CBO report: further restricting DTC advertising may be bad for public health

Guest blog by Susan Huggett, President of Torre Lazur McCann Canada

Periodically, there have been calls for greater limits on direct to consumer (DTC) advertising of new prescription drugs in the U.S.  One proposal that is often advanced calls for a moratorium on advertising during the first two years following a drug's approval by the Food and Drug Administration.  The U.S. Congressional Budget Office (CBO) recently evaluated the impact of the proposed advertising moratorium – in terms of cost to the health care system as well as its impact on public health. 

The brief published by the CBO highlighted that an advertising moratorium delaying the widespread use of new drugs:

• Could worsen rather than enhance public health
• Would likely have a limited impact on prescription drug prices

Decision to purchase drug dictated by physician’s prescribing and insurer’s coverage

One of the key concerns raised about direct-to-consumer advertising is that it may encourage broader use of certain drugs than their health benefits warrant.  The CBO report notes however that, “Prescription drug advertising cannot prompt consumers to take such independent action because they must receive a prescription before obtaining a drug.”  The report also notes that insurance coverage also plays a significant role in determining what drugs are prescribed.

While DTC advertising may raise patient awareness about a product or condition, it doesn’t necessarily translate into increased sales.  The CBO’s brief highlights the results of somestudies that found DTC advertising spurred individuals to seek treatment when they otherwise might not and improved patients’ compliance with prescribed drug regimens.

Newly approved drugs that are advertised account for 2% of market

The CBO report examined the extent to which DTC advertising of newly launched drugs contributed to increases in drug spending   According to the CBO, the impact of a moratorium on direct-to-consumer advertising for newly approved drugs would be small since newly approved drugs that are advertised accounted for only 2% of market in 2008 as compared to 10% in 1999.   The report noted that amoratorium may affect other marketing strategies used by drug manufacturers but would not be likely to have any significant impact on overall prescription drug costs.

Access to innovation?

The report also considered the patient safety issues associated with the impact of DTC advertising of new drugs. Specifically it examined the issue of whether DTC advertising may lead people to use drugs whose potential risks were not fully discovered during the drug approval process.

Prior to the approval of any prescription drug in the U.S, a team of physicians, statisticians, chemists, pharmacologists, and other scientists from the FDA’s Center for Drug Evaluation and Research reviews the company's data and proposed labeling.  If this independent and unbiased review establishes that a drug's health benefits outweigh its known risks, the drug is approved for sale.

There will still cases where additional side effects of medicines are discovered after approval, however these are not the result of weak standards but rather due to their rare occurrence.

The CBO report states that “…in some cases, a moratorium on consumer advertising could postpone the realization of a drug’s true risks—if, for example, the number of people taking the drug was reduced enough by a moratorium that the full risks were not discovered as quickly.”

DTC advertising and public health

The U.S. Congress has considered, but has not adopted, several bills in recent years that would limit DTC advertising of prescription drugs.  It is important to acknowledge the concerns raised as this most recent proposal over DTC advertising comes up for discussion, but there must also be consideration of the demonstrated positive public health impacts in the final policy decision.

New medicines play an essential role in addressing the economic and social burden of illness and disease. Responsible direct to consume advertising is an important tool in raising awareness about new medicines and the conditions and illnesses that they treat. The CBO report reminds us of many of the positive impacts that come from encouraging their patients to talk to their health care providers about new medicines.

Susan Huggett has specialized in healthcare marketing for over 20 years, with experience in both the Canadian and USA marketplace.  Having worked both client and agency side over the years, her approach is always integrated and collaborative -- a true strategic partner.  Located in Toronto, Ontario Susan is the President of Torre Lazur McCann Canada, one of the leading healthcare marketing agencies.