FIRM ANALYSIS REGULATORY
Firm Briefings
Healthcare: Pricing & Reimbursement
Highly recommended Covington & Burling Reed Smith Sidley Austin Recommended Arnold & Porter Cooley Hogan Lovells Morgan Lewis & Bockius
he FDA has become more risk-adverse in approving products, and one attorney claims that the current climate is “the most difficult regulatory environment that the pharmaceutical industry has ever seen.” These difficulties have pushed large pharmaceutical companies to develop medical device branches with the hopes of creating new revenue streams with products that have a better chance of getting approved faster. The healthcare IT space is benefiting from this shift, where major companies—such as GE and Phillips—are extremely active in getting personalized medical devices and applications into the marketplace. In addition, healthcare reform in the United States has created a very demanding regulatory environment within the domestic life sciences industry. Although Obamacare is in its third year of existence, industry companies are still working to reach pricing and reimbursement agreements with federal agencies. “Average Wholesale Price (AWP) agreements are taking up a lot of an attorney’s practice, “states one practitioner. “Ultimately the government wants to decide what they should pay private companies for health products and services, which conflicts with what the distributing parties want the government to pay them for their products and services. As you can imagine, it hinders the relationships between these companies and the government.” Arnold & Porter Arnold & Porter sports a formidable FDA practice that is wellknown by the market for assisting clients with pricing systems and reporting on behalf of their clients. It is “one of the regulatory firms to keep your eye on,” notes one rival. Daniel Kravoc, who colleagues see as “a leading figure in the pricing industry,” leads the group. In addition to his pricing work, Kracov also counsels clients on critical regulatory matters, including approval strategies, inspections, and FDA Advisory Committee meetings. Another outstanding member of the firm’s regulatory team is partner Jeffrey Handwerker. One peer sees him as “a great attorney who doesn’t get as much recognition as he deserves for his work in this field.” Handwerker successfully defended AstraZeneca Pharmaceuticals in a Public Health drug pricing program dispute. Cooley “They made a big splash in the regulatory section of the industry with their lateral hires this year,” remarks one peer about Cooley’s additions to its practice. Partners Wendy Goldstein and Kathleen Peterson joined the firm this year and have bolstered Cooley’s pricing and reimbursement capabilities. Recently, the firm advised Insys Therapeutics on their initial public offering. Another colleague adds about Cooley, “they have such a strong corporate practice that they can now team with a very impressive regulatory group.” Both Goldstein and Peterson bring decades of pricing and reimbursement experience to the firm. “Wendy has connections with so many important people in both New York and Washington DC,” remarks one competitor, adding that “the firm knew what it was doing with it hired both her and Kathleen.” Previously, Goldstein chaired Epstein Becker & Green’s Pharmaceutical Industry Health Regulatory practice group.
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LMG LIFE SCIENCES 2013
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