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House Panel Passes Protection For Drug Makers
The House Energy and Commerce Committee passed an amendment to their broad health reform bill giving drug makers 12 years of exclusive rights to market new biologic drugs, "a setback" to the administration and consumer advocates who hoped to make generic drugs more widely available, the Wall Street Journal reports. The panel voted 47-11 on the measure, which "would also allow "evergreening," the practice by pharmaceutical companies of making minimal adjustments to their drugs, such as creating extended-release versions, as a way to lengthen their monopoly."

BSD Receives FDA Humanitarian Use Designation For The BSD-2000 Hyperthermia System
BSD Medical Corporation (NASDAQ:BSDM) announced that the U.S. Food and Drug Administration (FDA) has granted Humanitarian Use Device (HUD) designation for the company"s BSD-2000 Hyperthermia System for use in conjunction with radiation therapy for the treatment of cervical carcinoma patients who are ineligible for chemotherapy. This is the first of the two steps required to obtain Humanitarian Device Exemption (HDE) marketing approval, which requires BSD Medical to demonstrate the device"s safety and probable benefit in treating a disease or condition that affects fewer than 4,000 individuals in the United States per year. Now that FDA has granted the Humanitarian Use Designation for the BSD-2000, which confirms that the intended use population is fewer than 4,000 patients per year, BSD can file an HDE submission with the FDA. FDA has 75 days from the date of receipt of the HDE submission to grant or deny an HDE application. This period includes a 30-day filing period during which FDA determines whether the HDE application is sufficiently complete to permit substantive review. During this review, FDA may refine the indications for use which received HUD designation to finalize the indications for use for which HDE approval will be granted. This decision will be based on the data that are available to support the device"s HDE application. The company believes that the data previously submitted to FDA and reviewed by the agency in the company"s pending PMA application can be used to support the HDE approval, and that this previous review may expedite marketing approval for the BSD-2000.
News of the day
Blogs Comment On Tiller's Death, Sotomayor, Other Topics
The following summarizes selected women"s health-related blog entries.~ "Dr. Tiller -- A Gynecological Superhero," Frances Irwin, Below the Waist: Kansas abortion provider George Tiller, who was shot to death on Sunday, was "a superhero" who "never failed to serve his patients regardless of the level of property damage, physical injury and intimidation he was subjected to as a result of his service," Irwin, who works for a Wisconsin-based family planning agency, writes. Irwin notes that, for nearly a year, the clinic she works at has been targeted by "pro-life" demonstrators. At various points they"ve carried signs reading, "Family planners promote child promiscuity," "Stop ALL Abortion," "Birth Control Leads to Abortion," and that new signs mention her by name. In the wake of Tiller"s death, Irwin writes that she "realize[s] that I could be intentionally injured by someone who opposes my work." She concludes, "To some extent allowing myself to worry about this feels like cowardice because Dr. Tiller was a superhero. And that"s a lot to aspire to" (Irwin, Below the Waist, 6/4).~ "Let"s Make an Abortion Deal," William Saletan, Slate"s "Human Nature": Some participants in the White House meetings to discuss abortion in the U.S. "aren"t trying hard enough" to find "common ground" and are "refusing the simplest concessions," Saletan writes. Saletan offers four recommendations to advocates on both side of the debate, including removing the distinction between reducing the number of abortions versus reducing the need for abortions. He writes, "No ordinary person sees a difference" between the two,"[s]o let"s focus on reduction through voluntary means and stop quibbling over how it"s described." His other recommendations include antiabortion-rights advocates conceding to increased access to contraception and both sides giving up "extremism." Saletan"s final recommendation is that abortion-rights opponents allow federal funding for reproductive health groups that offer abortion information or services. He writes that a ban on direct funding for abortions is "fine, " but the "indirect funding Obama restored is hardly radical," adding, "You might even discover that the most efficient way to prevent abortions in the long term is to fund the family planning organizations you keep trying to defund" (Saletan, "Human Nature," Slate, 6/4).~ "The ABCs of Antiabortion Activism," Tracy Clark-Flory, Salon"s "Broadsheet": Tiller"s murder "has opened up a Pandora"s box for pro-lifers, giving rise to all sorts of troublesome questions about the culpability of lenient law enforcement and the movement itself," Clark-Flory writes. She continues, "They certainly won"t find salvation from Pandagon"s Amanda Marcotte, who got her mitts on a disturbing antiabortion activist handbook" now online from Justice for All "that lays bare some of the lies, deception and cynical manipulation that might have led to Tiller"s assassination." According to Clark-Flory, "The single justifiable situation for an abortion is ectopic pregnancy, the manual explains," adding, "Deception of that sort is found throughout the handbook." She writes, "Activists are instructed that when confronting targets they are to pretend that they"re A-OK with contraception" so that "their mark will let his or her guard down and think that, you know, there"s actually a rational, fact-based discussion to be had." Clark-Flory continues, "The truth, of course, is that the manual goes on to arm activists with medical misinformation that they can spread about birth control." She concludes that Marcotte "puts this tactical deceit in perfect context: "It shows one face to the initiated and another to the public, especially on the topic of contraception. Once you realize this, the movement"s half-hearted denunciations of Dr. Tiller"s murder, coupled with the enthusiastic return to calling Dr. Tiller a monster, become all the more chilling"" (Clark-Flory, "Broadsheet," Salon, 6/4).~ "Late-Term Abortions: Facts
Endocrinology

Newly Nominated Surgeon General Will Need To Talk More Openly About HIV/AIDS, Opinion Piece Says

Newly nominated Surgeon General Regina Benjamin has a "tall order" ahead of her being "[c]hief health educator" of the U.S., "and, if confirmed, she will have to talk to us all in terms we plainly understand," Lorraine Teel, executive director of the Minnesota AIDS Project, writes in a Minneapolis Star Tribune opinion piece. She adds, "But when it comes to unintended pregnancies, sexually transmitted diseases and AIDS, the message becomes more difficult" than messages related to nutrition and obesity. Teel says that "former Surgeon Generals tried to educate us," on HIV/AIDS, such as Surgeon General C. Everett Koop, but he "was prevented from speaking frankly." Teel continues, "Let"s hope that this Surgeon General"s administration sounds the alarm, loud and clear, about HIV. A major factor in why we are not winning the battle against AIDS is because we have been forced to only politely talk about risk" (7/1). This information was reprinted from dailyreports.kff.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily U.S. HIV/AIDS Report, search the archives and sign up for email delivery at dailyreports.kff.org. © Henry J. Kaiser Family Foundation. All rights reserved.


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