Tylenol Maker Planned To Avoid Life Saving Regulation

Tylenol Maker Planned To Avoid Life Saving Regulation

by Jeff Gerth and T. Christian Miller, ProPublica,

Recently filed court documents show the makers of Tylenol planned to enlist the White House and lawmakers to block the Food and Drug Administration from imposing tough new safety restrictions on acetaminophen, the iconic painkiller’s chief ingredient.

An executive with McNeil Consumer Healthcare 2013 which counts Tylenol as its flagship product 2013 told the board of directors for parent company Johnson and Johnson about a campaign to “influence the FDA” and block recommendations made by an agency advisory panel in 2009.

About 150 Americans a year die by accidentally taking too much acetaminophen, the active ingredient in Tylenol. The toll does not have to be so high. Read the story.

After Dr. Janet Woodcock, the FDA’s top drug regulator, put off meeting with McNeil executives, the company’s president, Peter Luther, sent out an August 2009 email.

“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 wrote to other top executives. “We have to make this our top priority and pull out all stops.”

Acetaminophen is considered safe when taken as directed. But in higher doses, the drug can cause liver damage and death. Studies show the drug is the leading cause of acute liver failure in the U.S., with fatalities increasing seven-fold in the decade between 1995 and 2005 to more than 200 a year.

“‘We’re going to involve key opinion leaders, and we’re going to get them to help us influence the FDA to disregard what the advisors said,'” a plaintiff’s lawyer told a New Jersey court late last month, describing the contents of internal corporate documents.

The previously unreported lobbying campaign was disclosed as part of a trial scheduled to start today in Atlantic City that promises to draw new scrutiny to McNeil’s efforts to protect its painkiller from additional regulation and disclosures about the full extent of its risks.

Tylenol photo

Photo by Au Kirk

The case pits McNeil against Regina Jackson, a New Jersey state employee who claims she was hospitalized with elevated liver enzymes after inadvertently exceeding the daily recommended dose for Extra Strength Tylenol for a couple of days.

The Atlantic City case is being watched closely as it is the first to come to trial of more than two hundred lawsuits currently pending in state and federal courts that allege McNeil knew its drug was potentially dangerous while promoting its safety.

As detailed in a 2013 investigation by ProPublica and This American Life, McNeil has opposed warning labels, dosage restrictions and even public awareness campaigns over concerns of profitability.

At the same time, the investigation found that the FDA has delayed implementing suggestions to improve the safety of acetaminophen, taken by tens of millions of Americans every week. Though hearings began more than 38 years ago, the agency has yet to finalize regulations for the safe use of the drug.

The long-running battle between McNeil and the FDA over the safety of one of the country’s most popular painkillers has been a key focus during the run up to the trial, which is expected to last four to six weeks.

As New Jersey Superior Court Judge Nelson C. Johnson told attorneys at a hearing on Aug. 31: “I think the jury is going to learn that the margin of safety for acetaminophen may be more narrow than the public understands.”

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