Licks Attorneys' Government Affairs & International Relations Blog

Doing Business in Brazil: Political and economic landscape

Licks Attorneys' COMPLIANCE Blog

Lessons in Drug Promotion by the FDA

No items found.

The Food and Drug Administration (FDA) is the American agency responsible for protecting and promoting public health through the control and supervision of food safety, medicines and the like, a role similar to that performed by ANVISA in Brazil.

The FDA has an Office of Prescription Drug Promotion (OPDP), which is responsible for monitoring drug promotion in the United States. The office's mission is to protect and promote public health by ensuring that information on prescription drugs is consistent with the product label, truthful, balanced, and accurately communicated. The OPDP has the Bad Ad Program, designed to help healthcare providers recognize potentially false or misleading prescription drug promotion. The program’s goal is to raise awareness among healthcare providers including physicians, physician assistants, nurse practitioners, nurses, pharmacists, pharmacy technicians, and trainees about potentially false or misleading prescription drug promotion while also providing them with an easy way to report it to the FDA.

The Bad Ads Program is comprised of a one-hour training course to help healthcare providers and trainees learn how to recognize and report potentially false or misleading prescription drug promotion to the FDA. It includes modules regarding the Bad Ad Program, the Science of Influence, FDA Oversight of Prescription Drug Promotion, Common Prescription Drug Promotion Issues, Real-Life Scenarios, and Reporting Potential Drug Promotion Issues. The course is an example of good practice that should be followed by other drug agencies around the world.

An interesting aspect of this training is that the presented cases come from actual Warning and Untitled Letters, prepared by OPDP and addressed to companies that were allegedly violating good practices in drug promotion.

The OPDP establishes 3 (three) basic principles for the prescription drug promotion:

1. Not be false or misleading.

2. Have a balance between efficacy and risk information.

3. Disclose material facts about the product being promoted, including facts about consequences that may result from use of the drug.

Importantly, the OPDP regulates the promotion of prescription drugs and monitors (i) radio and TV advertisements, (ii) prescription drug promotional materials, (iii) internet-based promotion including social media, (iv) speaker program presentations and (v) sales representative presentations (advertisers). The OPDP does not regulate the promotion of OTC (Over the Counter) drugs, biological products, medical devices, food, drugs for animals, compounded drugs, cosmetics, and dietary supplements.

According to the ODPD, the major problems commonly identified in prescription drug promotion are:

1. Omitting or downplaying of risk.

2. Overstating the drug’s benefits.

3. Failing to present a “fair balance” of risk and benefit information.

4. Omitting material facts about the drug.

5. Making claims that are not appropriately supported by adequate studies.

6. Misrepresenting data from studies.

7. Intentionally misleading drug comparisons.

8. Misbranding an investigational drug still under investigation in trials.

Interestingly, one of the main purposes of the Bad Ad Program is encouraging complaints from healthcare providers, - even anonymous complaints are accepted. Another relevant aspect are the channels for receiving reports, as the whistleblower may choose from the following:

1. E-mail: BadAd@fda.gov

2. Call toll-free: 855-RX-BADAD or 855-792-2323

3. Write to: Bad Ad Program, FDA/CDER/OPDP, 5901-B Ammendale Rd, Beltsville, MD 20705-1266

Some interesting lessons are drawn from the Bad Ad Program, as listed below:

– Pharmaceutical companies spend about three times more money marketing prescription drugs to healthcare professionals (HCPs) than direct-to-consumer advertising, such as TV advertisements. The United States allows promoting prescription drugs directly to the consumer, whereas such practice is prohibited in Brazil, which only allows for promoting prescription drugs directly to professionals qualified to prescribe or dispense drugs. In 2017, for example, the pharmaceutical industry spent more than $24 billion on drug promotion, with more than $18.5 billion allotted for marketing to HCPs.

– For most prescription drug products, companies are only required to send their promotional materials to the FDA when they first appear in public. This means that the FDA sees most promotional materials at the same time as the public. And yet the pharmaceutical industry submitted more than 135,000 unique prescription drug promotion materials to the FDA, aimed at consumers and healthcare professionals. Such number gradually increases year by year.

– When the OPDP receives a report of abusive promotion and verifies its veracity, the Office may issue a letter of compliance to a pharmaceutical company in the form of a Warning or Untitled Letter. Such Letters warn a company of their concerns and request that the company stop violating the law and, in the case of a Warning Letter, request that the company take action to correct the issues cited therein.

– According to the OPDP, there are approximately 70,000 pharmaceutical sales representatives working in the field as of today, making 8-10 calls a day, promoting 1-3 products per call. This means that about 145 million to 546 million promotional presentations are made each year. Add to that over 100,000 unique pieces of prescription drug promotional materials, such as newspaper advertisements, sales aids, and emails distributed to consumers and healthcare professionals, and the number of messages designed to inform and influence healthcare professionals can be overwhelming.

– In the early 1960s, a medical disaster abroad drew public attention to the need for strong US government monitoring on drugs. In this case, thalidomide, a sedative used for morning sickness but never approved for use in the United States, caused tragic birth defects in thousands of newborns in other countries. This fact led to the creation of the Kefauver-Harris Amendment in 1962 to the Federal Food, Drug, and Cosmetic Act, requiring proof of effectiveness and safety before a drug could be marketed and giving the FDA stricter controls over drug testing.

– With regard to the science of influence, Dr. Robert Cialdini identified six principles of influence:

(i) scarcity – People want things that are in limited supply. Scarce things are seen as more attractive and valuable. The scarcity principle also explains why limited-time offers are more attractive than items permanently guaranteed for purchase.

(ii) social proof – People follow the lead of their equals, looking for what those like them do in a similar situation, and do the same thing, such as buying bestselling books or going to popular restaurants.

(iii) commitment and consistency – People want to be consistent with what they have already said or done, for example, signing a petition in support of a political candidate or giving a testimonial about a product makes people more willing to support such candidate or buy such product later on.

(iv) reciprocity – People are more willing to help each other if they think favors are to be returned, such as, for example, being more likely to buy a product after receiving a free sample, a small freebie or favor, such as a bottle of water, or the use of a representative's telephone.

(v) authority – People are more likely to take advice from experts in a given subject. Those with experience are more likely to accurately assess and respond to situations in their field of expertise and keeping up with them is generally good.

(vi) liking – People respond more often to requests made by other people that they like.

Indeed, the initiative by the FDA with OPDP is meaningful in combating inappropriate or abusive drug promotion, thus contributing greatly to the education of healthcare professionals, and more especially the physicians responsible for promoting such drugs.

No items found.