Pharmaceutical sales regulations are complex and can impact a pharmaceutical or biopharmaceutical company’s ability to sell its products. This is especially true for small and medium-sized companies.

One of the main objectives of the pharmaceutical industry is to persuade physicians to prescribe their brand drugs preferentially and in high volumes. This is accomplished through physician-pharmaceutical sales representative (PSR) interactions, also called detailing.

Regulatory Compliance

Pharmaceutical companies are under a lot of pressure to comply with regulations that govern their advertising efforts. These regulations are designed to ensure that consumers receive accurate information to help them make sound decisions about their health and promote a fair marketplace overall.

Regulatory compliance ensures that your business follows specific laws and requirements enacted by federal, state or local governments. It is an essential aspect of running a successful business. 

Developing a comprehensive compliance program that can accommodate your business’s goals and needs is essential. This should involve ongoing audits and review periods, as well as subject-matter experts who can monitor and track changes to the regulations that impact your business. Specialists in the area, like Chris Manfuso, can create marketing plans and educate salespeople. The complexity of pharmaceutical sales regulations has made pharma marketers need to focus on a strategic approach that includes compliance as a core part of how their business operates. This is especially true for international affiliates.

Trademarks

Trademarks are a great way to protect your company’s intellectual property. They are typically words, phrases or designs that help you distinguish your products and services from others in the marketplace.

They also make your business stand out from the competition and can help you increase consumer confidence in your brand. This is especially important if you are a startup or small business that wants to compete against large corporations with deep pockets and substantial marketing budgets.

Unlike patents and copyrights, trademarks can be bought, sold, and transferred between companies. Likewise, they can be challenged in court, which is why many jurisdictions have a variety of protections for trademark owners. For example, in the United States, an incontestable logo (or mark) statute protects registered trademarks that have been used continuously for over five years. These laws are designed to keep small businesses from being overrun by large corporations whose marketing departments can often afford the legal fees involved.

Clinical Trials

Developing new treatments for serious diseases, such as cancer, requires that scientists test new drug and treatment combinations in humans before the FDA can approve them. These trials, which are also called clinical research, can take months or years to complete.

Often, people participating in these studies help make major medical breakthroughs possible. They give researchers their time, money, and personal health information.

For example, research participants can be healthy people with no health problems who want to see if a new treatment works or who have a specific health condition that could benefit from the new therapy.

Depending on the type of trial being conducted, the sponsor of the study (the pharmaceutical company or a contract research organization working on behalf of the manufacturer) may use several strategies to recruit patients for the study. These include newspaper and radio advertisements, flyers and posters in places the patients might go (such as doctor’s offices), and personal recruitment by investigators.

Marketing

Marketing is a broad-spectrum function that spans the entire gamut of the business process. It includes sales and promotion, customer relationship management, product design, advertising, supply chain management, and market research.

The pharmaceutical industry is no exception. The Pharmaceutical Research and Manufacturers of America (PhRMA) and other organizations publish guidelines for companies to promote their products and services.

However, navigating the complexities of pharmaceutical sales regulations is a challenging task. For instance, six states have laws requiring pharma companies to disclose their advertising and marketing spending.

The pharmaceutical industry has worked hard to ensure its efforts comply with these rules, but it must also be creative in promoting its products and services. For example, they have developed KOL programs to help narrow the knowledge gap between current product data and physician awareness. In addition, they have restructured their sales and marketing programs to include incentives in line with OIG and other government requirements.