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FDA Gets Court Order Barring Pharmaceutical Company From Selling Unapproved and Unsafe Drugs

By April 22, 2009July 17th, 2019Dangerous Drugs

A court has ordered Neligen Pharmaceuticals and its parent company, Advent Pharmaceuticals, to immediately cease distributing more than 50 of its drugs. According to an April 10 Associated Press story, the U.S. Food and Drug Administration has a permanent injunction against the companies, barring them from manufacturing and distributing drugs that are adulterated, misbranded or not approved by the FDA. The drugs are mainly prescription cough and cold medicines — but none have gone through the FDA approval process, so their safety, labeling and effectiveness are all in doubt.
According to the FDA press release, the companies (which also do business as Unigen Pharmaceuticals Inc.) agreed to a consent decree that requires them to destroy all of the drugs they currently have and stop manufacturing any new medications without FDA approval. They must hire outside experts to advise them on complying with regulatory standards, and may not resume operations until they have written permission from the FDA. After they do, the FDA may order them to stop their operations at any time if it finds a regulatory violation. The agency may fine the companies $1,000 per violation and up to $5,000 per day for any continuing legal violations.
As a defective prescription drug attorney, I am pleased to see the FDA cracking down on drug companies that abuse the public’s trust. Most of us assume that a drug wouldn’t even be on the market without FDA approval, so we trust that prescription medications are safe to use and adequately labeled. Companies that illegally bypass the FDA approval process betray that trust and expose consumers to potential serious injury from defective drugs or unannounced drug interactions. As a dangerous prescription medication lawyer, I have seen too many pharmaceutical companies’ cynical marketing tactics to believe that they would all be immune from the temptation to cut costs if they were not held accountable.
Based in St. Louis, Carey, Danis & Lowe represents people in Missouri, southern Illinois and throughout the United States. Our pharmaceutical liability lawyers sue on behalf of people who have lost a loved one or been seriously harmed because of a prescription or over-the-counter medication they thought they could trust. In these defective drug lawsuits, victims can win the money they need to pay for medical care or other bills related to the tainted medication; replace lost wages while they are out of work; and compensate them for a serious injury or illness, permanent disability or loss of a loved one. To learn more at a free, confidential consultation, please contact the Lowe Law Firm today.