CRN to host webinars with Virgo Publishing
WASHINGTON The Council for Responsible Nutrition and Virgo Publishing on Wednesday announced plans to offer three webinars in 2010, with the first webinar — Dietary Supplement Safety: Understanding the Role of Adverse Event Reports in Product Recalls — taking place May 6, at 2 p.m.
The webinar will be moderated by Duffy MacKay, CRN VP scientific and regulatory affairs, and will offer attendees a better understanding around the role of a corporate post-market safety surveillance system that includes adverse event reporting to meet mandatory Food and Drug Administration reporting requirements. A panel of regulatory experts — Rick Kingston, president, SafetyCall International; Patrick Revelle, director, MedDRA MSSO; James Neal Kababick, director, Flora Research Labs; and Bob Moore of the Center For Science and Nutrition, Food and Drug Administration — will provide participants with insights on adverse event reporting, including the type and scope of information collected, how that information is reviewed and analyzed and how to both prevent and handle a product recall.
The webinars mark a continuation of a webinar partnership between CRN and Virgo that began in 2007. The second and third webinars for 2010 will take place Aug. 3 and Nov. 4, with topics and speakers still to be determined.
“We’ve created a great combination of CRN’s knowledge of and contacts in scientific and regulatory affairs and Virgo Publishing’s expertise in producing educational webinars for the industry which is evident from our participant numbers and evaluations,” stated Judy Blatman, CRN SVP.
Alabama to implement e-tracking program to block PSE sales
WASHINGTON The Consumer Healthcare Products Association on Tuesday expressed its support for Alabama law HB 528, signed into law by Gov. Bob Riley, that calls for implementation of a real-time electronic sales tracking system to block illegal purchases of cold and allergy medicines containing pseudoephedrine.
CHPA also commended Rep. Frank McDaniel, D-DeKalb and Marshall, and Sen. Lowell Barron, D-DeKalb, Jackson and Madison, for securing bipartisan support for this important piece of legislation which passed through both chambers unanimously.
Alabama joins nine other states — Arkansas, Illinois, Iowa, Kansas, Kentucky, Louisiana, Oklahoma, Missouri, and Washington — that have adopted e-tracking.
“We applaud Gov. Riley and the Alabama legislature for implementing a solution that will fight domestic meth production while maintaining consumer access to important cold and allergy medications,” stated Linda Suydam, president of the Consumer Healthcare Products Association. “This system offers an effective solution to reducing meth labs and is the only solution that works across state lines.”
The makers of PSE-containing medicines are providing an industry-funded system to allow law enforcement to identify “smurfers” or those who try to illegally violate limits in state and federal law on the amount of PSE-containing medicines individuals can purchase in a given period of time. E-tracking poses no new barriers to consumers, collects only the information already required under federal law, and enables law enforcement to find the meth labs that would otherwise go undetected.
According to a recent poll conducted by David Binder Research, more than three-fourths of Alabama voters support an e-tracking system. The poll also found that voters believe e-tracking will help law enforcement receive the information they need to identify those who are purchasing illegal amounts of medicines containing PSE. As many as 78% of those surveyed agree that e-tracking will be “a huge help to law enforcement.”
CDC continues to urge citizens to receive H1N1 flu shots
ATLANTA The Centers for Disease Control and Prevention still is recommending people who have not yet gotten their H1N1 flu shots that they do so. H1N1 vaccine is widely available, CDC officials noted.
In a conference call with reporters on Monday, the CDC that H1N1 has “not gone away,” with regional activity still being reported throughout the southeast, most notably in Alabama, Georgia and South Carolina. Hospitalizations attributed to H1N1 have been on the rise for three consecutive weeks.
“The H1N1 flu has made 2009-2010 flu season one of the most challenging in recent memory,” suggested U.S. Surgeon General Regina Benjamin. “It’s persistent in the southeast and now those states are experiencing more local and regional activity,” she said. “We’re at a critical moment in our national response to this virus and we need to continue to urge Americans to get vaccinated, especially people at high risk from complications from H1N1.”
To date, approximately 60 million Americans have been infected and there’s been 265,000 hospitalizations, the CDC reported. Close to 12,000 people have died from H1N1, about one-third the number of deaths attributed to influenza in a typical year. However, 11,000 deaths occurred in people under the age of 65, Anne Schuchat, CDC director of the National Center for Immunization and Respiratory Diseases, noted. “That’s much more deaths in a particular year among younger people than what we typically see with seasonal flu. We estimate that the rate of death in young people is probably five times higher than what we would typically see with seasonal influenza.”