New FDA Studies To Take Closer Look At Drug Advertising and Marketing

Federal regulators indicate that they will launch several new studies this year, which are designed to look at drug promotions and advertising that is designed to promote prescriptions of medications by raising awareness about underlying medical conditions. 

The FDA’s Office of Prescription Drug Promotion (OPDP) released a preview of upcoming studies (PDF) last week, which details how it intends to analyze the effects of television ads designed to promote “disease awareness,” instead of marketing a specific drug, and how it plans to look at accelerated approval of drugs to the market and other issues.

The OPDP describes its mission in the preview as protecting public health to ensure truthful, balanced and accurate prescription drug information. It also watches for false and misleading advertising, and attempts to foster better communication of information to patients and healthcare providers.

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The report indicates that the office intends to rely heavily on social science to reach its goals.

For one of the studies, the OPDP will compare claims of drug efficacy and safety in science publications, compared to the claims of those same drugs made in promotional pieces. The study will look at study quality, how the claims are made in medical journals, sales aids and how those sources could create potential differences in perception.

Two of the studies will look at television commercials that promote disease awareness, without directly trying to sell a specific drug product. The study will test how similar those ads are to direct-to-consumer drug ads. Researchers will look at how the ads are positioned and timed, and how they are perceived by consumers.

Another pair of studies will look at how information is promoted for drugs that went through accelerated approval processes. One of the studies will involve focus groups of consumers that tests how well consumers understand the accelerated approval program and what types of information they want when making decisions regarding those types of drugs. The other study will test different methods of disclosing accelerated approval information on websites.

The OPDP also plans to conduct a survey of healthcare professionals on how prescription drugs are promoted toward them. It will also interview healthcare professionals to see how well they understand and process risk information for newly promoted prescription drugs.

The plan does not indicate when the studies will begin or how long they will take to conclude, only indicating that they should all begin sometimes this year.


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