Johnson & Johnson (NYSE:JNJ) has used delaying tactics in its dealings with a Congressional committee looking into the recent recall of children’s Tylenol and other pediatric medicines, the chairman of the committee told The New York Times. Rep. Edolphus Towns, D-New York and chair of the House Committee on Oversight and Government Reform, said in some instances the company has provided misinformation. J&J has denied these allegations. The newspaper said Congressional investigators may turn to subpoenas to force the company to cooperate. Already, the U.S. Food and Drug Administration, which is investigating violations in quality controls behind the recalls, is considering criminal penalties and other actions against McNeil Consumer Healthcare, the J&J unit that produced the drugs.
The U.S. Food and Drug Administration has sent a 12-page warning letter to Pfizer (NYSE:PFE) for failing to quickly notify the agency of serious and unexpected potential side effects from some of its top drugs including Viagra, Lipitor, Lyrica, Reuters reported. The delays date back to 2004 and have grown worse in recent years, the FDA said. The agency told Pfizer it had not properly documented or investigated reported problems in patients after the drugs were approved for use. The agency has requested a meeting with the company to discuss the violations.
Chelsea Therapeutics International (NASDAQ:CHTP) said that the U.S. Food and Drug Administration requested that the company delay the initiation of its proposed mid-stage clinical study of its experimental rheumatoid arthritis drug CH-405. The agency wants additional detail from the preclinical studies previously submitted as part of the company's investigational new drug application. Chelsea anticipates specific written comments from the FDA in the next few weeks, but expects the data requested should be readily available, should not require additional studies and could be provided to the agency shortly after receiving the written response.