Generic cancer drugs are generally safe in
countries with rigorous regulatory programs similar to the FDA in the
United States. However, in countries with less rigorous regulation, such
as India, Iraq and Colombia, safety is far from certain, revealed a new study.
For the study - published in the November 2016 issue of Lancet Oncology
as part of a three-part series examining oncology drug safety - the
researchers reviewed clinical, policy, safety and regulatory data from
around the world, including unpublished data from the food and drug
administrations of Japan and the United States.
After analyzing safety
data, the safety of these drugs in developing countries was found to be
uncertain, suggested an international research team led by Dr.
Charles Bennett, Josie M. Fletcher professor and chairman of the S.C.
SmartState Center in Medication Safety and Efficacy at the College of
Pharmacy at the University of South Carolina.
‘Although generic oncology drugs can reduce patient costs and improve treatment access, the safety of these drugs in developing countries is uncertain, suggested a new study.’
Noting manufacturing problems with generic drug facilities in India,
the researchers found that U.S. FDA inspections of generic drug
manufacturers in India have nearly doubled from 59 in 2009 to 111 in
2015. About 40% of all generic drugs used in the United States
are manufactured in India, where the researchers reported three classes
of medications are created: branded drugs produced and promoted by
reputable Indian or multinational companies; branded generics produced
but not promoted by the manufacturer; and unbranded generics produced in
facilities that do not meet developed countries' regulatory standards
and are distributed only in India, highlighting the gap between patient
access to high quality generic drugs in developed versus developing
In addition, the researchers found that although generic oncology
drugs in the United States offer equivalent safety to brand-name drugs,
they do not offer patients the price savings seen in other developed
countries. According to the researchers, economic studies show U.S.
generics do not result in price competition unless four or more generic
options have received FDA approval.
However, they said time and cost barriers may prevent such
competition from emerging, noting the average FDA generic drug review
costs $6 million and takes 18 months. Given the high cost of cancer
treatment, Bennett and colleagues argue the agency should shorten the
application review period and slash application costs to improve the
U.S. cancer cost curve.
"Developed countries have an opportunity to improve health
disparities in developing nations by helping to build reliable supply
chains and robust regulatory systems," Bennett said. "Here in the United
States where branded and generic drugs are safe, we must also work to
lower treatment access barriers for patients by eliminating regulatory
hurdles that discourage competition in the generic manufacturing