Drug Topics - December 17, 2007 - (Page 20)

20 DRUG TOPICS DECEMBER 17, 2007 www.drugtopics.com NEWS Roundup Government & Law Kentucky R.Ph.s to Sen. McConnell: Ensure passage of S. 1951 Kentucky community pharmacy owners held a press conference at Capital Pharmacy and Medical Equipment urging Senate Minority Leader Mitch McConnell (R, Ky.) to help ensure S. 1951, the Fair Medicaid Drug Payment Act of 2007, is brought to the Senate floor for a vote before they adjourn this year. The bill fixes the Medicaid generic prescription drug pharmacy reimbursement cuts scheduled to take effect early next year, which threaten the economic viability of community pharmacy, as well as patient access to pharmacy services. For more information on this issue, go to www.ncpanet.org/pdf/leg/ facts-amp20070808.pdf. spective Schedule I hallucinogen, attached at any position(s) on the core structure, but in such manner that no new chemical functionalities are created and no existing chemical functionalities are destroyed relative to the respective Schedule I hallucinogen. The complete definition can be found at http://a257.g.akamaitech.net/ 7/257/2422/01jan20071800/edocket.access.gpo. gov/2007/E7-23413.htm. FDA issues guidance on off-label drug use The FDA has issued an internal draft guidance that would allow drug manufacturers and medical device companies to use journal articles to promote off-label use of their products without prior FDA review and approval. The chairman of the House Committee on Oversight and Government Reform, Henry A. Waxman (D, Calif.), called the guidance “ill advised” and said the change could improperly influence doctors’ prescribing habits and companies would be less likely to conduct clinical trials or seek FDA approval if they knew they could promote off-label uses for their products. As outlined in the draft, manufacturers could distribute reprints of peer-reviewed research from reputable medical journals as long as they were not written or influenced by companies or individuals with financial ties to the drug or device. A draft guidance is not legally enforceable, but instead describes the FDA’s current thinking on a topic and makes recommendations. The draft guidance can be accessed at http://oversight.house.gov/documents/ 20071130103225. pdf. GPhA to state governments: Increase access to generics In response to a new National Governors Association and National Association of State Budget Officers report showing that steadily rising healthcare costs are contributing to deteriorating state fiscal conditions, the Generic Pharmaceutical Association (GPhA) urged state governments to increase access to generic medicines to help them reduce their healthcare expenditure while also providing high-quality care to consumers at lower costs. GPhA president/CEO Kathleen Jaeger stated, “At costs of 30% to 80% less than brands, generics offer substantial savings for consumers, state governments, and the healthcare system. In fact, just a 1% increase in the use of generics could save $4 billion annually.” The report is available on-line at www.nga.org. eHealth to launch drug safety initiative eHealth Initiative is launching a new collaborative research project aimed at improving drug safety, the eHI Connecting Communities for Drug Safety Collaboration. The program, which brings together public health organizations as well as companies such as Pfizer, Johnson & Johnson, and Eli Lilly, will sponsor projects in Indianapolis and Boston. This initiative is intended to contribute to the creation of an active drug safety surveillance system—a key provision of the recently enacted Food & Drug Administration Amendments Act (FDAAA) of 2007. The collaboration also expects its findings to contribute to and build on those of the Reagan-Udall Foundation, a new private and independent nonprofit organization established by Congress under the FDAAA and chaired by former CMS head Mark McClellan. Results of the collaborative effort will be placed in the public domain to accelerate the timeliness and effectiveness of drug safety efforts. Final rule issued for positional isomers of Schedule I drugs The Drug Enforcement Administration (DEA) has issued a final rule that adds the definition of positional isomers to 21 CFR 1300.01 (b) (21). The change will allow for the systematic determination of which isomers of Schedule I substances would be subject to Schedule I control, according to the DEA. The Controlled Substances Act states that all salts, isomers, and salts of isomers of these substances are also Schedule I controlled substances. Specifically, positional isomers are defined as any substance possessing the same molecular formula and core structure and having the same functional group(s) and/or substituent(s) as those found in the re- http://www.drugtopics.com http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/E7-23413.htm http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/E7-23413.htm http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/E7-23413.htm http://www.ncpanet.org/pdf/leg/facts-amp20070808.pdf http://oversight.house.gov/documents/20071130103225.pdf http://oversight.house.gov/documents/20071130103225.pdf http://www.nga.org

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Drug Topics - December 17, 2007 Contents Noncompete Clause: Help or Hindrance? Don't Overlook Feminine Care and Family Planning Independent Pharmacies Are Dreaming of a Green Christmas Latest News Roundup

Drug Topics - December 17, 2007

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