Public hearing
The Food and Drug Administration (FDA) has just concluded a public hearing to debate the process of promoting regulated medical products, including prescription drugs, vaccines, blood products, and medical devices direct to the consumer. The two-day event, held on November 1 and 2, 2005 at the National Transportation Safety Board Boardroom and Conference Center, reflects the increasing importance and associated controversy that surrounds direct-to-consumer (DTC) advertising. Proponents of the practice insist that this form of product promotion enhances consumer knowledge and improves public health. Critics however, maintain that the system is designed by the pharmaceutical industry to bolster drug sales by misleading patients into believing that they need a drug that may be unnecessary or unsuitable for them. The FDA, thrown into the middle of the ensuing debate, held the meeting to respond to growing public and political dissent of the practice and their perceived lack of oversight. Over the course of two days, the agency heard arguments from both sides of the debate and listened to suggestions from pharmaceutical company executives, university researchers and consumer advocates on how to better convey complicated medical information through advertisements. No plans were made to implement any new regulations or guidelines to control DTC advertising and the FDA continues to take comments on the issue through the end of February 2006.
Self-control
Not surprisingly, Pharmaceutical Research and Manufacturers of America (PhRMA), the industry group that represents the country’s leading pharmaceutical companies are supportive of DTC advertising. However in recognition of the potential conflict of interest, PhRMA introduced a voluntary code concerning the DTC promotion of pharmaceutical products. This code which has the backing of 26 pharmaceutical companies will go into effect January 2006 and was discussed in the August 10, 2005 edition of the P.I.L.S Compliance Column. Scott Lassman, Assistant General Counsel at PhRMA attended the public hearing and made the following comment in support of the practice,
“PhRMA firmly believes that when patients have access to accurate and understandable information about their medical conditions and treatment options, they can partner more effectively with their health care providers to obtain the most appropriate treatment for their individual circumstance.”
Shirking responsibility
Much of the controversy that surrounds DTC advertising concerns the lack of independent oversight. Currently, the Office of Medical Policy Division of Drug, Marketing, Advertising and Communications (DDMAC) is charged with overseeing all promotional labeling and advertising for prescription drugs and the Federal Trade Commission regulate Over-the-Counter medicines. However, whilst DDMAC provides oversight, FDA approval is not required. Some speakers at the meeting expressed a belief that the FDA should exert more control over DTC advertising. Diana Zuckerman, Ph.D., president of the National Research Center for Women & Families, said,
"It should be FDA's job to make sure [ads are] understandable."
Representatives of the Consumers Union and the National Consumers League also stated their belief that all DTC advertisements for pharmaceutical products should be cleared by the FDA before they are broadcast or printed.
Senior policy analyst Bill Vaughan submitted testimony on behalf of the Consumers Union.
“Because the emphasis at the FDA is getting drugs quickly to market, the agency often doesn’t fully know the safety implications of some of these drugs,” said Vaughan. “The FDA shouldn’t allow advertising of these new drugs to millions of consumers until it has a clearer understanding of the risks.”
The Consumers Union support pre-approval of DTC advertisements before they are presented to the public, to prevent misleading marketing that may overstate benefits and understate risks. The independent, nonprofit testing and information organization also stated that if pre-approval is not possible, then substantial penalties should be incurred by companies for misrepresentation of any safety risks.
Breaking ranks
Unlike many of their colleagues, AstraZeneca joined the call for DTC advertisements to be submitted to the FDA for prior review. In a written testimony, the company stated,
"The PhRMA guidelines are a solid first step, but the proposals we're making today make clear that AstraZeneca views the PhRMA principles as a floor, not a ceiling," said Tony Zook, Senior Vice President, Commercial Operations, and President and CEO designate, AstraZeneca Pharmaceuticals LP. "If our collective goal is to ensure that accurate and responsible information is communicated to patients and health care providers, then manufacturers, patients, physicians and policymakers ought to welcome such a review process."
Naturally, not everyone was happy with this proposal.
Dr. Marlene Tandy a senior counsel for Johnson & Johnson, who was representing the medical device trade group AdvaMed at the hearing opposed AstraZeneca's plan, saying,
"It's an option. We don't think it should be mandatory".
Ban it
There are some critics of DTC advertising, including Consumer Alert Executive Director Gary Ruskin, that call for an all out ban of the practice.
"By law, only doctors may prescribe prescription medicine. There is no legitimate purpose in advertising what consumers may not directly purchase. For this reason alone, [direct-to-consumer] advertising should be prohibited,"
Moratorium opposition
John Kamp spoke on behalf of the Coalition for Healthcare Communication and warned the FDA about banning drug advertisements stating,
“First, it’s a non-sequitur. Cars, like drugs, are often recalled for safety reasons. Cars, like drugs, can kill if not used as directed. And even when used as directed, can have latent, unknown deadly safety risks. It makes no more sense to ban drug advertising in response to drug recalls than it would to ban car advertising in response to brake recalls.”
Kamp also spoke out against calls for a moratorium on DTC for new drugs,
“Also, let’s not fall for the seemingly sensible calls for a rigid one, two or even three year ‘moratorium’ on DTC for new drugs, especially those that propose it as a type of Phase IV clinical trial period where small populations might “test” safety or effectiveness. Such schemes undermine the very integrity of the FDA drug approval process, and need to be rejected outright.”
Advertising investment
While spending on DTC advertising grew overall in 2004, some companies did reduce their spending. According to Nielsen Monitor-Plus, Pfizer reduced spending by 41 percent, from $352 million in 2003 to $208 million in 2004. AstraZeneca cut its total DTC spending by 34 percent, from $236 million in 2003 to $155 million in 2004 and GlaxoSmithKline decreased DTC expenses by 14 percent, from $369 million in 2003 to $318 million.
While debate continues, controversy abounds, and some budget cuts are made, the amount of money invested by the industry in DTC advertising remains huge. In the most recent figures available from TNS Media Intelligence, $2.94 billion was spent on DTC advertising through August 2005, up from $2.88 billion during the same period in 2004. At this rate, pharmaceutical companies are on track to top the 2004 total of $4.44 billion. The industry is also looking for alternative and more effective ways to market their products to consumers, with an emphasis towards the Internet and away from television, radio and print. One thing is sure – DTC advertising is here to stay, so any processes to improve and monitor the practice have to be beneficial to all.
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