Jenny M. Markell

2 weeks ago | drugtopics.com | Brian Nowosielski |Jenny M. Markell

From the marketing of drugs with low-added benefit to manufacturers’ inability to follow FDA guidelines, direct-to-consumer advertising for prescription drugs has increased in the US and is beginning to raise alarms. “Under FDA guidelines, pharmaceutical companies are supposed to provide a balanced view of drugs in advertising in terms of their risks and benefits,” said Jenny Markell, BA, PhD Candidate of Health and Public Policy at the Johns Hopkins Bloomberg School of Public Health.

2 weeks ago | drugtopics.com | Brian Nowosielski |Jenny M. Markell

Formerly known as black-box warnings, the FDA’s boxed warning labels are the strongest safety warning that an approved drug can receive.1 Despite the FDA encouraging drugs with greater risk to include these warnings, the FDA does not require them, leading to adverse events and mixed patient preferences for prescription drugs.

3 weeks ago | drugtopics.com | Brian Nowosielski |Jenny M. Markell

Direct-to-consumer advertising of prescription drugs has become normalized in the US as top-selling, brand-name drugs flood the media with the ways they can benefit patients. However, as one of the only countries in the world that permits this advertising, research has shown dangerous trends that can mislead consumers and potentially harm patients.

3 weeks ago | drugtopics.com | Brian Nowosielski |Jenny M. Markell

Unlike many other countries, direct-to-consumer advertising for prescription drugs has been a constant in the US. While trends have changed over time, most experts would agree the recent increase in drug advertising is unlike anything the marketplace has seen.

Aug 30, 2024 | jamanetwork.com | Jenny M. Markell |Ilina C. Odouard |Gerard F. Anderson |Michael J. DiStefano

Introduction The US Food and Drug Administration (FDA) requires that direct-to-consumer advertising (DTCA) describe a drug’s benefits and risks in a balanced way and recommends presenting effectiveness and risk information quantitatively to improve consumer comprehension.1,2 Print product-claim advertisements must include a brief summary of all risks, but there is no requirement that every risk be prominently presented or severe risks be highlighted.3 Presentation of risk information in DTCA...