Aussies take big pharma to court as FDA proposes pulling cold and flu meds

After the FDA proposed pulling some over-the-counter cold and flu medications from shelves in the US, an Australian law firm has launched a class action suit against pharmaceutical giant Johnson & Johnson, claiming that it has knowingly marketed and sold ineffective decongestants for years.

In 2006, the Combat Methamphetamine Epidemic Act came into effect in the US, which banned over-the-counter (OTC) sales of cold and flu medicines containing pseudoephedrine. The Act was designed to prevent, or at least make it harder for, people to use the chemical to make meth in at-home laboratories. Restrictions on access to pseudoephedrine were adopted in Australia at around the same time.

In OTC decongestants, pseudoephedrine was substituted with phenylephrine, which can’t be used to manufacture methamphetamine. It was marketed as an oral decongestant as effective as pseudoephedrine. Except that it isn’t. Now, on the back of a US FDA report into the effectiveness of oral phenylephrine, an Australian law firm has launched a class action against pharmaceutical giant Johnson & Johnson, the maker of a number of popular cold and flu medications.

“Johnson & Johnson has manufactured and marketed a medication that decades of evidence have shown doesn’t work as claimed, relying on outdated, fallible studies to sell the Australian public products that don’t do what they claim on the packet,” said Rebecca Jancauskas, director of the boutique class action law firm, JGA Saddler. “Customers should be able to confidently buy medicines that work as advertised, and when they don’t, the company involved should be held accountable.”

The Johnson & Johnson products, all of which contain phenylephrine and have been marketed as decongestants, include the Codral, Sudafed, and Benadryl ranges. Codral is a very familiar brand for most Australians, who have been bombarded with television commercials urging them to ‘soldier on with Codral’ for years.

The class action follows an announcement made by the FDA on November 7th, 2024, where it proposed removing oral phenylephrine as an active ingredient from OTC nasal decongestants. The proposal was made after the agency conducted an extensive review of all available data on the compound’s safety and effectiveness, including the historical data used to support the substitution of pseudoephedrine with phenylephrine. The FDA is keen to point out that the issue is one of phenylephrine’s effectiveness, not its safety. The FDA’s report is available here in PDF form.

“It is the FDA’s role to ensure that drugs are safe and effective,” said Patrizia Cavazzoni, MD, director of the agency’s Center for Drug Evaluation and Research (CDER). “Based on our review of available data, and consistent with the advice of the [Nonprescription Drug Advisory Committee], we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant.”

Currently, it is only a proposed administrative order, meaning companies can continue to market OTC phenylephrine-containing oral decongestants; the order doesn’t relate to nasal sprays containing the compound. The FDA is seeking public comment on the proposed order, which can be submitted at Monographs@FDA. If, after considering public comments, the FDA is of the opinion that phenylephrine is ineffective as a nasal decongestant, it will issue a final order removing the compound.

Meanwhile, JGA Saddler is urging all Australians who purchased phenylephrine-containing Johnson & Johnson products at any time since 2005 to register for the class action at coldandfluclassaction.com.au. The website has a full list of relevant medications.

“It’s unconscionable and deeply unethical for corporations to sell healthcare products while knowing they don’t work,” said Dr Jo-Lyn McKenzie, a leading Australian ear, nose and throat (ENT) specialist. “This practice erodes trust in a space that depends on consumer confidence. When patients feel misled or duped, they may begin to question the validity of evidence-based treatments that are genuinely effective.

“This situation serves as a reminder for Australian consumers to be cautious and informed,” McKenzie continued. “Rather than relying on direct-to-consumer advertising, take the time to have meaningful conversations with health professionals who can provide evidence-based recommendations.”

Source: JGA Saddler via Medianet