The PharmaCertify™ Team

The weather has cooled, fall sports are in full swing, and the World Series is just around the corner. Then there’s that one additional reminder of the change of season: a new television season is upon us. Goodbye to the repeats and summer reality, and hello cliffhanger resolutions! We still have more premieres on the way, but for now we’d like to entertain you with  this week’s News Week in Review.

We begin our broadcast day with the news that Stryker has agreed to pay $1.5 million in legal fees to settle two shareholder suits. Stryker admitted no wrongdoing as a part of the settlement, but did agree to install a committee aimed at preventing violations of the FCPA and False Claims Act, and illegal promotional activities.

Lawmakers and the industry are asking the Administration to end the delay and implement the final rule for the Sunshine Act. Senator Herbert Kohl calls the delay unacceptable. Senator Grassley did not mince words, saying efforts to communicate with CMS had been met with resistance, and it was “[as if] Congress passing a law doesn’t make a difference in this town.” Tune in next week for the continuing drama on “Waiting on Sunshine.”

A Modern Family probably has at least one person who owns a smart phone, and a congressional representative from California plans to introduce a bill aimed to smooth the FDA’s evaluation process of apps for those phones. The bill, if passed, would establish an Office of Mobile Health at the FDA to provide recommendations on issues related to mobile apps and to support developers trying to understand regulations related to privacy. IT industry groups and developers are on board with the formation of the new office as an attempt to foster innovation while protecting patients.

A White House advisory group may have been feeling a little Grimm about the rate at which new drugs are being approved, so a plan was drafted to double the rate of approvals. The plan calls for faster approvals of drugs for high risk patients. The advisory group urged the FDA to use its “accelerated approval” process with more frequency to approve drugs for targeted patient populations. Patient and physician group representatives have praised the plan, saying it protects the public health while giving patients in high-risk situations access to medicine.

Once Upon a Time, Assistant Attorney General Lanny Breuer said the DOJ intended to release new, detailed guidance on the FCPA. Now it seems the promised guidance will be delivered in the next few weeks. (Ahem…CMS…take note) The guidance is expected to be released in advance of the October 10 Organization for Economic and Co-operation and Development meeting. In an interview with Compliance Week, the FCPA Professor, Mike Koehler, says he doesn’t expect there to be anything “groundbreaking” in the new guidance, but it is likely to address newer issues that were not addressed in the previous guidance.

Are Board members Persons of Interest in a corporate bribery investigation? A new survey of BOD members reveals one-third believe bribery is their company’s greatest fraud risk, while 63% believe their personal liability has gone up over the last three years. Two-thirds of those surveyed indicated their company did business overseas, with nearly 60% of those indicating they did business with foreign officials. According the Corporate Fraud Index latest quarterly report, reports of corporate fraud, including those concerning violations of the FCPA and UK Bribery Act, represent 23% of all compliance reports.

It’s Elementary that pharmaceutical and medical device industries face risks when it comes to bribery and doing business in other countries and now someone has created a list of the top five corruption risks. Spoiler Alert! The top risks are: state-owned healthcare enterprises, third-party agents, sponsorship of medical conferences, foreign clinical trials, and “anything of value.” As enforcement agencies focus more on the life sciences industry, training on the risks of doing business outside the U.S. has become even more critical. We can help with the customizable Understanding and Preventing Bribery in the Global Life Sciences Marketplace eLearning module.

Well that rounds out this week’s “broadcast.” Before we sign off, there is one more piece of “news” to bring you. While turning thirty is a milestone that is often looked upon with trepidation, that is certainly not the case in central Florida today, as the fine folks at the Walt Disney World Resort celebrate the 30th anniversary of EPCOT. Congratulations to our friends at “Spaceship Earth!”

Have a great week everyone!