The pharmaceutical industry is getting ready to bootstrap from the Supreme Court's IMS v. Sorrell decision overturning New Hampshire's privacy rules on datamining to get rid of the pesky FDA rules limiting their marketing activities to approved uses of drugs. As the Wall St. Journal reported recently, industry attorneys are gearing up to challenge longstanding FDA regulations that have been the source of dozens of legal settlements and even criminal convictions for deceptive marketing, most recently when Glaxo Smith Kline agreed to pay $3 Billion to the US government earlier this week to settle civil and criminal charges in the marketing of Avandia. Read the Pharmalot post and this article on Par Pharma.
This should be no surprise to anyone participating in the symposium on the Sorrell decision held last month at New Hampshire Law School, co-hosted by the Vermont Law School, where legal scholars and practitioners both supporting and disparaging of the US Supreme Court's decision agreed on its breadth and the potential that further litigation could expand the scope of the First Amendment to limit FDA marketing rules. Law professor Kevin Outterson addresses this issue in his post "The Last Drug Company Settlement for Off-Label Promotion" in his blog The Incidental Economist.
By the way, the industry is not going be content with letting this issue percolate through the courts. Leaked US negotiating textfrom recent TPPA trade negotiations (see more on this below) would require countries to allow drug companies to post "true information" on their websites and link to any other website in existence - including social media where so many problems have already cropped up.
For more information:
Sharon Anglin Treat, NLARx Executive Director
207-622-5597
