Drug Topics - February 18, 2008 - (Page 9)

www.drugtopics.com FEBRUARY 18, 2008 DRUG TOPICS 9 NEWS Roundup Government and Law Insomnia drug should be classified under Schedule IV, DEA says The Drug Enforcement Administration has proposed placing indiplon (Somposure and Somposure MR) in Schedule IV of the Controlled Substances Act once they are approved. The two insomnia drugs are a new chemical entity now being considered for approval by the Food & Drug Administration. According to an analysis by the Assistant Secretary of Health, the drug does not have enough abuse potential to be placed in Schedule III. So DEA believes it should go under Schedule IV. Those who wish to comment should send them to DEA by March 3. The DEA proposal appeared in the Jan. 31 issue of the Federal Register. tions would help to ensure that legitimate DMEPOS suppliers are furnishing items of DMEPOS to Medicare beneficiaries. Comments must be received no later than 5 pm on March 25. To submit comments, go to www.regulations.gov. Teamsters stage one-day strike at wholesaler’s Wash. facility Teamsters local staged a one-day warning strike at an AmerisourceBergen distribution hub in Kent, Wash. The strike was in protest against changes in working conditions that were not negotiated with the union and the company’s refusal to meet with workers to negotiate a contract. The union also filed a complaint with the National Labor Relations Board. “We value our employees and continue to negotiate in good faith and we don’t believe we’ve violated any laws,” responded Mike Kilpatrick, AmerisourceBergen spokesperson. The strike began Sunday January 27 and ended as scheduled on Monday January 28. According to Kilpatrick, service was not disrupted for any customers. Negotiations are ongoing between the company and the union. Pharmacy owner in steroid probe kills self John Rossi, a licensed pharmacist and the co-owner of Lowen’s Pharmacy in Brooklyn, N.Y., committed suicide on Monday amid a probe into on-line steroid and human growth hormone (HGH) sales involving the pharmacy. Authorities found 90 gm of raw HGH, worth an estimated $8 million, as well as testosterone, nandrolone, and stanozolol in an October raid on the pharmacy and arrested Edward Latendre, the pharmacy’s VP. Rossi had yet to be interviewed by the police. The probe was part of the expanding investigation of Signature Pharmacy in Orlando, Fla., for allegedly selling HGH and steroids online. Consumers Union to FDA: Make it easy to report Rx side effects Consumers Union is collecting 50,000 signatures for a petition to the FDA, demanding the agency make it easier for patients to report problems with their medications. The citizen’s petition requests the FDA to require all TV ads for Rx and over-the-counter drugs to include a toll-free number and Web address so the public can easily report adverse events. Self Care Report: Additives in infant formula could be harmful A report released by The Cornucopia Institute claims that new additives placed in infant formula are seriously endangering the health of some formula-fed newborns and toddlers. The report, “Replacing Mother—Imitating Breast Milk in the Laboratory,” details research questioning the alleged benefits of adding “novel” omega-3 fatty acids, produced in laboratories and extracted from algae and fungus, into infant formulas. The additives raised health and safety flags during preapproval testing while aggressive marketing campaigns by some infant formula manufacturers appear to have encouraged new mothers to give up nursing for the questionable products. The Cornucopia Institute is a Wisconsin-based farm and food policy research group and corporate watchdog. DT CMS proposes rule revising DMEPOS supplier standards CMS announced in the Federal Register of January 25 a proposed rule that clarifies, expands, and adds to the existing enrollment requirements that durable medical equipment and prosthetics, orthotics, and supplies (DMEPOS) providers must meet to establish and maintain billing privileges in the Medicare program. CMS is revising certain standards to ensure that DMEPOS suppliers understand how CMS interprets the DMEPOS supplier standards. CMS is also proposing several new standards. CMS believes that these revisions and addi- Photo: Jim Shive http://www.drugtopics.com http://www.regulations.gov http://a257.g.akamaitech.net/7/257/2422/01jan20081800/edocket.access.gpo.gov/2008/E8-1692.htm http://a257.g.akamaitech.net/7/257/2422/01jan20081800/edocket.access.gpo.gov/2008/E8-1692.htm http://a257.g.akamaitech.net/7/257/2422/01jan20081800/edocket.access.gpo.gov/2008/E8-1692.htm http://www.drugtopics.com/drugtopics/Drug+Topics+Daily+News/8-million-in-HGH-found-in-Brooklyn-pharmacyraid/ArticleStandard/Article/detail/467621?search-String=lowen http://www.drugtopics.com/drugtopics/Drug+Topics+Daily+News/8-million-in-HGH-found-in-Brooklyn-pharmacyraid/ArticleStandard/Article/detail/467621?search-String=lowen http://www.drugtopics.com/drugtopics/Drug+Topics+Daily+News/8-million-in-HGH-found-in-Brooklyn-pharmacyraid/ArticleStandard/Article/detail/467621?search-String=lowen http://www.drugtopics.com/drugtopics/Drug+Topics+Daily+News/8-million-in-HGH-found-in-Brooklyn-pharmacyraid/ArticleStandard/Article/detail/467621?search-String=lowen http://www.drugtopics.com/drugtopics/Drug+Topics+Daily+News/8-million-in-HGH-found-in-Brooklyn-pharmacyraid/ArticleStandard/Article/detail/467621?search-String=lowen http://www.drugtopics.com/drugtopics/Pharmacy/The-new-dynamic-duo/ArticleStandard/Article/detail/408541?searchString=signature%20pharmacy http://www.drugtopics.com/drugtopics/Pharmacy/The-new-dynamic-duo/ArticleStandard/Article/detail/408541?searchString=signature%20pharmacy http://www.drugtopics.com/drugtopics/Pharmacy/The-new-dynamic-duo/ArticleStandard/Article/detail/408541?searchString=signature%20pharmacy

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Drug Topics - February 18, 2008 Contents Get Ready to Usher in These New OTCs Top 200 Brand Drugs By Units in 2007 Top 200 Generic Drugs By Units in 2007 Earn Add-On Winter Sales With Medicated Skin Care Latest News Roundup

Drug Topics - February 18, 2008

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