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  • Regulatory NewsRegulatory News

    FDA Ban on CFCs in Asthma Inhalers Raised Costs for Patients, New Study Finds

    An environmental law which required the US Food and Drug Administration (FDA) to revoke the approval of products containing chlorofluorocarbons (CFCs) significantly raised the out-of-pocket expenses borne by patients with asthma, a new study published in the medical journal JAMA Internal Medicine . Background In 1987, the US signed an environmental agreement known as the  Montreal Protocol , an international agreement meant to preserve the ozone layer by phasing out ...
  • Regulatory NewsRegulatory News

    Australian Regulator Says Smoking Device too Similar to Inhaler

    The Therapeutic Goods Administration (TGA) this week issued a safety advisory over two smoking devices that bear strong resemblance to metered dose inhalers used to treat asthma and other medical conditions. TGA says the devices, known as the Puffit and Puffix-X, are designed to “burn vegetable material such as herbs or tobacco,” which is then inhaled as smoke. TGA’s Warning The agency fears that the products’ similarity to metered dose inhalers could create con...
  • FDA Prepares to Remove Last of CFC-Containing Products from Market

    US regulators are once again warning consumers that they are nearing the end of a multi-year process to phase out all medical products containing chlorofluorocarbons (CFCs), a propellant used in some asthma inhalers that is more broadly linked to the depletion of the ozone layer. Background The removal of the inhalers from the market has long been planned under an environmental protocol signed by the US in 1987 known as the Montreal Protocol, an international agre...
  • Environmental Regulations to Soon Force Two Asthma Products off Market

    A new missive to US consumers from the US Food and Drug Administration (FDA) warns them that, after a lengthy series of delays, they should prepare for the removal of the final two asthma inhalers containing chloroflurocarbon (CFC)-based propellants as of August 2013. Background The removal of the inhalers from the market has long been planned and has almost as long been a source of contention, particularly among some prominent legislators with authority over FDA. The ...
  • New Bill Seeks to Overturn EPA, FDA Ban of OTC Inhalers

    There are the regulations well-known to life science companies-those of the US Food and Drug Administration (FDA), for example. Then there are those regulations of lesser notoriety, though potentially of no less consequence. A bill introduced in the US House of Representatives on 25 July by Rep. Michael Burgess (R-TX) speaks to the impact of one of those lesser-known regulations. Burgess's bill directs the Environmental Protection Agency (EPA) to allow for the "distribut...