The worldwide economic downturn, the contentious debate over national healthcare reform, and important changes on the regulatory
front have all taken tolls on biomedical research and new drug development. Luckily, the new year brings optimism on both
fronts. Healthcare reform legislation will either become law or die a painful death. The new team heading up the Food and
Drug Administration will be firmly established and eager to implement new policies and programs. Pharma companies will be
consolidating operations following major industry upheavals. And all will be watching the following trends shaping drug development
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
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.