Consumer Understanding of the Scope of FDA’s Prescription Drug Regulatory Oversight: A Nationally Representative Survey

Abstract

Purpose:

Misperceptions of how the US Food and Drug Administration (FDA) regulates prescription drugs may affect how consumers assess the safety and efficacy of prescription drugs. The study objective was to survey the public on their knowledge of FDA oversight regarding prescription drug approval and advertising.

Methods:

In 2017, we conducted a nationally representative mail-push-to-web survey with 1,744 US adults.

Results:

Although most respondents (86%) knew that FDA approves prescription drugs, we found misperceptions about what that approval means. In addition, few respondents understood FDA oversight of prescription drug advertising, with approximately half of respondents reporting that they did not know whether FDA approved these ads or components of the ads, and several mis-reporting that FDA approves these ads (31%) or components of the ads (22-41%).

Conclusions:

Enhanced collaboration and communication with the public by key stakeholders in this space could increase public understanding of the roles and responsibilities of FDA.

Introduction

The Food and Drug Administration’s (FDA) regulatory oversight of prescription drugs stems from the Federal Food, Drug, and Cosmetic (FD&C) Act, enacted in 1938. Among other provisions, this law gave FDA the authority to require evidence that drugs are safe prior to marketing in the United States. In 1962, the Kefauver-Harris Amendments strengthened the rules for drug safety and allowed FDA to require that drug manufacturers prove drugs are effective prior to marketing [1]. The Kefauver-Harris Amendments also placed prescription drug advertising under FDA’s jurisdiction. These laws and FDA’s implementing regulations give FDA the authority to determine that prescription drug products are effective for their intended use and that benefits of the intended use of the products outweigh the known and potential risks to the intended population before those drug products are marketed to the American public [2]. FDA does this through an independent and unbiased review of the data on the drug’s effects, taking into account the condition or illness that the drug is intended to treat and the current treatment landscape.

In terms of FDA’s oversight of prescription drug advertising, FDA’s regulations stipulate that prescription drug ads must (1) not be false or misleading, (2) present a “fair balance” of information describing both the risks and benefits of a drug, and (3) include facts that are “material” to the drug’s advertised uses [3]. FDA regulations mandate that all prescription drug ads must be submitted to the agency at the time of initial publication or dissemination [4], and certain ads must be submitted prior to use [5]. In 2017, FDA received over 100,000 direct-to-consumer (DTC) and professional promotional materials for prescription drugs from sponsors at the time of initial dissemination and had one office in the Center for Drug Evaluation and Research responsible for reviewing these promotional materials [6]. Given the volume of materials received and the required timing of submission of these materials, FDA does not review all drug ads prior to their dissemination. FDA does not “approve” the final messaging (either in whole or in part) in any prescription drug ads (except in the rare case when it is required as part of a compliance action; [5]). However, FDA can take enforcement action when promotional pieces violate the regulations; therefore, companies have an incentive to create risk and benefit statements that are accurate and non-misleading [7].

FDA also has responsibility for regulating non-prescription (over-the-counter [OTC]) drugs and dietary supplements in the United States, but there are important differences in FDA’s regulatory oversight of these categories of products as compared to prescription drugs. With respect to OTC drugs, these products, like prescription drugs, must be safe and effective for their intended use(s); however, any non-prescription product that conforms to an OTC monograph may be marketed without submitting an application to FDA for review and approval [8]. A monograph is a regulatory standard for the labeling and ingredients for products within a specific category such as antacids, analgesics, etc. It stipulates acceptable ingredients, doses, formulations, what the drug is intended to treat, and labeling. The establishment of an OTC monograph involves a three-phase public rulemaking process (each phase requiring a Federal Register publication) resulting in the establishment of standards (drug monographs) for an OTC therapeutic drug class [9]. Manufacturers of OTC drugs that do not conform to an existing monograph are required to submit a New Drug Application (NDA) to FDA for review and approval prior to marketing.

In contrast to prescription and OTC drugs, dietary supplement manufacturers are not required to demonstrate that their products are safe and effective or to get FDA’s approval before producing or marketing these products. Federal law prohibits dietary supplement manufacturers from marketing their products in a manner similar to prescription drugs – as treatments or cures for specific diseases, or as treatments that can alleviate the symptoms of a disease. The Dietary Supplement Health and Education Act of 1994 (DSHEA; [10]) further mandated that dietary supplement manufacturers that choose to promote their products with claims about how the supplement may impact the structure or function of the human body must include a disclaimer in their ads, “prominently displayed and in boldface type,” that clearly states that the claims being made “have not been evaluated by the Food and Drug Administration,” and that the product “is not intended to diagnose, treat, cure, or prevent any disease.” Finally, while FDA has primary oversight over prescription drug advertising, the U.S. Federal Trade Commission (FTC) has primary oversight over OTC drug and dietary supplement advertising.

How much does the public know about FDA’s oversight and regulation of prescription drugs and prescription drug advertisements, including how this differs from FDA’s oversight and regulation of OTC drugs and dietary supplements? Three previous surveys, conducted in 1998, 2009, and 2014, asked US adults similar questions about their knowledge of FDA oversight regarding prescription drug approval [11, 12] and prescription drug advertising [11-13]. These studies provide an opportunity to qualitatively compare responses across surveys. Knowledge of FDA’s oversight was largely stable over time (Appendix A). In 2014, only 8% of respondents incorrectly thought the FDA did not approve prescription drugs; however, 44% incorrectly thought FDA only approves prescription drugs that are extremely effective (as opposed to the actual criteria FDA uses which is substantial evidence of effectiveness and considering whether the benefits of the drug outweigh the risks of the drug for the intended use), and 22% incorrectly thought that FDA only approves prescription drugs if they do not have serious side effects [11]. In the same survey, 69% of respondents incorrectly thought that FDA must approve prescription drug advertisements, 26% incorrectly thought that only prescription drugs that are extremely effective can be advertised, and 17% incorrectly thought that only prescription drugs without serious side effects can be advertised [11]. Two of these surveys also explored how demographic characteristics were associated with knowledge. One survey examined associations with age and education, finding that greater knowledge about FDA approval and advertising oversight was associated with higher education [12]. Another survey examined associations with age, sex, education, income, and race, finding that white respondents had greater knowledge of FDA prescription drug advertising oversight than did non-white respondents [13].

An understanding of what the public does or does not know about prescription drug approval and advertising can help focus stakeholder communication and outreach. This could, in turn, increase consumer understanding of the roles and responsibilities of FDA and help empower the public to critically evaluate information about prescription drugs so that they can be even more effective partners in their health care. With this survey, we sought to confirm and expand on previous findings by asking the public about FDA’s role in prescription drug approval and prescription drug advertising.

Methods

Data source

In 2017, we conducted a survey, collecting responses from 1,744 US adults ages 18 and over. The survey instrument went through a rigorous, multi-stage design and development process. When possible, we used survey items from previous surveys to create the initial pool of items. An expert review panel, including survey design and content area experts, provided recommendations on the items. Next, we conducted nine cognitive interviews to assess comprehension and usability. Finally, we conducted a pretest with a small sample of participants (N = 23) drawn by address-based sampling. Throughout this process, items were refined or deleted to create the final survey instrument (Appendix B). Respondents answered survey questions on prescription drug topics, including FDA oversight. They viewed one of two randomly assigned advertisements for fictitious high-cholesterol prescription drugs and answered questions about FDA’s oversight specific to prescription drug advertising. Respondents also reported demographic and health characteristics.

The survey used address-based sampling to draw a probability-based, nationally representative sample of US households and randomly selected an individual within each household to complete the survey. A mail-push-to-web methodology was used for the survey, initially inviting respondents by mail to complete the survey online, with paper surveys sent to nonresponders [14, 15]. The response rate was 28.2% (Figure 1).

Fig. 1.

CONSORT flow diagram

Analysis

Weighting is necessary to compensate for factors related to the sample frame, which was of household addresses, in order to make estimates about individuals. We weighted responses to compensate for differential probabilities of selection, reduce biases due to differential non-response, and make the estimates consistent with external population totals. We calculated descriptive statistics on valid responses using weighted percentages. We conducted logistic regressions to determine whether the ad that the respondents viewed, their demographics (age, sex, education, race/ethnicity, language spoken at home), and health characteristics (health literacy, self-reported health, prescription drug use, time of last healthcare provider visit; self-reported high cholesterol) were associated with responses to questions about FDA prescription drug advertising oversight.

Limitations

Survey response rates have been declining across survey modes [16]. In keeping with this trend, our survey had a low response rate; we assessed nonresponse bias and used weighting to address potential non-response bias the response rate may have caused. Respondents could take the survey in Spanish by telephone; however, the absence of a fully-integrated Spanish-language questionnaire limits the inferences to English-speaking audiences. In contrast to previous surveys, we included a “don’t know” option; therefore, comparisons across surveys may be difficult as they may have different rates of guessing or missing data. Finally, the stimuli we used were print ads; consumers may provide different responses with other media, such as television ads.

Results

FDA prescription drug approval oversight

Knowledge of FDA’s prescription drug oversight was consistent with previous findings. Most respondents (86.1%) knew that FDA approves prescription drugs, and 56.6% knew that FDA approves prescription drugs when the drug offers benefits that are greater than the risks (Table 1). Most respondents (75.2%) knew that FDA approval does not necessarily mean the drug will help everyone who uses it. However, only 25.1% of respondents knew that FDA approval does not necessarily mean the drug will help most people who use it. Finally, roughly half of respondents (57.1%) knew that FDA approval does not mean that the drug won’t harm someone who uses it, and 57.4% knew that FDA approval does not mean that the drug will cure the condition for which it is prescribed.

Table 1.

Questions about FDA prescription drug approval oversight from the National Survey of Health Information and Communication, 2017 (N = 1,744).

		Weighted percentages (%)
	Correct response	Yes	No	Don’t know
Which of the following products does the Food and Drug Administration – the FDA – approve before they are sold to consumers?
Prescription drugs	Yes	86.1	2.3	11.6
Over-the-counter drugs	No	69.3	9.1	21.6
Dietary supplements, including vitamins, minerals, and herbal remedies	No	24.9	50.6	24.5
When FDA approves a prescription drug it means that…
The drug offers benefits that are greater than the risks.	Yes	56.6	18.9	24.5
The drug will help everyone who uses it.	No	8.2	75.2	16.6
The drug will help most people who use it.	No	49.0	25.1	25.9
The drug will cure the condition for which it is prescribed.	No	17.5	57.4	25.1
The drug is safe and won’t harm someone who uses it.	No	22.7	57.1	20.2

Further investigation into public knowledge of FDA’s OTC drug and dietary supplement approval oversight yielded additional evidence of a lack of understanding related to the approval of such products. We found that 69.3% of respondents thought that FDA approves all over-the-counter drugs. One quarter of respondents (24.9%) believed FDA approves dietary supplements and another quarter (24.5%) did not know. We found this misunderstanding despite the fact that since 1994 any dietary supplement marketed with a claim about how it could affect the structure or function of the body has had to include a prominent disclosure that FDA has not evaluated the claim and the product is not intended to diagnose, treat, cure, or prevent any disease [17].

FDA prescription drug advertising oversight

Many respondents were unsure about FDA’s role in regulating DTC prescription drug advertisements (Table 2). For each of the four questions related to advertising, approximately half of respondents said they did not know the answer. Thirty-one percent of respondents (31.2%) incorrectly thought that FDA approves DTC advertising like the print ad example in the survey. For individual ad elements, we found that 41.2% incorrectly thought that risk statements are FDA-approved, 34.6% incorrectly thought that benefit statements are FDA-approved, and 21.6% incorrectly thought that images and graphs are FDA-approved.

Table 2.

Questions about FDA prescription drug advertising oversight from the National Survey of Health Information and Communication, 2017 (N = 1,744).

		Weighted percentages (%)
	Correct response	Yes	No	Don’t know
Is the Food and Drug Administration (FDA) required to approve ads like this before they can be used in advertising campaigns?	No	31.2	15.6	53.3
The ad includes statements explaining what the drug does and how well it works, circled in yellow below. Is FDA required to approve those statements before they can be used in an advertising campaign?	No	34.6	15.5	49.9
The ad includes a graph (an image) explaining what the drug does and how well it works, circled in yellow below. Is FDA required to approve the graph (image) before it can be used in an advertising campaign?	No	21.6	23.0	55.4
The ad also includes statements about the risks of the drug, circled in yellow below. Is FDA required to approve those statements before they can be used in an advertising campaign?	No	41.2	12.9	45.9

Note. Respondents were provided with the following instructions: “Next, we will show you an ad. Pretend that the ad is for a new prescription drug. After you've read the ad we will ask you some questions about it.”

When we examined the role of health characteristics, we found that respondents who took at least one prescription drug (none vs. one or more) in the last three months were more likely to correctly respond to all four questions, p < .05. For demographics, we found that age, education, and speaking English at home predicted knowledge of FDA prescription drug advertising oversight. Specifically, younger respondents (18-54 years vs. 55 years or older), those with more education (high school vs. college degree), and those who spoke English at home were more likely to know that FDA did not approve prescription drug advertising, p < .05. Younger respondents (18-54 years vs. 55 years or older) and those who spoke English at home were more likely to know that FDA did not approve DTC benefit statements, p < .05. Younger respondents (18-54 years vs. 55 years or older) and those with more education (high school vs. college degree) were more likely to know that FDA did not approve DTC graphs and images, p < .05. Respondents with more education (high school vs. college degree and some college vs. college degree) were more likely to know that FDA did not approve DTC risk statements, p < .05.

Discussion

The results from our survey are in line with results from previous studies and suggest that there is a consistent proportion of consumers who carry some misconceptions about prescription drugs, what FDA approval of prescription drugs means, and what FDA’s role is in the regulation of prescription drug advertisements. Our findings could suggest that some of the misconceptions held by consumers may have a negative impact on public health. For instance, we found that 42.9% of consumers were not able to accurately report that FDA-approved prescription drugs may cause harm. This is concerning because some adverse events require discontinuation or dose modification. Moreover, adverse event reporting is critical to pharmacovigilance and under-reporting of adverse events is a consistent problem worldwide [18, 19]. In addition, our data revealed that many consumers believe that FDA has reviewed and approved each of the elements in a prescription drug ad, which may contribute to less critical evaluation of the information in ads before making health-related decisions [20].

Other recent findings suggest that providing more information about FDA’s regulatory role can positively influence public perceptions of FDA and increase positive attitudes toward regulation [21]. FDA currently has a multi-faceted outreach program through which information is disseminated about FDA-regulated products [22]. For example, FDA delivers messages to the public through vehicles such as original web pages, public statements, alerts, campaigns, podcasts, social media postings, and targeted outreach to media, healthcare professionals, and other groups. Our findings show that there is an opportunity for stakeholders such as patient advocacy groups, entities that run health reference websites, pharmaceutical companies, healthcare professionals, and government agencies to enhance collaborative efforts and create outreach and educational campaigns that raise consumer interest in these important topics and reach more consumers to help them become better advocates for their own healthcare. This approach is supported by research that indicates that targeted, specific education about complicated concepts in DTC ads can be effective in correcting misunderstandings among consumers [11]. Perhaps by targeting consumers through multiple avenues with messaging that is more aligned with their interests, it will be possible to have an impact on the consistent proportion of consumers that carry misconceptions about FDA’s roles and responsibilities.

Any outreach and communication approach should ideally be designed to reach a broad audience, including people who are most vulnerable to being misled by these misconceptions and those who do not use or have easy access to the internet. Internet-based education campaigns may reach many people [23, 24], but there are still many who do not use or have access to the internet [25, 26]. Reaching this audience of non-internet users may be difficult, but also critical: the non-internet using population includes some of the more vulnerable groups we identified, such as older adults, who are also more likely than younger individuals to be taking multiple prescription drugs [23]. Health communication strategies that have been developed specifically to reach underserved and vulnerable populations might be leveraged in this area. For example, libraries have been used as a delivery point for consumers who do not otherwise have access to computers (27) and soap-opera style multimedia narratives have been employed with older adults uncomfortable with computer use (28). Because people with lower internet skills are more likely to seek out health information from HCPs than are those with higher internet skills [29], another option may be to educate HCPs on how to communicate educational messages using existing resources. For example, FDA websites and pamphlets can be printed for patients who have questions [30]. In addition, FDA could expand the messaging of its BadAd campaign (originally designed to educate HCPs about misleading prescription drug information; [31]) to include some information that HCPs can print for patients. FDA and other stakeholders may also consider developing content that could be shared via medical reference tools that are commonly used at the point of care by HCPs, like epocrates, Uptodate, and Medscape. This content could include patient-centric materials that HCPs could easily print and distribute. Consistent with good communication practices (32), effective messages should incorporate both the needs and characteristics of the audience and the design of the message itself.

To reach internet-users, more formal collaborations between stakeholders and the FDA may prove beneficial in educating patients and increasing the online audience for these stakeholders. For example, in 2010, Drugs.com entered into a Memorandum of Understanding with FDA to extend the reach of FDA Consumer Health information and provide consumers with better, more timely information concerning public health and safety topics, including alerts of emerging safety issues and product recalls [33]. By providing links to an authoritative source like FDA, stakeholders may be able to increase the credibility and trust in their own websites, which may help drive visitors to their sites [34, 35].

Social media platforms are also key to outreach and education [36]. Stakeholders could expand their use of social media to include themes such as FDA approval, prescription drug advertisements, and the importance of reporting adverse drug events. This may be particularly useful because social media can also be a source of adverse event monitoring [37, 38]. While there are often space limitations on social media platforms, stakeholders could link to FDA webpages that provide detailed information [39-42]. In highlighting relevant educational messages on multiple social media platforms and linking those messages to current events, trends, or stories that many online users are tracking, the messages may resonate more with audiences.

Another avenue that stakeholders could explore is the use of banner ads. Stakeholders may be able to target a particularly receptive audience by placing banner ads on general health reference websites like Drugs.com, WebMD.com, and mayoclinic.org as the individuals looking at these websites are deliberately seeking out health related information. These banner ads could include short messages communicating key facts about prescription drug approval and regulation of prescription drug advertisements and direct audiences to webpages for a more complete discussion of those topics.

Similarly, stakeholders may consider more extensive outreach to media sources, particularly popular online and broadcast news sources, which could allow for the broad dissemination of interviews and informational segments that are aligned with current events and topics of interest to consumers. This type of outreach may better aid consumers in understanding how information about FDA’s roles and responsibilities may be key to framing the news stories and events in which they are most interested.

Although we have framed these results as a discussion of misconceptions, another way to view the data is that respondents’ answers may give us insight into what they think FDA’s role should be. Viewed this way, people may expect a different role for FDA in the regulation of prescription drugs and their advertising. Future studies could delve into consumers’ perceptions of their needs in terms of FDA oversight in these areas.

The promotion of prescription drugs to consumers is legal and prevalent in the US [43], making consumer understanding in this area paramount. The results of this research indicate that there is an opportunity to enhance consumer understanding about prescription drugs, particularly in the areas of FDA approval and oversight of prescription drug advertising. Stakeholders may be able to reach a broader audience of consumers by enhancing collaborative efforts and developing specific, targeted messaging around these topics. These collaborations may result in benefits to the stakeholders in terms of increased credibility and popularity of their organizations, while also advancing key public health goals like increasing the effectiveness of pharmacovigilance programs, and empowering consumers to make better and more informed healthcare decisions.

Key Points.

• This nationally representative survey evaluated US adults’ knowledge of FDA regulation of prescription drug approval and advertising.

• The results highlight gaps in consumer knowledge of FDA’s roles and responsibilities, which could compromise key public health initiatives like pharmacovigilance programs.

• Strategies to reduce these gaps, including communication campaigns and stakeholder collaborations, may enable the public to critically evaluate prescription drug information.