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Major Legislative Milestones
Our lawyers worked on key pieces of health legislation while working as congressional staff members. These include the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA), the 1997 Food and Drug Administration reform law, the Orphan Drug Act, and the Health Insurance Portability and Accountability Act of 1996, and the Public, Health, Security and Bioterrorism Preparedness and Response Act. We have also worked on legislation involving specific changes to Medicare and Medicaid law. Today, our lawyers represent several leading pharmaceutical and biotechnology companies and industry trade associations in their implementation of and ongoing preparedness for these laws.
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Ryan White CARE Act
Our lawyers advocated on behalf of a national civil rights organization to assure the timely reauthorization of the Ryan White CARE Act, the largest publicly funded program dedicated to providing people with HIV/AIDS in the United States with a wide range of community-based health and support services.
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Guiding Clients through CMS
Our lawyers advised a coalition of leading academic medical centers and medical device manufacturers in the development of one of the first data registries under CMS’s Coverage with Evidence Development policy. We also represented a leading cancer center in obtaining a DRG reclassification for hospital inpatient reimbursement for an anti-cancer therapy for renal cell carcinoma and melanoma.
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Engaging FDA and Congress
On behalf of a national coalition of innovative medical technology companies, our lawyers engaged FDA and Congress regarding the appropriate regulation of break through genetic and molecular diagnostic tests. We also devised a strategy to persuade an FDA review division to accept a medical technology company’s proposed development plan, after the company had reached an impasse with the review division over its data requirements.
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Leading the Way for Innovative Treatments
Our lawyers advised an innovative early-stage company on obtaining a $102 million contract with the U.S. Department of Health and Human Services to develop an influenza neuraminidase inhibitor for the treatment of pandemic influenza.
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Biomedical Advanced Research and Development Authority (BARDA)
In a move that created enormous opportunities for early-stage life sciences companies, last year the U.S. Congress revitalized the federal government’s program supporting the development of medical countermeasures critical to protecting the nation against bioterrorism and pandemic threats. The resulting legislation created an agency within the Department of Health and Human Services (HHS), the Biomedical Advanced Research and Development Authority (BARDA). BARDA will inject more than $1 billion into research, development, and procurement of vaccines, antivirals and diagnostics. BARDA enhances coordination between government and emerging companies through support of advanced research and development, the vital phase that occurs in between basic research and commercialization. On behalf of the venture capital firm, Kleiner Perkins Caulfield & Byers, Foley Hoag worked with the HHS, Congressional members, and staff to craft legislation strengthening the nation’s response to pandemic outbreaks and bioterrorism. The key financing aspect of the legislation provides much-needed funding to allow early stage companies to traverse the “valley of death” before product commercialization. The legislation authorizes the Secretary of HHS to expedite contracts and grants, and the Director of BARDA to identify areas of unmet need, spurring further innovation and investment. BARDA institutionalizes the important partnership between the federal government and the life sciences industry, critical to safety, innovation and economic vitality.
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Strategic Advice on Landmark Legislation
On behalf of a national life science trade association and leading biodefense companies, our Government Strategies lawyers provided substantive counsel and strategic advice to leading Members of Congress and the Administration in the enactment of landmark legislation promoting advanced research and development against bioterrorist attack and pandemic infectious diseases.
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Bringing Law and Science Together
On behalf of a leading biotechnology company, our Government Strategies lawyers assembled a persuasive legal and scientific case that secured a critical federal policy decision affecting the coding and payment of important therapies for Medicare beneficiaries.
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