FDA allows DoD to distribute swine flu test to soldiers
ROCKVILLE, Md. The Food and Drug Administration will allow the Department of Defense to distribute a test for detecting the swine flu in soldiers serving overseas.
The FDA announced Tuesday that it had issued an emergency use authorization for the test, developed by the Centers for Disease Control and Prevention and called the CDC swH1N1 Influenza Real-Time RT-PCR. An EUA allows the use of unapproved medical products or unapproved uses of them during a declared public health emergency. The 2009 H1N1 influenza virus was declared a global pandemic this summer, making it the first influenza pandemic since 1968.
“The FDA worked quickly with the Defense Department to authorize the use of this test to better protect our troops,” FDA commissioner Margaret Hamburg said in a statement. “The test will aid in more rapid diagnosis of 2009 H1N1 influenza infections so that deployed troops can quickly begin appropriate medical treatment.”
NACDS utilizes Rapid Response program to dispute inaccurate assertions on drug importation
ALEXANDRIA, Va. The National Association of Chain Drug Stores implemented its Rapid Response Program, following a recent editorial on drug importation.
NACDS president and CEO Steve Anderson penned a response to the editor to the Delaware County Daily Times (Delaware County, Pa.) after an editorial ran on Aug. 19, which cited NACDS and asserted that chain drug stores should not be concerned about where prescription medications come from so long as they are less expensive for consumers to purchase.
“Pharmacies are convenient, accessible healthcare providers. Your neighborhood pharmacist counsels patients in obtaining the most cost effective and appropriate medications and therapies to improve their health outcomes,” Anderson wrote to the paper. “However, we do not believe that consumer safety should be compromised to achieve lower costs. Safety cannot be ensured in any system that allows for the personal importation of prescription medications. In addition, individuals who obtain prescription medications through a personal importation scheme do not have a licensed pharmacist available to consult with them about using the medications safely and effectively.”
The NACDS Rapid Response Program was created to address inaccurate or inappropriate portrayals of pharmacy, or call attention to an issue that impacts the pharmacy industry.
Tobacco Products Scientific Advisory Committee set in motion
ROCKVILLE, Md. The Food and Drug Administration has started exercising its newfound power to regulate tobacco.
The agency announced Tuesday the establishment of the Tobacco Products Scientific Advisory Committee as part of the implementation of the Family Smoking Prevention and Tobacco Control Act, which President Obama signed into law in June.
The committee will provide advice, information and recommendations to FDA commissioner Margaret Hamburg on health and other issues related to tobacco products. It will comprise 12 members, including nine medical, science and manufacturing technology experts and government officials who will each have a vote, and three industry representatives who will not.