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FDA Approves Generic Version Of Emergency Contraception Pills
FDA on Wednesday approved Watson Pharmaceuticals" generic version of the emergency contraceptive Plan B, the Wall Street Journal reports. The generic drug will be available without a prescription to women ages 18 and older on Aug. 24, when Duramed Pharmaceuticals" market exclusivity for Plan B expires (Kalish, Wall Street Journal, 6/25). The generic version will be available to women ages 17 and younger with a prescription, according to an FDA press release (FDA Web site, 6/24). Watson will market the generic version under the name Next Choice (AP/Washington Post, 6/24).A one-time use pack of the brand-name product, Plan B, currently costs $49.99 through the online retailer DrugStore.com. According to Bloomberg, generic drugs usually cost 30% to 80% less than brand-name versions (Larkin, Bloomberg, 6/24).

Obama Administration's Filings On Asylum For Abused Foreign Women Brings 'Overdue Dose Of Clarity,' Editorial Says
The Obama administration recently laid out "a clear but narrow pathway" toward asylum for foreign women who have experienced severe physical or sexual abuse, a New York Times editorial states, noting that the U.S. government has debated the issue for 15 years. According to the editorial, the "question is not the fact of persecution, but whether the women would qualify for protection under the law, which limits asylum to those who suffer due to their race, religion, nationality, political opinion or "membership in a particular social group."" It adds that attorneys general under former Presidents Clinton and George W. Bush "have gone both ways and in circles" in their decisions.Although "[n]ot all victims will qualify," the Obama administration "made it clear that some could," the editorial states. "A petitioner would have to demonstrate to a judge that domestic violence was widely tolerated by society and government in her country, that women were viewed as subordinate to men and that she had no place within its borders to find a safe haven," the editorial adds.Department of Homeland Security lawyers say the new definition could apply to a severely abused Mexican woman, identified only by her initials, whose asylum petition is before a San Francisco immigration court. The editorial notes that DHS "did not immediately recommend asylum" for the woman, but "it did urge that she be allowed to continue to gather evidence and to refine her case according to the standards it proposed." The editorial concludes, "Advocates who have fought for years to advance women"s rights are celebrating the department"s action, which brings reasoned compassion, and an overdue dose of clarity, to an issue of anguish and difficulty" (New York Times, 7/19).
News of the day
Vertex Initiates Phase 3 Registration Program For VX-770, An Oral CFTR Potentiator Targeting The Defective Protein Responsible For Cystic Fibrosis
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the initiation of a Phase 3 registration program for VX-770, an investigational Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) potentiator that targets the defective CFTR protein that causes cystic fibrosis (CF). The VX-770 registration program will consist of three clinical trials, including a primary 48-week Phase 3 trial that is currently open to enrollment of patients aged 12 years and older who carry the G551D mutation on at least one allele. Two additional trials will evaluate VX-770 in patients aged 6 to 11 years with the G551D mutation on at least one allele and in patients homozygous for the F508del mutation, respectively.
Diagnostics

Report Looks At HIV Prevalence Among Chicago Gay Men

In Chicago, 17.4 percent of gay men are estimated to be HIV-positive, compared with 1.2 percent of the general male population, according to a new report by the Chicago Public Health Department, the Chicago Sun-Times reports. The report is based on data collected from 570 Chicago men through the National HIV Behavioral Surveillance system, and found that half of the men with HIV were unaware they were infected (Thomas, 7/25). "Health officials said Friday, information in the report on HIV infection mark the first time Chicago health officials have used blood-testing to determine infection rates among men," the AP/Chicago Tribune reports. In the past, estimates have relied on interviews with gay and bisexual men, according to Christopher Brown, the Public Health Department assistant commissioner. The report also found that "black men who have sex with other men have double the HIV infection rates of white and Hispanic men," the AP/Tribune reports (7/24). 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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