Life Science Compliance Update

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June 04, 2013

FDA to Survey Direct to Consumer Advertising and Prescribers

Earlier this year, the Office of Management and Budget (OMB) approved a request by the Food and Drug Administration (FDA) to conduct research on direct-to-consumer (DTC) advertising. FDA previously asked the White House to conduct the survey back in October 2012, and proposed the studies in March 2012.

FDA released a Draft Guidance for Industry, entitled "Direct-to-Consumer Television Advertisements – FDAAA DTC Television Ad Pre-Dissemination Review Program," back in March 2012, we reported. In addition, FDA released a study in early 2012 showing no evidence that consumer understanding of risk info is affected by the "emotional (affective) tone of images."   

Specifically, FDA plans to survey physicians about their experience with DTC ads, following a similar survey FDA conducted in 2002. The prior survey, according to MedPage Today, found that "one-third of physicians said they believed DTC advertising had a negative impact on their practice, while one-third said it had a positive influence, and the remaining third said it made no difference."

As reported by MedPage, the 2002 survey "also asked physicians to think about a time when DTC advertising impacted a specific patient. A total of 18% of physicians reported that seeing the ad led to problems with that patient, compared with 41% who said it was a benefit to the patient. The data, which was published in late 2004, also showed that 41% of physicians said their patients were confused about the effectiveness of drugs due to DTC advertisements."

The respondents for FDA's upcoming survey will be recruited from the American Medical Association's master file and other relevant professional organizations for the physician extenders. FDA hopes to gather 2,000 responses from 500 general practitioners, 500 specialists, 500 nurse practitioners and 500 physician assistants. The study, however, will not be completed until March 2015.

"The FDA will send pre-notification letters before initiating the surveys, which will be conducted online. The FDA will disclose its sponsorship on survey materials and conduct reminder telephone calls to increase response rates. The survey is expected to take providers 20 minutes to complete," MedPage reported.

Unlike the 2002 survey, the new survey will include nurse practitioners and physicians assistants, which FDA said DTC ads have an impact on as well. FDA said it plans to also measure survey results to reflect age, race, and sex. The survey will also incorporate physician opinions about the use of social media.

"The question of whether a similar pattern will emerge now, despite the growth of DTC advertising, is a vital one," a Federal Register notice outlining the program stated. "Furthermore, FDA will benefit from knowing more detail about the various types of perceived effects DTC advertising might have."

The agency also said it will "benefit by knowing more about healthcare professionals'awareness of new and emerging drug promotion sites and practices," the FDA said.

DTC Ads Have Positive Benefits

In light of the proposed study, "A recent study released by the National Bureau of Economic Research (NBER) states that although consumer-directed drug promotion increases utilization and thus overall drug costs, it also helps to educate consumers, induce physician contact and promote adherence," as reported by the Coalition for Healthcare Communication (CHC).

According to CHC, "The February 2013 NBER study report discusses the role of promotion to both consumers and physicians and whether such promotion is persuasive and/or informational." CHC notes that the study presents empirical evidence that pharmaceutical promotion has both informative and persuasive elements; and that "there is no strong indication that either consumer- or provider- directed promotion substantially raised retail-level prices."

Study author Dr. Dhaval Dave, associate professor of economics at Bentley University and research associate for the NBER, told CHC that there "may be several potential benefits associated with pharmaceutical advertising."  Specifically, he stated that "advertising directed at consumers can expand the total market for drug treatment by educating consumers with regard to treatment options for their symptoms, by facilitating contact between the patient and the physician," and by reminding patients who already have prescribed medications to adhere to their drug therapy.

"Thus, in one sense, consumer ads can avert underuse and expand treatment to undertreated/under-diagnosed conditions," Dave told CHC. He continued, physician-directed promotion "has been shown to mostly have brand-specific effects rather than expanding the total market for the therapeutic class. Though, at least in the beginning phases of a drug's launch into the market, provider-directed promotion may have some informational content and may help to educate physicians regarding the availability of newer drug treatments, and their indications and contraindications."

As reported by Medical, Marketing & Media, the study also did not find much evidence that advertising caused price inflation. In fact, MMM cited to a study, which found that "DTC drives down retail prices by spurring insurers and pharmacies to more intense price negotiations. Nor does DTC pose any barrier to entry by competitors, branded or generic."

Additional DTC Research

While FDA plans on studying DTC, it was recently reported that promotional funding on DTC dropped 22 percent to $3.1 billion in 2012. Cegedim Strategic Data predicted more DTC in 2013 with newer brands and approvals, particularly for diabetes. As we continue to wait for FDA's long anticipated Guidance on the use of social media or internet communications in DTC ads, spending on such promotion will probably continue to decrease. Interestingly, however, Pfizer recently launched a website for sales of Viagra, in an attempt to ward off drug counterfeiters. The website will be run through CVS pharmacies.

What may be worrisome for drug companies and marketers in light of the recently proposed DTC-study, are results from another survey conducted by CMI/Compass focused on physicians perceptions of DTC, surveying both primary care and specialty physicians. According to the survey of only 104 physicians, as reported by the World of DTC, 53% of physicians felt that DTC ads should be scaled back. Other findings from the survey included:

  • Over 89% have received a specific medication request from a patient as a result of an advertisement they saw. 43% changed their prescribing as a result.
  • 78% feel that DTC ads leads to a preference for brand name drugs
  • 48% of physicians agree (5% strongly; 43% somewhat) that DTC pharmaceutical advertising informs, educates and empowers patients.
  • 68% of physicians agree (18% strongly; 50% somewhat) that DTC pharmaceutical advertising encourages patients to contact a clinician.
  • 64% of physicians agree (13% strongly; 51% somewhat) that DTC advertising promotes patient dialogue with health care provider(s)
  • Only 20% of physicians agree (5% strongly; 15% somewhat) that DTC pharmaceutical advertising strengthens a patient's relationship with a clinician.
  • 52% of physicians agree (9% strongly; 43% somewhat) that DTC pharmaceutical advertising removes stigma associated with certain diseases.
  • 63% of physicians agree (15% strongly; 48% somewhat) that DTC pharmaceutical advertising misinforms patients.
  • 74% of physicians agree (28% strongly; 46% somewhat) that DTC pharmaceutical advertising overemphasizes drug benefits.
  • 68% of physicians agree (14% strongly; 54% somewhat) that DTC advertising promotes new drugs before safety profiles are fully known
  • 81% of physicians agree (25% strongly; 56% somewhat) DTC pharmaceutical advertising encourages drug overutilization
  • 65% of physicians agree (23% strongly; 42% somewhat) that DTC pharmaceutical advertising is not rigorously regulated.
  • 78% of physicians agree that DTC ads ultimately increases cost of healthcare.

Based on these findings, Richard Meyer, author of the blog, predicted that similar findings by FDA from the proposed survey noted above could result in "new guidelines around DTC ads the likes of which they have never seen before." Meyer made an important point, however: even if patients ask for a branded drug, insurers often mandate the generic.

Moreover, he pointed out in a related post that more than "40 brand-name drugs — valued at $35 billion in annual sales — lost their patent protection" last year, and during the first nine months of 2012, sales of generic drugs increased by 19 percent over the same period in 2011, to $39.1 billion from $32.8 billion, according to Michael Faerm, an analyst for Credit Suisse. "Sales of branded drugs, by contrast, fell 4 percent during the same period, to $174.2 billion from $181.3 billion."

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