Meanwhile, shortages and security are causing serious health problems around the world. The President's Emergency Plan for
AIDS Relief (PEPFAR), which has provided $1.2 billion in antiretroviral drugs to some five million people in Africa and other
nations during its first 10 years, is taking steps to ensure the security of its supply chains. An April 2013 report from
the Government Accountability Office (GAO) notes the need for better inventory controls and records to avoid shortages, waste
and loss of supplies—especially if the program is to expand to serve 23 million eligible people.
Notice to Industry: Own It
Efforts to control and treat tuberculosis have been hampered by shortages of first-line treatment isoniazid (INH) in the United
States and abroad. While US public health officials are worried, the situation is more deadly in India and other regions where
there's great danger of generating multi-drug resistant TB strains if patients have to stop taking medicines. Manufacturers
Sandoz and Teva have moved to ramp up production in response to a temporary shut-down at VersaPharm. But delayed and unclear
procurement projections by government health programs, as well as low prices for these widely used drugs, have discouraged
additional manufacturers to move into the TB drug market.
A flood of counterfeit and falsified antimalarial drugs in Africa and other developing nations has generated calls from the
Obama administration and international organizations for more aggressive strategies to track drug supplies. Many of the bogus
products have no active ingredient, while diversion of genuine drugs robs public health programs of vital treatments. These
developments raise the specter of generating resistance to effective medicines, which would undermine a decade of progress
in reducing malaria-related deaths.
The President's Malaria Initiative is working with local authorities to better protect international and local supply chains,
while also encouraging manufacturers to add special markers or tags to packages of artemisinin-based combination therapies,
currently the most effective antimalarials. The fight against malaria may be strengthened by progress in development of a
synthetic version of artemisinin, with has begun production at a Sanofi plant in Italy. In addition, FDA is testing use of
a handheld counterfeit drug detection device, developed by agency scientists to determine quickly if a medical product is
real or bogus.
Jill Wechsler is Pharm Exec's Washington correspondent. She can be reached at