FDA wants to study whether doctors understand drug ads
The FDA has asked the White House for approval to launch a national study that will analyze how well clinicians understand drug advertising.
The agency requires drug companies to disclose drug's indications, how it should be administered, efficacy and clinical trial data in their advertising. But there is limited published research on the impact of those disclosures in prescription drug promotions, whether they're directed to consumers or healthcare professionals, according to the FDA.
"These disclosures may influence healthcare professionals and consumer comprehension and decision-making and may affect how and what treatment [providers] prescribe for their patients," the agency said in a notice posted Tuesday on the White House's OMB site. "Are healthcare professionals and consumers able to use disclosures to effectively frame information in efficacy claims in prescription drug promotion?"
The request comes as the FDA also seeks to include even more information in drug advertisements in the coming years. Last month, the Senate passed a measure that would provide HHS with $1 million to implement proposed rules requiring drugmakers to disclose the price of their prescription drugs in advertising.
In the proposed study, the FDA said it would ask clinicians to review mock promotional print pieces for different prescription drug products in a web-based survey.
The FDA sought comments on the proposal last year before submitting it to the White House. Novartis questioned why the study only targeted print ads, given the increasing use of social media and mobile device advertising.
"We suggest that the study include electronic advertisements in addition to print advertisements to account for and reflect changes in consumer consumption of media, including the increase of electronic promotion and advertising of products by sponsors," Elizabeth Adamson, regulatory intelligence manager at Novartis, said in a comment letter.
While the FDA acknowledged that promotions are moving to the digital sphere, it maintained that the study's fundamental questions would be the same no matter the ad's presentation. Moreover, the mock print ads are similar to what might be shown on a website, which is a prominent electronic format, it said.
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