Will the Sunshine Act force medical device companies to lay off even more employees? Perhaps at a rate of 2-4 per year? Let’s do some simple math:
It’s estimated that compliance with the Sunshine Act will cost medical device companies about $200,000 per year. If the average annual salary of an employee within a medical device company is $65,000, that’s roughly 3 employees. Ouch.
I think the overwhelming majority of the American public would like to see more transparency between physicians and medical device companies. But are the outrageous compliance costs of the Sunshine Act worth 2-4 jobs per company per year? Better yet, once the data from the legislation is made public, will ‘Joe Patient’ even be able to interpret it?
To help answer some of these questions, enter David Hoffmeister, partner at Wilson Sonsini Goodrich & Rosati. In this interview, David provides us with actionable rules regarding physician and HCP consulting arrangements in addition to helping us understand the overall impact of the Sunshine Act on medical device companies.
Here’s What You Will Learn
- Origin, scope, and purpose of the Sunshine Act and the problems this legislation hopes to solve.
- Will patients be able to decipher the public data resulting from the Sunshine Act? And will they even care?
- Resource constraints that will be forced upon medical device companies because of the Sunshine Act.
- How will medtech startups be affected by the legislation?
- Consequences within medical device companies if adequate policies are NOT put in place. Hint: David thinks it’s like driving a car without car insurance.
- Policies and procedures that medical device companies need to have in place in order to comply with the Sunshine Act. We also cover the 2 exceptions.
- Are their any loopholes in the Sunshine Act that medical device companies can exploit?
- Importance of consistent ‘needs assessments’ pertaining to HCP consultants.
- David’ lasting advice to medtech companies in regards to the Sunshine Act.
- And much more!
This Is What You Can Do Next
1) You can listen to the interview with David Hoffmeister right now:
2) You can also download the mp3 file of the interview by clicking here.
3) Read the following transcripts from my interview with David Hoffmeister. Also, feel free to download the transcripts by clicking here.
Read the Interview with David Hoffmeister
More About David Hoffmeister
David Hoffmeister is a partner at Wilson Sonsini Goodrich & Rosati, where he plays a major leadership role in the firm’s drug and device regulatory and healthcare law practice within the life sciences practice. David was named as one of the “25 Leading Biotech Attorneys” in California in 2011 by the Daily Journal, and is recognized as one of the leading food and drug regulatory lawyers in the country.
Before joining Wilson Sonsini Goodrich & Rosati, David was senior counsel for drug and device law at Syntex U.S.A., Inc., where his primary focus was advising senior management on worldwide issues affecting the ability of the corporation and its affiliates to develop, manufacture, and distribute pharmaceutical, device, diagnostic, and over-the-counter drugs in compliance with the Federal Food, Drug, and Cosmetics Act.