Life sciences companies often advertise newly-approved drug to the public. But as companies seek approval for products to treat or prevent COVID-19, an extraordinary amount of public interest in those products may require a different commercial and regulatory approach on the part of sponsors. AgencyIQ explains.
By Lily Rosenfield and Alexander Gaffney, RAC
The FDA may be months, or perhaps years away from approving a new treatment for vaccine for COVID-19. But while much of the current focus of regulators and public health officials is on developing and testing those products, it’s worth thinking about how they are likely to be marketed, advertised and promoted to the public once approved.
COVID-19 is unlike any other public health event in recent history, and the promotion of any pharmaceutical or biological products is unlikely to be similar to any other product in modern American history.
Role of media
One key difference is likely to be the scope and extent of media coverage of any product approval. Already, media coverage has made drugs like hydrochloroquine and remdesivir household names even before the drugs are indicated for use in COVID-19.
Prior to COVID-19, announcements of new FDA approvals were generally covered by niche media outlets. Rarely were they covered as front-page news. Now, public interest is captivated by the development of new products intended for use with patients with COVID-19. Information about new research, the initiation of new research, preliminary results and regulatory developments are now front-page news for many media outlets.
The FDA’s approval of a product for COVID-19 is likely to be a landmark event in the agency’s history, and front-page news across the United States.
For life sciences companies, this coverage upends the classic rationale for advertising their products: to increase awareness of the disease, of the drug and its uses.
Though greater awareness may reduce the need to purchase expensive advertising to promote a product, this dynamic has significant potential deficiencies as well. Take, for example, Gilead Science’s investigational drug remdesivir—a drug currently in clinical testing for COVID-19. Public awareness of remdesivir is extremely high, but that interest also means that every leak of clinical data results in changes in public perception about the product. By the time a product is approved, the general public may have accumulated a significant amount of incorrect information about the drug and its uses.
The path ahead
Under normal circumstances, direct-to-consumer (DTC) advertising is an essential part of most product launches. A report from The Journal of the American Medical Association showed that from 1997 to 2016, annual spend on DTC advertising increased from $2.1 billion to $9.6 billion, which represented an over 20% increase in portion of total spend.
That spending, which includes television and magazine advertisements, generally includes two different types of advertisements: Product-specific advertisements, which are aimed at increasing awareness of a specific prescription product, and disease awareness advertisements, which are aimed at increasing viewer awareness of the existence of a condition and that treatments are available for it.
COVID-19 will present challenges to both types of promotional approaches. There are few people alive who would be unaware of COVID-19, making the utility of disease awareness advertising minimal.
Similarly, many people might be aware of a drug prior to its approval thanks to extensive media coverage of its development, clinical trials and even clinical results.
For companies, then, advertising used to promote a product for COVID-19 could be more akin to corrective advertising, most often used by companies to correct misinformation included in a previous advertisement. Such advertising might include information about a product and its benefits and risks, but also information correcting misconceptions or misinformation about its proper indications for use.
Due to abbreviated timelines, it’s likely that the company may not know some of the side effects associated with a product at the time of first marketing. While this isn’t unusual—even large clinical trials generally don’t have enough people participating to discover all serious side effects associated with a drug—it may mean advertisements will need to frequently be updated to reflect the most current information about a products’ risks or side effects.
Alternative advertising approaches
It also remains a possibility that the FDA could relax its normal advertising requirements for COVID-19. Already, the FDA has frequently indicated that it will exercise “enforcement discretion” to allow companies to bring products to market more quickly and with less rigorous oversight than is usually required to meet the threat of COVID-19.
Were the FDA to take a similar approach for DTC advertising, it might involve allowing a company to promote a product using an abbreviated list of side effects. That approach could serve to promote the use of a product—say, a vaccine—by reducing the perception that a product is risky for use. Under current FDA regulations, companies must present the benefits and risks of a product (known as the “major statement”) in “fair balance,” meaning that equal weight, time or space must be given to each. That balance can make it seem that an otherwise safe product is potentially dangerous, even if those risks are relatively rare.
“Concern exists that, as currently implemented in direct-to-consumer ads, the major statement is often too long,” wrote Kit Aiken, a research team lead in the FDA’s Office of Prescription Drug Promotion (OPDP). “This may result in reduced consumer comprehension, minimizing important risk information and, potentially, therapeutic non-compliance due to fear of side effects.”
The FDA has previously proposed a similar approach for all prescription drug products, which would involve companies providing a list of the most serious risks, plus a disclosure that additional risks are associated with a product and can be found on an accompanying website.
This type of approach might be especially useful for a vaccine product as a means of promoting its use. For example, an abbreviated list of side effects could help to indicate that the product is relatively safe for use (assuming it it). However, it is just as likely that consumers would get the majority of their information about a product from sources other than the drug company’s advertisement. Sources of information could include media reports, promotions from government agencies (like a health board), other advertisements (such as for a health care provider offering vaccinations), social media, and more.
As a result, some companies with approved products may do minimal advertising.