Industry companies in Canada announce plans to voluntarily disclose payment data. Massachusetts institutes new disclosure requirements, the DOJ offers smaller penalties in exchange for self-reporting, an administrative court in France recommends the provision for allowing DPAs be removed from bribery legislation, and Shionogi receives a warning letter for a co-pay coupon.
April showers bring May flowers, and outside the News in Review offices, we’re already feeling the brunt of that whimsical rhyme. But, the bright colors and fragrant blooms are just around the bend, so we’ll tolerate a bit of turbulent transitional weather for the opportunity to soon enjoy nature’s bountiful beauty. In the meantime, after you dry out the umbrellas and shake off the cold rain, we offer the latest in the compliance news fit to blog, with this edition of the Compliance News in Review.
There’s only Sunshine on the horizon in Canada. Ten of the country’s top drug firms plan to voluntarily disclose aggregate physician and healthcare organization payment data. The movement was started by GSK Canada, and they were joined by other multinational firms including, Abbvie, Purdue, BMS and Lilly. Canada’s industry trade organization praises the initiative. Critics claim the plan will yield no meaningful information, and are pressuring Canadian lawmakers to pass a U.S.-style Sunshine Act.
New disclosure requirements are blooming for physicians in Massachusetts. The state’s Medical Society is now requiring its members to disclose financial ties to industry, including the receipt of free goods or services from companies, when they post information or review a medical procedure or service on the Internet. The requirement comes as a result of growing concern about physicians promoting treatments on social media platforms.
Could a respite from the bribery enforcement storm be on the horizon? The Department of Justice announced a one year pilot program for companies to self-report violations of the FCPA, in exchange for reduced penalties. Under the program, companies that self-report and take steps to remediate identified problems will be eligible for significantly lower fines. The head of the agency’s fraud unit says the program draws a line between companies that self-report and those that cooperate once violations are identified by the DOJ.
There’s a light rain falling on France’s new anti-bribery efforts. The country’s highest administrative court has recommended removal of the provision for Deferred Prosecution Agreements in foreign bribery legislation. The recommendation did not come as a surprise, considering the calls from numerous organizations to remove the provision.
A co-pay coupon brought out the dreary side of the FDA for Shionogi. The company received a warning letter for omitting risk information on a co-pay coupon for a drug approved to treat lice. The FDA says the coupon touted the efficacy of the product without stating any of the risks. The coupon did provide the website addresses where consumers could read the full prescribing information but the letter claims that is not enough to address the full risk information requirement.
The FDA’s position on truthful off-label statements has been the focus of recent headlines. Ensuring that colleagues are trained on the requirements related to promotional statements is critical. According to a study, the FDA cited omission of risk in 60% of the untitled and warning letters that were issued between 2013 and 2015. You can read about our observations on those letters here. Everything from press releases to statements made by hired speakers is subject to FDA oversight, providing training to all who are in a position to make promotional statements is important.
Well, that’s the news for now. We look forward to seeing you, rain or shine, for the next edition of the Compliance News in Review.