Foley Hoag’s team of state regulatory and legislative attorneys is one of the most knowledgeable and experienced in Massachusetts, with particular expertise in the regulation of the life sciences industry on the federal and state levels. We interface regularly with state and local government agencies in Massachusetts and other states on a wide variety of legislative and regulatory matters affecting the life sciences, and offer experience and expertise in numerous areas of complex regulatory compliance.
Our healthcare and life sciences regulatory team of lawyers has extensive experience in state regulatory and legislative initiatives relative to pharmaceutical policy and regulation. Many of our attorneys 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.
While our attorneys have the expertise, experience and relationships to lead lobbying efforts on life sciences and healthcare regulation on both the executive and legislative levels, we have found that our strategic approach to legal matters – which is based in a long Foley Hoag tradition of public sector representation and administrative law – has been well suited for collaboration with our clients’ internal and external lobbyists.
In the course of our state based regulatory and legislative initiatives, our attorneys have provided our clients with both legal and strategic advice through partnerships with major lobbying and public relations firms both in Massachusetts and other states. Our lawyers strive to gain an in depth understanding of our clients’ business and 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.
Representative engagements include:
State Regulation of the Pharmaceutical and Medical Device Industries
As a top law firm with offices in Boston, New York, Paris and Washington D.C., Foley Hoag has a longstanding engagements with several major life sciences clients with operations in Massachusetts and other states, for which we function as outside counsel on legislative and regulatory issues of concern. By way of representative engagements, we have advised clients with respect to state efforts to restrict Medicaid formularies, broaden prior authorization requirements for specialty drugs, and establish insurance exchanges. Finally, our healthcare attorneys are also monitoring the impact of the federal Affordable Care Act (“ACA”) on the state level and the impact on our pharmaceutical, biotech and medical device clients. Of major concern to life sciences companies is the push towards the formation of accountable care organizations (“ACOs”) and the impact of payment bundling and other downward cost pressures on the industry. Other concerns include the impact of health insurance exchanges, specialty drug tiering, and the expansion of the Medicaid program. We understand that, overall, cost reduction efforts may fail to account for innovative technologies; in our representation of other companies on the state initiatives, we have stressed the need for state policymakers to recognize access to innovation in developing in any payment model.
On a more local level, our attorneys have advised our pharmaceutical and medical device clients with respect to the Massachusetts pharmaceutical marketing law, its regulations, and guidance issued by the Department of Public Health. Most recently, Foley Hoag has 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 with respect to proposed amendments to the Massachusetts anti-kickback statute that now permit the use of co-pay assistance coupons.
Employer Issues
Our attorneys have broad experience with state economic statutes and regulations concerning taxation and other forms of state regulation of businesses. In particular, we are experts in identifying and negotiating economic benefits for our pharmaceutical clients that elect to relocate or expand in Massachusetts. In this regard, our expertise lies in the analysis of the substance of tax and other economic incentive proposals, strategizing about creative approaches to funding, and the negotiation of the required agreements. Foley Hoag has represented several pharmaceutical companies in negotiating and securing economic benefit packages related to in-state relocations and expansions. We have also represented our pharmaceutical clients in matters related to state tax regulation both in Massachusetts and in neighboring states. Our projects have included analysis of and proposed amendments to tax legislation concerning combined reporting, investment tax credit, and net operating loss extension provisions, among others.
In sum, Foley Hoag’s administrative law and state government strategies departments employ attorneys and health policy specialists who are experts in a wide range of areas, with a specific emphasis on the regulation of biopharmaceuticals. While our attorneys represent a breadth of practice areas and specialties, our strengths lie in a collaborative approach to the achievement of our clients’ legislative and regulatory aims.
