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Executive Summary

HOECHST's MERITAL: JUSTICE DEPARTMENT ENDING FOUR-YEAR INVESTIGATION into the reporting of adverse reactions in connection with the prescription antidepressant product after Hoechst AG agreed to pay fines related to four charges filed in Newark federal court Dec. 12. "The agreement resolves four misdemeanor charges against Hoechst AG relating to the unintentional failure to make timely reports of adverse reactions involving two patients who received the drug in Europe," the company said in a same-day press release. "Hoechst AG agreed to pay a fine of $202,000." The investigation, carried out by the U.S. Attorney in Newark, New Jersey, was an outgrowth of hearings held by Rep. Weiss (D-N.Y.) in 1986. The inquiry began following Hoechst's 1986 worldwide withdrawal of Merital (nomifensine) on reports of cases of hemolytic anemia in Europe. The product, which was launched in the U.S. in the summer of 1985, was marketed in this country for only a few months. Hoechst AG's U.S. subsidiary Hoechst-Roussel Pharmaceuticals was not a target of the investigation, according to the release. The U.S. Attorney's Office noted that the charges "mark the first time that a foreign drug manufacturer has been prosecuted for failing to provide the FDA with reports of adverse events occurring outside the United States." Specifically, the Justice Department's charges involved two cases of hemolytic anemia, both involving death. One case was transmitted to FDA with a statement saying that there was insufficient information for a full report. The second case, a suicide, was deemed by the company to be unreportable. According to the New Jersey U.S. District Attorney's Office, one case occurred in Italy in 1981 and the other in France in 1984, but FDA was notified of both cases in 1986, after the product was withdrawn. Hoechst AG was charged with failing to report the deaths "first while Merital was being tested and then again after it was approved." The company had reported other instances of hemolytic anemia that had less serious consequences. Hoechst AG asserted that the government's charges "were based on ambiguous provisions of the FDA's regulations that were clarified after the drug was withdrawn from the market, and that physicians in the U.S. were informed of the possibility of fatal cases of hemolytic anemia when the drug was introduced to the U.S. market in July 1985." The U.S. Attorney's office was assisted in the investigation by FDA compliance staff in Newark and other FDA personnel.

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