False Claims Act Insights - Are All Healthcare “Kickbacks” Subject to FCA Liability?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 204: Accelerating Life Sciences Startups with James Chappell of SCbio
Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 195: Life Sciences and Healthcare Workforce Development with Dr. John Hauser of Gaston College
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 194: Workforce Development for the Life Sciences Industry with David Stefanich of Rymedi
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Changes in FDA, Cannabis Policies and AI Developments
340B Drug Pricing Program Compliance
Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist
Episode 183: Site Development for Life Sciences Companies with Adam Bruns of Site Selection Magazine
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 171: Laura Gunter, President of the NC Life Sciences Organization
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 169: Shirley Paddock, Senior VP of Clinical Development, Syneos Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 168: Christine Harhaj, Senior Director of Advocacy & Strategic Alliances, PhRMA
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 165: Doug Edgeton, President and CEO of the North Carolina Biotechnology Center
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 163: David Ellison, Chief Data Scientist for Lenovo’s Infrastructure Solutions Group
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
DOJ Files Complaint in AWP False Claims Act Suit Against Pharmaceutical Ingredient Seller - On November 8, 2021, the Department of Justice (DOJ) announced that it intervened in a qui tam suit and filed a False Claims Act...more
The engagement of Clinical Research Organizations (CROs) by pharmaceutical and medical device companies to manage some or all of their clinical trial-related duties and functions is becoming more and more relevant as the...more
Although Big Pharma has taken deserved heat for selling its drugs by slathering doctors with cheesy tchotchkes, lavish or even cheap meals, and pricey trips, as well as lucrative consulting and speaking opportunities, medical...more
A recent settlement announced by DOJ serves as a good reminder of the need for device and pharmaceutical manufacturers to periodically revisit their prior authorization assistance programs, to assure that the programs are...more
After a sidetrack into the ethical train wreck detailed by the SEC Cease and Desist Order re: KPMG yesterday, I am returning to the blog post series I am running based upon the New York Times (NYT) reporting by Alexandra...more
In a May 17, 2019 press report that has been widely distributed in Brazil and the United States, Brazilian Federal Prosecutor Marisa Ferrari confirmed that the U.S. Federal Bureau of Investigation (FBI), the U.S. Department...more
On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more
Over this two-part blog post series, I have been considering the Stryker Corporation 2018 Foreign Corrupt Practices Act (FCPA) enforcement action brought by the Securities and Exchange Commission (SEC)....more
For years, the Justice Department and the Securities and Exchange Commission touted the FCPA “sweep” of the pharmaceutical and medical device industries. With good reason, DOJ and the SEC turned the drug and medical device...more
A comprehensive understanding of the constantly evolving layers that make up federal anti-corruption statutes, sanctions regulations and export control restrictions is imperative for both the pharmaceutical and health care...more
Just when we thought 2016 was over and we could all breathe a sigh of relief, DOJ and the SEC have continued to run with a string of new enforcement actions. To all of those prognosticators, paparazzi, commentators, chicken...more
The SEC finished with the last nail in GSK China’s coffin by announcing a $20 FCPA million settlement for GSK’s violations in China. The Justice Department declined to prosecute this case. In 2014, a Chinese court...more
Last week a true American original died when Richard Trentlage passed away. If you do not know his name you certainly know signature contribution to American culture, the Oscar Meyer Weiner Song. Rather amazingly Trentlage...more
In order to provide an overview for busy in-house counsel and compliance professionals, we summarize below some of the most important international anti-corruption developments from the past month, with links to primary...more
Germany recently adopted new anti-corruption laws that now criminalize “taking bribes in the health care sector” and “giving bribes in the health care sector.” These new laws have implications for certain segments of the food...more
Medical device and pharmaceutical companies know the risks of conducting business in China. Company after company has had to settle FCPA enforcement actions in China. Many of these enforcement actions include fact patterns...more
The SEC’s FCPA enforcement action for $14.6 million against Bristol Meyers Squibb (“BMS”) in China provides a textbook example of how things can go wrong in China. For the compliance practitioner (as well as CEO and...more
On March 1, 2014, Circular No. 50, which the Chinese National Health and Family Planning Commission (NHFPC) recently promulgated to regulate the conduct of pharmaceutical and medical device companies that do business in...more
In an article, entitled “GSK China probe flags up wider worries”, in the Wednesday edition of the Financial Times (FT) reporters Andrew Jack and Patti Waldmeir discussed the ongoing bribery and corruption scandal involving...more
What is a sweep? It is certainly a well-known and relevant term in the sporting world....more
As the Glaxo controversy unravels each day, it is important to remember the enforcement context in which the current prosecution in China is occurring. ...more
Mark Twain, one of my favorite authors, always said it best – “Do the right thing. It will gratify some people and astonish the rest.” - For drug and device companies, Mark Twain’s observation is becoming the industry...more
This week, reports have arisen that Chinese authorities in the cities of Shanghai, Beijing, and Changsha detained high-level GlaxoSmithKline (GSK) managers as part of an investigation into potential “economic crimes.” The...more
Pharmaceutical and medical device companies have a raw deal when it comes to domestic and foreign bribery. ...more