The US government has the healthcare products industries in its crosshairs over the promotion of drugs and devices for off-label use and it's not just companies that could go to the wall; individuals are also being faced with crippling fines, jail sentences and ruined careers. A recent settlement of $2.3 billion by Pfizer for marketing the anti-inflammatory drug Bextra and several other products for off-label uses is the largest of its kind to date, but it is just the latest in a string of other settlements relating to pharmaceutical and medical device companies alike. The Regulatory Affairs Journal - Devices has published an article that sets out in detail critical steps that companies can take to stay out of the firing line.
Everyone agrees that companies that produce and market medicines and medical devices should behave in a manner that is beyond reproach: they should have patient health and well-being as a top priority and should operate their businesses to the highest ethical standards. Unfortunately, this is not always the case. Recent headlines have highlighted the deliberate mis-marketing of drugs, sometimes with fatal consequences.
“More than $7 billion has been paid out in manufacturer settlements for off-label promotions,” says Retta M Riordan, president of regulatory consultancy firm Riordan Consulting LLC and author of the article in the September/October issue of RAJ Devices. “This figure will keep growing as all indications are that the US government is going to continue its zero tolerance enforcement of the marketing activities of both large and small companies.”
“The best way a company can protect itself against off-label promotion allegations is through an effective compliance programme that: establishes clear rules prohibiting off-label promotion; provides training to ensure employees understand the rules and what is expected of them; monitors promotional activities to catch any questionable activities and fix potentially troublesome practices; and investigates when such violations are suspected,” explains Riordan.
Under the US Federal Food, Drug, and Cosmetic Act, a company must specify the intended uses of a product when it files its marketing application with the Food and Drug Administration. Once the product is approved, it may not be marketed or promoted for so-called "off-label" uses - ie any use not specified in the company's application that has been approved by FDA.
“Over the past several years, the US Department of Justice has undertaken unprecedented actions against manufacturers and, increasingly, against individuals as well,” says Riordan. “The most recent precedent-setting case was settled by Pfizer. In addition to the fine, the government also imposed a range of novel provisions upon the company, which included sweeping monitoring and transparency requirements.”
“Companies should take critical steps to ensure that they will not be the next to appear in the headlines,” continues Riordan. “A corporate-wide ethical culture, effective compliance programmes, education and training for all relevant employees, clear policies and procedures, strong communications, and a comprehensive system for monitoring activities and investigating any problems are of paramount importance.
“In addition, any non-US companies who are venturing into the US to do business must carefully adopt and follow US compliance standards.”
Everyone agrees that companies that produce and market medicines and medical devices should behave in a manner that is beyond reproach: they should have patient health and well-being as a top priority and should operate their businesses to the highest ethical standards. Unfortunately, this is not always the case. Recent headlines have highlighted the deliberate mis-marketing of drugs, sometimes with fatal consequences.
“More than $7 billion has been paid out in manufacturer settlements for off-label promotions,” says Retta M Riordan, president of regulatory consultancy firm Riordan Consulting LLC and author of the article in the September/October issue of RAJ Devices. “This figure will keep growing as all indications are that the US government is going to continue its zero tolerance enforcement of the marketing activities of both large and small companies.”
“The best way a company can protect itself against off-label promotion allegations is through an effective compliance programme that: establishes clear rules prohibiting off-label promotion; provides training to ensure employees understand the rules and what is expected of them; monitors promotional activities to catch any questionable activities and fix potentially troublesome practices; and investigates when such violations are suspected,” explains Riordan.
Under the US Federal Food, Drug, and Cosmetic Act, a company must specify the intended uses of a product when it files its marketing application with the Food and Drug Administration. Once the product is approved, it may not be marketed or promoted for so-called "off-label" uses - ie any use not specified in the company's application that has been approved by FDA.
“Over the past several years, the US Department of Justice has undertaken unprecedented actions against manufacturers and, increasingly, against individuals as well,” says Riordan. “The most recent precedent-setting case was settled by Pfizer. In addition to the fine, the government also imposed a range of novel provisions upon the company, which included sweeping monitoring and transparency requirements.”
“Companies should take critical steps to ensure that they will not be the next to appear in the headlines,” continues Riordan. “A corporate-wide ethical culture, effective compliance programmes, education and training for all relevant employees, clear policies and procedures, strong communications, and a comprehensive system for monitoring activities and investigating any problems are of paramount importance.
“In addition, any non-US companies who are venturing into the US to do business must carefully adopt and follow US compliance standards.”
