In the last of her five-part series, contributor Lori Weiman takes a deep dive into FDA guidelines and explains how pharmaceutical advertisers and their partners can avoid costly violations.
Welcome to the final article of my series on how to work more effectively with ad partners in highly regulated industries.
My goal has been to show advertisers how to embrace, not fear, the federal ad regulations governing them and their partners. In highly regulated industries, a simple marketing mistake that ignores these regulations — even by your partners — can lead to a federal-level, multi-million dollar lawsuit for you.
As the CEO of The Search Monitor, I have access to thousands of ads run on millions of keywords. The data has shown me that affiliates will knowingly (or unknowingly) break their advertisers’ rules. It happens, so the best response is to be prepared. More on that in a sec.
Previous articles have provided recommendations for advertisers in Finance, Retail and Education. Today, we focus on pharmaceuticals. In the mid-1980s, drug companies began direct-to-consumer (DTC) advertising, which required a new set of federal advertising guidelines. Itroduction Part 1 lays out the foundation for this seies.
The Food & Drug Administration (FDA)
In past articles, we’ve focused exclusively on the Federal Trade Commission as the government watchdog in control. While the FTC still governs over-the-counter drugs, the FDA has oversight on prescription drug advertising.
The FDA has a Center for Drug Evaluation and Research (CDER) whose mission is to “ensure that companies that sell prescription drugs also provide information that is truthful, balanced and accurately described.” The CDER uses its Office of Prescription Drug Promotion (OPDP) to conduct research on DTC ads, including telephone surveys of consumers and doctors, to help decide if the ads are truthful.
Like the FTC, the FDA provides pharmaceutical advertisers with specific ad guidelines and breaks them into three main examples:
- Product claim ad: This ad type is used for performance claims and must not be false or misleading. It must include three mandatory elements: drug name (brand and generic), the FDA-approved use of the drug, and the most significant risks. A big regulatory issue here is off-label promotion, or promoting benefits not approved by the FDA. GlaxoSmithKline was hit with a $3 billion lawsuit in 2012, for example, which included charges of off-label promotion for its Paxil and Wellbutrin drugs. Read more about this ad type, and see this example of an approved ad.
- Reminder ad: This summarized ad type is meant for audiences who are already familiar with the drug. As such, it does not discuss the drug’s uses and has fewer mandatory elements. Read more about this ad type.
- Help seeking ad: This ad type introduces a series of symptoms to consumers and encourages them to see a doctor to learn more. While it doesn’t recommend a specific drug as a solution, it does list the sponsor’s logo. Read more about this ad type.
In addition to these ad types, the OPDP released guidelines in 2014 on how to include mandatory FDA language when communicating in character-limited ads, such as with Facebook or Twitter. In short, if advertisers cannot include the mandatory info (i.e., its intended usage, benefits, and significant risk) and be accurate and honest, they should consider not using the platform. Learn more by checking out the OPDP’s social media guidance document.
While I’ve just spoken about a few of the FDA’s rules so far, there are definitely nuances. Start by reviewing the FDA’s very detailed list of ad violations with your team and your ad partners, and then don’t be shy about seeking their advice when questions arise.
Drug companies must submit ads to the FDA as they’re released to public, but they are not required to seek prior review. If the FDA believes an ad violates the law, it has several responses.
Its first response is to send a warning letter to the company asking it to halt the ad. This warning letter will also be published on the FDA website. In some cases, the FDA will require the advertiser or its partner to run a corrective ad.
In extreme cases, the FDA will seize drug supplies, ban specific promotional activities, or even bring criminal charges against the company.
Don’t forget HIPAA
In addition to knowing FDA regulations backwards and forwards, pharma advertisers must also get comfortable with the Health Insurance Portability and Accountability Act (HIPAA). In particular, advertisers must focus on HIPAA’s “Standards for Privacy of Individually Identifiable Health Information,” known as the Privacy Rule.
Here are four Privacy Rule elements for you and your ad partners to understand:
- Marketing communications: First, HIPAA defines what constitutes marketing communications, since pharma companies have many reasons to share personal data (e.g., between doctors). They say: “So as not to interfere with core health care functions, the [Privacy] Rule distinguishes marketing communications from those communications about goods and services that are essential for quality health care.” Learn more about this distinction, since your communications might not be governed by the rules that follow.
- Authorizations: Advertisers must obtain authorization from consumers to disclose their personal health data for marketing purposes, with specific details on how the data can be used. Authorizations must also state if remuneration is involved. Learn more (Scroll down to Marketing Authorizations).
- Minimum necessary: Advertisers can only request and disclose the “minimum necessary” personal consumer data. A patient does not need to to provide their whole file, for example, if an advertiser wants to use them for an endorsement. Learn more about this requirement.
- Business associates: HIPAA also governs sharing personal data between companies. The Privacy Rule requires that covered entities “obtain satisfactory assurances that the business associate will use the information only for the purposes for which it was engaged by the covered entity, will safeguard the information from misuse, and will help the covered entity comply with some of the covered entity’s duties under the Privacy Rule.” In addition, these covered entities as HIPAA calls them (Read: advertisers) may not sell protected information to a third party for that party’s own interest. Learn more.
Recent FDA actions
The FDA’s Office of Prescription Drug Promotion publicly posts every Warning Letter it sends to pharma advertisers. Take a look. They start in 1998 and provide helpful examples of what not to do. A common theme is a false and misleading ad that fails to disclose full risks associated with a drug.
I’ll call your attention to a few interesting Warning Letters to pharmaceutical manufacturers:
- Pfizer: A YouTube Video was deemed misleading for omitting risks and material facts about intended drug uses.
- Duchesnay: A Kim Kardashian Instagram post was deemed misleading for the same reasons as above. This Forbes article provides a helpful review of the incident. In this case, the FDA required that a corrective ad “should be distributed using the same media, and generally for the same duration of time and with the same frequency that the violative promotional material was disseminated.”
Don’t forget the engines
The government isn’t the only organization trying to protect consumers. Search engines and other advertising networks may have their own rules to protect themselves from consumer lawsuits, so check with each one before you sign up to advertise.
Google, for example, has a detailed and complex list of pharma ad requirements. For example:
- Rules differ based on prescription drugs vs. over-the-counter medicines.
- Rules may only apply to the country you’re advertising in. For example, pharma manufacturers may only promote prescription drugs on Google in the United States, Canada and New Zealand.
- Google restricts the promotion of online pharmacies. They are only available in some countries, and biddable keywords are restricted as well.
- Both pharma manufacturers and online pharmacies must be certified by Google to even advertise.
- Google has a list of unapproved substances for advertising and prohibits false or misleading health claims.
- Read more from Google here. And don’t forget to check with the other engines you or your partners use. Bing has its own rules, for example.
Tips for pharma advertisers
Since The Search Monitor has been monitoring advertisers since 2008, I’ve seen more and more pharma companies embrace automated crawling technology to keep an eye on ad partners and avoid regulatory issues. My advice to these advertisers is fairly straightforward, but effective:
- Educate your team and partners: Share this article and its links, and follow up with training. Get confirmation the rules are understood.
- Monitor actively: Use the latest ad-monitoring technology to alert you if your affiliates’ ads do not contain required disclosures or are making unsubstantiated claims. Let the technology do the heavy lifting since it’s impossible to do a thorough job manually. Also, require your affiliates to monitor their own ads as a backup.
- Enforce rules & remove violators: Don’t stand for repeat violations. Terminate contracts with any partner who breaks your rules!
- Check in with the FDA: If you have questions, try to seek advice from the FDA before you post. While they don’t require an ad review, their site mentions that some drug companies seek advice before running an ad.
Final thoughts on managing ad regulations
The goal of my five-part series was to show advertisers that a thorough understanding of ad regulations in their industry will let them embrace, not fear, the complexities of government regulations.
In my previous articles on Finance, Retail and Education, along with this one on pharmaceuticals, I’ve discussed important regulatory concepts related to product claims, paid endorsements, character-limited ads, native ads and your affiliates’ sub-affiliates.
Know these ad regulations backward and forward, and understand how to quickly catch any violations. A little work upfront will make you better equipped than any of your competitors to avoid costly lawsuits, protect your brand, optimize your ad partners and improve your own ad performance. Here’s to keeping the government out of your business!
Some opinions expressed in this article may be those of a guest author and not necessarily Marketing Land. Staff authors are listed here.