The PharmaCertify™ Team
It’s that time of year again. It’s the season when we’re inundated with television commercials compelling us to wait in long lines for the latest must-have items. It’s back to school time! And we have a reading assignment for you…this week’s News Week in Review. The bell is about to ring, pencils out please.
Medicines Australia is starting the school year with a group project: determine the best way to publically disclose information about payments to doctors. The organization’s Working Group on Transparency is comprised of members of the medical community, consumer groups and pharmaceutical companies. While Medicines Australia has stated its commitment to improving transparency of physician payments, the Australian Medical Association is concerned about the identification of individual doctors. Their concerns echo those that have been raised by medical groups here in the U.S. about the Sunshine Act, including the potential for misrepresentation of the data to the public.
The DOJ appears to be cutting back the amount of “school supplies” it requires of companies accused of FCPA violations. During 2012, the DOJ pulled back on the requirement that companies hire an independent monitor. Only three of seven companies have been required to hire the monitor thus far this year. The others have been asked to self-monitor and then report to the DOJ. In recent years, the problems with the independent monitors have been a source of embarrassment for the Department, and that may be the reason for the cut back. While we’re on the FCPA, check out this list of the top 10 corporate settlements. Guess what industry did not make the list?
A new study finds doctors are more likely to move sales reps carrying iPads to the head of the class. According to the study, 65% percent of doctors say when they’ve seen reps carrying an iPad. More importantly, 35% of doctors say they are more likely to request a sample from a rep that is carrying an iPad, and 29% say they are more likely to prescribe.
We’ve reached the lunch portion of our “school day.” If your beverage of choice is chocolate milk made with Hershey’s syrup, it may not be as nutritious as the label led you to believe. The FDA issued a warning letter to the chocolatier regarding wording on the labels of a couple of the syrups. One product said “plus calcium” and another used the wording “fortified with vitamins and minerals.” Neither product met the guidelines necessary to make those claims. The company has since changed the labels.
Vein treatment device maker, Vascular Solutions, seems to have gotten on the class monitor’s list. The company has announced the federal government will intervene in an off-label investigation. The investigation stems from a complaint filed with the U.s Attorney’s office alleging the company’s promotional practices cost the government around $20 million in damages. The company said it will continue to cooperate with the U.S. Attorney’s investigation, but will defend the case “as something that’s factually inaccurate and without merit.”
PhRMA, AdvaMed, Biotechnology Industry Organization (BIO) and Medical Imaging and Technology Alliance (MITA) teamed up on a letter writing assignment this week. The industry trade groups sent a letter to CMS this week regarding the pending final rules for the Sunshine Act. The groups expressed their appreciation to CMS for their careful consideration of the many comments received on the proposed rules and requested CMS allow manufacturers 180 days to implement the final rule before beginning data collection.
Speaking of AdvaMed, a gold star goes to the group for its hiring program for returning military veterans. The program is called MedTech Veterans Program Boot Camp for Returning Heroes, and it will provide training in resume building and interviewing skills. Additionally, 25 vets will be provided mentors to help them transfer their skills into jobs in the med tech sector.
The bell is about to ring, so time to pack up and head to the next class. For those of you who are still on “summer vacation,” enjoy the final beach weekends before you’re rockin’ the school’s carpool line. Have a great week everyone!