Trade Resources Policy & Opinion FDA Releases New Guidance on Prescription Drug Promotion

FDA Releases New Guidance on Prescription Drug Promotion

1.0 (2 Votes)

The US Food and Drug Administration (FDA) has released new guidance for drug makers on prescription drug promotion.

FDA has released two Federal Register notices pertained to prescription drug promotion from the FDA Center for Drug Evaluation and Research’s Office of Prescription Drug Promotion.

The first Federal Register notice is related to product name placement, size, prominence, and frequency in promotional labeling and advertisements for human prescription drugs such as prescription biological products and animal prescription drugs.

The second Federal Register notice is linked to FDA proposal to study the ability of consumers and healthcare professionals to spot and report deceptive prescription drug promotion practices.

Patients can use information from drug promotions such as information about a product’s efficacy and risks when exploring treatment options and making treatment decisions, while health care professionals can take information from promotional materials when making prescribing decisions.

Consumer can take the help of health care professionals on specific drugs, if the information is false or misleading.

FDA commissioner Dr Scott Gottlieb said: "Promotional material that drug makers share with patients and providers can be a helpful tool for encouraging patients to seek medical care and raising awareness about new and different treatment options.

“The FDA plays an important role in helping to make sure these presentations are truthful, balanced, and nonmisleading, and we need to study promotional material to constantly improve our oversight over these activities.

“A key to our oversight is recognizing claims in prescription drug promotion that have the potential to deceive or mislead consumers and health care professionals.”

Contribute Copyright Policy