|UNITED STATES||$81.9 billion (18.9%)|
|GERMANY||$34.4 billion (7.9%)|
|CHINA||$21.5 billion (4.9%)|
|SWITZERLAND||$25.9 billion (4.7%)|
|BELGIUM||$18.33 billion (4.2%)|
|FRANCE||$18.27 billion (4.2%)|
|UNITED KINGDOM||$18.1 billion (4.2%)|
|JAPAN||$17.3 billion (4%)|
|NETHERLANDS||$11.7 billion (2.7%)|
|SPAIN||$11.6 billion (2.7%)|
|CANADA||$8.7 billion (2%)|
|RUSSIA||$7.2 billion (1.7%)|
|AUSTRALIA||$5.6 billion (1.3%)|
|POLAND||$5.4 billion (1.2%)|
FDA relies on establishment registration and drug listing information for:
▪ Drug establishment inspections.
▪ Post market surveillance.
▪ Drug quality reports.
▪ Adverse event reports.
▪ Monitoring of drug shortages and availability.
▪ Supply chain security.
▪ Drug import and export.
▪ Identification of products that are marketed without an approved application.
Here are the main issues:
1. False or Misleading Benefit Presentation.
2. False or Misleading Claims about Efficacy.
3. Omission of Material Fact.
Prescription drug advertisements and labeling (promotional communications) misbrand a drug, if they make false or misleading claims and representations about the risks associated with and efficacy of a drug.
The determination of whether a promotional communication is misleading includes, among other things, not only representations made or suggested in the promotional communication, but also the extent to which the promotional communication fails to reveal facts material in light of the representations made or with respect to consequences that may result from the use of the drug as recommended or suggested in the promotional communication.
Promotional communications include:
▪ Social Media Platforms.
▪ Online Banners.
▪ TV Shows.
▪ Direct-to-consumer broadcast television advertisement (TV Ad or Commercial).
These violations are concerning from a public health perspective, because the promotional communication creates a misleading impression regarding the overall benefit a patient may expect as a result of the treatment, and minimizes the risks associated with taking the drug.
For your information, the Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) reviews online promotional communication and sponsored links.
Registration of an establishment or listing of a drug does not denote approval of the establishment, the drug, or other drugs of the establishment, nor does it mean that a product may be legally marketed.
Any representation that creates an impression of official approval or that a drug is approved or is legally marketable because of registration or listing, is misleading and constitutes misbranding.
Furthermore, FDA’s acceptance of registration and listing information, inclusion of a drug in its database of drugs, or assignment of an NDC, does not denote approval of the establishment or the drug or any other drugs of the establishment, nor does it mean that the drug may be legally marketed.
Any representation that creates the impression that a drug is approved or is legally marketable because it appears in the FDA’s database of drugs, has been assigned or displays an NDC, or the establishment has been assigned an establishment registration number or Unique Facility Identifier, is misleading and constitutes misbranding.
Also, failure to register a drug establishment, constitutes misbranding.