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President Obama Reverses Bush Policy Preventing Consumers From Suing Product Makers In State Courts
President Obama on Wednesday ordered federal agencies to rescind regulations enacted by former President George W. Bush"s administration that protect manufacturers of such products as medical devices from product-liability lawsuits in state court, the Wall Street Journal reports. The decision could affect a wide range of manufacturers and products because the Bush administration "aggressively" encouraged federal agencies to make rules that pre-empt and override state laws, which often meant protecting manufacturers of medical equipment from lawsuits, according to the Journal. Obama in a two-page memo wrote that federal agencies and departments could claim state law is pre-empted by federal law only when there is a well-defined legal basis. The memo stated that state laws are important because they supplement federal regulations. "State and local governments have frequently protected health, safety and environment more aggressively than has the national government," Obama wrote (Mundy/Kendall, Wall Street Journal, 5/21). Obama ordered agencies to review regulations from the past decade and look for possible occasions in which the government improperly declared federal pre-emption (Yost, AP/Kansas City Star, 5/20). According to the Journal, business groups oppose the decision (Wall Street Journal, 5/21).
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Gene Signature Predicts Good Outcome In Breast Cancer
Researchers have identified a genetic signature that can predict an improved clinical outcome in patients with breast cancer, and which could help in the development of new targeted therapies.
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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.
Sexual Health

Vigils Held Worldwide To Protest Jailing Of Iranian Physicians Who Addressed HIV/AIDS

Health professionals on Tuesday held vigils in several cities worldwide to protest the imprisonment of Iranian brothers Kamiar and Arash Alaei -- physicians and leading HIV/AIDS advocates in the country -- following the release of Iranian-American journalist Roxana Saberi, the Albany Times Union reports. Vigils were held in cities such as New York City and Washington, D.C., as a day of global protest against the brothers" imprisonment. Vigils also were held in cities across Africa, Asia, Europe and South America, according to the Times Union.Jonathan Hutson -- a spokesperson for Physicians for Human Rights, which is leading a campaign for the brothers" release -- said, "The release of Ms. Saberi has shifted the world"s attention to the plight of others who are likewise jailed in Iran on trumped-up charges." He added, "This is not an issue of politics, but of global health. The only battle they were engaged in is the public health battle to prevent and treat the deadly epidemic of AIDS. They need to be allowed to return to their lifesaving work" (Grondahl, Albany Times Union, 5/13). Related Editorials Three newspapers recently published editorials related to the Alaei brothers. Summaries appear below. *Boston Globe: "[I]f Iran"s leaders want to convey a message of conciliation and justice, they should have" the Alaei brothers "exonerated on their appeal of convictions for working with an "enemy government" and "seeking to overthrow the Iranian government,"" a Globe editorial says. The Globe adds the PHR and "several other public health and human rights groups are sponsoring rallies in New York; Washington, D.C.; and other cities around the world to call for the doctors" release," concluding, "We hope Iran"s leaders get this message as well" (Boston Globe, 5/12). *Los Angeles Times: "Human rights activists say there are several hundred political prisoners jailed in Iran solely for exercising rights that in the West are often taken for granted," a Times editorial says. The editorial continues that Iran "should allow international human rights organizations or independent jurists access to" the Alaeis" case records and "provide fair and open trials to all prisoners," concluding that "[d]efendants should be innocent until proven guilty, and the burden of proof must be on the prosecution" (Los Angeles Times, 5/12). *New York Times: The recent release of Saberi, who "had been sentenced to eight years in a notorious Iranian prison on espionage charges, is welcome news and a humanitarian gesture by Iranian leaders" but "should not be overstated," a Times editorial says. "Working conditions are still treacherous for journalists and other professionals in Iran," the editorial says, adding that PHR is "campaigning" for the release of the Alaei brothers, "whose unfair trials and horrifying sentences are still intact" (New York Times, 5/12). 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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