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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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Pirfenidone May Help Lung Function In IPF Patients According To Large Clinical Trial
A large, well-controlled, multi-national clinical trial program has demonstrated the effectiveness and safety of what may become the first FDA-approved medicine for idiopathic pulmonary fibrosis, or IPF.
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Study Shows Risks Of Delaying ACL Reconstruction In Young Athletes
More and more children are participating and getting hurt playing sports each year. A new study presented at the American Orthopaedic Society for Sports Medicine"s (AOSSM) Annual Meeting in Keystone, Colorado, (July 9-12) details the benefits and risks of repairing a torn anterior cruciate ligament (ACL) in young athletes under the age of 14.
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The Teaching And Learning Of Writing Is The Focus Of Journal Special Edition

A special monograph of the British Journal of Educational Psychology , published this month, highlights the very latest psychological research into the teaching and learning of writing. Contributions in this edition of the monograph series include: - Steve Graham and Karen Harris from Vanderbilt University (USA) who reviewed teaching interventions and present 13 clear but evidence based recommendations for teaching writing; recommendations recently endorsed by the National Writing Project in the USA. - Debra Myhill from the University of Exeter, who examined the translation of thought to text, and found that poor writing often contains more oral speech characteristics; concluding that children need to be helped to move away from writing the way they talk and to shape their texts more carefully. - Julie Dockrell from the University of London, who investigated the poor writing skills of children with specific language impairment and found that limited vocabulary, lack of fluency and very poor spelling in particular constrain these children when trying to write. - Anna Barnett from Oxford Brookes University who introduces details of a new handwriting speed test for educational use: the DASH. - Charles MacArthur from the University of Delaware (USA), who reviewed research on the effects of word processing technology, and assistive technology such as spell checkers and word prediction, concluding that children need to be taught how to use electronic tools in order to gain from them. The editor of the special monograph, Vincent Connelly from Oxford Brookes University, said: "It is very important that children become competent writers. These reviews all point out that more needs to be done so that the lessons from this latest research feed through to schools in order to support the teaching of writing and help devise new teaching methods built on the latest findings." British Psychological Society


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