Weekly Roundup – 10/05/07

J0401613Well, autumn inside the nation’s first-city is getting off to a difficult start, made more so by a complete lack of rain that makes it look as if they only autumn color is going to be brown.  One can’t even dress it up with fall colored sweaters given the fact that the temperature remains in the 80′s.  I long for a steaming bowl of homemade french onion soup by the fire on the first chilly day…

Meanwhile.

  • SCHIP Vetoed – Unable to resist the impulse to again do the wrong thing, President Bush has vetoed the SCHIP program which would have provided added insurance coverage for thousands of the nation’s poor children.  The Democrats have set October 18 as a target date to attempt to override the veto.
  • FDA Seeks Nominations for Reagan-Udall -   The agency announced that it is seeking nominations for individuals to serve on the board of directors of the to-be-formed Reagan-Udall Foundation, an invention of the newly enacted Food and Drug Administration Amendments Act of 2007.  According to the release, the purpose of the Foundation is to act as a "vehicle for private and public stakeholders to collaborate to address the priorities and opportunities identified in so called Critical Path, and to help modernize the product evaluation sciences. The board consists of 14-members: 4 representatives from the general pharmaceutical, device, food, cosmetic and biotechnology industries; 3 representatives from academic research organizations;  2 representatives from patient or consumer advocacy groups; 1 member representing health care providers; and, 4 at-large representatives.  Interested persons may submit nominations by facsimile to Lisa Rovin or Nancy Stanisic at 301-443-9718, or by e-mail to Reagan-Udall-Board@fda.hhs.gov. All nominations must be received on or before Oct. 15, 2007.
  • FDA Launches Initiative to Bolster Generic Drug Program – It is called the Generic Initiative for Value and Efficiency, or GIVE, and it is supposed to modernize and streamline its generic drug approval process.  The release states that this will happen because "FDA is revising the review order for certain drug applications. For example, first generic products, for which there are no blocking patents or exclusivity protections on the reference listed drug, are identified at the time of submission for expedited review. This will mean that these products, for which there are currently no generic products on the market, may reach the consumer much faster."  There is a GIVE Website for more information.
  • Annual Bibliography of Significant Advances in Dietary Supplement Research – The annual publication became available this week.  According to the NIH release, the 2006 Annual Bibliography highlights emerging findings from a diverse array of laboratory and human studies. These include the potentially favorable effects of black cohosh in bone remodeling, ginkgo and omega-3 fatty acids in cognitive health and slowing the progression of Alzheimer’s disease, resveratrol as an anti-inflammatory compound, and vitamin D in reducing prostate cancer risk. You can download a copy of the Bibliography.
  • FDA to Explore Behind the Counter (BTC) Drugs – The Federal Register carried a notice this week that the FDA is announcing a public meeting to obtain comments regarding behind-the-counter (BTC) availability of drugs.  FDA is interested in obtaining public comment as it explores the public health benefit of certain drugs being available without a prescription but only after intervention by a pharmacist. The purpose of the meeting is to solicit information and views from interested persons on specific issues associated with BTC availability, including the impact on patient access to safe and effective drug products.  Dates and Times: The public meeting will be held on November 14, 2007, from 8 a.m. to 5 p.m.  Location: The public meeting will be held at the National Transportation Safety Board Conference Center, 429 L’Enfant Plaza SW., Washington, DC 20594.

Have a good weekend everyone!

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