Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

HOECHST’s MERITAL: JUSTICE DEPARTMENT ENDING FOUR-YEAR INVESTIGATION

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in Italy in 1981 and the other in France in 1984, but FDA was notified of both cases in 1986, after the product was withdrawn.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.

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth

UsernamePublicRestriction

Register

LL1126093

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel