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, ProPublica reports.
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.
|FDA's Janet Woodcock|
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."
McNeil is keeping quiet about the alleged lobbying efforts, declining to comment on pretrial proceedings to ProPublica, but saying that it would defend itself at trial. "The company has acted appropriately, responsibly and in the best interests regarding Tylenol, which has one of the most favorable safety profiles among OTC pain relievers," company spokeswomen Jodie Wertheim said (as quoted by ProPublica).
But not everyone is as confident about Tylenol's safety. Up to 80,000 people overdose on Tylenol a year, the FDA said in 2013, and about 500 cases are fatal. Bearing those numbers in mind, the agency has already taken a few steps to crack down on the drug. After weighing the recommendations of its expert panel, the FDA in 2010 decided to lower the daily recommended dose for Tylenol and put safety warnings on the drug's label. In 2011, J&J changed dosing instructions on the label of Extra Strength Tylenol from 8 pills a day to 6 "to help encourage appropriate acetaminophen use and reduce the risk of accidental overdose," the company said at the time.
But the agency stopped short of making an extra-strength version of the med available only by prescription, suggesting a compromise between McNeil and the FDA. Woodcock declined to comment because the company's lawsuit is still pending, she told ProPublica.
Meanwhile, McNeil still faces more than two hundred lawsuits pending in state and federal courts over Tylenol safety, including the first to go to trial in Atlantic City. The company has a lot riding on the case as it defends sales for its product. McNeil rakes in about $400 million in revenue for its extra-strength line, compared with about $14 million from its regular strength med, R. Clay Milling, one of the plaintiff's attorneys in the Atlantic City case, told ProPublica.
"This petitioning of the government is not just petitioning of the government. It goes right to what the heart of this case is, saving Extra Strength Tylenol, their billion-dollar product," Milling told the judge, as quoted by ProPublica.
- read the ProPublica story
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