Here’s why direct-to-consumer drug ads need FDA oversight

Many physicians in different fields have voiced criticisms against direct-to-consumer (DTC) prescription drug ads. First, a 2013 survey found that 74 percent of physicians believe DTC drug ads overemphasize the benefits of the drugs and misinform patients. Steven Nissen, a Cleveland Clinic cardiologist, interviewed by Rebecca Ruiz on DTC prescription drug ads states, “It’s almost impossible for the public to actually parse the ads and come to their own independent conclusions.” This implies that DTC prescription drug ads may be worded or presented in such a manner as to convince viewers of the drug’s usefulness and negate personal conclusions about the drug.

Second, Harvard Medical School internist, Jerome Avorn, states that drug manufacturers have excessively pushed the envelope with appealing messages and fewer descriptions of the risks. An infamous example is Vioxx, a Merck and Co manufactured and FDA-approved drug that was withdrawn in 2004 for elevating the risk of heart attack and stroke. It was widely accepted by physicians for treating acute or chronic pain and heavily commercialized.

In 2008, Merck reached a $58 million settlement with 30 state attorney generals over the ads for Vioxx. And third, physicians at the Interim Meeting of the American Medical Association on November 17, 2015, called for a ban on DTC prescription drugs ads. This ban was motivated by various reasons for which two are aforementioned. Despite this call to a ban two years ago, Kaiser Health News reported in March 2017 that spending on DTC prescription drug ads has increased by 62 percent since 2012. Additionally, the cost of prescription drugs is rising relative to spending on DTC prescription drug ads. In 2016, $5.2 billion was spent on DTC prescription drug ads by the drug industry. These criticisms are worth addressing because, in essence, every prescription drug ad is a tool. When the tool is utilized for wrongful purposes for profit, it has immeasurable financial and health costs to patients. However, when DTC prescription drug ads are utilized in a rightful manner, it becomes an effective tool for meeting patient needs and generating revenue for future drug research.

A systemic solution to addressing criticisms against DTC prescription drug ads

DTC prescription drugs ads are, for the most part, a freely utilized tool available for drug manufacturers. The FDA regulates prescription drugs ads; however, it does not review and approve all drug ads before their release. Federal law does not require that drug companies submit these ads for approval, only that the drugs are approved by the FDA. Federal law also doesn’t allow the ban on ads of drugs with serious adverse risks nor the use of hard-to-understand medical language in ads. Furthermore, DTC prescription drug ads are not required to tell you the cost of the drug, whether a generic version is available that has fewer risks, the biological mechanism or even if a change in behavior can result in a better quality of life equivalent to what the drug can afford a patient. Lastly, the FDA is also not involved in the creation of any drug ads and, therefore, cannot see if any violations such as subjective coercions are intentionally made for the generation of profit for drug manufacturers at the expense of the patient. Therefore, a sound solution is to promote the FDA’s role as a governing body with oversight and approval rights over DTC prescription drug ads.

Three advantages of allowing the FDA a governing role over DTC prescription drug ads

First, if federal law allows the FDA to approve prescription drug ads based on whether the data supports the ads’ content, it creates an additional safety net to prevent unwanted and costly health circumstances for patients. The FDA can also regulate the appropriate content on the ad that is feasible for consumers to fully understand whether or not the drug is suitable for their needs. This aids in eliminating overuse of drugs and confusion by consumers about the drugs they see in the ads. Second, a central governing role by the FDA that involves physicians in the decision-making process allows for physicians to have a role over the drug ads their patients see on a daily basis. If the FDA and physicians work in tandem with drug companies and their ad firms, it allows for a wholesome process to make and approve ads that satisfy physician concerns, patient safety, and manufacturers’ demands. Third, when the FDA is allowed some oversight into the approval of drug ads, it eliminates the potential for social media-driven advertising as well. This is inspired by Kim Kardashian’s promotion of Diclegis on July 20, 2015.

Diclegis is a drug manufactured by Duchesnay for alleviating nausea and vomiting in pregnant women. The original Instagram post by Kim Kardashian didn’t provide details of risks such as urinary retention and somnolence that are associated with Diclegis. The FDA had to intervene in this circumstance by notifying Duchesnay of the violation and prompting Kim Kardashian to alter the post to add the missing details.

Hence, allowing the FDA oversight and approval rights will aid in eliminating future incorrect endorsements as well as ensuring patient safety. These are systemic changes that allow the FDA oversight in governing DTC prescription drug ads. Ultimately, it also aids drug manufacturers to avoid legal violations and for physicians and their patients to effectively utilize the drug without the drawbacks of overuse or misconceptions.

Zachariah Tman is a public health student.

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