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Senate HELP Panel Begins Mark Up Of Bill Placing Tobacco Under FDA Oversight
The Senate Health, Education, Labor and Pensions Committee on Tuesday began marking up a bill (S 982) that would allow FDA to regulate tobacco products, CongressDaily reports. The bill would allow FDA to place larger, color warning labels about the health risks of smoking on cigarette packs, as well as to regulate the marketing of tobacco products and advertising to children. The agency could not ban tobacco products or eliminate nicotine from cigarettes, but it could regulate their production and ban flavored cigarettes other than menthol. Sen. Chris Dodd (D-Conn.) said, "Over the years, this bill has been reviewed; it has been vetted; it has been debated, over and over and over again. The time has come to act." The House in April passed its version of the bill, 298-112 (Hunt, CongressDaily, 5/20). The committee by voice vote approved an amendment proposed by Sen. Jeff Merkley (D-Ore.) that would give FDA priority to review products that contain nicotine, such as candies. Committee ranking member Mike Enzi (R-Wyo.) proposed two amendments, one that would have given regulatory authority over tobacco to CDC and another that would have ordered FDA to study which flavors to ban, instead of a current provision that bans specific flavors. Both amendments were defeated. Enzi said, "I think the FDA is the wrong regulator. It approves cures, not poisons." The only Democrat who opposed the bill was Sen. Kay Hagan (N.C.), who said the measure would harm the tobacco industry in her home state (Armstrong, CQ HealthBeat, 5/19). The panel"s other member from North Carolina, Sen. Richard Burr (R), said he would filibuster the bill. He said, "I put my fellow senators on notice: This is something that will be a much longer time on the floor than it will be in this hearing" (CongressDaily, 5/20). The committee plans to continue marking up the bill Wednesday and possibly Thursday.The Obama administration has expressed its support for the bill (CQ HealthBeat, 5/19). FDA Commissioner Margaret Hamburg also has said her agency should regulate tobacco (Armstrong, CQ HealthBeat, 5/18).
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Shire Has Filed A Treatment Protocol For Velaglucerase Alfa For Gaucher Disease
Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that, at the request of the FDA, in view of a potential restriction on the availability of the current approved and marketed treatment for Gaucher Disease patients, it has filed a treatment protocol for velaglucerase alfa, its enzyme replacement therapy in development for the treatment of Gaucher Disease.
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Federal Appeals Court Upholds Virginia Abortion Ban
The full U.S. Court of Appeals for the 4th Circuit in a 6-5 decision on Wednesday upheld Virginia"s 2003 law banning what abortion-rights opponents call "partial-birth" abortion, a procedure known medically as intact dilation and extraction, the AP/Hartford Courant reports (O"Dell, AP/Hartford Courant, 6/24). In 2005, a three-judge panel of the U.S. Court of Appeals for the 4th Circuit ruled 2-1 to strike down the Virginia law on the grounds that it does not include adequate exceptions to protect a woman"s health. The U.S. Supreme Court two years ago ordered the appeals court to revisit the issue when it upheld the Partial Birth Abortion Ban Act of 2003, a federal law similar to the Virginia law (White, Washington Post, 6/25). The three-judge appeals panel again struck down the law in 2008 (AP/Hartford Courant, 6/24). The Virginia law permits women to choose various abortion procedures but makes it a crime for providers to perform an intact dilation and extraction, which involves crushing a fetus" skull to ease removal (Washington Post, 6/25). Abortion-rights supporters said that the Virginia law is unconstitutional because its broad definition of intact dilation and extraction could also prohibit standard dilation and extraction, the more common form of second-trimester abortion. Violations of the law would be considered a felony and punishable by up to 10 years in prison. The case is Richmond Medical Center v. Herring (AP/Hartford Courant, 6/24). William Fitzhugh, the Richmond doctor who challenged the Virginia law, said that the banned procedure is necessary to protect the life of the woman in some cases and that the law could prevent abortion providers from performing legal procedures out of fear of prosecution. Stephanie Toti, a Center for Reproductive Rights attorney who represented the plaintiffs, said that the Virginia law is broader than federal law because it punishes abortion providers who accidentally violate the law while performing legal abortion procedures. Judge"s Opinions Judge Paul Niemeyer in the majority opinion wrote that Virginia law protects physicians who are taking needed steps to save a patient"s life and should prevent "a Morton"s fork, where the doctor must choose between criminal liability or care that the doctor believes is not in the best interest of the patient." He added that the circumstances in which doctors could face criminal liability are so limited that they should not invalidate the law in every other case. Judge Blane Michael wrote in the dissenting opinion that the law will create a "real fear of criminal liability" among physicians because it will have the effect of criminalizing the actions of those who seek to perform legal procedures but need to use the banned procedure in rare instances. Michael wrote that the law therefore "places an undue burden on a woman"s right to obtain a pre-viability second trimester abortion -- a constitutional right repeatedly reaffirmed by the Supreme Court" (Washington Post, 6/25).Next StepsToti said that no decision has been made on whether to appeal the decision to the Supreme Court. The Supreme Court"s 2007 decision on the federal law made it clear that abortion bans must include exceptions for the health of the woman, the AP/Hartford Courant reports. Toti said that the appeals court"s decision "just really ignores that precedent." She added, "It"s really insulting to women"s dignity that the court would put so little priority on protecting women"s health and well-being" (AP/Hartford Courant, 6/25). Toti also said, "It puts doctors in a really untenable position because it forces doctors to choose between taking all the steps necessary to protect their patients and committing a felony" (Washington Post, 6/25). Virginia Attorney General Bill Mims said, "While we anticipate that the U.S. Supreme Court may be asked to review the decision, I am confident that the Supreme Court ultimately will uphold the law" (AP/Hartford Courant, 6/25).
Medical Devices

H1N1 Confirmed In Three More African Countries; Cambodia, Indonesia Confirm First Cases

The H1N1 (swine flu) virus has reached the sub-Saharan African countries of Cape Verde, Ethiopia and Ivory Coast, according to the WHO, the AP/Boston Herald reports. Last week, South Africa became the first country in the region to confirm a 12-year-old, who had returned from the U.S., tested positive for the H1N1 virus. "WHO says African countries are particularly vulnerable because of their fragile health care systems and the widespread presence of other health problems such as HIV and tuberculosis," the AP/Boston Herald writes (AP/Boston Herald, 6/24). There have been no newly confirmed cases of H1N1 in Ethiopia since two patients tested positive for the virus last week, according to the Ethiopian Minister of Health, Ethiopian Review reports (Tesfaye, Ethiopian Review, 6/24). The WHO and Cambodian health officials on Wednesday confirmed that a 16-year-old American girl visiting Cambodia has become the country"s first confirmed case of H1N1, Reuters reports. Also on Wednesday, health officials in Indonesia confirmed the country"s first cases of H1N1 in Jakarta and the island of Bali. "Health Minister Siti Fadillah Supari ò€¦ said she was concerned that if H1N1 got a foothold in Indonesia there was a risk it could combine with the much deadlier H5N1 bird flu virus," Reuters writes (Madra, Reuters, 6/24). This information was reprinted from globalhealth.kff.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Global Health Policy Report, search the archives and sign up for email delivery at globalhealth.kff.org. © Henry J. Kaiser Family Foundation. All rights reserved.


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