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    FDA Drug Advertising Study Tracker

    The US Food and Drug Administration (FDA) frequently studies consumer behavior, particularly as it relates to how members of the public (and medical professionals) understand pharmaceutical advertising. Our FDA Drug Advertising Study Tracker keeps tabs on these studies and explains what they're trying to accomplish in plain terms.   Date Topic Study Summary January 2012 Corrective Advertising Study to assess whether and how corrective advertising—used to cor...
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    FDA Considers Allowing Drug Companies to Drop Some Warnings in TV Commercials

    The US Food and Drug Administration (FDA) has announced its plans to study whether consumers would benefit if direct-to-consumer television advertising contained a shorter list of major side effects instead of the now-lengthy list of nearly all of them. Background The study, first proposed in February 2014, is meant to address a regulatory hypothesis: That consumers, bombarded with a long list of side effects, might have a difficult time deciding between drugs. In the s...
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    How Should Diagnostic Tests be Regulated? Congress Wants to Know

    A new white paper published by the House Energy and Commerce Committee is calling for feedback on the US Food and Drug Administration's (FDA) proposal to regulate laboratory developed tests (LDTs) more similarly to how they regulate in vitro diagnostics. Background Under a longstanding regulatory exemption, lab-developed tests—products developed and used within a single laboratory—have not been subject to FDA’s premarket controls. Instead, the products are subject to th...
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    Does Your Spouse Affect How you Perceive Drug Safety? An FDA Study Aims to Find out

    The US Food and Drug Administration (FDA) has announced another proposed study of consumers who watch drug advertising on TV—the second this week—this time trying to assess how spouses influence how consumers understand a drug's benefits and risks. Background FDA frequently studies consumer behavior as it related to drug advertising. An overview of recent studies is as follows: Date Topic Study Summary January 2012 Corrective Advertising Study to assess wh...
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    Barraged by Drug Ads? FDA Wants to Know How That Makes You Feel—About the Drug

    There's no shortage of pharmaceutical advertising on US television stations. Watch a TV show for long enough, and chances are good you might even see the same drug ad several times. Now the US Food and Drug Administration (FDA) says it's interested in studying whether consumers who view the same drug ad multiple times perceive the safety or efficacy of the advertised drug differently than those who view it only once. Background FDA frequently undertakes studies on direc...
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    Do Distractions in Drug Ads Put Consumers at Risk? FDA Study to Find out

    The US Food and Drug Administration (FDA) has received approval to go forward with a proposed study to study the effects of "distractions" in direct-to-consumer drug advertising, which it hypothesizes may reduce consumers' ability to remember risk information about a product. Background FDA announced the proposed study in May 2014, saying that while "previous research has shown that factors such as multiple scene changes and music in advertising can be distracting," t...
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    As FDA Tries to Regulate Lab-Developed Tests, Congress Signals Potential Opposition

    Last month, the US Food and Drug Administration (FDA) announced it would soon seek to regulate lab-developed tests more similarly to in vitro diagnostics (IVDs), citing the devices' increasing complexity and role in critical clinical decision-making. And while the plan has received some pushback from legal groups , including the Washington Legal Foundation, it might soon have another, more prominent opponent: Members of Congress. Background LDTs are, as their name imp...
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    Can FDA Regulate LDTs Through Guidance? Legal Analysis Casts Doubt

    In recent weeks the US Food and Drug Administration (FDA) has undertaken major steps meant to bring lab-developed tests (LDTs)—devices developed, tested and used within a single laboratory—under stricter regulatory controls. But now new questions are being raised about whether the agency is using the correct methods to enact those changes. Background Under normal circumstances, medical devices can reach the market in one of two ways. Either they obtain FDA approval thro...
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    In Major Shift, FDA to Regulate Lab-Developed Tests as Normal Devices

    The US Food and Drug Administration (FDA) announced Thursday that it plans to reverse a decades-old policy and begin regulating Lab-developed Tests (LDTs) more similarly to in vitro diagnostic devices (IVDs). Background Under normal circumstances, medical devices can reach the market in one of two ways. Either they obtain FDA approval through the premarket approval (PMA) process—a difficult and expensive pathway that requires clinical data to support an application—or a...
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    Do Teenagers and Young Adults Understand Drug Ads? FDA Study Aims to Find Out

    How do teenagers and young adults interpret messages contained in direct-to-consumer pharmaceutical advertisements? The US Food and Drug Administration (FDA) wants to know, and is now moving forward with a study of how adolescents and young adults (ages 13 to 30) understand the benefits and risks of drugs they learn about through advertising. The study was first announced in October 2013 . At the time, FDA noted that adolescents may understand drug advertisements ...
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    DOD Steps Onto FDA Turf, Seeking to Evaluate Safety and Effectiveness of LDTs

    The US Food and Drug Administration (FDA) may be the federal government's regulator of most medical products, but at least one federal agency is looking to conduct basic reviews of the safety and efficacy of one type of medical product FDA says it has the authority to regulate. Background Under normal circumstances, medical devices can reach the market in one of two ways. Either they obtain FDA approval through the premarket approval (PMA) process—a difficult and e...
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    Do 'Distractions' in DTC Advertising Affect Patient Risk Perception? FDA Wants to Know

    The US Food and Drug Administration (FDA) has put the finishing touches on a proposed eye-tracking study intended to assess how patients assess the benefits and risks of direct-to-consumer (DTC) drug advertising when subject to on-screen "distractions." FDA has conducted similar research in the past, it notes in its 27 May 2014 Federal Register announcement. Prior eye-tracking research determined that consumers understand drug risks better when they are simultaneously ...