Life Science Compliance Update

July 11, 2016

Industry Expresses Concerns About FDA DTC Study

AbbVie, Eli Lilly, and Merck are all raising questions about the Food and Drug Administration's (FDA) plan to investigate the impact on consumer perceptions of prescription drugs when efficacy claims are included in advertisements. The Office of Prescription Drug Promotion (OPDP) conducted a study of direct-to-consumer (DTC) print advertising of drugs in 2015. OPDP plans to continue grappling with a better understanding of how consumers make choices and whether or not they really focus on efficacy claims or not.

The study, along with several others, follows the introduction of a bill by Representative Rosa DeLauro that would place a three-year moratorium on DTC ads of newly approved prescription drugs to fight rising drug prices and protect consumers from misleading information.


Prior research has found that marketing cues can have an influence on perceptions of drug quality and that patients and consumers may rely on those cues in the absence of quality information.

According to the FDA,

The objective quality of prescription drugs is not easily obtained from promotional claims in direct-to-consumer (DTC) ads; thus consumers may rely upon extrinsic cues to inform their decisions. Market claims such as '#1 Prescribed' and 'New' may act as extrinsic cues about the product's quality, independent of the product's intrinsic characteristics. Prior research has found that market leadership claims can affect consumer beliefs about product efficacy, as well as their beliefs about doctors' judgments about product efficacy.

FDA Study Plans

OPDP will run a main study, along with a follow-up, that will analyze consumer responses to fictitious prescription drug ads for a diabetic neuropathy treatment. There are two variables of interest to OPDP: the type of market claim (i.e., "#1 Prescribed," "New," etc.) FDA notes that the efficacy information will be in the form of realistic quantitative information (think, "46 percent of patients felt their nerve pain reduced by at least half, compared to baseline").

In the follow-up study, participants will complete a fifteen-minute paired choice experiment and will be asked to choose between two hypothetical drugs based on print advertisements, one of which includes a market claim from the Main Study. Participants will be provided with 48 sets of choices, with varying levels of efficacy information and market claims, and will be asked which drug they prefer based on them.

Industry Reaction and Comments

AbbVie raised concerns with questions in the study being biased by attitudes toward advertising in general that "may go well beyond the pharmaceutical ad" and that ads that present numeric efficacy claims and safety information may be susceptible to interpretation by participants.

Eli Lilly, on the other hand, has concerns with one of the research objectives for the main study, believing that it "suggests that the study will measure perceptions of the doctors' acceptance of the drug by respondents. Since respondents will only be seeing a print ad and not interacting with a doctor, we believe the research setting will be too artificial to gain meaningful insights into this topic."

Merck takes issue with several aspects of the study and would like for the FDA to "focus their efforts and research first on improving the health literacy of approved patient labeling and then on DTC print advertising. In addition, FDA should consider exploring the inclusion of benefit information in patient labeling, which may help improve consumer understanding and comprehension of patient labeling." Merck further suggests that for the follow-up study, the FDA reduce the number of trials for respondents across health literacy levels, as respondent fatigue can occur. Respondent fatigue is concerning because it can result in a reduced focus and unreliable responses.

The FDA somewhat responded to these concerns, noting that prior research has shown that consumers can actually reach numeric judgments about efficacy and risk despite the fact that no numeric information has been presented in an ad and that the FDA worked with an expert reviewer at OPDP to "produce efficacy claims that are realistic for this drug class."

The FDA agreed with Merck's concerns about the follow-up study and respondent fatigue, noting that pretest data "may reveal that the experiment can be shortened without loss to validity."

March 16, 2016

Senate Introduces Bill Eliminating the Tax Deduction for DTC Advertising

Four Democrats have introduced a Senate companion bill to the House bill to ban nearly all direct-to-consumer (DTC) advertising. The Senate bill, "Protecting Americans from Drug Marketing Act," would prevent pharmaceutical companies from writing off the money that they spend on advertising and marketing as a tax deduction, as they currently can do.

The bill was introduced by Senators Al Franken, Sheldon Whitehouse, Sherrod Brown, and Tom Udall, and defines DTC as any advertisement "primarily targeted to the general public," specifically: print, radio, television, telephone communication systems, and social media.

Critics of DTC advertising often repeat the same messages, constantly reminding us that the United States and New Zealand are the only two countries that permit pharmaceutical companies to market directly to consumers.

Senator Franken's Viewpoint

Senator Franken, who had previously introduced this bill in 2009, argued that increased spending on advertising contributes to higher drug costs, since many ads feature newer and pricier medicines. Franken issued a statement, saying that drug makers are "trying to encourage Americans to buy the most expensive drugs, even when cheaper, equally effective drugs are on the market...This is just a common sense measure to help cut down health care costs."

In his statement, Senator Franken stated, "doctors and medical professionals are in the best position to provide information to patients, not drug company advertisers aiming to make a profit."

Senator Franken hopes that without the tax benefits provided through advertising, pharmaceutical companies will stop focusing on advertising, and instead turn their focus and resources to developing new drugs.

Senator Franken's argument follows the argument that the American Medical Association made back in November when they called for a ban on DTC advertising and promotion.

Analysis and Reaction

It has been mentioned that the four senators who introduced the bill would like to have it added to the health care reform legislation, possibly even offering it as an amendment when the full Senate considers the proposed bill. Such a move would put a previous "handshake deal" between pharmaceutical companies and the Obama administration and Senate Finance Committee leaders in jeopardy. That deal called for drugmakers to pick up an estimated $80 billion in health care costs in exchange for no further crackdowns on the industry.

John Kamp, executive director at the Coalition for Healthcare Communication, believes that laws "that ban truthful messages are a violation of the First Amendment and an insult to patients seeking information to enrich their discussions with their doctors and empower their medical decisions."

A spokeswoman for the Pharmaceutical Research and Manufacturers of America (PhRMA), stated that criticisms about DTC advertising "are being drive by the false notion that DTC plays a direct role in the cost of new medicines and ignores the positive impact of health care communications." She also enforced the idea that advertisements "provide scientifically accurate information to help patients better understand their health care and treatment options.

The bill was introduced on March 3, 2016, was read through twice, and has been referred to the Committee on Finance.

March 15, 2016

FDA National Direct to Consumer Advertising Survey – Again

If at first you don't succeed try, try again. That seems to be the theme of a recent announcement by the Food and Drug Administration (FDA) on the proposed collection of consumer attitudes towards Direct to Consumer Advertising (DTC).

Under the Paperwork Reduction Act, federal agencies are required to publish notice in the Federal Register of any proposed collection of information and to allow sixty days for public comment in response. This most recent notice by the FDA solicits comments on research entitled, "National Direct-to-Consumer Advertising Survey." The objective of the research is to survey the American population about their experiences with, and attitudes toward, direct-to-consumer (DTC) prescription drug advertising.

The FDA last surveyed patients about their experiences with and attitudes toward DTC advertising in 2002, and as numerous changes have been made that affect the DTC landscape, the FDA is interested to see whether the changes have had an influence on consumer attitudes and behaviors. Some of the changes include: declines in print readership, the rise in online prescription drug promotion, and self-imposed industry guidelines for DTC advertising.

The survey is expected to contain questions about "respondents' knowledge of FDA's authority with respect to prescription drug advertising, their exposure to DTC advertising, their beliefs and attitudes about DTC advertising, and the influence of DTC advertising on further information search and patient-physician interactions." At the end of the survey, participants will be asked to view one of two ads for fictional prescription drugs intended to treat high cholesterol and will be asked questions about the FDA's authority regarding specific claims found within the ad.

The general purpose of the survey is to build on previous research through a wider range of respondents (approximately 1,765, enticed to respond with 2 $1 bills found in a pre-survey invitation envelope), weighting the data to make it more representative, and asking more questions about DTC promotion. The FDA believes that offering a small token of value to the participates will establish a "latent social contract and subsequent reciprocity."

This survey comes after Representative Rosa DeLauro introduced a bill that, if passed, would prohibit all DTC ads for the first three years after a new drug is approved. Physicians at the American Medical Association (AMA) have also called for a ban on DTC ads for pharmaceuticals.

For those who are interested, information and study summaries of previous FDA surveys about advertising, including DTC advertising, can be found here.

The FDA is asking for comments, in either electronic or written format, to be submitted by close of business on April 29, 2016.


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