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.
Although healthcare reform could bolster pharmaceutical industry sales over the long run, analysts still expect industry growth
to be relatively modest because of the global economic downturn, patent expirations, and growing pressure to reduce prices.
Pharmaceutical manufacturers will be watching key trends and developments in 2010 that will shape drug development and production
for years to come.
The 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.
Foreign manufacturers are expanding vaccine production as well, including developing new vaccine production and testing methods.
Novel antigens are in the works, and vaccine-makers are moving forward with long-discussed cell-based manufacturing technology
for influenza vaccine. In the US, an antismoking vaccine from Nabi Biopharmaceuticals (Rockville, MD) with support from GlaxoSmithKline
(London) is moving into late-stage testing, while scientists continue to seek therapeutic vaccines for cancer and other conditions.
In Washington This Month
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.