Whitelaw Compliance Group attending the CBI PCC Conference
On January 26-27, 2016, Whitelaw Compliance Group will be attending CBI’s Pharmaceutical Compliance Congress in Washington, D.C. We’ll be hanging out at the Life Science Compliance Update exhibit so...
View ArticleWhitelaw Compliance Group attending the CBI PCC Conference-Now in April
With the record snowfall here on the East Coast, we hope that everyone is safe and warm. Unfortunately, we won’t be seeing you at CBI’s Pharmaceutical Compliance Congress in Washington, D.C. this...
View ArticleThe FDA Commissioner is not a Hockey Puck
Despite all the criticism of Congressional Republicans for playing partisan politics, the Democrats are not above throwing their own temper tantrums. Senator Edward Markey (D-Mass.) has decided to...
View ArticleWoe Is Me – Compliance Needs to Be Job 1 in India
We have seen for some time now that the Indian pharmaceutical industry is under sharp scrutiny from U.S. regulators. In particular, the U.S. Food and Drug Administration has stepped up its inspection...
View ArticlePharmacy Woes Continue – Pharmacists Facing Jail Time
Earlier this year, we predicted that 2016 was going to be the Year of the Pharmacy, and not in a good way. It seems we were right as the pharmacy woes continue. This week two Alabama pharmacists...
View ArticleA Voyage of Discovery – FDA & Truthful Off-label Speech
As developments in the world of off-label promotion continue to unfold, we clearly are on a voyage of discovery and ahead lies the New World. First, we had the Amarin case suggesting that the...
View ArticleThe Forgotten Patients in Pain
Everyone seems to be on the opioid abuse bandwagon. Now the White House has joined in by asking Congress for $1.1 billion for the FY 2017 budget to “combat the nation’s spiraling opioid epidemic.”...
View ArticleHow to be a Democratic Brat – Play Parlor Games with the FDA
As I mentioned in an earlier post, Senator Edward Markey (D-Mass.) is holding the nomination of the new FDA Commissioner hostage. Now despite the fact that the FDA tried to meet him half-way, he still...
View ArticleCompany Killer – The Cost of Non-Compliance
As a seasoned Compliance Officer, I’ve spoken to my management teams many times about the cost of non-compliance and its potential impact on the company. I’ve referenced the usual Government...
View ArticleMarch Issue of Life Science Compliance Update Is Here!
This month’s issue of Life Science Compliance Update focuses on the importance of compliance culture. First, we examine the difference between what current CIA’s require in compliance programs versus...
View ArticleThe Acorn and the Oak
Many clients have asked me about the acorn and oak that are part of the Whitelaw Compliance Group logo. So I thought I’d post the story for everyone. When I was forming the firm, my wife asked me to...
View ArticleMed-Tech Compliance Comes of Age
It is no secret that compliance programs in many med-tech companies lag behind current compliance best practices. There are many possible reasons for this: Life Science compliance is dominated by...
View ArticleThe Government Doesn’t Have to Win to Inflict Pain
Since the recent publication of the so-called Yates memorandum [1] setting out the Department of Justice’s (DOJ) strategy of targeting individuals for prosecution, we’ve seen several recent cases where...
View ArticleUpping the Ante – FCA Penalties Double Today
Today is the first day of August and the start of high vacation season. For compliance officers, however, there is no holiday. As of August 1, 2016, the U.S. Department of Justice (DOJ) has now...
View ArticleCVS, Opioids & Lack of Compliance
The Year of the Pharmacy continues as CVS again makes negative headlines involving opioids. This time, a pharmacist in Georgia is accused of stealing more than 3,000 pills from them including...
View ArticleTransparency’s Uncertain Future
I just returned from speaking at CBI’s 10th Annual Forum on Transparency and Aggregate Spend. After 10 years and 3 CMS Open Payments reporting cycles, I’m struck by how uncertain the once bright...
View ArticlePricing – The Next Alamo
It started with Turing, continued with Valeant. moved on to Gilead and now has engulfed Mylan. What is it? It is pharmaceutical pricing. The questions are simple. How can pharmaceutical companies...
View ArticlePharma Pricing & One Bold CEO
It did not take long. In the midst of the pricing debacle created by Mylan and the EpiPen, one bold CEO has stepped forward. Brent Saunders, Allergan’s leader, has taken a clear stand. Writing on...
View ArticleMylan’s Ethical Meltdown
It has been quite a month for Mylan beginning with its first ethical lapse when it raised the price of the EpiPen by $500 from its 2008 price. Facing a tidal wave of criticism, Mylan, a week later,...
View ArticleDrug Pricing Need Not Be This Hard
Mylan’s EpiPen continues making news, prompting patients to compare drug prices. They look at the prices in Canada, our closest neighbor, and they wonder why the prices here are two to three times...
View Article