Sunshine, FDA Commissioner, & Gardner News

Sunshine Deadlines

As a reminder, U.S. Federal Physician Payments Sunshine Act (Open Payments) reports are due March 31. There are also state and municipal deadlines that have either passed or are coming up, including:

  • January 1:
    • Vermont: submit Compliance Officer Form
    • California: post compliance declaration on website (annually, no due date)
    • Massachusetts: perform annual audit during year
    • AdvaMed: make certification (optional)
  • January 15
    • Nevada: submit list of pharmaceutical sales representation
    • Miami-Dade County, Florida: register/renew sales representatives annually
    • Chicago: register/renew pharmaceutical sales representatives annually
  • March 1
    • Nevada: make pharmaceutical sales report disclosure
  • March 31
    • Federal: submit Physician Payments Sunshine Act (Open Payments) reports
  • April 1
    • Vermont: submit disclosure report
    • Vermont: submit sample report
    • Nevada: submit drug pricing and sales report
    • Federal: submit drug sample report
  • May 1
    • Nevada: perform annual audit during year (covering May 1 – April 30)
    • Minnesota: submit payments to practitioners report
  • June 1
    • Nevada: submit compliance form (AB128 certification)
  • July 1
    • Massachusetts: submit marketing disclosure report
    • Connecticut: report payments to advanced practice registered nurses
    • Miami-Dade County, Florida: submit sales representative expenditure reports
    • Washington, D.C.: submit sales representative reports (also, register representatives every 2 years)
  • August 31
    • Massachusetts: registration and filing renewal (generally between early July and late August)

For more information and a survey of international requirements, visit our website.

New FDA Commissioner?

Who will be the permanent FDA Commissioner? Currently, Janet Woodcock, M.D., a long-standing, well respected FDA official, and former Director of the Center for Drug Evaluation and Research (CDER), is the Acting Commissioner. A recent letter to President Joe Biden, penned by six former FDA commissioners stops short of endorsing Dr. Woodcock as permanent Commissioner, but applauds her leadership. The letter is at the very least a tacit endorsement for making Dr. Woodcock FDA Commissioner. Former FDA Commissioners that signed off on the letter include Robert Califf, MD, Scott Gottlieb, MD, Margaret Hamburg, MD, Jane Henney, MD, and Mark McClellan, MD. Despite this, Acting Commissioner Woodcock is facing criticism for approving opioids during her time at the helm of CDER. A former FDA official, Joshua Sharfstein, MD, is also considered a candidate for the position, although some argue his luster, like Woodcock’s has faded. Others predict that neither Woodcock nor Sharfstein will get the job and that President Biden is looking outside of the Agency. We still view Dr. Woodcock as the lead candidate for the role. Time will tell.

Our Team Is Growing

Here are some new faces at Gardner Law. We have added lawyers that specialize in Quality, Regulatory, and Privacy  laws and regulations and a former FDA Compliance Officer as a consultant.

Brynn Stanley, J.D., Associate Attorney

Brynn Stanley

Brynn specializes in counseling medical technology and pharmaceutical companies on FDA law and regulations. She possesses deep expertise in quality system compliance and remediation. She started her career at Boston Scientific as a design assurance engineer and from there worked in advancing engineering roles at St. Jude Medical (Abbott), American Medical Systems (Boston Scientific), Covidien-Medtronic, and most recently at Monteris Medical. Brynn is an Adjunct Professor of Law at Mitchell Hamline School of Law (St. Paul, MN) where she teaches Drug & Device Law.

Paul Rothermel, J.D., C.I.P.M., Associate Attorney

Paul Rothermel

Paul specializes in privacy compliance matters including HIPAA, GDPR, and other state and international privacy laws. Prior to practicing at Gardner Law, Paul worked in Privacy and Data Protection at Medtronic. counseling on privacy issues for medical technology companies and other health care organizations. Before that, Paul was an Associate General Counsel for the State of Minnesota.

Nathan Downing, J.D., Associate Attorney

Nathan Downing

Nate focuses on counseling medical technology and pharmaceutical companies on FDA regulatory/submissions work and copy review. Before practicing at Gardner Law, Nate was at Medtronic where he held the position of Principal Regulatory Affairs Specialist. Prior to that, Nate was a Law Clerk at the Colorado 2nd Judicial District Court and a Research Associate at R&D Systems (Bio-Techne).

Tim Philips, Consultant

Tim Philips is a quality assurance and regulatory affairs professional with over 30 years of experience in commodities regulated by the U.S. Food & Drug Administration (FDA). He is an expert and instructor in FDA law / regulation, quality systems, inspections, evidence development, enforcement actions, and product recalls with an emphasis on post-market compliance of medical devices. Tim is an Adjunct Professor at the University of St. Thomas (St. Paul, MN) in the Regulatory Science Program in the School of Engineering.

New Website

We recently updated our website to include more content. Visit GardnerLaw.com to read contemporary industry news and learn about our practice areas, including: Compliance, Ad Promo Review, Sunshine Reporting, Regulatory, Quality, Enforcement, Clinical, and Privacy.

Recent Topics We’ve Reported On

OIG issued a Special Fraud Alert that applies to pharmaceutical and medical technology company-sponsored speaker programs.

2020 Regulatory Update from Both Sides of the Pond

Last fall we held a complimentary 4-part webinar series tailored to MedTech and Pharma companies. Watch presentations by U.S. and E.U. attorneys and download the slides.

Topics:

  • Privacy (GDPR, CCPA, HIPAA)
  • Regulatory (EUA, MDR)
  • Health Care Compliance (Virtual Detailing, Recent Cases, Sunshine, Speaker Program Fraud Alert)
  • Due Diligence for Buyers and Sellers (U.S./E.U.)

Speakers:

FDA resumes domestic inspections. Are you ready?

As recently reported, the FDA has resumed routine domestic inspections. This Gardner Law Regulatory Alert offers tips on how you and your team can get prepared for a visit from the Agency.

The Court of Justice for the European Union recently invalidated the EU-US Privacy Shield, a mechanism relied upon by many companies to ensure adequate safeguards for the cross-border transfer of EU citizen data. This recent ruling has left many companies—including medical technology and pharmaceutical companies with EU operations, such as sales, marketing, manufacturing, and/or clinical activities—scrambling and confused.

COVID-19 has changed the way health care professionals (HCPs) and industry interact. Many providers do not allow company staff on-site. As a result, pharmaceutical and medical technology makers are promoting products virtually via Zoom and similar platforms.

Seeking FDA Emergency Use Authorization for a COVID-19 medical device?

How to avoid “going viral” with the FDA

Have you completed your annual Audit?

Are you meeting the new transparency requirements?

Did you know that U.S. Federal Physician Payments Sunshine Act (Open Payments) recently changed to include nurses? Are you aware of the new Colorado and New Jersey laws and that the Massachusetts deadline is approaching? Are you aware of international requirements?

Medical technology and pharmaceutical companies interact with health care professionals (HCPs) in various capacities from product conceptualization through commercialization. Manufacturers consult the AdvaMed Code to inform their decision making and to ensure policies are consistent with industry standards. Several states (e.g., California, Nevada, Connecticut) have enacted laws that require device manufacturers to comply with industry codes like the AdvaMed Code. Other states are even more restrictive than the Code, e.g., Vermont and Massachusetts.

Contact Gardner Law for help on your next assignment.

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