Lewes, DE -- (SBWIRE) -- 03/10/2014 -- Pharmaceutical companies are facing far greater opportunities and challenges than the Affordable Care Act (ACA). Healthcare reform in the US could have sought significant monetary contributions from drugmakers, but this did not materialise in a meaningful sense, primarily due to industry cooperation when the legislation was being drafted. Of greater near-term concern to pharmaceutical companies is the shifting pricing and reimbursement landscape globally.
>> Pharmaceuticals: US$341.2bn in 2013 to US$342.7bn in 2014; 0.4% growth in local currency terms. Forecast slightly up from Q114 due to industry factors.
>> Healthcare: US$2,978bn in 2013 to US$3,157bn in 2014; +6.0%
Key Trends And Developments
>> In February 2014, the FDA was considering significant changes to OTC medicine regulations, making it easier to react to new information on a product's safety or recommended use. Current rules are over 40 years old and do not require manufacturers to get approval as long as the main ingredient had previously been deemed safe and effective for that entire category of medicines. A public hearing on the matter will take place in late March 2014.
>> In January 2014, the FDA acted to prohibit Ranbaxy Laboratories from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug products. The agency noted that the Toansa facility is now subject to certain terms of a consent decree of permanent injunction entered against Ranbaxy in January 2012. The decree contains, amongst other things, provisions to ensure compliance with cGMP requirements at Ranbaxy facilities in Paonta Sahib and Dewas, India, as well as provisions to address data integrity issues at those facilities. In September 2013, the FDA added Ranbaxy's Mohali facility to the cGMP provisions of the decree.
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