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New Study Wants More FDA DTC Explanations

New Study Wants More FDA DTC Explanations

“The authors feel consumers misunderstand what FDA approval means.”
-Bob Ehrlich

Two physician researchers, Drs. Schwartz and Woloshin, have studied and published on DTC for years. They have generally been critical of drug industry communications. In their latest study published 9/12/2011 in the journal “Archives of Internal Medicine”, they want FDA approval to be a better understood term by consumers.

The authors feel consumers misunderstand what FDA approval means. Conusmers think FDA approval means a drug is very safe and more effective than older drugs. Of course the reality is that FDA approves drugs with a favorable risk/benefit profile. The drug does not need to be safer or more effective than older and cheaper drugs. Schwartz and Woloshin say “ approval does not mean FDA believes benefits are large… or all serious side effects are known.”

They conducted research to see if adding statements that added depth to what FDA approval really means. They wrote a statin drug ad where they added a statement differentiating a lower cholesterol outcome with preventing heart attacks. By using a control group they determined that they got a modest switch in consumer preference to a drug proven to prevent heart attacks. They also tested concepts of older drugs being safer and found once consumers were informed that it takes time to establish safety records, more consumers chose an older drug.

The issue here is what the FDA should do to provide better depth of explanation both on their own
and what to require in manufacturer advertising of drugs. If consumers see DTC ads as an implied
endorsement of better safety and efficacy, then it is fair that FDA better explain what their approval
signifies. On the other hand, should FDA require drug companies to add statements that their drug may
not be more effective than older drugs and that safety evaluation takes a long time in market?

I can agree that FDA should educate the public on the significance of FDA approval. Drug companies,
however, should not be compelled to cast doubt on long-term safety and comparative efficacy. The data
is available to physicians and they can compare drug effectiveness and risk/benefit before prescribing.
Consumers are not skilled in determining the nuances between old and new drug efficacy and safety.
Drug companies are required by FDA to make accurate statements on risks and benefits. Forcing drug
companies to cast doubt on long-term safety is likely counter -productive as consumers may resist new
medications that they need.

Schwartz and Woloshin raise valid concerns that consumers may read too much into an FDA approval
as an endorsement of use. That may require FDA investment in its own DTC to temper consumer
expectations. It is not fair to extend or require that explanation to DTC brand ads. Consumers are
advertising skeptics for most categories’ ads. Therefore they conduct additional searches of product
information from competitors, objective reviewers, peers and learned parties.

Bob Ehrlich, Chairman
DTC Perspectives, Inc.

Bob Ehrlich
Chairman & Chief Executive Officer at DTC Perspectives
Bob Ehrlich has over 20 years marketing experience in pharmaceutical and consumer products. Bob is the CEO of DTC Perspectives, Inc., a DTC services company founded in 2000. DTC Perspectives, Inc. developed the DTC National Conference, the largest DTC conference in the industry. DTC Perspectives, Inc. also publishes DTC Perspectives, a quarterly journal dedicated to DTC issues and practices. In addition DTC Perspectives, Inc. does DTC consulting for established and emerging companies, and provides DTC marketing plans for pharmaceutical companies.
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