MASSDEVICE ON CALL — EpiPen providers Pfizer (NYSE:PFE) and Mylan Specialty agreed to a $625,000 settlement to close the books on charges that they misled consumers about the efficacy of the emergency allergy medication dispenser.
The companies in April aired a television commercial, and ran a parallel print ad, that showed a mother and her son discussing the EpiPen system on the way to a birthday party.
The mother consoles her son by telling him that they’ll have a good time at the party, "even with your peanut allergy and a cake made of who-knows-what."
"Because we’re prepared, right Jake? With EpiPen," she says.
The companies pulled the ad after parents and allergy advocacy groups raised a ruckus, getting the attention of the FDA, which issued a warning letter on the product.
The FDA called the ad "false and misleading," warning that consumers may mistakenly think that the EpiPen may constitute all the medical help necessary to avert an emergency allergy situation.
"While EpiPen is an important medication that can provide emergency assistance for severe allergic reactions, these advertisements put consumers at risk by giving an overall misleading impression that the product alone removes the need to take precautionary measures," Massachusetts Attorney General Martha Coakley said in prepared remarks.
No light yet at the end of the Obamacare website tunnel
Healthcare-related websites continue to suffer outages, most recently taking out Regulations.gov this week for about 2 days, preventing constituents from accessing programs that allow them to "engage in the regulatory process."
AirXpanders lands Aussie approval for breast tissue expansion technology
AirXpanders landed a regulatory win Down Under for its AeroForm breast tissue expansion technology, a needle-free, patient-controlled technology that helps expand breast tissue in preparation for reconstructive surgery.
Direct Flow lands $50M debt financing from PDL BioPharma
California device maker Direct Flow Medical plans to use some of the cash from its new $50 million debt financing transaction from PDL BioPharma to fund commercialization of its transcatheter aortic valve technology.
FDA surveys providers on medical device and extreme weather
The FDA surveys health care providers in hopes of learning how prepared their medical devices are in the face of severe weather and storms that may affect the quality and safety of hospital technologies.