Safety concerns linger for generic oncology drugs in developing countries

November 2, 2016

Although generic oncology drugs can reduce patient costs and improve treatment access, the safety of these drugs in developing countries is uncertain, according to 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.

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drug safety—the researchers reviewed clinical, policy, safety and regulatory data from around the world, including unpublished data from the food and drug administrations of Japan and the United States .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, , they found that 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 , they wrote.

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 percent of all 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 nations.

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 sector."

Explore further: U.S. pays highest prices for cancer meds: study

More information: Y Tony Yang et al, Generic oncology drugs: are they all safe?, The Lancet Oncology (2016). DOI: 10.1016/S1470-2045(16)30384-9

Related Stories

U.S. pays highest prices for cancer meds: study

June 6, 2016
(HealthDay)—The United States pays the highest prices in the world for generic and brand-name cancer drugs, a new study has found.

First generic version of cancer drug Doxil approved

February 4, 2013
(HealthDay)—The first generic version of the cancer drug Doxil (doxorubicin hydrochloride liposome injection) has been approved by the U.S. Food and Drug Administration, which says the action should help relieve shortages ...

ACP: Doctors should prescribe generic medications whenever possible

November 23, 2015
All clinicians should prescribe generic medications whenever possible as a way to improve adherence to therapy and clinical outcomes while containing costs, the American College of Physicians (ACP) advises in a new paper ...

Economists throw doubt on generic drug price advantage over branded version

September 16, 2013
(Medical Xpress)—People given a choice between generic or branded drugs should look closely at the ingredients in the drug they are buying, argue economists from Deakin University's Graduate School of Business.

Can the high cost of prescription drugs in the US be contained?

August 23, 2016
In a Special Communication in JAMA, "The High Cost of Prescription Drugs in the United States Origins and Prospects for Reform," Kesselheim and colleagues reviewed the peer reviewed medical and health policy literature from ...

Low-cost generic direct-acting antiviral treatment for hep C is equivalent to branded formulations

April 16, 2016
Data presented today demonstrates that generic direct-acting antivirals (DAAs) are as effective and safe as branded treatments to cure Hepatitis C.

Recommended for you

Study provides insight into link between two rare tumor syndromes

August 22, 2017
UCLA researchers have discovered that timing is everything when it comes to preventing a specific gene mutation in mice from developing rare and fast-growing cancerous tumors, which also affects young children. This mutation ...

Retaining one normal BRCA gene in breast, ovarian cancers influences patient survival

August 22, 2017
Determining which cancer patients are likely to be resistant to initial treatment is a major research effort of oncologists and laboratory scientists. Now, ascertaining who might fall into that category may become a little ...

Study identifies miR122 target sites in liver cancer and links a gene to patient survival

August 22, 2017
A new study of a molecule that regulates liver-cell metabolism and suppresses liver-cancer development shows that the molecule interacts with thousands of genes in liver cells, and that when levels of the molecule go down, ...

Zebrafish larvae could be used as 'avatars' to optimize personalized treatment of cancer

August 21, 2017
Portuguese scientists have for the first time shown that the larvae of a tiny fish could one day become the preferred model for predicting, in advance, the response of human malignant tumors to the various therapeutic drugs ...

Scientists discover vitamin C regulates stem cell function, curbs leukemia development

August 21, 2017
Not much is known about stem cell metabolism, but a new study from the Children's Medical Center Research Institute at UT Southwestern (CRI) has found that stem cells take up unusually high levels of vitamin C, which then ...

Searching for the 'signature' causes of BRCAness in breast cancer

August 21, 2017
Breast cancer cells with defects in the DNA damage repair-genes BRCA1 and BRCA2 have a mutational signature (a pattern of base swaps—e.g., Ts for Gs, Cs for As—throughout a genome) known in cancer genomics as "Signature ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.