The PharmaCertify Team™
He’s golden, famous and the subject of a lot of buzz lately. He’s Oscar! (You thought we were going Big Bird didn’t you?) Yes, he’s been on the lips of critics and studio PR folks a lot lately as those “Oscar type” movies begin to show up in theaters. This weekend’s big Oscar-buzz release was Argo. Did you see it? Was Ben Affleck’s performance worthy of another Oscar statue? Several months remain before the race begins with the nominations, so kick back and view some news you can use now. Time to raise the curtain on this week’s News Week in Review.
First to arrive on our red carpet this week is news that GSK will make detailed data from its clinical trials available to other researchers. GSK will create an independent expert panel to judge the scientific merit of data requests. The program is expected to begin early next year.
Two weeks ago, we announced it as a coming attraction, and last week the Serious Fraud Office officially released the revised guidance for the UK Bribery Act. The new guidance makes the SFO’s position on self-reporting clear – companies can be prosecuted even if they self-report violations. That’s a change from the previous version, which suggested the office would prefer to settle self-reported cases civilly.
Meanwhile the Department of Justice seems to be taking a cue from last year’s Best Picture winner, The Artist, and is staying silent on its plans to update the FCPA guidance. The long-awaited guidance was expected to be released last week. It didn’t happen. No word from the DOJ on a release date.
In the “foreign” category, India and China announced plans to roll out new medical device regulations. The Drug Controller General in India will launch a program to look for manufacturing discrepancies in devices. In addition, the DCGI will introduce the Drug, Cosmetics and Medical Device Bill in Parliament in the winter. China’s State Food and Drug Administration released regulations for the labeling of foreign medical devices. The regulations, which go into effect April 1 of 2013, require manufacturers of foreign medical devices to include a label written in Chinese and documentation that guarantee the product’s safety and effectiveness.
Ireland’s Medical Council brought the drama this past week with the release of guidance for physician relationships with the industry. Highlights of the guidance include a recommendation that drug samples only be accepted for use on emergency night calls and a prohibition on the acceptance of gifts, hospitality or payments for travel and accommodations related to medical conferences. Physicians are allowed to accept fees for contractual services. The guidance cautions physicians that information gathered at a promotional program cannot be trusted and should not be used as continuing education credits unless the program is approved by a professional body.
The OIG was in the news last week, as they released a report that summarizes another roundtable discussion attended by representatives of 32 companies that have entered into CIA agreements since 2009. The agency will consider using the feedback to determine requirements for CIAs in the future. The participants worked in small groups discussing four topics:
- The definition of covered person and relevant covered persons, and CIA requirements regarding Code of Conduct, policies and procedures and training.
- The role of the compliance officer, internal audit and auditing plans, and the role of the Board of Directors.
- Claims review requirements.
- Arrangements review requirements.
The discussion included the burden of tracking to 100% completion and the difficulties of completing new hire training within 30 days of hire. Participants felt the OIG’s topic requirements were too prescriptive and that it would be better if companies determined their own annual training topics. The participants also suggested removing requirements around training hours in favor of a focus on whether training thoroughly addresses topics in the CIA.
Well, we’ve reached the final reel of the NWR. Before the final credits roll, we’d like to call your attention to our newest star on the rise – mobile learning. From full iPad-compatible training modules to just-in-time apps that deliver content where and when you reps need it most, PharmaCertify offers the mobile solutions you need to integrate effective compliance policies into your staff’s daily activities.
Have a great week everyone!