FDA GETTING MUCH NEEDED OVERHAUL The Food and Drug Administration is overhauling the most common way medical device manufacturers bring their products to market in an attempt to advance new technol- ogies faster and fairer. Since 1976, manufacturers have been able to pursue an expedited approval process if they could prove new products were substantially equivalent to those that were grandfathered in when Congress established the pathway, known as 510(k). What this means is some new products entering the market are comparing themselves to technology that’s decades old, yes decades. The FDA is now looking to retire those predicates, or older base products, which sometimes aren’t even on the market anymore, and make it easier for companies to establish new ones. The new and improved 510(k) approval process, has the FDA wanting companies to base new products on devices that are no older than 10 years old. The agency is also consider- ing publicizing devices and manufacturers whose products are based on even older technology. Early next year, the FDA plans to finalize its guidance on establishing an alternative accelerated pathway for new products.
CVS AND AETNA MERGER APPROVED
CVS Health and Aetna have received the final state approval needed to complete their $69 billion merger deal and things should be finalized before the end of November.
CVS and Aetna announced the deal last December. The Department of Justice granted preliminary approval in October on the condition that CVS and Aetna removed overlap between their Medicare Part D plans. Aetna said it would sell its Medicare Part D drug plan business to WellCare Health Plans for an undisclosed amount to ease the concerns.
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SPOTLIGHT ON BUSINESS MAGAZINE • NOVEMBER 2018
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