FDA, FTC take action against fradulent ads of products for swine flu
ROCKVILLE, Md. The Food and Drug Administration and Federal Trade Commission have taken action against Web sites that advertise fraudulent products for the 2009 H1N1 influenza virus, popularly known as swine flu.
The two agencies urged the public Friday to be wary of Web sites and other promotions for products that claim to diagnose, prevent, mitigate, treat or cure the virus and advising companies that operate the Web sites that they must take prompt action to correct or remove promotions of the products lest they face enforcement action.
“Consumers who purchase products to treat the novel 2009 H1N1 virus that are not approved, cleared or authorized by the FDA for the treatment or prevention of influenza risk their health and the health of their families,” FDA acting associate commissioner for regulatory affairs Michael Chappell said in a statement. “In conjunction with the Federal Trade Commission, the FDA has developed an aggressive strategy to identify, investigate and take regulatory or criminal action against individuals and businesses that wrongfully promote purported 2009 H1N1 influenza products in an attempt to take advantage of the current flu public health emergency.”
WHO raises pandemic alert level, tells nations to prepare
GENEVA The World Health Organization on Wednesday raised its influenza pandemic alert level from phase 4 to phase 5, meaning that all countries should immediately activate their pandemic preparedness plans.
“Influenza pandemics must be taken seriously precisely because of their capacity to spread rapidly to every country in the world,” stated Margaret Chan, WHO director general. “On the positive side, the world is better prepared for an influenza pandemic than at any time in history. … For the first time in history, we can track the evolution of a pandemic in real-time.”
According to WHO, nine countries so far have officially reported 148 cases of swine influenza A/H1N1 infection.
“All countries should immediately activate their pandemic preparedness plans. Countries should remain on high alert for unusual outbreaks of influenza-like illness and severe pneumonia,” she said. “This change to a higher phase of alert is a signal to governments, to ministries of health and other ministries, to the pharmaceutical industry and the business community that certain actions should now be undertaken with increased urgency, and at an accelerated pace.”
Chan reported that she has contacted both Roche and GlaxoSmithKline on their respective manufacturing capacities in the production of Tamiflu and Relenza, respectively.
“I have also reached out to influenza vaccine manufacturers that can contribute to the production of a pandemic vaccine,” she said.
The swine flu situation to date is characterized by the unknown, Chan warned.
“It is possible that the full clinical spectrum of this disease goes from mild illness to severe disease,” she said. “From past experience, we also know that influenza may cause mild disease in affluent countries, but more severe disease, with higher mortality, in developing countries. … We do not have all the answers right now, but we will get them.”
WHO has advised no restriction of regular travel or closure of borders, as of yet.
Missouri may leave Plan B distribution to pharmacy operators
JEFFERSON CITY, Mo. The Missouri legislator is leaning toward allowing pharmacy operators to decide on whether or not they stock the emergency contraceptive Plan B, according to published reports.
The House voted 115-43 on Tuesday to amend the provisions to professional licensing legislation that already cleared the Senate.
Missouri’s pharmacy licensing laws currently don’t address whether pharmacies must carry emergency contraceptives, the report stated.