Foley Hoag LLP

SUMMARY

Personalized medicine – getting the right treatment to the right patient at the right time – will be a major pillar of efforts to bring increased effectiveness and efficiency to healthcare. Today, we know far more about the molecular heterogeneity of major diseases, including cancer. It is clear that targeted and more effective medical treatments will often be unattainable unless physicians have precise molecular information about the patient’s disease. In short, is a priority that our healthcare system (both private payors and Medicare) facilitates the adoption of new molecular technologies when they are shown to be efficient and effective.

SUMMARY

In a decision that will have far reaching implications for drug and medical device development, the Court of Appeals for the Federal Circuit held yesterday that the Hatch-Waxman safe harbor of 35 U.S.C. § 271(e)(1) is inapplicable to patented research tools that are not themselves subject to the FDA review process. While the decision is good news for the providers of research tools such as drug screening assays, it will make drug and medical device development in the United States costlier and more risky.

SUMMARY

In recent months, the Massachusetts Legislature has been considering legislation to limit or ban certain marketing activities of pharmaceutical and medical device companies. On the last day of the legislative session, July 31, the House and Senate voted to accept the conference committee report concerning health care cost containment legislation, (Senate 2863.) This legislation includes the provision regulating gifts by pharmaceutical and medical device manufacturers to physicians.

SUMMARY

Understanding Medicare coverage and payment policy is critical to the successful launch of any new life sciences technology. Foley Hoag’s Medicare Coverage & Payment Practice provides regulatory and legislative advice to a broad array of leading life sciences companies, including:

• global pharmaceutical and biotechnology firms,
• trade associations,
• venture capital and investment funds,
• patient associations and advocacy groups, and
• early-stage companies.

SUMMARY

Foley Hoag’s Food and Drug Practice provides regulatory and legislative advice to leading biotechnology, pharmaceutical, medical device, and health care companies regulated by the Food and Drug Administration (FDA). Lawyers at Foley Hoag understand the critical regulations and policies affecting product development schedules, regulatory compliance, and timely product approvals. In representing clients, our lawyers work with senior agency managers, congressional staff, and Members of Congress to shape agency interpretations, clarify regulatory guidance, challenge adverse decisions, develop effective compliance plans, and enact legislation into law.

SUMMARY

In recent months, the Massachusetts Legislature has been considering legislation to limit or ban certain marketing activities of pharmaceutical and medical device companies. In April 2008, the Massachusetts Senate approved a proposal that would significantly restrict pharmaceutical marketing to physicians and health care facilities. This proposal was subsequently revised by the Massachusetts House on July 16, 2008. The progress and outcome of this marketing legislation is of significant importance to anyone involved in the Massachusetts biotechnology, health care, and drug and device sectors.

SUMMARY

According to a study by PricewaterhouseCoopers and the National Venture Capital Association, venture capital (VC) investing hit a five-year high in 2006, with $25.5 billion invested. Notably, the Life Sciences sector, which includes biotechnology and medical devices, accounted for 28% of VC money invested, the largest investment sector in 2006.

As Life Sciences venture capital investing has risen, the biotechnology industry has become increasingly dependent on such funding. This is particularly true for start-up companies that cannot rely on revenue from marketed biologics to fund their research and development pipeline. To cover the nearly $1 billion capital investment required to bring a biologic drug to market (from discovery through clinical trials and FDA approval), early-stage companies rely on VC investing. Investing in emerging companies, however, is risky for a venture capitalist: only 1 in 10 drugs discovered actually makes it to market, and despite the more than $50 billion spent on biotech drugs in 2006, the great majority of early-stage companies never reach the point of net profitability.

SUMMARY

Legislative and regulatory matters are critically important for life sciences companies. The lawyers in Foley Hoag’s Government Strategies Practice have extensive experience in the development and implementation of legislation and regulations affecting the biotechnology, pharmaceutical, medical device, and health care provider industries. The regulatory environment can pose significant burdens to life sciences companies, but intelligent strategic advocacy in Congress and before federal regulatory agencies can also open up new markets and opportunities for innovative products. Lawyers at Foley Hoag work directly with Congressional staff and federal agencies, including the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS), on a variety of matters relating to the life sciences.

Focuses include:

• Biotechnology, Pharmaceuticals and Medical Devices
• Legislative
• Coverage and Reimbursement
• Food and Drug
• Bioterrorism and Pandemic Preparedness

SUMMARY

On June 16, 2008, Massachusetts Governor Deval Patrick signed into law legislation (.pdf) that provides a total of $1 billion over the next ten years to support the development of the life sciences industry in Massachusetts. The legislation, commonly known as the Life Sciences Initiative (LSI), is designed to stimulate research, development, manufacturing, and commercialization in the life sciences sector and, ultimately, to increase employment and associated tax revenues. To achieve these goals, the LSI significantly expands the activities of the recently created Massachusetts Life Sciences Center (LSC) by dramatically increasing the funding available for capital expenditures, grant programs and other incentives. The LSI also establishes an aggressive set of tax incentives that include a broad array of refundable and other types of tax credits. 

SUMMARY

Established in December 1980 by the partners of law firm Foley Hoag, The Foley Hoag Foundation is a private foundation that seeks to combat racism, especially among youth, in the City of Boston. The Foundation awards grants to organizations working to improve the racial climate in Boston by addressing issues of diversity and racism. Grantee organizations achieve their goals through a variety of means, including arts and cultural activities, youth leadership and recreational programs. Other grantees provide advocacy assistance, enabling individuals to confront racism through legal or political action. Some grantee organizations work to prepare young children to live in the reality of a multicultural society, others engage teens, and a few target a primarily adult constituency.

The Foley Hoag Foundation was the first—and remains the only— foundation to focus exclusively on the improvement of race relations in Boston. The trustees are fortunate to have the unqualified endorsement of Foley Hoag, which has provided an enormous amount of financial, administrative and moral support.

SUMMARY

"Crossing the Chasm: A New Health System for the 21st Century" has been cited thousands of times in the effort to bring transformational change to the American healthcare system. Published by the Institute of Medicine in 2001, the report describes a “chasm” between the circumstances of today and the possibilities of the future.

SUMMARY

Key Members of the House Committee on Energy & Commerce have introduced bipartisan legislation which would create an abbreviated approval pathway for biosimilars or follow-on-biologics (FOBs). The Pathway for Biosimilars Act, H.R. 5629 introduced by Congresswoman Anna Eshoo (D-CA) and committee ranking member Joe Barton (R-TX), enhances the prospects for congressional action in 2008, following Senate HELP Committee action last year on S. 1695, a comparable bipartisan bill introduced by Senators Kennedy, Enzi, Clinton and Hatch. 

SUMMARY

We believe that public policy should enhance the lives of citizens—and that can best be accomplished through partnership with business. Foley Hoag’s Government Strategies practice is focused on achieving results for our clients that are mutually beneficial to everyone involved.

We work with Fortune 100, start–up businesses and other clients to help develop effective new public policy, assess the impact of recent regulations and refine the implementation of enacted legislation.

We will help you overcome your legal, policy, and political challenges by:

• Providing strategic management of complex legislative and regulatory issues
• Building lasting relationships with key decision makers
• Anticipating future policy challenges and advising you accordingly
• Building coalitions to advocate on behalf of shared interests
• Providing counsel through crisis management and congressional investigations
• Enhancing understanding of agency decisions, authority and statutory changes
• Monitoring all types of legislative activities and advising you of their status
• Negotiating with regulatory agencies

The core strength of Foley Hoag’s Government Strategies practice is the unsurpassed experience of our lawyers. Most of our government strategies lawyers have worked in senior-level positions in the White House, on Capitol Hill, in regulatory agencies, and in industry trade associations.

Our trademark is a unique combination of broad-based legislative and regulatory experience and significant substantive knowledge, particularly in the following areas:

• Life sciences, including pharmaceuticals, biotechnology and medical devices
• Energy and regulated industries
• Energy technology and renewables
• Education
• Foreign policy and interactions with sovereign governments
• Corporate social responsibility
• International trade

SUMMARY

Drug company scientists discover that a rare debilitating disease may be treated with a drug licensed to treat an unrelated ailment. The Food and Drug Administration (“FDA”) has not approved the drug for the rare disease. While the company begins time consuming and expensive clinical trials to test this discovery, patients with the rare disease ask their doctor for the drug. Doctors seek as much information as possible on this “off-label” use. The drug company wants to get the word out quickly about the new use.

• Should a drug company be permitted to promote the drug for the new use before FDA approval, and if so, what can the company say?
• Should doctors be permitted to prescribe a drug for an unapproved use, and if so, under what conditions?
• If doctors can prescribe the drug, how do they obtain information on the correct dosage and adverse side effects?
• Under what circumstances can a company provide “off-label” information to doctors?

Download A Low Dose Prescription: Criminal Prosecution of Off-Label Drug Promotion (.pdf)

SUMMARY

On October 25, 2007 the Food and Drug Administration (FDA) released the “Draft Guidance for Industry and FDA Staff: In Vitro Diagnostic (IVD) Device Studies – Frequently Asked Questions,” open for public comment for 90 days.This is the third draft guidance related to in vitro diagnostic (IVD) tests that FDA has released in the last 14 months, marking notably increased agency attention to these products.

SUMMARY

This guide is intended to provide foreign businesspeople with an introduction to the basic kinds of laws and regulations that affect the conduct of business in the United States, and particularly in the Commonwealth of Massachusetts. The level of detail is varied, reflecting the nature of the legal areas discussed. For example, environmental law and taxation are subjects of detailed and technical regulation, while labor relations are governed as much by custom and practice as by direct regulation.

SUMMARY

Since implementation in 1994 of a substantially improved small business investment company program, the number of privately-managed small business investment companies receiving reasonably-prices, government-backed financing has increased rapidly.  In the federal fiscal year ended Sept. 30, 2000 alone, SBICs invested nearly $5.5 billion in over 3,000 businesses.  This represents an increase of 30% over the prior year, due primarily to the growing popularity of the Small Business Administration's equity leverage program.  Not only have the levels of government-backed funding for program participants increased dramatically, but at the same time those funding levels have become more reliable by becoming less dependent on Congressional budget appropriations.