NeuAge Institute (NAI)

Drug Promotion Best Practices: A Guide for Regulatory Affairs Professionals in Training

Regulatory affairs professional in a pharmacy after regulatory affairs training

Effective drug promotion is essential for communicating the benefits and risks of medical products to healthcare professionals and patients alike. In the pharmaceutical field, Drug Promotional Literature (DPL) constitutes a significant marketing tool companies use to disseminate essential information about their products, including the product name, pharmacological characteristics, pricing, marketing claims, and supporting references. 

While DPL can be highly informative and beneficial, studies have shown that when prescribers primarily rely on DPL for new information, it can lead to inappropriate prescribing practices, resulting in the irrational use of medication. This highlights the importance of critically evaluating DPL to ensure the appropriateness and accuracy of the information presented and subjecting it to critical appraisal and review. Regulatory oversight is also vital.

This blog aims to provide regulatory affairs career hopefuls with a comprehensive guide to drug promotion best practices, specifically focusing on the standards set forth by the U.S. Food and Drug Administration (FDA). If you’re drawn to a position that empowers and qualifies you to contribute to enforcing the safety and efficacy of food and medical products, the NeuAge Institute’s Regulatory Affairs Certification can equip you with the right knowledge and skills to be successful and positively impact the industry.

Drug Promotion Literature Standards and Guidelines

The World Health Organization (WHO) defines medicinal drug promotion as “all informational and persuasive activities by manufacturers and distributors, the effect of which is to induce the prescription, supply, purchase, and/or use of medicinal drugs.” 

According to the WHO, promotional claims in drug promotion should adhere to several key principles: they should be true, reliable, informative, balanced, updated, and based on authentic information.  As you’ll discover in regulatory affairs courses, these guidelines are essential to ensure the integrity and accuracy of promotional materials and to promote responsible and ethical marketing practices within the pharmaceutical industry.

Regulatory affairs professional in conversation with a woman after regulatory affairs training
After regulatory affairs training, you may be responsible for ensuring that DPLs are in line with regulatory standards and guidelines.

Pharmaceutical industries are expected to adhere to the following WHO criteria to ensure the completeness of DPL:

  • The names of the active ingredients using either international nonproprietary names or the approved generic names of the drug
  • The brand name
  • Content of active ingredient per dosage form or regimen
  • Name of other ingredients known to cause problems
  • Approved therapeutic uses
  • Dosage form or regimen
  • Side effects and major adverse drug reaction
  • Precautions, contraindications, and warnings
  • Major interactions
  • Name and address of the manufacturer or distributor
  • Reference to scientific literature as appropriate

FDA Regulations for Drug Promotion in the United States

The oversight of prescription drug advertising and promotion in the United States is conducted by the FDA’s Office of Prescription Drug Promotion (OPDP). Prescription drug advertising and promotion in the United States are primarily governed by two key regulatory frameworks: the Federal Food, Drug, and Cosmetic Act (FDCA) and Title 21 of the Code of Federal Regulations Part 202 (21 CFR Part 202). These regulations outline the requirements and restrictions on how pharmaceutical companies can promote prescription drugs to healthcare professionals and consumers.

According to FDA regulations, promotions for prescription drugs should: 

  • Be consistent with the FDA-approved prescribing information
  • Be truthful and non-misleading
  • Contain a fair balance of product benefits and risks, and include material information

Notable Drug Promotion Best Practices For Regulatory Affairs Professionals

After regulatory affairs training, regulatory affairs professionals play a critical role in ensuring that drug promotion adheres to ethical standards and regulatory requirements. To ensure this, regulatory affairs professionals should make sure that all promotional materials accurately reflect the FDA-approved prescribing information for the drug. Consistency with the approved labeling is crucial to provide healthcare professionals and patients with reliable and trustworthy information.

After regulatory affairs training, regulatory affairs professionals ensure that DPLs meet regulatory guidelines and standards
Ensuring that medical products reflect accurate labelling and prescribing information is part of the duties of regulatory affairs professionals after regulatory affairs training.

Further, regulatory affairs professionals should ensure that drug promotion is truthful and non-misleading. All claims made in promotional materials should be supported by substantial evidence, avoiding exaggerations or misrepresentations. Providing accurate and reliable information is vital to maintain public trust and promote patient safety.

Balancing the presentation of product benefits and risks is a key best practice in drug promotion. Regulatory affairs professionals should ensure that promotional materials provide a fair and accurate representation of both the benefits and risks associated with the drug.

Interested in our regulatory affairs program?

Contact the NeuAge Institute for more information.

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