After a year of considerable turmoil in Washington policy and regulatory circles, there is optimism that healthcare coverage and requirements for medical-product development will gain some clarity in the coming months. National healthcare reform legislation either will become law in some form, or will die a painful death. The new team heading up the US Food and Drug Administration will be firmly established and eager to implement new policies and programs.
GlobalizationThe future of pharmaceutical sales lies in the global marketplace, and industry is running hard to become more firmly established in growth regions. The desire to build a presence in China, India, Brazil, and other newly industrialized nations, and the desire to cut production and research costs at home are driving more foreign ventures. Novartis (Basel, Switzerland), for example, is investing $1 billion in research and development (R&D) in China in anticipation of that country becoming a top market by 2015.
Tapping emerging markets also involves increased industry investment in developing new vaccines and therapies to improve treatments for malaria, tuberculosis (TB), and neglected tropical diseases. FDA is actively supporting such efforts and is likely to do more under Commissioner Margaret Hamburg, who has a strong background in public health and infectious disease. The agency is advising on research methods for testing new TB treatments to replace ineffective old therapies and to help counter a resurgence in drug-resistant TB strains. There's also hope that the agency's priority-review voucher program will stimulate industry R&D on neglected diseases.
To better monitor the growing volume of food products and pharmaceutical ingredients imported into the US, FDA has been establishing overseas offices and plans to double the number of foreign inspections it conducts each year. New legislation to overhaul food safety would further expand the agency's inspections of food facilities in the US and abroad. In addition, FDA is partnering with European regulatory authorities to share inspection information and conduct joint inspections of foreign API producers, an initiative that could expand if beneficial.
The battle against infectious disease has spurred worldwide investment in new vaccine development and production, and this surge is slated to continue. Global funding of a vaccine to combat the H1N1-influenza pandemic has spurred construction of new vaccine manufacturing faculties in the US and globally. New vaccines to combat malaria and TB are undergoing clinical trials, and scientists remain optimistic about moving forward with the long-sought vaccine to prevent HIV infection.
FDA and other regulatory authorities are working closely with vaccine- makers to develop new test methods and innovative treatments and to strengthen the World Health Organization's vaccine prequalification program to facilitate access to therapies in developing countries.