Suspension of disbelief is a key element to the success of many dramas, so it seems fitting that even as the results of one of the most dramatic elections in US history became apparent, hardly anyone could believe it. The Coastal Elites – feeling every bit like the blue parentheses the country’s population centers resemble on the electoral map – can be forgiven for aching like a drug sponsor does when a product is rejected by FDA even after it’s been endorsed by an agency advisory committee. Their data told them it would succeed, and they won a popular vote, but they are still left profoundly disappointed and wondering what to do next. Sometimes life itself can resemble being regulated by FDA.
Now that Donald Trump has been approved for domestic and external use, the pharmaceutical industry will need to be ready for the benefits and side effects of that prescription. The efficacy is immediate, but the challenges are significant as well. Last year, we recommended that companies begin preparing for the possibility of a Trump presidency but the circus atmosphere of the ensuing campaign made such reasoned forethought difficult at best
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