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Ohio Supreme Court Restricts Mifepristone Use In State To Scope Of FDA's Approval Letter
In answering two certified questions from the U.S. Court of Appeals for the 6th Circuit, the Ohio State Supreme Court on July 1 declared that a state law regulating the use of mifepristone -- which is used in medication abortion -- bars physicians from prescribing it for off-label use, BNA reports. The court confirmed that doctors who use the drug to induce abortion must do so in compliance with the 49-day gestational limit included in FDA"s 2000 drug approval letter. Doctors also must prescribe the drug in accordance with the protocols and dosage indications included in its FDA-approved labeling.Interpretation of State Law in ContentionThe Ohio General Assembly in 2004 passed a law (Section 2919.123 (A)) that required any health care professional prescribing or dispensing mifepristone to comply with "all provisions of federal law that govern the use" of the drug. The law defines "federal law" as "any law, rule or regulation of the United States or any drug approval letter" from FDA "that governs or regulates the use of" mifepristone for inducing abortion. FDA"s approval letter states that the drug "is indicated for use in the termination of pregnancy (through 49 days" pregnancy) and has no other approved indication for use during pregnancy." In addition, the drug"s label states the recommended dosage and that its use requires three office visits by the patient. Planned Parenthood Southwest Ohio Region challenged the law in district court, arguing that neither FDA"s approval letter nor any other federal provision bans the off-label use of mifespristone to induce abortion beyond 49 days" gestation. The group also argued that the state law was unconstitutionally vague because it did not notify abortion providers in advance regarding which FDA documents were included in the state"s criminal law. In addition, Planned Parenthood said that prohibiting the evidence-based use of the drug would infringe on the rights of women, requiring them to take higher-than-necessary dosages of the drug or to undergo surgical abortions when a noninvasive alternative is available. The district court ruled in favor of Planned Parenthood, saying that the law was void because of vagueness. The state appealed the decision to the 6th Circuit, which then submitted two questions to the state Supreme Court seeking its interpretation of the law.The state Supreme Court ruled that FDA"s drug approval letter is included in the definition of "federal law" and that the state law is not ambiguous, according to BNA. The court said that because the drug approval letter incorporated FDA"s labeling text, Ohio physicians cannot prescribe or provide mifepristone to induce abortion outside of the stipulations of the drug approval letter and approved label. According to BNA, product liability law experts say the ruling will not have an impact outside of mifepristone or the state of Ohio.Case Returns to Appeals CourtRoger Evans of Planned Parenthood Federation of America said that he is not sure if the court"s decision helps or hurts the group"s case. Evans said that the district court declared the law unconstitutional based on an interpretation that the statute operates in the same way the state Supreme Court ruled it does. He noted that there are other possible interpretations of the law that would have solved the constitutional issues at the center of the litigation. However, because those issues were not resolved, the case now returns to the 6th Circuit, which will decide if the statute is constitutional based on the state Supreme Court"s interpretation. If the circuit court agrees with the district court that the statute is unconstitutionally vague, the state of Ohio could seek a U.S. Supreme Court review. If the circuit court finds that the statute is constitutional, the case likely will be sent back to the district court for resolution of some other issues in the case, according to BNA (BNA, 7/6).
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Molecular Insight Pharmaceuticals, Inc. Receives European Medicines Agency Approval To Proceed With Phase 3 Development Of OnaltaTM
Molecular Insight Pharmaceuticals, Inc. (NASDAQ: MIPI) announced that the European Medicines Agency (EMEA) has approved its Phase 3 protocol for Onalta (Yttrium-90 edotreotide). Onalta is the Company"s lead radiotherapeutic product candidate under development for the treatment of metastatic carcinoid and pancreatic neuroendocrine tumors in patients whose symptoms are not controlled by conventional therapy. The compound has shown the potential to selectively deliver lethal radiation to cancer cells. The proposed Phase 3 trial will confirm that administration of Onalta results in stabilization, regression or complete remission of the carcinoid tumor, and improves carcinoid-related symptoms when compared to a high-dose regimen of the current standard therapy for this disease, Sandostatin®. With EMEA"s approval of its proposed Phase 3 protocol in hand, Molecular Insight can proceed with the final clinical trial that will position Onalta for marketing authorization in the EU.
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Adult Brain Changes With Unsuspected Speed
The human brain can adapt to changing demands even in adulthood, but MIT neuroscientists have now found evidence of it changing with unsuspected speed. Their findings suggest that the brain has a network of silent connections that underlie its plasticity.
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Namibia Close To Reaching Some MDGs

Namibia"s recently released second MDG Report 2008 finds that the country is making progress toward achieving some of the U.N. Millennium Development Goal (MDG) targets. However, the Prime Minister says the global economic situation could reverse progress and notes that the country is behind on some health-related targets, New Era reports. The report says the country has achieved goals pertaining to the reduction of HIV/AIDS prevalence rates in people between the ages of 15 and 19 years old, malaria incidence and others. "These targets fall under MDGs relating to eradicating extreme poverty and hunger, achieving universal primary education, promoting gender equality and empowering women, combating HIV/AIDS, malaria and other diseases," New Era writes. Prime Minister Nahas Angula said the country must focus on education, agriculture and health in order to achieve other MDG targets. He highlighted the need to focus on primary health care, malnutrition, sanitation and maternal health. The report noted that Namibia likely will not reach the MDG targets for maternal and infant mortality. "Something must be done. Even if it means training young people to train their fellow young women on prenatal care and Traditional Birth Attendant to assist with deliveries, we should do it," Angula said. Acting U.N. Resident Coordinator Joyce Mends-Cole said the global economic situation "will directly affect" efforts to achieve MDG targets. "In comparison with past performance, the poor unemployment picture suggests that the rate of progress will even be slower," she said (New Era, 6/23). 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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