Week in Review, July 22, 2014

The Minnesota Board of Pharmacy confirms that payments to nurse practitioners and PAs must be reported, the FDA issues more Warning Letters, a grand jury indicts FedEx for shipping drugs for illegal pharmacies, and industry funding for CME continues to decline.

With summer in full swing, Major League Baseball took a break from the pennant races for its annual showcase of the best and brightest stars from both leagues…and the ratings were up. In what seems to be the trend lately, the American League came out on top and National League fans were left lamenting the fact that should their team make it to their World Series, they will once again be denied the coveted home field advantage (strange rule indeed). Now, as trade talks heat up and races tighten, we step up to the plate with this week’s News in Review.

First up, we have news from the state that hosted the All Star Game, Minnesota. The Minnesota Board of Pharmacy released a memo confirming that 2014 payments to nurse practitioners, physician assistants, veterinarians and dental technicians must be reported in May 2015. The Board advised manufacturers to begin tracking data for these professionals since it expected the legislature to require companies to report those payments.

Batting second this week is the always confusing topic of social media. The FDA recently issued an Untitled Letter to Gilead and a Warning Letter to Zarbee’s Naturals regarding the company’s use of social media for product promotion. In its letter to the company, the FDA cited an ad that used Google’s AdWords. The ad neglected to provide risk information, and the drug was misbranded. The ad also did not include the generic name of the product and only featured the brand name in a couple of URLs listed in the ad. Zarbee’s Warning Letter focused on the use of Facebook “likes.” The FDA equates “likes” top promotions and the company “liked” several customer testimonials on its page.

Companies that manufacture products for human use aren’t the only ones running afoul of the FDA’s promotion regulations. A Warning Letter was issued recently to the French pharmaceutical facturer, AB Science, for the off-label marketing of a veterinary drug. The letter cited several off-label statements on a product website. The FDA also noted that the company neglected to list important safety information on the product website and other promotional material.

The federal government took a swing at FedEx recently when a federal grand jury indicted FedEx for shipping drugs for illegal pharmacies. According to prosecutors, the company was warned for over a decade that they were shipping drugs for illegal pharmacies, but that those warnings went unheeded. Rather, the company “departed from its usual business practices” to continue shipping the drugs. According to prosecutors top managers at FedEx approved the continued shipping to known illegal pharmacies. A senior vice president for FedEx said the company was innocent of the charges levied against it, and would plead not guilty.

It’s a single for industry support of CME…a single digit decline in funding that is. According to the ACCME’s Annual Report, industry funding of accredited CME dropped by 1.9% in 2013. Support from industry represents 27% of all CME income. This is a far cry from 2008, when industry funding represented almost half of CME funding. Physician attendance at CME events was down in 2013 by just over 4%, but attendance by non-physicians was up by 5%.

As we wind down this week’s version of the Week in Review, we offer one last pitch about the importance of reviewing your Sunshine Act training needs – particularly in light of the ongoing activities around Open Payments registration and data review. The PharmaCertify™ eLearning module, The Sunshine Act: The Federal Physician Spend Disclosure Law, is designed to bring your team up to speed on reportable and excluded expenditures, and the information required for submission to CMS.

Have a great week everyone!

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