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California Lawmaker Introduces Legislation To Support National Caribbean American HIV/AIDS Awareness Day
Rep. Barbara Lee (D-Calif.) introduced legislation that seeks to encourage state and local governments, as well as media organizations, to recognize June 8th as National Caribbean American HIV/AIDS Awareness Day, the American Chronicle reports. The legislation also supports the development of a national AIDS strategy that aims to reduce new HIV infections in the U.S., particularly among minorities (American Chronicle 6/9).
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Health Subcommittee Considers Bill To Eliminate Pre-Emption For Medical Devices
The House Energy and Commerce Health Subcommittee on Tuesday heard testimony on the Medical Device Safety Act of 2009 (HR 1346), which would allow consumers to sue medical device manufacturers in state courts, CQ HealthBeat reports. The bill responds to last year"s Supreme Court ruling that says medical devices with FDA pre-marketing approval can be pre-empted from lawsuits under state law, in accordance with the Medical Device Amendments of 1976. Rep. Frank Pallone (D-N.Y.), who introduced the bill, said that the 2008 Supreme Court ruling "ignor[ed] congressional intent" by providing blanket immunity for medical device makers. According to Rep. John Dingell (D-Mich.), a co-sponsor of the bill, the original 1976 law sought to grant regulatory authority to FDA for medical devices, but it did not aim to eliminate state liability. Committee Chair Rep. Henry Waxman (D-Calif.), another co-sponsor, said last year"s ruling already has caused 1,400 injury cases to be thrown out of court, adding that the threat of litigation provides manufacturers with additional safety incentives. David Vladeck -- a law professor at Georgetown University Law Center who testified at the hearing -- added that immunity from lawsuits "removes incentive to manufacturers to fix devices quickly and get defective devices off the market."Rep. Nathan Deal (R-Ga.) said the class of device that must obtain pre-marketing approval -- which includes pacemakers and replacement heart valves -- represents only 2% of all approved medical devices each year. Rep. Michael Burgess (R-Texas) added that the measure could create an inconsistent system that allows both FDA experts and jurors in various states to make decisions on medical device safety standards. In addition, Rep. Joe Pitts (R-Pa.) cautioned that the bill might encourage manufacturers to limit distribution of their devices to certain states (Kim, CQ HealthBeat, 5/13). Related Editorial
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Access To Abortion Services In Kansas Hindered After Closure Of Tiller's Clinic
After the murder of abortion provider George Tiller and the closure of his Wichita, Kan., clinic, residents of the city face about a three-hour drive to the nearest abortion provider, a distance experts say is not uncommon for access to abortion services in southern and midwestern states, the Wichita Eagle reports. Jenny O"Donnell of the Abortion Access Project said that southern and midwestern states have the heaviest restrictions on abortion, adding that "substantial populations don"t have an abortion provider" in states such as Mississippi and Arkansas. According to 2005 statistics from the Guttmacher Institute, 87% of U.S. counties have no abortion provider; the figure rises to 94% of counties in the Midwest and 96% of counties in Kansas. The number of abortion providers in Kansas declined from 15 in 1992 to seven in 2005, while the number of providers nationwide dropped from 2,380 to 1,787 over the same time period, according to Guttmacher. Experts say the decline is the result of several factors, including public pressures, increased regulation that has driven up the cost and complexity of providing abortion and a general trend in the health care industry toward consolidated, more specialized practices.Vicki Saporta, president and CEO of the National Abortion Federation, said that the decrease in the number of abortion providers is misleading on some levels. The decline primarily has occurred among hospitals and small providers who perform a few procedures a year, while major clinics that specialize in abortion have remained essentially stable, Saporta said. Peter Brownie, executive director of Planned Parenthood of Kansas and Mid-Missouri, said that the group"s clinics have experienced an increase in contacts from women from south-central Kansas since Tiller"s clinic closed a little more than one week ago. He added, "At the present time, there"s no place between Denver and Kansas City where a woman can obtain abortion care. That"s a significant barrier for women throughout the state that have that need." NAF has established a national hotline to offer referrals for women who have to make new arrangements for abortion care because of the closure of Tiller"s clinic, Saporta said (Lefler, Wichita Eagle, 6/9).
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New Guidelines To Standardise Access Criteria For IVF Treatment

The National Infertility Awareness Campaign (NIAC) welcomed the document "Standardising Access Criteria to NHS Fertility Treatment"1 produced by Infertility Network UK (I N UK) and funded by the Department of Health. The NICE Guideline issued in 2004 recommended that eligible couples should receive three full cycles of IVF or ICSI NHS treatment, and defines a cycle as one which includes frozen embryo transfers (FET), but more than five years on there remains considerable disparity not only in the number of cycles being funded by the Primary Care Trusts (PCTs) but equally importantly in the access criteria applied by the PCTs in determining who can receive treatment. Recent measures announced by the Government to encourage implementation of the Guideline have led to an improvement in the provision in some areas but more needs to be done by Primary Care Trusts in England to ensure that patients have equal and timely access to the full range of treatment recommended by NICE, and to tackle the ongoing variations in provision that exist across the country. Clare Lewis-Jones, Chair of NIAC and Chief Executive of Infertility Network UK said "Although there has been an improvement recently in the provision of treatment by some PCTs, there still remains considerable variation in the criteria used to determine whether or not couples can access treatment. We welcome the recent measures announced by the Government to encourage implementation of the Guideline but particularly with the move towards single embryo transfer (SET) more needs to be done by the PCTs to fund three full cycles as recommended in the NICE Guideline and to standardise the access criteria they use to determine who can access NHS treatment and allow couples to have the treatment they need to help them have their family. It is totally unacceptable that patients are denied treatment simply because of where they live or on the basis of their age, and we urge all PCTs to implement these new recommendations and make access to fertility services fair, consistent, cost effective and clinically effective across the country." 1 The document "Standardising Access Criteria to NHS Fertility Treatment" produced by Infertility Network UK can be accessed via the Infertility Network UK Website http://www.infertilitynetworkuk.com Infertility Network UK


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