The rising importance of overseas markets for drugs and medical products, along with pressure to cut production and research costs at home, is driving pharma overseas. Marketers are becoming established in China, India, and other newly industrialized nations that will be major markets within the next five years. Astra-Zeneca recently announced plans to outsource production of active pharmaceutical ingredients to Asia, and Novartis is investing $1 billion in R&D in China.A presence in developing countries means more investment in new treatments for malaria, tuberculosis, and other neglected diseases. FDA is encouraging such efforts, and is likely to do more under its public health–oriented commissioner Margaret Hamburg. The agency supports development of new tuberculosis treatments to replace ineffective old therapies, and is promoting a priority review voucher program to stimulate industry R&D in tropical conditions. To better monitor the growing volume of pharmaceutical imports and foreign clinical trials, FDA is establishing overseas offices and doubling the number of foreign inspections it conducts each year. Collaboration between FDA and European regulatory authorities to conduct joint inspections and share information could expand from APIs to other areas.
The battle against infectious disease has spurred worldwide investment in vaccine development and production; this surge is slated to continue. Global funding of a vaccine to combat the H1N1 influenza pandemic has financed construction of new vaccine manufacturing facilities in the US and abroad. Vaccines to combat malaria and TB are in clinical trials, and scientists remain optimistic about moving forward with a long-sought preventive to HIV infection. Novel antigens are in the works; an anti-smoking vaccine is moving into late-stage testing; and scientists continue to seek therapeutic vaccines for cancer and other conditions.
Ensuring Drug Quality
Longer supply chains and rising imports raise questions about the ability of drug manufacturers to document the quality and safety of drug products. Because FDA can never check all the thousands of products and ingredients coming into the US, it expects manufacturers to do more to ensure that contractors and suppliers have a commitment to quality, and that products and ingredients are routinely monitored and inspected. The aim is to prevent future adulteration crises, such as contaminated heparin and products with melamine.
An electronic drug registration and listing system was fully implemented in 2009, and should make it easier for FDA to identify and track products. Industry also could gain from a long-promised FDA guidance on reducing the volume of manufacturing supplements that require preapproval—an initiative designed to provide more predictability for companies contemplating improvements in manufacturing processes.
Safety Over All
FDA continues to implement provisions in the FDA Amendments Act of 2007 (FDAAA), designed to ensure the appropriate use of approved medicines through the product life cycle. FDAAA has authorized postapproval label changes when new safety issues arise, along with penalties for manufacturers that fail to conduct agreed-upon post-marketing studies. There are mandates for more extensive listing of clinical trials and study results on the ClinicalTrials.gov/ Web site, and for Risk Evaluation and Mitigation Strategies (REMS) governing postmarket prescribing and surveillance. FDA has approved REMS for more than 50 products, and is formulating a REMS for the entire class of extended-relief opioid medicines in order to provide continued access for patients suffering from chronic pain, while also curbing inappropriate prescribing, unintentional overdosing, and intentional abuse.