News Feature | August 6, 2014

FDA Hikes User Fees For Foreign Pharma Manufacturers

By Lori Clapper

Pharmaceutical manufacturing facilities located outside of the U.S. are now required to pay 12 to 15 percent more in annual facility fees following the release of new rates by the U.S. Food and Drug Administration (FDA), the Economic Times says.

The newly released rates affect user fees for certain applications and supplements for human generic drug products. The fees go into effect on October 1st, 2014 and will be enforced through September 30, 2015, according to the FDA.

Now, following these new regulations a foreign finished dosage form (FDF) facility will pay $262,717 now, as compared to $235,152 a year ago — an increase of 12 percent. A foreign active pharmaceutical ingredient (API) manufacturer will now shell out $56,926 in annual fees — 15 percent higher than the current facility fee rate.

If a plant houses both FDF and API production, it will incur both fees.

How do foreign and domestic generic drug fees compare?  Foreign facilities will be shelling out $15,000 more than U.S. plants because of the high cost of foreign inspections. For the U.S. facilities, the FDF facility fee this year is US$247,717 and the API facility fee is US$ 41,926.

India’s pharma manufacturing industry, in particular, could feel the pain of the increased fees, since the country is the largest supplier of generic medicines to the United States, The country houses over 150 FDA-approved plants, and its U.S. business accounts for nearly 25 percent of the $15 billion in pharma exports. 

The FDA estimates that 1,065 ANDAs and 449 PASs will be submitted to them in the next year. However, if case fees are not paid, “No new generic drug submission referencing the facility will be received until fees are paid. Further, all FDFs or APIs manufactured in the non-paying facility and all FDFs containing APIs manufactured in such a facility are deemed misbranded,” the Economic Times reported.