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U.S. regulators have backed off an attempt to limit Pacira Pharmaceuticals Inc.’s promotion of its pain drug, striking an agreement that’s likely to fan the flames of debate over free speech and drug marketing...After the drugmaker filed suit citing its constitutional rights to free speech, the Food and Drug Administration agreed to let Pacira broadly promote the medication Exparel (bupivacaine), rather than limiting its sales team to talking only about its use after bunion and hemorrhoid surgeries...The painkiller, a non-narcotic shot, hadn’t been studied for use with other surgeries, such as dental or orthopedic procedures. While its FDA-approved label notes that fact, it doesn’t explicitly say the medication can only be used for surgeries that have been studied. Pacira argued that meant it could market the treatment for broader use...FDA has faced difficulty in its efforts to police drug marketing. In August, a court ruled the agency couldn’t bar Amarin Corp. from talking to doctors about unapproved uses of its fish-oil pill. While doctors are already allowed to prescribe drugs off-label, drugmakers have been restricted on promoting such uses...Drugmakers are able to give doctors information about unapproved uses if doctors specifically request it. The Amarin ruling allows pharmaceutical companies to hand out the information more widely without a request…

It isn't too often that drugmakers and journalists go head to head in court. But as part of Amgen's latest legal battle, it's asking a federal judge to force a reporter to testify about an article he wrote that prompted a shareholder suit against the company and to spell out how he got information about an abandoned clinical trial…. shareholders claiming the company failed to disclose information about the study...

On May 19, 1983, Boots aired the first broadcast television commercial in the United States for a prescription drug, the pain reliever Rufen...Within 48 hours of the ad’s airing, the federal government told the company to take it down. And more than 30 years later, the fight over marketing prescription drugs directly to the public is still raging...Now, the American Medical Association, the largest doctors group in the United States, wants to stop direct-to-consumer advertising for prescription drugs in the belief that the ads encourage patients to seek medicines unnecessarily. But the effort to have drug ads banned alongside tobacco ads will face plenty of obstacles, none bigger than the First Amendment. Perhaps the most unusual thing about this decades-long saga is that it’s an issue at all...The United States is one of only two countries in the world to allow these ads. How did this little-noted example of American exceptionalism come to be?...It started with Boots.

Amarin won what was being called a First Amendment free speech victory for drugmakers. It got a federal court to say the FDA cannot bar Amarin from discussing off-label use of its fish-oil drug Vascepa for a wider group of patients than it is approved for…not clear how big a victory the ruling will be given it came in a lawsuit Amarin brought against the FDA as a defensive move.

On August 7, 2014, Federal District Court …blocked the Food and Drug Administration from enforcing restrictions on the marketing and promotion of off-label use of the drug icosapent ethyl (Vascepa),..If the case heralds the future of jurisprudence, responsibility for the oversight of the truthfulness of pharmaceutical promotions may shift from the nation’s leading science-based regulatory agency, the FDA, to the courts. If it does, the market for medications in the 21st century may revert to a time of more claims and less evidence to guide clinical care… Judges should refrain from using the First Amendment to undermine core regulatory functions.