FIRM ANALYSIS REGULATORY
Firm Briefings
states, “They work so well with government agencies and it allows them to help clients along the bumpy road through the FDA.” Part of what makes the firm unique is their experience working with a variety of drug products. Partner Arthur Tsien has represented clients in FDA generic drug approval and exclusivity issues on over 20 different types of drug products. One of Tsien’s peers believes he is “a very underrated attorney in this field and one of the brightest lawyers I have met.” Tsien also helped author the pharmaceutical regulatory practice chapter in the FDA Modernization Act. Reed Smith The healthcare practice at Reed Smith is among the largest in the industry, with over 40 partners committed to this aspect of regulatory law. Nearly 250 lawyers work together with the healthcare and life sciences practice to help support the firm’s core team. “It is clear to see the firm has put an emphasis on this part of the industry with the sheer size of their practice,” remarks one partner. Over the past two years, the firm has added several partners to their Washington DC group, including former senior regulatory attorneys from the in-house side of the industry. According to competitors, Reed Smith has “exceptional capabilities” with regards to pricing and reimbursement issues. One partner, who is viewed by his contemporaries as, “a leading pricing authority in the industry,” is Joseph Metro, who recently represented a pharmaceutical manufacturer in a matter that addressed the treatment of distribution fees in US government price reporting programs. Among Metro’s clients is industry heavyweight Novartis Pharmaceuticals. Clients praise the firm’s strength in this segment of the industry. “They have such a great team and are such a pleasure to work with,” says one. “On top of all of that, they brought such a great product to us and we are thrilled to continue working with them.” Ropes & Gray Clients speak with a high level of enthusiasm when discussing their experience with the FDA pharmaceutical team at Ropes & Gray. “Anything we need—they are there to help at the drop of a hat,” praises a client. “My experience with the group at the firm has been nothing but pleasant, and it has also paid dividends from a business standpoint.” Ropes does a large amount of work with the FDA, especially with organizations that represent pharmaceutical companies. The firm represented the Medical Information Working Group (MIWG), an informal working group of 13 major pharmaceutical companies, including Amgen, Eli Lilly, Pfizer, and other major players in the industry. The firm filed an amicus brief on behalf of MIWG relating to off-label promotion issues. One of the managing partners of the Washington DC office is Alan Bennett, who colleagues call “one of the best regulatory attorneys the industry has to offer,” was lead counsel for MIWG on the matter. Partner Paul Rubin was recently added to strengthen the firm’s FDA group. “It was a great acquisition for the firm,” remarks one attorney. “Paul is brilliant and I am sure his clients see that through his work.” Previously Rubin served as co-chair of the FDA practice at Patton Boggs and brings over 20 years of experience working with Federal Trade Commission (FTC) and the Consumer Product Safety Commission (CPSC) to Ropes. “A complete pharmaceutical regulatory practice,” concludes one rival about the firm’s FDA team. Sidley Austin “I don’t think it would be exaggeration to say that they have the most complete regulatory practice in the industry,” declares one competitor about the team of attorneys at Sidley Austin. Another
The percentage of all regulatory respondents with prior work experience at the FDA.
15%
peer admires the firm for, “creating a truly complete practice that can deal with any issues a client may have, not just in the US, but all over the world as well.” The firm’s pharmaceutical and medical device teams, led by global life sciences head Scott Bass, offer clients full-service regulatory capabilities. Sidley’s practice depth is one reason why the firm has represented companies like Bayer, Genentech, and Allergen in this space, as well as a laundry list of other familiar industry names. Among the firm’s most active attorneys in this space are partners William Sarraille and Jeffrey Senger. Sarraille is viewed by colleagues as “one of the leading regulatory attorneys in the US” and was responsible for representing Bayer with a host of regulatory and reimbursement issues on its prostate cancer treatment drug, Xogifo. Senger is currently providing strategic counseling to St. Jude Medical on FDA matters stemming from a product liability action, a complex matter that includes ongoing recall-related communications, medical device reporting issues, and a post market surveillance order issued by the FDA. “Jeff is one of the hardest working attorneys I know,” states one competitor. “He deserves to be recognized for his work in the field.” Perhaps the most boisterous praise for Sidley Austin’s regulatory team comes from the firm’s clients. “I have no reason to go to any other firm for this type of work,” is how one client described working with the firm. “They have really set the standard for how a law firm should not only handle their client’s issues in a legal sense, but also how to make their clients feel at ease even with all of these question marks surrounding their company.”
LMG LIFE SCIENCES 2013
27