Understanding PFAS: Insights from Vineet Dubey’s Presentation at LACBA
Co-founder Vineet Dubey, known for his success in holding corporations accountable for the products they sell that contain dangerous, cancer-causing chemicals, was a featured speaker at the Los Angeles County Bar Association’s Prop. 65 Panel held Dec. 1.
Vineet introduced the audience to what PFAS are, why the chemicals haven’t been detectable until recently, and how the fight over PFAS chemicals in water and consumer goods will likely play out in California courts under Prop. 65. Here’s how that conversation went:
Over-the-Counter Risks: Dubey’s Critique of FDA’s Drug Recall Practices
In his latest column for Law360, Vineet argues that manufacturers of many over-the-counter health products, such as eye drops and decongestants, shouldn’t so easily be let off the hook by the FDA when their products cause injuries or do not perform as advertised. He lays out the case below. (Reprinted with permission.)
FDA And Companies Must Move Quickly On Drug Recalls
By Vineet Dubey Law360
Drugstore shelves are loaded with over-the-counter products that consumers regularly purchase and use without a second thought. Every household’s medicine cabinet holds cough syrups, decongestants and eye drops, because every household experiences coughs, colds and dry eyes.
But how do we know if those products actually provide relief for our ailments? Could they actually hurt us? Why would consumers pay good money for drug products that might be ineffective — or, even worse, harm them?
On Oct. 29, the U.S. Food and Drug Administration issued an alert for 26 brands of eye drops sold at Target Corp., CVS Health Corp. and Rite Aid Corp. stores.[1] The eye drops, marketed under off-brand names including CVS, Rite Aid, Leader, Rugby and Velocity, were manufactured under potentially unsanitary conditions and could cause infections leading to blindness.[2]
The eyedrops were manufactured in a foreign factory, where inspectors documented factory workers not wearing masks, gloves and gowns and working barefoot in areas that were supposed to be sterile.[3] A manager told FDA officials that “this is their standard practice,” according to reports. Elsewhere in the factory, FDA staff noted cracked floors, water stains and peeling paint on walls and ceilings.
Some of these unsanitary products might still be sitting on store shelves. An FDA alert is merely a warning that retailers should pull products and an advisory to the public that they should not use an affected product.
The FDA eye drop notice included assurances that nationally recognized name-brand products were not affected by the recall, and would continue to be safe to use. For consumers who — for budgetary or other reasons — choose to purchase generic products, this is little comfort.
Store-brand drug products often include captions touting their comparability to higher-priced name-brand products. A customer seeking to save money does not expect to put their eyesight at risk by using off-brand eye drops. Although no adverse reactions were reported by the FDA and the notice was both widespread and timely, who would bear liability if a user went blind?
Presumably, the manufacturer who failed to meet sanitation standards and the retailer whose name appeared on the product label would be held legally responsible for the resultant injury. But for reasons explained below, the FDA, charged with ensuring the safety and efficacy of all regulated drugs, they would face no consequences.
And when a drug is simply ineffective, there is no urgency to act. Indeed, there may be no action at all — for years or even decades.
Hazardous and Ineffective Products
On Sept. 12, 2023, a panel of experts appointed by the FDA unanimously voted against the effectiveness of oral over-the-counter medicines made with phenylephrine, a decongestant ingredient widely used in cold and cough syrups.[4] The vote could finally lead to the removal of the ingredient from products such as Benadryl, Advil and Tylenol.
But this vote had been a long time coming. Researchers first reported that phenylephrine did not work three decades ago.[5] They reviewed memos to the FDA from the 1960s and 1970s that had not been peer-reviewed, ran data analysis and concluded that the drug was no better than a placebo.[6]
Granted, an ineffective decongestant will not cause users to go blind. But consumers who spend good money to alleviate their bad colds should also expect to be protected by the government watchdog.
Consumers shelled out significant amounts over many decades, enriching manufacturers who knew the drugs were worthless, who had the ability to reformulate those drugs, and who failed to notify the public or issue recalls.
Now, with the outside panel’s vote and significant press coverage, the FDA is likely to pull the drugs off the market. But it should not have taken almost half a century to get to this
point.
Voluntary Recall Process
The entire premise of the FDA’s recall system is that it is voluntary. The operative law — Title 21 of the Code of Federal Regulations, Section 7, subpart C7 — says that manufacturers and distributors have the “responsibility to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise defective.”
In fact, the FDA often will not issue a public notice when a product is subject to recall, relying instead on doctors, pharmacists and drug manufacturers to alert patients to potential risks. For products that are in wide distribution, such as over-the-counter eye drops, or whose use poses serious health hazards, the agency is more likely to notify the public and the news media.
Drug recalls are often initiated by companies that discover safety violations or other potential problems, but they may also be requested by the FDA.[8] If the FDA believes that a company has failed to adequately notify the public about a recall, it may elect to do so to protect patients and consumers.
The FDA’s primary role in any recall — whether initiated by the company or the agency — is to oversee the affected company’s recall strategy, assess its adequacy, and classify the recall as Class I, Class II, or Class III, based on the level of hazard to patients. If the agency finds that a company’s recall efforts are ineffective, it may ask the company to take additional steps to protect patient health.
The recall regulations note that the FDA could initiate “court action for removing or correcting violative, distributed products,” but that recall is the better option in most cases, offering “better protection for consumers than seizure, when many lots of product have been widely distributed.”[9]
In compliance with the rules, the FDA has established specific procedures for monitoring recalls and assessing the adequacy of a firm’s recall efforts. In March 2022, the agency issued nonbinding recommendations for initiating voluntary recalls.[10] It has also posted video guidance to help companies prepare for and respond to product recalls.[11]
Room for Improvement
The FDA’s drug recall process is a mixed bag. When there is an imminent threat to consumer health and safety, as was the case with over-the-counter eye drops, the response can be timely and effective. Notices were immediate and widespread, companies moved quickly to remove products from shelves and consumers appear to have escaped injury.
But when only pocketbooks are at risk — as in the phenylephrine case — feet may be dragged for decades. Companies apparently have little to no responsibility for taking action on ineffective drugs, and the FDA may look the other way until forced by scientific consensus to do something.
When a drug doesn’t work as promised or as expected — whether or not lives and health are at stake — the public should be notified, and the product should be discontinued. The same rules that apply to tainted eye drops should extend to ineffective medications containing unneeded ingredients.
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November 18, 2024