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Verrill Dana Welcomes Former FDA Counsel Katlin McKelvie Backfield

July 11, 2018 Press Releases

(July 11, 2018) – Verrill Dana is pleased to welcome attorney Katlin McKelvie Backfield to the firm's nationally recognized Health Care Group. Katlin comes to Verrill Dana with more than 15 years of pharmaceutical regulatory experience, including more than a decade at the Food and Drug Administration.

While at the FDA, Katlin served as Associate Chief Counsel for Drugs in the Office of Chief Counsel and as a Regulatory Counsel in the Division of Drug Marketing, Advertising, and Communications (DDMAC) (now the Office of Prescription Drug Promotion). Prior to joining the FDA, she practiced at Hogan & Hartson LLP (now Hogan Lovells LLP).

Katlin's in-depth experience at the FDA and in private practice will be a valuable asset to the Health Care Group's thriving life sciences and clinical research practice areas. She helps clients navigate the complex pre- and post-approval stages of drug development and address high-stakes FDA regulatory compliance matters. Katlin's areas of focus include, among others, advertising and promotion, manufacturing and inspections, the drug development process (including INDs, BLAs, and NDAs), and post-marketing safety requirements.

Katlin served as a law clerk for the Honorable Douglas P. Woodlock of the U.S. District Court for the District of Massachusetts. She received her law degree from the Georgetown University Law Center and earned her bachelor's degree from Davidson College.

Firm Highlights

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Verrill Welcomes Jeffrey A. Smagula, Experienced Health Care and Life Sciences Attorney, Former Health Plan Compliance Executive

(May 12, 2021) – Verrill is pleased to welcome Jeffrey A. Smagula to the firm’s Boston office as Counsel in its nationally recognized Health Care & Life Sciences Group. Jeff Smagula brings to Verrill...

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65 Verrill Attorneys Recognized by Best Lawyers® 2022, Including Eight Named Lawyers of the Year

(August 31, 2021) – 65 Verrill attorneys were recognized as "Best Lawyers" by Best Lawyers® 2022 , including 8 attorneys named “Lawyer of the Year,” a distinguished recognition for only a single lawyer in...

Publication/Podcast

“If I've told you once, I've told you eight times…” HHS OIG Issues Another Audit Report on Hospitals’ Failure to Report Credits for Explanted Cardiac Devices and Lays the Groundwork Collection of Overpayments

Publication/Podcast

340B Providers Get Partial Relief from New Dispute Resolution Regulation

1. 340B ADR Process Established At long last, more than ten years after Congress directed it to do so, HHS has finalized an alternative dispute resolution (“ADR”) process for both providers and pharmaceutical manufacturers...

Publication/Podcast

The Regulatory Sprint is Over - What’s at the Finish Line Under the New Stark and AKS Final Rules?

The U.S. Department of Health and Human Services (HHS) completed its “Regulatory Sprint” by finalizing changes to regulations pertaining to two federal fraud and abuse laws. On December 2, 2020, the Centers for Medicare...

Publication/Podcast

HHS Confirms Providers’ Right to 340B Discount Pricing for Contract Pharmacies

As a holiday gift to providers, the U.S. Department of Health and Human Services (HHS) General Counsel recently issued a strongly worded Advisory Opinion indicating that federal law requires drug manufacturers to deliver covered...

Publication/Podcast

Fraud and Abuse Investigations Handbook for the Health Care Industry, Second Edition.

Health care attorney Paul Shaw co-authored Fraud and Abuse Investigations Handbook for the Health Care Industry, Second Edition with Robert Griffith, published by the American Health Law Association (AHLA). Paul and Robert provide legal...

Publication/Podcast

Hospital Price Transparency Rule: Full Steam Ahead

Neither COVID-19 nor continued legal challenges appear likely to derail the Centers for Medicare & Medicaid Services ( CMS) Hospital Price Transparency Rule from going into effect on January 1, 2021. Hospitals therefore should...

Publication/Podcast

Massachusetts Health Care Bill Makes Several Significant Changes

While you were celebrating the New Year, Governor Baker signed Chapter 260 of the Acts of 2020, an “Act promoting a resilient health care system that puts patients first,” the result of the Legislature’s...

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