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- Publication:2015/9/23
Johnson & Johnson ($JNJ) is gearing up for the first trial over claims that it promoted its blockbuster painkiller Tylenol without disclosing potentially dangerous side effects. And the company could face a rocky road, as new court documents show that J&J's McNeil Consumer Healthcare unit planned to lobby government officials to prevent the FDA from implementing safety restrictions, ProPublicareports.
Back in 2009, the agency called a meeting with independent experts to discuss Tylenol's safety, and the panel recommended a laundry list of reforms. In particular, experts said the FDA should reduce the total daily dose of acetaminophen, the active ingredient in J&J's big-selling Tylenol brand, and make extra-strength pills available only by prescription, ProPublica says.
None too pleased with the recommendations, McNeil hatched a plan to enlist the White House, the Office of Management and Budget, and lawmakers to "influence the FDA" and make sure regulators didn't follow the experts' advice, according to court filings seen by the watchdog group. Janet Woodcock, the FDA's top drug regulator, delayed meeting with McNeil to discuss the issue, prompting McNeil President Peter Luther to send an email to top execs rallying them to the cause.
"We're being too nice and too worried about stepping on FDA's toes. It may be time to let members of Congress to put some pressure on FDA," Luther said in the email, as quoted by ProPublica. "We have to make this our top priority and pull out all stops."