Practice

State Legislative & Regulatory Policy For Life Sciences Companies

Making sense of complex regulatory environments

Our healthcare and life sciences regulatory team regularly interfaces with state and local government agencies on a wide variety of legislative and regulatory matters affecting the life sciences. We strive to gain an understanding of our pharmaceutical and medical device clients’ business including their particular strengths and vulnerabilities to state regulation, and in the process are able to effectively manage local lobbying and regulatory initiatives on our clients’ behalf. 

Many of our lawyers and policy specialists have worked in healthcare regulatory agencies and legislative committees on both the state and federal levels, and in the process have developed first-hand knowledge of the political intricacies of policymaking affecting the pharmaceutical industry. While some of our attorneys are registered as federal and state lobbyists, we regularly work alongside lobbyists and public affairs professionals in the development and implementation of state based regulatory and legislative initiatives on behalf of our pharmaceutical clients. Our strengths lie in a collaborative approach to the achievement of our clients’ legislative and regulatory aims.

Areas of Focus

Our deep experience in state government strategies for life sciences includes:
  • State regulation
  • Employer issues
  • Tax and other economic incentive proposals

Experience

STATE REGULATION OF THE PHARMACEUTICAL AND MEDICAL DEVICE INDUSTRIES

  • Our attorneys have advised our pharmaceutical and medical device clients on the Massachusetts pharmaceutical marketing law, its regulations  and guidance issued by the Department of Public Health.  We have been involved in an initiative to align the state reporting regulations with the requirements of the Federal Sunshine Act. 
  • We have also advised our clients on proposed amendments to the Massachusetts anti-kickback statute that now permit the use of co-pay assistance coupons.
     

EMPLOYER ISSUES

  • Foley Hoag has represented several pharmaceutical companies in negotiating and securing economic benefit packages related to in-state relocations and expansions.
  • We have represented our pharmaceutical clients in matters related to state tax regulation both in Massachusetts and in neighboring states.  Our projects include analysis of and proposed amendments to tax legislation concerning combined reporting, investment tax credit and net operating loss extension provisions, among others.