Direct-to-Consumer Pharmaceutical Advertising

Media That Distribute Direct-to-Consumer Drug Ads

Channels used to distribute DTCPA most commonly include television, print (magazines, newspapers), radio, the Internet, and other forms of mass media (billboards and direct mailings).^4,5 Promotional brochures that are supplied to health care professionals to distribute to patients can also be considered DTCPA, even though they aren’t provided directly to the consumer by the manufacturer.⁴

Many marketers are also beginning to recognize the enormous potential of online DTCPA, which reaches millions of potential consumers globally.^15,16 Though the vast majority of DTCPA budgets are still allocated to traditional media (television, newspaper, magazine, radio), marketers are beginning to shift some of their promotional spending to digital promotion, such as product Web sites, online display advertising, search engine marketing, social media campaigns, and mobile advertising.^15,16

History and Regulation Of Direct-to-Consumer Drug Advertising

The FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) is responsible for the regulation of DTCPA.⁵ The FDA was given the authority to approve pharmaceutical products for marketing in the U.S. as a result of the Federal Food, Drug, and Cosmetic Act, passed in 1938.¹⁷ In 1962, Congress specifically granted the FDA statutory authority to regulate prescription drug labeling and advertising.¹⁷

In 1969, the agency issued final regulations for prescription drug advertising, which stipulated that these ads must (1) not be false or misleading, (2) present a “fair balance” of information describing both the risks and benefits of a drug, (3) include facts that are “material” to the product’s advertised uses, and (4) include a “brief summary” that mentions every risk described in the product’s labeling.¹⁷

During the 1980s, the political climate in the U.S. became more favorable to the pharmaceutical industry.⁴ In addition, a cultural shift occurred that caused patients to start actively participating in medical decision-making with their health care providers.^18,19 In response to both of these changes, an increase in DTCPA occurred.^19,20 In 1981, Merck ran the first direct-to-consumer (DTC) print advertisement for its new antipneumococcal vaccine, Pneumovax(pneumococcal vaccine polyvalent) in Reader’s Digest.^2,4

Shortly afterward, Boots Pharmaceuticals ran the first DTC broadcast advertisement, which promoted the lower price of its prescription brand of ibuprofen (Rufen), compared with Motrin (McNeil Consumer), in 1983.²

With this introduction of DTCPA, the FDA had to consider new questions about how consumer drug advertising should be regulated. In 1983, FDA Commissioner Arthur Hayes asked the pharmaceutical industry to observe a voluntary moratorium while the agency studied the issue.^2,20

In 1985, the FDA published a notice in the Federal Register claiming regulatory jurisdiction over DTCPA and stating that prior standards of “fair balance” and “brief summary” that had been established for advertising to health care providers were sufficient to protect American consumers against deceptive or misleading claims.^2,4

This ruling triggered an onslaught of widespread print, but not broadcast, DTCPA.⁴ The need to include complete information about risks from the package insert to satisfy the “fair balance” and “brief summary” regulatory requirements could be satisfied with small type in a product claim print ad.⁴ However, the cost of purchasing enough time to include this information in product claim broadcast ads was prohibitive.²

Therefore, the only types of DTCPA that pharmaceutical companies broadcast on the radio and television were reminder, or help-seeking, ads, which do not make product claims, and so “fair balance” doesn’t apply and a brief summary doesn’t need to be included (see Table 1).^4,5

In 1995, the FDA held a hearing to discuss easing broadcast DTCPA regulations in recognition of the prohibitive time and expense that the rules then required.² In 1997, the FDA issued draft guidance on this topic (and final regulations in 1999) that allowed broadcast DTC product claim ads to include a “major statement” and “adequate provision” to satisfy the “fair balance” requirement, rather than the lengthier “brief summary,” which listed all product risks.^2,4

Now, advertisers had to include only “major risks” and provide an “adequate provision” that would direct viewers elsewhere to access complete “brief summary” information (from a toll-free number, a health care provider, a Web site, or a print ad).⁴

In 2004, the FDA further relaxed regulations concerning DTCPA, eliminating the need to reprint complete prescribing information in print product claim ads and allowing the inclusion of a “simplified brief summary” instead.^20,21 This change allowed pharmaceutical companies to present information on only the “major risks” and in simplified language that would be easier for the average consumer to understand.^4,20,21

Rapid Growth of Direct-to-Consumer Ads After FDA Regulations Were Relaxed

Many believe that the relaxation of the rules for DTC broadcast advertising in 1997 was responsible for the deluge of DTCPA that we experience today; however, there is evidence that this trend began much earlier.^2,4 For example, in 1980, total spending on DTCPA was $12 million; in 1990, it was $47 million; and in 1995, it was $340 million, representing a nearly 3,000% increase in expenditures during a 15-year period before broadcast ad regulations had even been relaxed.²

In 1997, after the FDA issued revised draft guidelines for broadcast DTCPA, the budgets for consumer drug advertising more than tripled to $1.2 billion in 1998 (Figure 1).³ Spending on DTCPA nearly quadrupled again during the following decade, topping $5 billion in 2006 and 2007, before dropping to $4.5 billion in 2009.^2,3 In 2008, spending decreased because of the financial crisis and subsequent economic slowdown—this was the first substantial reduction in DTCPA since the late 1990s.²²

Prior to 2005, the Government Accountability Office (GAO) had estimated that DTCPA was growing at approximately 20% per year, or twice as fast as spending on pharmaceutical direct-to-physician (DTP) advertising or on drug research and development.²³ The growth in DTC advertising expenditures was not without reason, being that it was estimated that every dollar spent on DTCPA would increase sales of the advertised drug by an estimated $2.20 to $4.20.^24–26

Still, in 2005, DTCPA accounted for only 14% of industry expenditures, whereas DTP advertising totaled 24%.^6,26

Although the relaxation of FDA rules in 1997 might not have been totally responsible for the rapid growth of DTC drug advertising, it did have an impact on the most preferred media for DTCPA.^15,17 Most of the budget for DTCPA is now spent on television commercials.^26,27 The average American television viewer watches as many as nine drug ads a day, totaling 16 hours per year, which far exceeds the amount of time the average individual spends with a primary care physician.^5,23,27

In recent years, drug marketers have also increased their expenditures for marketing efforts on the Internet, as searching for health-related information has become the third most common activity for online users.^22,26 In 2003, the pharmaceutical industry spent $59 million on DTC promotion on the Internet, and spending is now estimated to have grown to $1 billion.^15,26 This channel of promotion also promises to be lucrative; data show a 5:1 return on investment for online DTCPA, which is much better targeted than print or television ads in reaching the intended audience.²²

The average American TV viewer watches as many as nine drug ads a day, totaling 16 hours per year, which far exceeds the amount of time the average individual spends with a primary care physician.

Difficulty Enforcing FDA Regulations

The FDA has the authority to enforce regulations and take action against companies that do not abide by DTCPA rules.^4,5 However, the FDA’s capacity to enforce drug advertising regulations seems to have substantially. weakened.⁶ In recent years, the number of regulatory actions taken by the FDA against DTCPA violations has fallen off dramatically, which could reflect better industry compliance but could also be a result of a decline in FDA oversight.⁶

Several factors may be responsible for the apparent weakening of the FDA oversight of DTCPA. In 2002, the Secretary of Health and Human Services (HHS) began requiring that all draft regulatory warning letters be reviewed and approved by the FDA’s Office of Chief Counsel before they are issued.⁶ A GAO report noted that this required legal review seems to have resulted in a reduced number of warning letters to be issued as well as in delays that frequently caused them to be sent long after an advertising campaign ended.⁶

This conclusion was based on the fact that more than twice the number of regulatory letters (68 vs. 28) were sent by the FDA in 2001, compared with 2002, the year the legal review requirement was implemented (Figure 2).⁶ This decline in regulatory letters has continued, since in 2006, the FDA issued only 21 citations, in contrast to 142 that were sent in 1997.^6,24 Interestingly, during the same time period, the proportion of regulatory letters citing problems with DTCPA increased from 15.5 percent to 33.3 percent.⁶

Difficulties are also encountered because the number of FDA staff members dedicated to reviewing drug ads has remained relatively constant.⁶ In 2009, only 59 full-time employees were reportedly responsible for reviewing 71,759 industry submissions of both DTCPA and DTP promotional material, and they could cope with only a fraction of them.²⁸

With respect to DTCPA, in September 2006, fewer than half a dozen people were assigned to review more than 15,000 DTC advertisements and brochures.²⁰ In 2008, only 35% of broadcast DTCPA materials had been reviewed as a result of staff shortages.²⁰

This difficulty of keeping up with pharmaceutical ad review, including DTCPA, seems to be due to the disproportionately low funding of the FDA, in comparison to the pharmaceutical industry’s expenditures on advertising.²⁴ In 2010, the industry’s budget for DTCPA alone was reportedly nearly twice the entire budget for the FDA.²

Need for Regulations Regarding Online Direct-to-Consumer Ads

The FDA has not yet issued formal guidelines regarding online DTCPA.^15,28 However, in April 2009, the FDA did send warning letters to more than a dozen pharmaceutical manufacturers regarding company-sponsored search engine links that failed to mention product risks.¹ The ads typically contained the product name, the disease or condition it treats, the potential benefits, and a link to a product’s Web site.¹

The FDA stated that because the links mentioned the product name and its use (and sometimes even other product claims), risk information also had to be provided.¹² In response, drug company–sponsored links now include the indication or the name of the drug—but not both.²⁸

In the absence of formal guidelines regarding online media, drug companies have asked the FDA for guidance about what is acceptable, particularly in the context of social media. In response, in November 2009, an FDA hearing on online drug marketing was held, during which pharmaceutical companies argued in favor of allowing the use of space-limited online media for DTCPA.¹ Many companies also requested that the FDA rule on whether companies or their surrogates could directly interact with patients or physicians via online chat rooms or social media Web sites.¹

Participants at the hearing also debated whether companies were responsible for identifying reports of adverse reactions made online by individuals as well as the need for transparency regarding company-sponsored content.¹

Calls for Banning Direct-to-Consumer Drug Ads

There have periodically been calls for the FDA to severely curtail or ban DTCPA.⁹ However, free speech arguments regarding the right of a manufacturer to market its products, for the most part, prevent this.⁵ In a series of cases dating back to the 1970s, the courts had ruled that product advertisements were a form of “commercial speech.”⁹ Banning or restricting commercial advertising therefore violates the First Amendment protections of freedom of speech.⁹

By 1980, the Court had developed a set of criteria, the Central Hudson test, which is still used today for determining whether a ban on commercial speech is permissible.⁹ This test examines whether the advertising is misleading, whether banning it directly advances a substantial government interest (e.g., preserving public health), and whether the government’s interest could be achieved through a less restrictive route, such as by adding a special label.⁹

Some scholars object to this test, but nonetheless, the Court has repeatedly referred to it when overruling prohibitions on the advertising of alcohol, tobacco, and medications.⁹ Legal scholars therefore believe that the courts would overturn a complete ban on DTCPA on the basis that it is unconstitutional.^9,18,29

However, some experts suggest that increased regulation of DTCPA, rather than a ban, could satisfy the Central Hudson test and survive constitutional scrutiny.¹² Other measures have also been proposed, such as the Say No To Drug Ads Act, first introduced by Representative Jerrold Nadler (D-N.Y.) in 2002, and reintroduced most recently in February 2011.^5,30 This Act would amend the Internal Revenue Code to prevent drug manufacturers from claiming the cost of DTCPA as a tax deduction.⁵ Other representatives have introduced or supported legislation similar to Mr. Nadler’s.⁵

This is taken from a long document. Read the rest here: ncbi.nlm.nih.gov

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