Generic Cancer Drugs May Be Unsafe in Developing Countries

A recent international study found that generic oncology drugs may not be safe in certain developing countries that do not have strict regulatory authorities.

In 2015, the FDA approved 700 generic drugs in the United States, many being oncology drugs. Generic drugs offer great benefits to patients since they can increase access and drive down prices.

Recently, the launch of the generic version of Gleevec (imatinib mesylate) by 2 pharmaceutical companies could save more than $9.1 million over 5 years for insurers with 100 patients with chronic myeloid leukemia. In countries such as the United States with rigorous regulatory organizations, safety of the contents of pharmaceuticals is not typically a concern; however, in developing countries, this is a large concern.

Investigators in a study published by Lancet Oncology reviewed clinical, policy, safety, and regulatory data from around the world for a 3-part series of studies to determine oncology drug safety. They also examined unpublished information from the regulatory agencies in Japan and the US.

After analyzing this data, they found that generic oncology drugs are typically safe in countries with regulatory organizations similar to the FDA. They also found that generic oncology drug safety is uncertain in countries such as Iraq, India, and Colombia, where there are less regulations.

Approximately 40% of the generic drugs used in the United States are manufactured in India. According to the study, there are 3 classes of drugs created there: branded drugs manufactured and promoted by reputable Indian or multinational companies, branded generic produced but not promoted by the manufacturer, and unbranded generics produced in facilities not up to the standards of developed countries and are only used in India.

The investigators noted that FDA inspections of generic drug manufacturers in these countries increased from 59 in 2009 to 111 in 2015. These inspections are not regarding the drugs that are being distributed to patients in India, and highlights the differences in patient access to safe generic drugs in developed and developing countries.

Generic drugs are typically thought to offer great cost savings opportunities, but the investigators have not found this to be true in all cases. Generic oncology drugs sold in the United States do not offer the same level of cost savings seen in other developed countries, according to the study.

This price discrepancy is likely due to a lack of market competition. The investigators said that there must be 4 or more generics offered to achieve significant cost savings.

Additional competition may be thwarted due to time and cost barriers, since the typical generic review from the FDA costs $6 million, and may take as long as 18 months to complete.

The investigators suggest that the FDA should speed up the review time, and decrease the application costs to allow more patients to access the treatments.

“Developed countries have an opportunity to improve health disparities in developing nations by helping to build reliable supply chains and robust regulatory systems,” said lead researcher Charles Bennett, MD, PhD, MPP. “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 sector.”