The House Committee on Oversight and Government Reform will hold a hearing this morning at 10 am to investigate the recent recall of more than 40 of McNeil Healthcare’s infants’ and children’s medications. See the link on the committee’s website to connect to the live webcast.
Testimony by Joshua Sharfstein, FDA’s principal deputy commissioner, and Colleen Goggins, worldwide chairman of Johnson & Johnson’s Consumer Group, will shed light on “discrepencies” between FDA’s and McNeil’s accounts of the recall noted by the committee during its investigation. The committee invited William C. Weldon, chairman and CEO of Johnson & Johnson, and FDA Commissioner Margaret Hamburg to testify at the hearing, but neither could attend.
On a related, sad note, the Washington Post reported yesterday that the original marketer of Tylenol, Robert L. McNeil Jr., died of a heart ailment last Thursday at age 94. The Post article includes interesting details about his life, including the following:
- In 1938, McNeil was hired by his family’s company, McNeil Laboratories, which was started in 1879 by his grandfather in Philadelphia.
- He proposed to market prescription Tylenol as an aspirin alternative in 1951, and in 1955 the company introduced Tylenol Elixir for Children.
- McNeil and his brother sold the company to Johnson & Johnson in 1959 for $30 million in stock, and Tylenol became available over the counter shortly afterward.
- He was a director of the American Pharmaceutical Manufacturers Association. In 2005, he received the American Institute of Chemists’ Gold Medal Award.
It’s a shame that McNeil’s signature product has had such difficulties recently, which has likely negatively affected the company’s reputation. In addition to correcting the manufacturing issues, Johnson & Johnson is working to repair its image in the public eye. In a May 7 open letter, Weldon said the recalls were “…a disappointment to me, and to the employees of the Johnson & Johnson Family of Companies. You can be confident that we will make whatever changes are needed at McNeil to fully restore the quality of its manufacturing.” He added, “We will work hard to earn back your confidence.”
On Tuesday, a post on the company’s blog, JNJ BTW, outlined several steps the company will take to improve drug quality and manufacturing conditions. Three major points of the company statement are 1) that McNeil hired an independent third-party consultant to fix problems at the Fort Washington, PA, facility (where the recalled products were produced), 2) that the company has stepped up employee training and created new procedures for conducting quality investigations, and 3) that the company has made “significant organizational changes” so it can improve the company’s quality and operations leadership. Finally, McNeil stated it is developing a comprehensive plan for quality improvements that it will share with FDA by July 15. This plan includes implementing governance and management controls, providing training and a culture of compliance, conducting a full assessment and improvements, and providing frequent updates to FDA.