FDA issues warning on unregistered breast cancer drug
The Food and Drug Administration (FDA) has warned healthcare professionals and the public against the use of a cancer drug that did not undergo government registration and evaluation to ensure its efficacy and safety.
An advisory from the regulating agency states that Trastuzumab with trade name CANMab 440 mg Lypophilised Powder for I.V. infusion poses potential danger or injury to the consuming public and that its importation or selling in the country is a direct violation of the Food and Drug Administration Act of 2009.
“All healthcare professionals and the general public are hereby warned to be vigilant of the drug product,” states the FDA advisory signed by Health Secretary Janette Garin, also acting director general of the regulatory body.
CANMab injection, which contains Trastuzumab, is manufactured by Bangalore-based generic pharmaceutical company, Biocon. It is marketed as a “targeted therapy” for the treatment of HER2-positive breast cancer and certain types of stomach or esophagus cancer in certain patients.
In February 2014, the Delhi High Court ordered the company to stop selling the drug, a biosimilar or the generic version of a breast cancer drug manufactured by Swiss firm Roche, until it could convince the court that the product had undergone adequate testing.
To protect public health and safety, the FDA ordered all its field regulatory operations officers to seize the unregistered product found in the market and penalize those who would be found selling it.
All local government units and law enforcement agencies have also been advised to be vigilant and to ensure that the product would not be sold or offered for sale in their areas of jurisdiction.
“All consumers are advised to purchase their medications only from FDA-licensed establishments,” it said.
The agency further explained that on top of inspection of establishments, product evaluation, registration and testing were measures being undertaken by the government to ensure the quality, safety and efficacy of all health products before they are made available in the market.
It reminded the public that drug products registered with FDA Philippines must carry information in English and/or in Filipino in their labels for all consumers to understand.