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Innovative Treatment Approach Offers New Hope For Eczema Sufferers With Moderate To Severe Disease
Today sees the European launch of the first topical calcineurin inhibitor to be approved for the maintenance treatment of eczema to prevent flares and prolong flare-free intervals. PROTOPIC ointment (tacrolimus monohydrate) is already licensed to treat moderate and severe eczema (atopic dermatitis), often involving the treatment of flares as and when they occur.* It is now also approved for twice-weekly application to previously affected skin to prevent these exacerbations and prolong flare-free periods in PROTOPIC-responsive patients.ò€  Clinical studies have shown that this new approach brings significant benefits with over 40% of patients with moderate to severe eczema remaining flare-free for at least a year.1 Flares are known to place an enormous burden on patients. The International Study of Life with Atopic Eczema (ISOLATE) found that about 55% of these patients worried about the onset of their next exacerbation and that they spent on average over a third of the year (136 days) with their eczema in flare.2
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NCPA To Congress: Health Reform Should Empower Community Pharmacies To Improve Patient Outcomes, Reduce Costs
National Community Pharmacists Association (NCPA) Executive Vice President and CEO, Bruce T. Roberts, RPh testified today before the U.S. House Energy and Commerce Subcommittee on Health, offering four different recommendations to strengthen a health care reform proposal currently working its way through Congress.
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White House Budget Chief Says Issue Of Abortion Coverage In Health Reform Still Under Debate
In an appearance on "Fox News Sunday," White House Office of Management and Budget Director Peter Orszag said that he is "not prepared to say explicitly" whether health care reform legislation would prohibit the use of federal tax revenue to fund abortion coverage, the New York Times reports. Orszag"s statement came in reply to a question asking whether he was prepared to say that "no taxpayer money will go to pay for abortions." Orszag said, "It"s obviously a controversial issue, and it"s one of the questions that is playing out in the debate" (Pear/Liptak, New York Times, 7/20).Sen. Judd Gregg (R-N.H.), who also appeared on "Fox News Sunday," said, "No matter what your views are on abortion, you shouldn"t ask people to use their tax dollars if they think that abortion is taking a life." Gregg added, "I would hate to see the health care debate go down over that issue. We do really need health care reform, and it has to be substantive. ... So hopefully we won"t get ourselves wrapped around the wheel of abortion in this debate" (FoxNews.com, 7/19). According to the Times, there is an ongoing behind-the-scenes debate over handling abortion coverage in health overhaul legislation. The debate affects both the public insurance plan the legislation would create and private insurers, who would receive tens of billions of dollars in federal subsidies to expand coverage for low- and moderate-income U.S. residents. A provision in the House health reform bill (HR 3200) calls for a federal advisory committee to advise the HHS secretary on an "essential benefits package" that most insurers would be required to provide. Abortion-rights opponents want abortion coverage excluded from the package, while abortion-rights advocates say the decision should be left to medical professionals. House committees working on health reform legislation have rejected Republican amendments that would have restricted abortion coverage. The Hyde Amendment, first enacted in 1976, prohibits the use of federal Medicaid money for abortion services. However, abortion-rights opponents argue that federally subsidized coverage of the uninsured would not be subject to the existing restrictions. The National Right to Life Committee issued an analysis of the House bill, stating, "There is no doubt that coverage of abortion will be mandated, unless Congress explicitly excludes abortion from the scope of federal authority to define "essential benefits."" According to the group, even if the HHS secretary did not require abortion coverage, "federal courts would interpret the broadly worded mandatory categories of coverage to include abortion" (New York Times, 7/20).
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National Organization for Rare Disorders (NORD) Sponsors Rare Disease Summit

A shortage of new pharmaceutical products in the pipeline-combined with new scientific tools-has created a climate of opportunity for the rare disease community, a senior Food and Drug Administration (FDA) official said at a conference hosted by the National Organization for Rare Disorders (NORD). "The blockbuster model is no longer viable," said Janet Woodcock, MD, director of the Center for Drug Evaluation and Research at FDA. As a result, she said, companies are more willing to consider new options, including more products for rare diseases. Former National Human Genome Research Institute Director Francis Collins, MD, PhD, agreed, adding that it"s time to "de-risk" orphan drug development, making it a more viable business model for companies. Collins and Woodcock were among several speakers at a "Partners in Progress Summit" hosted by NORD in Washington, DC. NORD represents the nearly 30 million Americans who have rare diseases, or ones affecting fewer than 200,000 people. Peter L. Saltonstall, NORD"s president and CEO, noted that most rare diseases have no FDA-approved treatment and many patients are denied insurance for unapproved treatments. NORD sponsored the summit, he said, to develop a policy agenda for action to spur development of new therapies and ensure that patients have access to them. Former FDA Commissioner David Kessler, MD, moderated the event. Speakers included thought leaders in government and industry working with rare diseases and orphan products. A theme articulated by several speakers was that now is the time for rare disease patients and researchers to press their case. "The healthcare system we know today is going to be completely transformed over the next 12 months," said Tommy Thompson, former governor of Wisconsin and former Secretary of Health and Human Services. "Now is the time for action." NORD Board of Directors Vice Chairman Frank Sasinowski announced the formation of a Rare Disease Congressional Caucus to seek creative solutions to problems faced by patients and to serve as a forum for discussion of issues related to access, research, and increased innovation. The Caucus will also seek to increase funding for two government agencies-the National Institutes of Health Office of Rare Diseases Research and the FDA Office of Orphan Products Development. In addition, it will address regulatory issues facing the pharmaceutical, biotechnology, and medical device industries, Sasinowski said. Social Security Commissioner Michael Astrue described efforts to expedite the process of applying for Social Security disability assistance for people with severely disabling rare diseases. Under Commissioner Astrue, the Social Security Administration last fall launched a new "Compassionate Allowances" initiative to reduce problems encountered by people with certain severe diseases when they apply for assistance. Presentations from the Partners in Progress Summit will be posted soon on the NORD website at http://www.rarediseases.org. National Organization for Rare Disorders (NORD)


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