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FDA Issues Advertising Guidelines On Product Risk Information
FDA on Tuesday posted on its Web site advertising guidelines for drugmakers and medical device manufacturers, offering suggestions on how to present risk information to health care professionals and consumers, the Wall Street Journal reports. Agency officials said the industry had asked for guidance on how to comply with its rules, which require a balanced presentation of a product"s risk and effectiveness. Exclusion or minimization of risk information is the most commonly cited violation each year in FDA-issued warnings or enforcement letters. The new guidelines include detailed information on how aspects such as font, types of contrast and white space in print materials can appropriately present risk information. According to the Journal, the 24-page document is not binding. FDA will accept public comments for 90 days prior to issuing final guidelines (Corbett Dooren, Wall Street Journal, 5/27).
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Olanzapine Long-Acting Injection (LAI) Efficacy And Safety Data Presented At American Psychiatric Association Annual Meeting
Eli Lilly and Company presented data on the short- and long-term efficacy and safety of olanzapine long-acting injection (LAI) in the treatment of adults with schizophrenia or schizoaffective disorder. Olanzapine LAI is an investigational formulation that combines the atypical antipsychotic Zyprexa(R) (olanzapine) with pamoic acid, allowing for the sustained delivery of olanzapine for up to four weeks.
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Pfizer To Give Away 70 Of Its Most Widely Prescribed Drugs To Those Who Lost Jobs
Pfizer on Thursday announced a new program that would provide some of its existing customers access to more than 70 types of medications at no cost if they have recently been laid off or lost their prescription drug coverage, USA Today reports. The program -- called MAINTAIN, or Medicines Assistance for Those who Are in Need -- will begin July 1. To receive the drugs, individuals must show that they have been unemployed since Jan. 1 and that they no longer have prescription drug insurance. They also must prove that they cannot pay for their medications and that they were taking a medication listed under the program for at least three months prior to losing their jobs. Those who meet the eligibility requirements would receive their medications at no cost for up to one year, or until they have insurance coverage. Pfizer will accept applications through Dec. 31 (Petrecca, USA Today, 5/15).According to the AP/Detroit News, medications listed for the new patient drug-assistance program include some of Pfizer"s "top money makers," such as the anti-cholesterol drug Lipitor, the painkiller Celebrex, the fibromyalgia treatment Lyrica and the impotency treatment Viagra (Johnson, AP/Detroit News, 5/14).Ray Kerins, a spokesperson for Pfizer, declined to reveal how much the program would cost the pharmaceutical company or how many potential customers might benefit from it (Bloomberg/Miami Herald, 5/15).According to the AP/News, the program "could earn Pfizer some goodwill" after "long being a target of critics of drug industry prices and sales practices" (AP/Detroit News, 5/14). Scott Morgan, president of ad agency Brunner, said, "It goes beyond goodwill. There"s definitely a marketing strategy behind this about defending against generics and maintaining your consumer base. ... It"s a pretty savvy move" (USA Today, 5/15).
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Health Information Technology Lobby Group Rallies Support For Certification Group; Critics Question Group's Ties

The Healthcare Information and Management Systems Society has asked HHS to give the Certification Commission for Healthcare Information Technology authorization to determine which electronic health records systems can receive funding from the economic stimulus package, the Washington Post reports. In a letter dated April 27 to HHS officials, HIMSS officials wrote, "To ensure continuity, recognize CCHIT as the certifying body" of EHRs.Some health care industry officials have raised issue with giving CCHIT the responsibility of certifying EHR products because of the commission"s associations with various IT and health care companies, the Post reports. CCHIT has ties with HIMSS, which played a role in its inception in 2004 and is now managed by Mark Leavitt, the former chief medical officer of HIMSS. In 2005, the commission received a three-year, $7.5 million contract from HHS.According the Post, Internal Revenue Service tax documents show that HIMSS technically paid Leavitt"s salary through 2008, which was reimbursed by CCHIT. However, Leavitt said he is accountable only to CCHIT"s board members and he "was not supervised by HIMSS." He said he expects CCHIT will be "the body or one of several certifying bodies that are recognized" by HHS in part because it already is tasked with certifying health IT products. According to Leavitt, some of the commission"s critics are IT vendors who have failed to meet CCHIT"s standards. The Post reports that the provision in the stimulus package that requires health care providers to demonstrate "meaningful use" of health IT has become an issue because federal officials, IT systems vendors, and physicians and patient advocates have not been able to reach a consensus on the definition of meaningful use. Under the provision, providers must demonstrate meaningful use of health IT in order to receive Medicare and Medicaid incentive payments for adopting the technology (O"Harrow, Washington Post, 5/21). Blumenthal In related news, National Coordinator for Health IT David Blumenthal on Wednesday at a Brookings Institution seminar said the incentive payment and financial assistance provisions in the stimulus package will play a "critical" role in the success of health IT adoption, CQ HealthBeat reports. Blumenthal said, "If we can show physicians and hospitals that they can be better at their basic work with this technology than they could ever be without it, if we can show the value that it provides day in and day out in the provision of patient care, if we can show that same thing to the American public, then I think the money will be a sweetener but not a determinant of adoption" (Reichard, CQ HealthBeat, 5/20). Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation. © 2009 Advisory Board Company and Kaiser Family Foundation. All rights reserved.


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