The only developed countries that allow DTC advertising of prescription drugs are the United States and New Zealand (Frosch et al, 2007). In the United States, DTC advertising is unique for two reasons: the product cannot be purchased without a physician's prescription and it is regulated by the FDA (Huh and Langteau, 2007).
The FDA regulates the advertising of prescription drugs under the Federal Food, Drug, and Cosmetic Act (FFDCA) (Rados, 2004). The Division of Drug, Marketing, Advertising, and Communications (DDMAC) within the FDA's Center for Drug Evaluation and Research (CDER) is responsible for implementing the regulations governing DTC advertising (United States, 2002). Section 502(n) of the FFDCA requires that an advertisement include "the established name, the brand name (if any), the formula showing quantitatively each ingredient, and information in brief summary which discusses side effects, contraindications, and effectiveness." (Advertising, 2007). This requirement is further defined in the prescription drug advertising regulations in the Code of Federal Regulations, Title 21, part 202 (21 CFR part 202). These implementing regulations specify that prescription drug advertisements must not be false or misleading, must not omit material facts, and must present a fair balance between effectiveness and risk information.
From the 1950s to the early 1980s, pharmaceutical advertisements were absent in the mass media (Donohue, 2006) but were directed primarily to medical personnel. Relying on the strength of the traditional doctor-patient relationship, pharmaceutical companies targeted their marketing dollars to physicians. This changed with the airing of the earlier mentioned Rufen commercial and the advent of an advertising campaign by Merck and Dohme of its pneumonia vaccine, Pneumovax (Donohue, 2006). These pioneering advertisements were the result not of any sudden change in federal regulations. Rather they came from the pharmaceutical companies' recognition that the doctor-patient relationship had changed with the rise of consumer and patients' rights movements. According to Julie Donohue, these two drug-marketing campaigns "broke with tradition and pursued a marketing strategy that depended on consumers' taking a more active role in prescribing decisions" (United States, 2006). Following these early advertisements, concerns were raised about DTC advertisements, including their potential to mislead the public. In response, the FDA called for a voluntary moratorium on DTC advertising in 1983 so that it could create a more explicit policy.
The moratorium ended in 1985 when the FDA released guidelines that prescription drugs should adhere to the same rules that govern pharmaceutical advertising to physicians. Therefore the advertisements had to include the product generic name, side effects and contraindications, and could not be false or misleading (Bradford and Kleit, 2006).
Although it had been legal for pharmaceutical companies to engage in broadcast advertising, the big increase in this form of marketing took place in 1997 when the FDA relaxed rules that had made it difficult for companies to air effective advertisements. That year the FDA ended a prohibition on using the drug's brand name and benefits in the same advertisement, eliminating a source of confusion for consumers. Prior to this, the companies operated under rules governing advertising to physicians, which allowed "reminder" advertisements that uses the drug's name but didn't say what it was intended to treat. This policy change made it easier for drug companies to advertise on television (Donohue, 2007) because it eased the type of risk disclosure needed. Pharmaceutical companies could now tell consumers where to find additional information, such as by referring them to a Web site or an 800 number. In 2004, the FDA announced that print advertisements would no longer need to include full prescribing information (Sheehan, 2007).
The FDA describes three types of DTC advertisements:
Drug companies are required to submit final prescription drug advertising materials to the FDA when they are first shown to the public. While they are generally not required to show these materials prior to dissemination, some drug companies voluntarily submit draft DTC advertising materials to the FDA (GAO, 2006). One problem with not requiring advertising companies to show these advertisements to the FDA prior to dissemination is that a misleading commercial that is not submitted could complete its run on television by the time the DDMAC issues a letter (Jaramillo, 2007).
- Product Claim Advertisements: The most common of the
three, these typically include both the brand name and the condition
the drug treats. They also describe the risks and benefits associated
with taking the medication.
- Help-Seeking Advertisements: Also known as disease-awareness
communications, these mention the disease or health condition
but not the name of the drug that treats it. The purpose of
this type of advertisement is to create an awareness of symptoms
or conditions among consumers. (GAO, 2002) These advertisements
are not required to provide risk information and are not regulated
by the FDA.
- Reminder Advertisements: This type of advertisement,
which is exempt from risk disclosure requirements, names the
drug and dosage form or cost information. It does not mention
the condition it treats or make claims or representations about
The FDA provides safeguards against abuse. If the FDA identifies a violation of laws or regulations in a DTC advertisement, the agency may issue a regulatory letter asking the drug company to take specific actions. This may be either an untitled letter or a warning letter (United States, 2002). Untitled letters address violations, such as overstating the effectiveness of the drug. Warning letters target pharmaceutical companies that engage in continued violations of the act or address companies engaged in serious violations that affect consumer safety or health. In a warning letter, the FDA may tell a drug company that it will take further action, including judicial remediation. Both types of letters cite the violation and request that the company respond in writing to the FDA within 14 days, and require the company to take specific actions (United States, 2006).
In 2006, in response to a request from U.S. senators concerned about the effects of pharmaceutical advertising, the GAO issued a report criticizing the time the FDA takes to issue regulatory letters (GAO, 2006). From 1997 to 2001 the FDA took an average of two weeks to issue a regulatory letter; however from 2002 to 2005, that had risen to an average of four months. The number of regulatory letters also dropped from 142 in 1997 to 21 in 2006 (Donohue et al, 2007), largely due to a 2002 decision by the FDA to have all such letters undergo review by its Office of Chief Counsel.
A second reason for the decline in regulatory letters issued is the small number of staff members who review advertisements while advertising grows substantially (Donohue et al, 2007). In June 2002, there were only five DDMAC staff members who reviewed 248 DTC broadcast advertisements and an unknown number of DTC print advertisements. These were DTC advertisements that were submitted to DDMAC at the time of their dissemination in 2001 (United States, 2002). By September 2006, there were still fewer than a half a dozen staff members reviewing more than 15,000 DTC advertisements and brochures (United States, 2006).
With concerns growing about these advertisements, in 2007, Senators Ted Kennedy and Mike Enzi introduced S. 1082, the Food and Drug Administration Revitalization Act, in an attempt to require mandatory moratoriums on advertising new prescription drugs, preclearance of DTC advertisements, and a mandate that certain language be included in these advertisements. House Commerce Chairman John Dingell introduced H.R. 2900, the Food and Drug Administration Amendments Act (FDAAA) of 2007, which contained advertising provisions similar to S. 1082, as it was originally introduced. After pressure from the American Advertising Federation (AAF) and the advertising community, these restrictions were removed from the bill. The AAF contends that mandatory moratoriums on pharmaceutical advertising would violate the First Amendment protection for commercial speech (DTC, 2007).
When the FDAAA of 2007 was signed into law by President George W. Bush on September 27, 2007, this Act, among other things, reauthorized and expanded the Prescription Drug User Fee Act (PDUFA) for 2008 to 2012. PDUFA, enacted in 1992 and revised in 1997 and 2002, authorizes the FDA to collect fees from pharmaceutical and biotechnology companies to fund the new drug approval process. In this program, industries provide user fees in exchange for an FDA agreement to meet drug-review performance goals, which emphasize timeliness to bring the drugs to market more quickly. While the agency can only recommend changes, the FDAAA enables the FDA to levy fines of $250,000 for the first violation using false and misleading advertisements, not to exceed $500,000 for subsequent violations (H.R. 3580, 2007). However, on January 15, 2008, the FDA announced that the DTC user fee program for advisory review of DTC television advertisements in the FDAAA will not commence due to inadequate funding by Congress. This user fee program would have paid for increased FDA staff, which would have helped rein in misleading drug advertisements; currently, only 35% of the DTC advertisements that make it on the air are viewed by DDMAC staff members (Kritz, 2008).
On February 4, 2008, the Bush administration proposed a 5.7% increase in the FDA's budget for fiscal 2009. If approved by Congress, this funding increase would, among other things, include the user fee program. The CDER would also get an additional 283 employees (Strattera, 2008).
In addition to FDA regulations, the pharmaceutical industry attempts to self-regulate through a 15-point code of conduct issued by its trade association, PhRMA (PhRMA, 2005). They state, for example, that all such advertising should be "accurate and not misleading, should make claims only when supported by substantial evidence, should reflect balance between risks and benefits, and should be consistent with FDA-approved labeling." Under these vague and voluntary guidelines (Frosch et al, 2007), the pharmaceutical companies promise to hold off on consumer advertising of a new medicine until they spend an "appropriate" amount of time educating health care professionals about the medicine.
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