federal Trade Commission is now in the process of investigating the pharmaceutical company’s Internet privacy policy. When it comes to IT, security and privacy are paramount priorities and I’m curious to hear everyone’s perspective on the HIPAA subject and how they plan to utilize IT solutions to address it. Andrew Weissberg VP OF BUSINESS DEVELOPMENT AND CHIEF TECHNOLOGY OFFICER CPRI COMMUNICATIONS Medical Privacy: At What Cost? I am concerned that HIPAA, the Health Insurance Portability and Accountability Act, with all of its costcreating complexity, does not seem to address the real fact that there are occassions — for example, clinical trials — where a significant majority of patients may not even know what their options are for addressing their illnesses. Preventing the free exchange of data in such circumstances, as HIPAA does, effective ly robs patients of knowledge that could ben efit their decisionmaking process. John Hollway CHIEF PRIVACY OFFICER AND SENIOR VP OF MARKETING ACURIAN INC. Interest is Up Just got my copy of PharmaVoice and I have to say, each issue is getting better and better. The November/December issue really looks great! I see some interesting and provocative things popping up. Beth Porteous VP, CORPORATE COMMUNICATIONS COMMONHEALTH LETTERS Information Technology: Privacy an Issue I’m curious to hear everyone’s perspective on the HIPAA subject and how they plan to utilize IT solutions to address it. — Andrew Weissberg Should the FDA collect special user fees from pharmaceutical manufacturers to analyze and disseminate data regarding the reallife performance of new drugs and biologics after they are released into the general population? Special fees are currently collected only for the purpose of supporting an infrastructure within FDA to speed the drug approval process. The legislation authorizing the collection of these fees, known as the Prescription User Fee Drug Act (PDUFA), is set to expire at the end of September 2002. According to some industry experts, the impact of this improved process is most assuredly a boon for U.S. citizens, but at the same time it requires that the pharmaceutical industry perform greater surveillance once those drugs are in nonclinical trial use. Should postmarket surveillance continue to be an essential pro grammatic function for the FDA? Or should the industry become its own watchdog? Judith A. Cahill, executive director of the Academy of Managed Care Pharmacy, provides four proposals: A new user fee imposed on manufacturers to be added to PDUFA for the purpose of postmarket surveillance; an aggressive educational cam paign targeted at providers stressing the importance of reporting adverse drug effects; an audit of current notifi cation systems; and, finally, consideration of an alterna tive: the creation of a new, separate agency to focus on postmarket surveillance. WHAT’SYOUR OPINION? Please email your comments to feedback@pharmalinx.com. What’s Your Opinion? 6 J a n u a r y / F e b r u a r y 20 0 2 PharmaVOICE

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