Hot take – I disagree with the notion that the goal of a life science compliance program should be to build a “speak up culture.”
A compliance program that is effective doesn’t have a “speak-up” culture – “-” . Here’s
Curto Pharma Law and Compliance Blogs
Latest from Curto Pharma Law and Compliance
Five Career Defining Moments That Drive Me To Work With Life Science Companies
Feeling a little nostalgic about my career, which probably has a lot to do with my son starting his career journey this week.
I’ve been incredibly lucky to work with some of the best and most innovative life science companies.
Four Ways To Measure If You Have An Effective Compliance Investigation Process
A hallmark of an effective compliance program is the existence of a well-functioning process for the investigation of allegations of misconduct. Is your compliance investigation process well-functioning? The four signs I look for are (1) a comprehensive written protocol; (2)
Internal Audit + Compliance: Relationship status – it’s complicated!
When the U.S. Department of Justice measures an effective compliance program one of the factors it looks to is whether internal audits are conducted. So, why is this relationship complicated? It’s three issues:
There is often a mismatch in
What is a "Culture of Compliance" anyway?
Lately I’ve been thinking a lot about what it means to have a “culture of compliance.” I know … I sound super fun at dinner parties!
The business often thinks a culture of compliance is when the CEO or another
First big DOJ Pharma settlement of 2022! Mallinckrodt will pay $260 million to settle two cases
Mallinckrodt will pay $260 million to settle two pending DOJ lawsuits.
The first case claimed that Mallinckrodt underpaid Medicaid rebates for Acthar. The government alleged in the complaint that Mallinckrodt and its predecessor Questcor began paying rebates for Acthar in
Vyera settles FTC claims it prevented generic competition for $40 million
Vyera (formerly Turing), the company founded by Martin Shkreli, settled a federal antitrust lawsuit brought by the FTC and the New York AG that alleged that Vyera engaged in anti-competitive practices to keep generics off the market after it hiked
Interim Analysis: Former Immunomedic CFO arrested; WOW-jail time for OIG exclusion violation
- Former Immunomedic CFO Arrested For Insider Trading
The US Attorney’s Office for the District of New Jersey arrested Usama Malik, the former CFO of Immunomedic and Lauren Wood, the former head of Corporate Communications of Immunomedic, for insider trading. As
Pharma Settlement: Kaleo pays $12.7 million, related to pharmacies submitting false prior auths
In a first of its kind settlement, Kaleo, Inc, a Virginia based pharmaceutical manufacturer that sells three marketed products in the US, agreed to pay $12. 7 million to settle claims that it encouraged its customers to use “preferred” pharmacies
Medical Device False Claims Settlement – Arthrex will pay $16 million to resolve HCP kickback claim
On Nov. 11, 2021, the US DOJ announced that Arthrex agreed to pay $16 million to resolve a qui tam lawsuit initiated by a whistleblower that alleged that Arthrex bribed a physician by agreeing to pay him royalties on products