The FDA has tightened regulations on medical sales representatives over the years.
The medical industry is one of the most highly-regulated industries in the business world, especially when it comes to marketing and advertising. The Food and Drug Administration (FDA) is responsible for developing rules and regulations for medical marketers. The FDA actually created a separate division, called the Division of Drug Marketing, Advertising, and Communications (DDMAC) to help do just that.
Legislation
The FDA has been regulating medical advertising since 1906, when the Food and Drugs Act was introduced. This act was the first of over 200 laws that protected consumers from malicious medical products as well as the marketing of those products. The Federal Food, Drug, and Cosmetic Act of 1938 was enacted after a legally advertised toxic elixir killed 107 people. The Food and Drug Administration Amendments Act (FDAAA) of 2007 gave the FDA additional authority to regulate medical advertising.
Pharmaceutical Regulations
The Division of Drug Marketing, Advertising, and Communications (DDMAC) regulates pharmaceutical and healthcare companies' advertisements and promotional materials to "ensure that the information contained in these promotional materials is not false or misleading". After the Food and Drug Administration Amendments Act of 2007, DDMAC helped develop an additional regulation for healthcare companies: for direct-to-consumer advertisements for prescription drugs, companies were required to communicate the fact that consumers should report any side effects to the FDA. As a general rule, healthcare and pharmaceutical advertisements must present an objective, "fair balanced" message in every communication that's marketed to customers as well as internal employees.
Medical Device Regulation
The FDA's Center for Devices and Radiological Health (CDRH) regulates medical device companies who manufacture, repackage, and market medical devices sold in the United States. Regulations on advertisements for medical device companies are similar to regulations on pharmaceutical companies, in that advertisements must present an objective look at both the features and the risks of the medical device that's being advertised.
Future Regulations
Social media is a hot new marketing channel in all industries, including the medical industry. Healthcare companies are trying to figure out advertise their products and services through social media sites, but current regulations make it difficult for them to do this. Social media leads to free-flowing online conversations, which is a problem for medical advertisers for two main reasons. First, the FDA imposes strict regulations on medical companies to report adverse events in patients. This puts a strain on medical companies to monitor every conversation taking place about their product, which requires significant resources. Second, medical companies can get into trouble when consumers start talking about off-label uses (which means unapproved uses) of their products. This is an area the FDA also regulates tightly.
Tags: Food Drug, Drug Administration, Food Drug Administration, medical companies, Administration Amendments, advertisements must