DTC advertising includes, for example, broadcast  advertisements (such as those on television and radio), print  advertisements (such as those in magazines and newspapers), and Internet  advertisements (such as consumer advertising on drug companies’ Web  sites). In January 2002, at the direction of the Deputy Secretary of HHS,  FDA implemented a policy change requiring OCC to review and approve  all regulatory letters prior to their issuance, including letters drafted by the  DTC Review Group, to ensure “legal sufficiency and consistency with  agency policy.” In its written comments on a draft of our 2002 report,  FDA stated that, prior to the policy change, there had been complaints that  FDA would not follow up on many of its regulatory letters, and that the  goal of the policy change was to promote voluntary compliance by  ensuring that drug companies who receive a regulatory letter understand  that the letter has undergone legal review and the agency is prepared to go  to court if necessary. Drug Company Spending on DTC Advertising Has Increased More Rapidly Than Spending on Promotion to Physicians or Research and Development

The amount that drug companies spend on DTC advertising increased  twice as fast as spending on promotion to physicians or on research and  development. The studies we reviewed also suggest that DTC advertising increases  prescribing by prompting some consumers to request the drugs from their  physicians, and that physicians are generally responsive to the patient  requests. In contrast, other research  suggests that DTC advertising can have negative effects, such as  encouraging increases in prescriptions for advertised drugs when  alternatives may be more appropriate. FDA Reviews a Small Portion of DTC Materials and Cannot Ensure It Is Reviewing the Highest-Priority Materials

FDA reviews a small portion of the increasingly large number of DTC  materials it receives. However, FDA does not apply  these criteria systematically to the materials it receives. As a result, the agency cannot ensure that it is  identifying or reviewing the materials that are the highest priority. FDA officials told  us that, to target available resources, the agency prioritizes the review of  the DTC advertising materials that have the greatest potential to impact  public health. Since the 2002 Policy Change, FDA’s Process for Issuing Regulatory Letters Has Taken Longer and the Agency Has Issued Fewer Letters

Since the 2002 policy change requiring legal review by OCC of all draft  regulatory letters, the agency’s process for drafting and issuing letters has  taken longer and FDA has issued fewer regulatory letters per year. 2.) For letters issued from 2002 through 2005, once  DDMAC began drafting a letter for violative DTC materials it took an  average of about 4 months to issue the letter. In comparison, for regulatory letters issued from 1997 through  2001, it took an average of 2 weeks from drafting to issuance. 3.) Effectiveness of FDA Regulatory Letters at Halting Dissemination of Violative DTC Materials Has Been Limited

FDA regulatory letters have been limited in their effectiveness at halting  the dissemination of false and misleading DTC advertising materials. By the time these letters were issued, drug  companies had already discontinued more than half of the cited materials. For the materials that were still being disseminated, drug companies  removed the cited materials in response to FDA’s letter. Despite halting the dissemination of both cited and other violative  materials at the time the letter was issued, FDA’s issuance of these letters  did not always prevent drug companies from later disseminating similar  violative materials for the same drugs. From 2004 through 2005, FDA issued regulatory letters citing DTC  materials an average of about 8 months after the violative materials were  first disseminated. Recommendations for Executive Action

To improve FDA’s processes for identifying and reviewing final and draft  DTC advertising materials, we recommend that the Acting Commissioner  of the Food and Drug Administration take the following three actions:    document criteria for prioritizing materials that it receives for review,    systematically apply its documented criteria to all of the materials it  track which materials have been reviewed. Delays in  issuing regulatory letters limit FDA’s effectiveness in overseeing DTC  advertising and in reducing consumers’ exposure to false or misleading  advertising. To examine the relationship between DTC advertising and prescription  drug spending and utilization, we conducted a literature review. We examined the content of FDA’s most  recent regulatory letters—the 19 regulatory letters, 6 warning letters and  13 untitled letters, FDA issued from 2004 through 2005—in order to  determine the types of violations that FDA identified and the actions that  the agency requested the drug companies to take.
Why GAO Did This Study

The Food and Drug Administration (FDA) is responsible for overseeing direct-to-consumer (DTC) advertising of prescription drugs. If FDA identifies a violation of laws or regulations in a DTC advertising material, the agency may issue a regulatory letter asking the drug company to take specific actions. GAO was asked to discuss (1) trends in drug company spending on DTC advertising and other activities; (2) what is known about the relationship between DTC advertising and drug spending and utilization; (3) the DTC advertising materials FDA reviews; (4) the number of regulatory letters that cited DTC materials and FDA's process for issuing those letters; and (5) the effectiveness of these letters at limiting the dissemination of violative DTC advertising. GAO reviewed research literature, analyzed FDA's processes, and examined FDA documentation.

What GAO Found

Drug company spending on DTC advertising--such as that on television and in magazines--of prescription drugs increased twice as fast from 1997 through 2005 as spending on promotion to physicians or on research and development. Over this period, drug companies spent less each year on DTC advertising ($4.2 billion in 2005) than on promotion to physicians ($7.2 billion in 2005) or research and development ($31.4 billion in 2005). Studies GAO reviewed suggest that DTC advertising has contributed to increases in drug spending and utilization, for example, by prompting consumers to request the advertised drugs from their physicians, who are generally responsive to these requests. Evidence suggests that the effect of DTC advertising on consumers can be both positive, such as encouraging them to talk to their doctors, and negative, such as increased use of advertised drugs when alternatives may be more appropriate. FDA reviews a small portion of the DTC materials it receives. To identify materials that have the greatest potential to impact public health, FDA has informal criteria to prioritize materials for review. However, FDA has not documented these criteria, does not apply them systematically to all of the materials it receives, and does not track information on its reviews. As a result, the agency cannot ensure that it is identifying or reviewing those materials that it would consider to be the highest priority. FDA has taken longer to draft and review regulatory letters and the agency has issued fewer letters per year since 2002, when legal review of all draft regulatory letters was first required. From 2002 through 2005, from the time FDA began drafting a regulatory letter for a violative DTC material, it took the agency an average of 4 months to issue a regulatory letter, compared with an average of 2 weeks from 1997 through 2001. FDA has issued about half as many regulatory letters per year since the 2002 policy change. The effectiveness of FDA's regulatory letters at halting the dissemination of violative DTC materials has been limited. The 19 regulatory letters FDA issued in 2004 and 2005 were issued an average of 8 months after the materials were first disseminated. By the time FDA issued these letters, companies had already discontinued use of more than half of the violative materials. When the cited materials were still being disseminated, drug companies complied with FDA's requests to remove the materials, and identified and removed other materials with similar claims. FDA's issuance of regulatory letters did not always prevent drug companies from later disseminating similar violative materials for the same drugs. These issues are not new. In 2002, GAO reported that, by delaying the issuance of regulatory letters, the 2002 policy change had adversely affected FDA's ability to enforce compliance. At that time, GAO recommended, and FDA agreed, that letters be issued more quickly. GAO continues to believe this is necessary in order to limit consumers' exposure to false or misleading advertising.