Food and Drug Administration Warns Sharon Bio Medicine on Generic Drug-User Fee

Sharon Bio-medicine, the Dehradun-based facility receives a warning letter from US Food and Drug Administration (FDA) for failure to pay generic drug user fee by its owner for three years starting 2013.

The facility would be barred from shipping products to the US if the dues are not cleared. FDA said the owner of Sharon Bio-medicine has failed to pay the appropriate facility fee for the facility as required by the Generic Drug User Fee Amendments of 2012 (GDUFA).

The facility has not paid the 2013, 2014 and 2015 fees as required by GDUFA. It is a violation of federal law to ship misbranded products in interstate commerce, including causing such products to be imported into the United States.

"Failure to correct these violations promptly may result in regulatory action, including but not limited to seizure or injunction without further notice. Your facility may also be placed on import alert such that any drug the facility manufactures will be refused admission into the United States," the US health regulator said.

The company should take prompt action to correct the violations noted above by immediately paying fiscal years 2013, 2014, and 2015 fees, it noted.

GDUFA was first passed into law in 2012 under the Food and Drug Administration Safety and Innovation Act (FDASIA) - a legislation which contained hundreds of reform measures and several user fee components meant to increase funding for the US drug regulator.

Under GDUFA, generic pharmaceutical companies are supposed to pay a fee to the US regulator for many of its routine activities, including generic drug filings and manufacturing facility inspections.

Source: Medindia