Week In Review, October 14, 2011

The PharmaCertify™ Team

Oh happy day! It’s finally here…iDay! The new iPhone is available! Granted, the iPhone 4S was met with a lukewarm reception by some of the technorati, but the lines formed early this morning anyway. Hey, if the Woz is willing to wait in line for one, it can’t be all bad, right? So while you wait for yours (or are sitting comfortably somewhere laughing at those who have camped out), here’s this week’s PC News Week in Review to keep you occupied.

Facetime with Apple good; face time with judge, not so good. A Washington doctor was sentenced to pay $12,700 in fines and restitution for gifts he accepted from Guidant (a unit of Boston Scientific). The judge said the fine represented every payment the doctor had received from the company. While $12,700 is no small change, this guy certainly wasn’t at the top of Pro Publica’s list of these types of payments. However, the doctor in question worked for the federal government, where accepting payments and gifts over $20 is prohibited.

It was a slow quarter for DDMAC (make that the OPDP) in terms of enforcement. The office issued only four letters; two warning letters and two Notices of Violation. The letters covered both digital and printed media, and dealt with a variety of issues, including unsubstantiated claims and promotional of an investigational drug.

Lawyers are finding a way to “jailbreak” HIPAA for consumers affected by security breaches of their personal health information. HIPAA offers no recourse for consumers to sue covered entities when their information is exposed, but lawyers are finding avenues to sue using state privacy laws.

A couple of stories from the “we’ve got an app for that” file: First, in the wake of the Mediator scandal in France, the French National Assembly has approved a law that would fine advisers to the country’s regulatory agency for failing to reveal conflicts of interest. The law must still be approved by the French senate. If it passes, the law would also require companies to maintain a public register of payments and agreements with those involved with health care. Shades of Sunshine, no?

Also taking a cue from pharma are veterinary medicine schools. Many of the schools are concerned about the influence gifts and meals from feed and pharmaceutical companies may have on decisions made by students and faculty. Some vet schools have created policies that ban or restrict the provision of meals and free products to students and faculty, and require faculty to disclose any relationships they have with these companies. The American Association of Veterinary Medicine Colleges recently adopted a set of ethical guidelines, in the hope that colleges will use the document to develop their own policies.

A new benchmarking survey has revealed that the increase in FCPA enforcement is causing businesses to upgrade their anti-corruption operating systems. The study surveyed over 100 companies globally in areas such as internal audits, procedures in acquisitions, and third-party intermediaries.

If you’ll be doing some Halloween costume shopping after waiting in line for the new iPhone, the FDA has a word of warning for you. Beware of decorative contact lenses. Yes, that set of vampire or werewolf eyes may permanently cause damage if they are not worn, handled or fitted properly. The agency says there is nothing inherently dangerous with the lenses, but they should be purchased from, and fitted by, a qualified healthcare professional and not through a costume store or other outlet. The agency says a qualified professional can also provide proper instruction in care and handling of the lenses.

We’ve reached the end of this week’s review. For those still waiting in line to purchase that phone, we hope you’ve at least moved up a few spaces since you started reading.

One more reminder: The PCF Compliance Congress is scheduled for November 2-4 in Washington DC. Don’t forget to get your early bird discount by registering through PharmaCertify!

Have a good week everyone!

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