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. Here are five career defining moments:
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 why:
The phrase “speak-up” conveys that obvious bad conduct could take place and the issue
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) consistency of handling and discipline; (3) after-action learning takes place; and (4) reporters are directly
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 the financial fraud expertise of most internal auditors and the regulatory, legal and industry code
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 executive tells her team that we take compliance rules seriously. This isn’t enough.
At its
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 2013 as if Acthar was a “new drug” first marketed in 2013, rather than a
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 the price of Daraprim by more than 4,000%. I’m not going to put much analysis
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 you may recall, Immunomedic was acquired by Gilead in October 2020 for $21 billion.
According
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 that in turn submitted false or misleading prior authorizations for one of Kaleo’s products. The
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 Arthrex sold in order to induce him to use Arthrex’s products. I will have an
