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New guidance to ensure medicine label claims are genuine

The FDA guidance is titled “Providing Regulatory Submissions in Electronic and Non Electronic Format — Promotional Labeling and Advertising Materials for Human Prescription Drugs.” The focus of the document is to provide guidance for pharmaceutical manufacturers, packers and distributors in relation to promotional materials for human
prescription drugs.

By promotional labeling this generally refers to any labeling, other than the FDA-required labeling, that is devised for promotion of the product and can include TV ads, brochures, booklets, websites and any other source, be that paper-based or digital.

The guidance considers appearance, layout, format, and visible impression of promotional materials submitted, and, in tune with the modern age, embraces everything from the style of a promotional booth to the marketing of medicines through the use of video games.

An example of inaccurate marketing is provided by Forbes. This relates to the company Allergan which produced a new eyelash thickening drug Latisse in 2019, promoted by Brooke Shields. While the marketing material showcased the actor’s longer, thicker lashes from the drug, it was called up by the FDA for not mentioning the possible side effects, which can include “hair growth outside of the treatment area, a permanent darkening of eye color and bacterial infections that can lead to blindness.”

Not only is it important to get marketing material right, it is also of necessary to ensure that fake medicines do not get onto the market.

Concerns with misleading or falsified medicines is a global problem and one which pharmaceutical companies and regulators are seeking to address.

One of the important characteristics, according to the website Healthcare Packaging, is the use of unique identifiers for each item of medicines. This helps with the track and tracing of the product. Such an approach also fits in with the growing interest in technologies like blockchain.

A blockchain is a time-stamped series of immutable record of data that is managed by a cluster of computers not owned by any single entity (this means it is ‘decentralized’).This makes the technology ideal for tracking supplies, and ensuring that required storage conditions have been achieved and that goods have not been tampered with.

READ MORE: Blockchain helps pharma with product traceability

According to a NASDAQ article, the application of blockchain could save the pharmaceutical sector billions of dollars as well as providing a securer supply of medicnes for patients.

Written By

Dr. Tim Sandle is Digital Journal's Editor-at-Large for science news. Tim specializes in science, technology, environmental, and health journalism. He is additionally a practising microbiologist; and an author. He is also interested in history, politics and current affairs.

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