Idaho Dispatch has been asked by some citizens why the COVID-19 vaccine commercials from the Idaho Department of Health and Welfare do not contain risk disclosures.
First, Idaho Dispatch did reach out to the IDHW for comment on their commercials specifically. Before we mention what the IDHW said in their statement, we wanted to discuss some aspects of the commercials themselves and what is required according to the research we found.
The Food and Drug Administration is the government agency that oversees prescription drug commercials.
According to the FDA’s website, there are different advertising requirements for prescription drugs and over-the-counter drugs. The FDA is responsible for the over-the-counter drug advertising requirements.
Here is what part of the FDA website says about “Product Claim Ads” which purport to have specific benefits:
Product claim ads are the only type of ads that name a drug and discuss its benefits and risks. However, these ads must not be false or misleading in any way. We encourage companies to use understandable language throughout product claim ads that are directed to consumers.
A former FDA commissioner, Dr. Robert Califf, told CNBC in May 2021 that if the vaccine manufacturers did advertise on TV, they would have to disclose both benefits and risks associated with their products. However, at the time, all of the manufacturers were still under Emergency Use Authorization, and advertising was not allowed.
Because the IDHW ads do not promote a specific product, they do not fall into the same category as the manufacturer’s advertising requirements.
The IDHW ads that Idaho Dispatch has reviewed contain Idahoans explaining why they got a COVID-19 vaccine. The ads also state that the COVID-19 vaccines are “safe and effective.” However, none of the ads we reviewed had any disclosure about potential risk or a typical drug disclaimer to “talk to your doctor” about getting the COVID-19 vaccine(s).
Idaho Dispatch spoke with Greg Hahn, a Public Information Officer, about the advertisements and asked about the “risk” disclaimer and why they didn’t put one in. Here is what Hahn said,
One of my colleagues passed your question about drug disclaimers along. In answer, federal regulations do not dictate generic PSAs on getting vaccinated or seeking medical assistance when faced with a specific condition. These are considered “help-seeking” adverts which are not regulated by the FDA because they don’t promote a specific drug.
Hahn discusses in his statement “help-seeking” advertisements that do not require risk disclosure according to the FDA.
From the FDA’s website, here is what they say about the “help-seeking” ads:
Help-seeking ads describe a disease or condition but do not recommend or suggest a specific drug treatment. Some examples of diseases or conditions discussed in help-seeking ads include allergies, asthma, erectile dysfunction, high cholesterol, and osteoporosis. The ads encourage people with these symptoms to talk to their doctor. Help-seeking ads may include a drug company’s name and may also provide a telephone number to call for more information.
When done properly, help-seeking ads are not considered to be drug ads. Therefore, we do not regulate true help-seeking ads, but the FTC does regulate them. If an ad recommends or suggests the use of a specific drug, however, it is considered a product claim ad that must comply with FDA rules.
Because the IDHW ads do not recommend a specific drug, there is no requirement to disclose potential risks.
In a follow-up question, Idaho DIspatch asked Hahn whether or not the agency had considered risk disclosure from the COVID-19 vaccine(s) even if they were not required by law. Here is what Hahn told us:
In short, no.
The Department of Health and Welfare follows the recommendations of the Centers for Disease Control and Prevention, which posts comprehensive information about vaccines including efficacy, risks, and approval processes. The efficacy, risks and approval processes are also covered on our website.
On the IDHW COVID-19 vaccine portion of their website, there is some information listed.
For instance, on the “AFTER YOU GET VACCINATED” section, here is what is listed for potential side effects:
COVID-19 vaccines may cause mild to moderate reactions, including pain or swelling at the injection site, muscle pain, headaches, and mild to moderate fevers. These are normal signs the body is producing an immune response. You may report adverse events following vaccination at https://vaers.hhs.gov/
If you scroll to the bottom of the COVID-19 vaccine page, a “Frequently Asked Questions” link is there. When you click on that link, there is another section titled “Vaccine safety and efficacy” and another section titled “Side effects/reactions to COVID-19 vaccine.”
Here is a screenshot of the questions listed on the website, but please note that you will have to click on the link here to go and read the answers to each of the questions (story continues below):
Another question some Idahoans had was whether Idaho was still under “Crisis Standards of Care.” The CSC was officially ended on November 22 for everywhere except the Panhandle Health District.
On December 20, the CSC was also ended for the Panhandle Health District, meaning nowhere in Idaho is currently under the CSC.
Tags: Covid-19, Idaho, Idaho Department of Health and Welfare, Vaccine