A Swiss plasma product manufacturer’s U.S. division, Octapharma USA, has received a warning letter from the U.S. Food and Drug Administration over what was described as “false and misleading” advertisements in a journal and product catalog.
The U.S. regulator said in the April 10 letter that an ad for its octagam immune globulin intravenous 5% published in “BioSupply Trends Quarterly” and the BDI Pharma Product Catalog left out a boxed warning that the product can cause serious adverse reactions, including death. The drug is used to treat immune system disorders.
The FDA also referenced other instances when the black box warning was excluded from promotional materials. It referred to another warning letter in 2005, when Hoboken, New Jersey-based Octapharma USA failed to include the risk information.
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“We request that you immediately cease the dissemination of violative promotional materials described … and the same or similar materials for Octagam,” the letter said.
The letter requests the company to stop disseminating certain promotional materials. It is also asking the company to detail how it will communicate corrective messages over the product’s safety.
Octapharma voluntarily pulled octagam 5%, along with its other octagam products, from the market in August 2010 after an increase in thromboembolic events, which can include stroke, myocardial infarction, pulmonary embolism and deep vein thrombosis. It reintroduced the drug in November last year with FDA approval after the company made changes to the manufacturing process for octagam 5% and the company implemented a quality-control test on every batch of the product released to the market.
At the time the company announced octagam 5%’s reintroduction to the U.S. market, Octapharma USA President Flemming Nielsen said in a company statement: “Our collaboration with the FDA over the last year has enhanced awareness of the industry-wide concerns regarding procoagulant activity and TEEs. Octapharma has always believed that patient safety comes first, so the octagam 5% that we will return to the U.S. market in a few weeks will enjoy the highest level of safety scrutiny available today …”
