FDA practice will change if high court affirms off-label ruling

12/31/2012 | Philadelphia Inquirer, The

The Supreme Court could fundamentally alter a system designed to protect Americans from bad drugs if it affirms a federal appeals court decision protecting the off-label promotion of drugs, according to this article. The government has not decided whether to appeal the ruling, according to the Justice Department. PhRMA said "as the Supreme Court, and now the Second Circuit, have recently affirmed, speech by biopharmaceutical companies is protected by the First Amendment, and any policy that restricts speech by biopharmaceutical companies, while allowing others to freely engage in similar speech, is subject to heightened constitutional scrutiny."

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Philadelphia Inquirer, The

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