Congress Members Urge FDA to Review Lotronex
Several members of Congress, including Sen. Orrin Hatch (R-Utah), who has received "substantial" financial backing from Glaxo Wellcome's political action committee, urged the FDA to fast-track its review of the company's irritable bowel syndrome drug Lotronex, the Raleigh News & Observer reports. Although clinical trials indicated that Lotronex could cause "serious" side effects, the FDA approved the drug in February on an "expedited, priority basis." Since then, the FDA has received reports of five deaths and dozens of cases of severe health problems resulting from complications with the drug, prompting the agency to consider additional safety measures. In a Jan. 21 letter, Hatch wrote, "Because of the number of people affected by (irritable bowel syndrome), an estimated 10% to 20% of the general population, it is important that the new drug Lotronex be reviewed as expeditiously as is possible." The FDA approved Lotronex about two weeks later for the treatment of certain forms of irritable bowel syndrome in women, but agency officials deny that requests from Congress influenced their decision. "There is nothing unusual about members of Congress writing letters," FDA spokesperson Jason Brodsky said, adding that the number of letters written on behalf of Lotronex "pales in comparison" to the number written on behalf of some other drugs. Glaxo spokesperson Ramona DuBose declined to comment on the Hatch letter, but she said that letters from Congress only reinforced the seriousness of irritable bowel syndrome and the need for a safe and effective treatment. "We are absolutely certain beyond any doubt that the FDA's decision to approve Lotronex was based solely on the agency's review of the data from clinical trials and on the counsel of its advisory committee," DuBose added. Hatch spokesperson Christopher Rosche explained that the Utah senator wrote the letter in response to a request for help from a Utah woman who suffered from irritable bowel syndrome, adding that contributions from Glaxo's PAC played no role in the decision to write the FDA. "This was a very routine constituent letter. I doubt very much if that had any impact on the FDA's final determination," he concluded. Glaxo's PAC has donated $15,000 to Hatch's presidential and Senate campaigns since 1998, according to Federal Election Commission records. In addition, Glaxo CEO Robert Ingram and his wife contributed $4,000 during the same period. However, most of the letters sent to the FDA on behalf of Lotronex came from Democratic members of Congress -- including Sens. Barbara Mikulski (D-Md.) and Herb Kohl (D-Wis.) and Rep. Barney Frank (D-Mass.), and members of the Congressional Caucus on Women's Issues including Louise Slaughter (D-N.Y.), Nancy Pelosi (D-Calif.) and Rosa DeLauro (D-Conn.). Glaxo's PAC has contributed $9,500 to Mikulski "over the past two election cycles," but there is "no record" of contributions during that period to Frank, Kohl and "most of the other members" writing the FDA about Lotronex (Krueger, Raleigh News & Observer, 11/15).