Cancer Drugs Not Fit in US are marketed in Colombia

A patient association filed a complaint with a laboratory for marketing in Colombia an oncology drug that was removed from the shelves in the United States. for sanitary irregularities in its manufacture.
Cancer Drugs Not Fit in US are marketed in Colombia

A drug used to treat various types of cancer is freely marketed in Colombia, despite having been withdrawn from the US.

This is Genfilgras, a drug severely questioned by the US Food and Drug Administration (FDA) because of the irregularities found after an inspection at one of its plants located in India, Semana reports.

Illustrative imageHallan a drug that prevents cancer and heart attack
According to a 16-page report issued by the FDA, the drug factory found remains of pigeon droppings and failures in electrical service, which led to the suspension of its commercialization in the United States.

The Patients Colombia movement demanded an explanation from the Ministry of Health about why circulation of the drug had been allowed, despite the FDA's warning. This medicine, being the result of a process similar to biotechnology, is 30 to 60% cheaper on the market.

However, the movement stressed the importance of not only ensuring access to medicine at reasonable prices, but also being appropriate for patients: "I am convinced that safety, efficiency, quality and price can go hand in hand . "It can not be that we have to lower it to the quality to have greater profitability", said Denis Silva, spokesman of the organization.

The laboratory version is that the company, beyond the report that it does not meet FDA quality standards in certain factories, "regularly performs microbiology analysis in Colombia" to ensure that the chronological products are "totally safe" .

Abbot also alleges that the National Institute of Drug Surveillance of Colombia (Invima) "inspected the third plant in India, where this product is manufactured, and issued the certification, effective until 2020, of compliance with good manufacturing practices, ensuring that the criteria of the World Health Organization are met. " This basically transfers the responsibility to the Colombian institutionality to endorse the commercialization of the drug.