Fraudulent pharmaceutical sales and other business practices including false advertising are highly illegal and are regulated on several levels such as local, state, and federal by offices like the U.S. Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS), among others. 100% compliance with prevailing laws and regulations is the only way to prevent pharmaceutical businesses from being subject to hefty fines and other penalties which can ultimately cost these companies millions of customers as well.
Restrictions on pharmaceutical sales advertising for prescriptions do exist – and for good reason. Honest advertising keeps pharmaceuticals safe while also keeping consumers safe. Learn some finer points about why the restrictions exist.
Identification
For starters, a drug is labeled “prescription only” when a medical professional is required to supervise the drug’s use due to the patients possible inability to use the drug safely on their own, according to the FDA. Because of this, the U.S. Congress has laid out different requirements for prescription and non-prescription or over-the-counter drugs and advertising these prescriptions comes with its own set of challenges. It’s important to note that while the FDA monitors and regulates ads for prescription drugs, the Federal Trade Commission (FTC) handles ads for over-the-counter, non-prescription drugs.
The FDA breaks up pharmaceutical advertisements in the following categories: product claim advertisements, reminder advertisements, and help-seeking advertisements.
Product Claim Ads
These advertisements are the only type that name a drug and discuss the benefits and risks. The catch is that these ads must not be false or misleading in any way. All product claim ads, regardless of the media in which they appear (print, broadcast, etc.), must include specific components within a main portion of the ad. These components include the name of the drug (brand or generic), at least one FDA-approved use of the drug, and the significant risks associated with taking it. These advertisements must present both the benefits and risks of a prescription drug in a balanced manner, says the FDA.
Print ads are required to include a brief summary about the drug that generally includes the risks listed in its approved prescribing information as well a statement encouraging anyone taking the drug to report negative side effects to the FDA.
Broadcast advertisements are also required to include the drug’s most important risks and one of the following: all risks listed as part of the prescribing information or at least provide sources for viewers to find the prescribing information for the drug (an associated website, etc.).
Reminder Ads
Reminder advertisements simply provide the name of a drug but don’t mention or expand upon its uses, as they assume that the audience is already familiar with the drug’s use.
These ads are not required to contain risk information about the drug such as side effects, etc., because the ad doesn’t include exactly how well the drug works or what the drug. And, as the FDA notes, “Unlike product claim ads, reminder ads cannot suggest, in either words or pictures, anything about the drug’s benefits or risks. For example, a reminder ad for a drug that helps treat asthma should not include a drawing of a pair of lungs, because this implies what the drug does.”
Lastly, reminder ads are not allowed for certain prescription drugs with serious risks associated with taking them. These drugs typically have a special warning often called a “boxed warning” its FDA-approved prescribing information. Because of their seriousness, the risks must be included in all ads (print or broadcast) for these drugs.
Help-Seeking Ads
When done properly, help-seeking advertisements are not considered to be drug ads by the FDA and thus, are not regulated by them – the FTC actually regulates them. However, if an ad recommends or suggests the use of any specific drug, it is then considered a product claim ad and is subject to FDA rules.
From the FDA’s website: “Help-seeking ads typically describe a certain disease or condition but do not recommend or suggest a specific drug treatment.” Diseases or conditions mentioned in help-seeking ads may include various allergies, asthma, erectile dysfunction, high cholesterol, and osteoporosis among others. These ads encourage people with these symptoms to talk to their doctor and they sometimes include the name of the drug company and could provide a phone number for more information.
Internal Compliance
Pharmaceutical companies and sales reps can influence people and essentially market their products by advertising directly to physicians and other health care providers.
In an attempt to limit this type of marketing and influence, the “Compliance Program Guidance for Pharmaceutical Companies” was published by the HHS in 2003 and requires businesses engaged in drug sales and distribution to develop policies on internal market compliance. These market compliance policies mainly relate to the interaction between pharmaceutical representatives and physicians. The practice of offering health care providers with drug samples, gifts, and consultations as a marketing strategy by sales reps can actually make a pharmaceutical company criminally liable under the anti-kickback statute (Arizona Republic).
Additionally, under what is commonly referred to as the “Sunshine Rule,” a pharmaceutical business is required to report and disclose activities related to the marketing of products. Federal law also requires that companies disclose gifts offered to physicians that exceed $500 each year (individual states may have disclosure requirements as well). As the Arizona Republic notes, the Pharmaceutical Research and Manufacturers of America “Code on Interactions with Healthcare Professionals” also requires pharmaceutical businesses to disclose any payments exceeding $100 made to physicians as gifts.
The reality is that advertising pharmaceutical products to consumers and even to physicians can be a bit tricky. However, these “tricky” restrictions are in place to protect everyone involved from sales reps, patients, doctors, and even the pharmaceutical companies themselves. Regardless of all the red tape surrounding the pharmaceutical industry, pharmaceutical sales jobs are more readily available now than ever before, and sales reps enjoy above-average wages and incredible perks that create job satisfaction. Start your search for a career in pharmaceutical sales today!
