The United States Food and Drug Administration wants to know if both doctors and consumers are able to spot drug advertisements that use deceptive marketing tactics. According to Bloomberg BNA, the FDA has proposed a study that would examine the ability of physicians and patients to identify and report misleading statements or representations in prescription drug promotions. The study would examine the nature of these representations on drug manufacturer websites.
The study’s outline has been given to the White House Office of Management and Budget, which will review the material and determine whether or not it should be approved.
FDA Commissioner Scott Gottlieb said that the goal of the study is to ensure the agency’s advertising rules “protect consumers and help ensure that the information provided to them is useful for protecting their health. The FDA plays an important role in helping to make sure these presentations are truthful, balanced, and no misleading, and we need to study promotional material to constantly improve our oversight over these activities.”
However, the Public Citizen’s Health Research Group has argued that the study may not be as useful as the FDA has claimed. Sammy Almashat, a researcher with the group, claimed that not many consumers actually know when a prescription medication advertisement is deceptive. Consumers may not know what is in a prescription label and, further, they do not know what drug manufacturers must reveal in their online advertisements.
Almashat added, “We would like to point out that the FDA has a primary responsibility to enforce its own law and unfortunately, this has been happening less and less over the previous decade or so.”
Almashat further said that the amount of FDA warning letters that have been sent to manufacturers has also declined in recent years. The FDA has also sent fewer untitled letters that serve to inform manufacturers that their advertising practices violate rules and regulations. On the contrary, the amount of drug advertisements has not decreased at all, Almashat commented.
As of around the middle of December of 2017, the FDA had only sent three untitled and warning letters for advertising violations from its Office of Prescription Drug Promotion (OPDP).
In 2016, just 11 letters were sent from the OPDP.
Almashat commented, “Essentially there’s little to no enforcement going on of prescription drug promotion, especially direct-to-consumer advertising; because OPDP simply doesn’t have the resources to follow up on all these ads and when they do identify an ad, they have to go through this very lengthy review process before they can even send a letter.”
Almashat also noted that the FDA has not fined a company since 2007 for violating prescription drug advertising rules, even though it has the authority to do so. The FDA Amendments Act of 2007 provided the FDA with the power to fine companies when direct-to-consumer ads are deceptive or false. Frustrated, Almashat remarked, “The most the FDA is doing is issuing warning letters that have no consequences whatsoever for the company.”
The FDA’s advertising rules include guidelines on how drug names are displayed in advertisements and in promotions. These guidelines include rules on the size, placement, prominence, and how often a drug name may be used in an ad or promotional piece.
The FDA explained, “The disclosure of the product name in promotional materials is important for the proper identification of the products to ensure their safe and effective use.”
Drug manufacturers and injuries to consumers
If drug manufacturers are misleading or provide false information about the medications they release into the market, they may be held liable for damages in a products liability lawsuit.
In a products liability lawsuit, a claimant alleges that he or she has been injured by a defective product. Products liability lawsuits must include several elements for the victim to prevail. These elements are:
- The product was used as intended by the manufacturer.
- The victim suffered injuries.
- The product was defective.
- The victim’s injuries are directly related to the defect in the product.
Each element must be proven for a claim to move forward through the court system. If the evidence does not support one of the elements, the claim will fail, and the injury victim will not be qualified to any damages from the manufacturer.
Three types of product defects may be actionable in a products liability lawsuit.
Manufacturing errors occur while the product is being produced or distributed to consumers. For example, if a batch of medication was contaminated as it was being produced in a factory, consumers may be able to file a products liability lawsuit if the contamination caused injuries.
Design defects occur when the product is defective due to its structure or design. For example, consider a medication that includes a chemical that turns out to be harmful to many consumers. The chemical was not accidentally included in the manufacturing process; the manufacturer intended for the chemical to be present in the drug. Therefore, the defect is a design defect.
Marketing defects include a failure to warn about the potential harm that may occur while using a product. Marketing defects also encompass a lack of instructions with a product. For example, perhaps clinical trials reveal that medication may cause seizures in some patients if it interacts with other types of medication. However, no such warning is printed on the medication or in its packaging. If a number of consumers take the medication and suffer seizures, they may be entitled to damages.
In a products liability lawsuit, a variety of damages may be available. These damages include:
- Medical bills incurred due to injuries caused by the defective product.
- Lost wages due to the time the victim had to take off of work to recover.
- Pain and suffering.
- Emotional distress.
- The cost of any future medical care that may be required.
- The cost of alterations that are required in a victim’s home, such as chair lifts or wheelchair ramps.
- Loss of consortium, which is generally filed by the family members of a victim who are seeking compensation for the harm their relationships have suffered.
- Punitive damages, if the manufacturer’s behavior was especially reckless or egregious.
The types of damages available vary significantly depending on the individual facts of the case. To maximize the damages a victim recovers in a products liability claim, it is wise to consult with experienced products liability attorneys as soon as possible. These attorneys understand the complicated process of pursuing a products liability claim through the court system. Products liability claims have multiple deadlines and other types of legal requirements that must be met for a claim to proceed. If these requirements are not met, the case could be dismissed. For example, if a claimant waits too long to pursue legal action, the claim may be dismissed, and the claimant will be forever barred from seeking damages against the manufacturer.
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