FDA ‘actively pursuing’ McNeil Consumer Healthcare
WASHINGTON The Food and Drug Administration on Monday posted a media update to its Web page around the most recent McNeil Consumer Healthcare recall, suggesting that the entire McNeil Consumer Healthcare division has come under review.
“FDA is actively pursuing issues related to this recall,” the agency stated. “Drug safety analysts and other medical professionals at FDA have begun a comprehensive review of complaints received by the agency to determine the significance of any adverse events reported and any connection to the use of the recalled products. The FDA is conducting a company-wide investigation of McNeil Consumer Healthcare’s drug manufacturing practices to determine whether similar problems exist throughout the company and what additional steps the agency must take to ensure that these problems do not recur.”
In addition to increased regulatory scrutiny, the House Committee on Oversight and Government Reform on Friday announced it will hold a hearing addressing the latest McNeil recall on May 27 “to examine the circumstances surrounding the voluntary recall of over 40 over-the-counter variations of infant and children’s medicines produced by Johnson & Johnson/McNeil Consumer Healthcare.”
Expected to testify before that panel is Johnson & Johnson chairman and CEO Bill Weldon.
McNeil implemented a voluntary recall of its infant’s and children’s liquid drug products due to manufacturing deficiencies, which may have affected the quality, purity or potency of the drugs on April 30, the FDA noted. McNeil has also ceased production at its Fort Washington, Pa. facility. The agency also reiterated its belief that the chance of serious adverse health consequences associated with the recalled products is remote.
FORT MYERS, Fla. —The SilverCare personal monitor from SilverPlus was named by retailers attending the ECRM Home Health Care conference in March as the “hot new product” at the show.
The SilverCare monitor is a multifunctional, daily-living assistant, the company stated, with functions including a dedicated 911 button, a hands-free speaker and medication reminder in the body of a digital wristwatch. By 2011, SilverPlus hopes to launch a model that will include a motion sensor, which could trigger an alert due to a fall, for example. And by 2012, the SilverPlus vision is to fold its product line into a comprehensive and multifunctional telehealthcare tool, where remote healthcare professionals can help with disease and wellness management.
Each unit consists of a base console and wristwatch, and retails for a suggested $449, with no monthly service contract fee associated with the use of the product, the company added.
Pharmavite announces partnership with AAFP
LEAWOOD, Kan. Pharmavite has aligned with the American Academy of Family Physicians’ Consumer Alliance Program, the company announced Friday. As part of the partnership, Pharmavite will underwrite the development of nonbranded, physician-reviewed consumer education content on vitamins, supplements, general health and heart health, which will be featured on AAFP’s consumer health site FamilyDoctor.org.
Serving as an online destination for patients seeking information on health questions, issues and concerns, FamilyDoctor.org recently was named one of “Five Great Health Sites” on a Newsweek.com blog, and one of the “‘Top Ten’ Most Useful Web Sites” by the Medical Library Association. FamilyDoctor.org welcomes, on average, 3.5 million unique visitors each month.
“The Consumer Alliance Program helps fulfill the AAFP’s objective of improving the health of the public, in that it allows new opportunities for excellent patient education through FamilyDoctor.org,” stated AAFP EVP and CEO Douglas Henley.
While FamilyDoctor.org and the AAFP do not endorse any specific brand, product or service, the Consumer Alliance Program is an opportunity for Familydoctor.org and AAFP to collaborate with consumer products companies that share the common goal of informing consumers, as well as medical professionals, about new advances in product science, nutrition and best practices for good health and a balanced lifestyle.
“Generally the best way to ensure you get the vitamins and minerals your body needs is through a balanced and varied diet, but that is not always possible,” Henley said.
Americans increasingly are using vitamins and dietary supplements to prevent nutritional deficiencies. Nielsen’s Scantrack point-of-sale data indicates that use of vitamins, minerals and supplements by U.S. consumers increased 31% from 2005 to 2009.
With increased use of these products comes an increased need for patient education to ensure their proper usage. As part of their counseling, physicians can now refer their patients to the educational materials on FamilyDoctor.org about the appropriate use of vitamins and supplements.
“We know that many of our patients already use vitamins and supplements,” Henley said. “As family physicians, it is important that we counsel our patients on how to use these products properly, what vitamins and minerals they might not be getting enough of in their diet, and recommend appropriate dosages to resolve those deficiencies if they exist. It is also important to remind them that taking supplements does not replace the need to eat a healthy diet.”
The AAFP maintains complete editorial control over the content developed for FamilyDoctor.org to ensure creation of balanced, evidence-based content that can help consumers make informed decisions. The content is reviewed extensively by family physician editors, members of the AAFP Commission on Health of the Public and Science and credentialed expert consultants.