GSK Consumer Healthcare to FDA: Smoke out smokeless tobacco products
PARSIPPANY, N.J. GlaxoSmithKline Consumer Healthcare is urging the Food and Drug Administration to remove smokeless tobacco products from the market.
GSK Consumer Healthcare, which manufactures such nicotine-replacement therapy products as Nicorette and NicoDerm CQ, submitted a comment to the FDA on the potential public health impact of oral dissolvable tobacco products, "calling for such products to be withdrawn from the market until their sponsors can demonstrate to [the FDA] that their marketing is appropriate for the protection of public health," the company noted in a release Tuesday.
The announcement comes after the American Heart Association issued a policy statement on smokeless tobacco products, which said that such products are not safe alternatives to smoking and are associated with heart attack, stroke and certain cancers.
GSK Consumer Healthcare also said that it is committed to working with the FDA, in addition to medical and clinical experts to make smoking-cessation products safe and available for consumers.
In testimony, NACDS hails federal effort to simplify patient medication information
ROCKVILLE, Md. Federal efforts to simplify and standardize the information that patients receive with their prescription medications are laudable and should continue, the chain pharmacy lobby told Obama administration health officials Monday.
That message to the Food and Drug Administration came from the National Association of Chain Drug Stores, which has pushed for simpler patient package inserts, and on a more basic level, a single standard for conveying patient medication information. In a presentation to an FDA public hearing, NACDS VP government affairs and pharmacy adviser Kevin Nicholson said his group is “very pleased” that the agency appears to be moving toward a single information document with standardized format and content. He urged federal health officials to “continue to move toward this laudable goal with all reasonable haste.”
Under current FDA rules, Nicholson testified, “Patients receive several different types of information, developed by different sources that may be duplicative, incomplete, or difficult to read or understand.” The agency should work with NACDS, other pharmacy groups, manufacturers and patients themselves, he asserted, to come up with a “one document solution” to the knotty issue of PMI.
“Patients want a useful document, designed and written for them, that recognizes their information needs, that focuses concisely on critical information and that provides them with clear instructions on where to go for further advice and instruction,” Nicholson told the FDA panel. What’s more, he said, “The provision of multiple documents, containing redundant or even conflicting information, creates logistical and financial burdens for pharmacies that compromise effective patient counseling. It would be far more convenient, efficient and ultimately more effective for pharmacists to counsel patients by providing a single document that could easily be understood and facilitate a discussion concerning proper use of medication.”
That said, the NACDS executive noted, “our first recommendation is for FDA approval of all PMI. However, considering that FDA approval may not be feasible, we urge the agency to develop pilot programs to test various modes of ensuring standard content and format, including using simplified and modified PPIs as PMI. Any pilot program should also test different modes of patient access and delivery to the patient at the pharmacy, at the point of prescribing and via the Internet and/or electronic health records,” Nicholson concluded. “The key to success for PMI will be for continued collaboration among the agency, manufacturers, pharmacies, prescribers and consumer groups.”
In mid-2008, NACDS and seven other pharmacy and consumer organizations submitted a citizen petition to urge the FDA to move to “a concise, plain-language document for patients that would consolidate and replace the multiple written communications pharmacies currently are required to distribute to patients.” Adopting a standard, easier-to-understand medication information format, Nicholson told the agency, would help boost patient adherence, improve health outcomes and cut needless healthcare expenditures.
Target-funded study highlights cost of hunger in Minnesota
ST. PAUL, Minn. — A Target-funded study, conducted by the University of Minnesota Food Industry Center, found that hunger costs Minnesota residents more than $1.62 billion annually in direct and indirect health and education costs.
The study found that hunger leads to poorer health and education outcomes. For example, Minnesotans pay $925 million in such annual direct medical expenditures as hospitalizations and medications related to hunger, as well as $333 million annually in such indirect medical expenditures as treating headaches and colds. Furthermore, the study found hungry teens likely will develop depression, while hungry adults more likely will be obese or have Type 2 diabetes.
To close the hunger gap in the state, Target has pledged 60,000 lbs. of nonperishable items to the Hunger-Free Minnesota coalition, which seeks to change the way individuals, organizations and governments view and respond to hunger. Target’s donations are part of the company’s continuing involvement in hunger relief nationwide. The coalition includes six Minnesota food banks.
In related news, Minnesota Public Radio is partnering with the collaboration to underscore hunger awareness with events and radio and digital promotions.
Click here to learn more about Hunger-Free Minnesota.