Increased Evolution of Regulations Affecting the Pharmaceutical Law Practice

Jean Frydman, US General Counsel & Chief Compliance Officer, Ferring

The increase of regulations over the last two to five years for pharmaceutical companies has become a nightmare for sales representatives working for those companies and for internal staff charged with assuring the companies’ employees are following the most recent regulations affecting their actions every work day. One area where there has been an increase of regulations is state reports. Currently, pharmaceutical companies are reporting various payments or exchanges of financial value to physicians, healthcare providers (HCPs) and affiliated healthcare organization (HCOs) to meet the complex state specific filing requirements of 6 states and Washington DC. Since 2006, 20 states have introduced legislation requiring pharmaceuticals companies to make these disclosures and it is anticipated that more states will require the reporting. The current state reporting requirements are neither consistent from state to state and can be broadly interpreted regarding the definitions of reportable entities and/or the type of transactions to be reported. The current state reporting requirements include:

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USA Regulation Pharmaceutical November 2010 Vol. 4, No. 13, Autumn 2010

Jean Frydman

Ferring

Ferring Pharmaceuticals is a research-driven biopharmaceutical company devoted to identifying, developing and marketing innovative products in the fields of reproductive health, urology, gastroenterology, endocrinology and osteoarthritis. The company’s research activities and products are connected by a common thread focused on the provision of tailored treatments that work on the body’s own terms to enable doctors to combat numerous diseases and medical conditions. The company has gained international recognition over the last 20 years for the creation of inventive medications that improve the quality of life of children and adults all around the world. Ferring has its own production facilities in several European countries, in South America, Israel and China. With the acquisition of Bio-Technology General in 2005, it has capabilities in recombinant biotechnology as well as more traditional pharmaceutical manufacturing. Ferring’s marketing, medical services and sales teams, led by corporate headquarters in Saint-Prex, Switzerland, operate from more than 45 countries and employ more than 3700 people throughout the world, while treatments are available in more than 70 countries. This expansion has allowed Ferring to maintain a double digit annual growth rate over the last two decades Ferring’s R&D projects complement Ferring’s product portfolio and will add a new generation of products to some of the company’s most successful specialty brands. R&D facilities are located in Denmark, Israel and California, USA. Ferring is committed to a future where it will continue to provide new and innovative medicines by utilising existing and acquired skills and the development of pioneering technologies and, where necessary, through partnerships with academic institutes and other companies.

USA Regulation Pharmaceutical November 2010 Vol. 4, No. 13, Autumn 2010