FDA sends drugmakers warning letters reminding them to pay up

Most FDA warning letters are about problems that inspectors have found during visits to plants that manufacture APIs or finished formulations, and they generally will mean cash outlays for companies as they deal with the issues at hand. But sometimes, the letters are just for cash.

That is when plants have failed to pay their user fees. This week, the agency posted three warning letters sent to generic drugmakers in three different countries as reminders that they need to pay up if they intend to sell products in the U.S.

Letters went to Sharon Bio-Medicine in Dehradun, Uttarakhand, India; Wuxi Kaili Pharmaceutical in Yixing City, Jiangsu, China; and Syntho Pharmaceuticals in Farmingdale, NY, for failing to meet their obligations under the Generic Drug User Fee Act (GDUFA). The companies were notified not only that they owe the money but that if left unpaid, the agency can stop products from entering the U.S. or even seize those that are already in the country. The companies also join nearly three dozen others on the FDA arrears list.

The fees for each plant, which cover such things as FDA drug evaluations and some costs for plant inspections, are not cheap. GDUFA fees run $41,926 for a domestic API plant and $56,926 for a foreign API plant. They are much higher for finished drug facilities. Domestic plants must pay $247,717 each year, while foreign finished drug facilities each owe $262,717.

- the warning letters can be accessed here
- here's the arrears list

Related Articles:
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BioCentury finds FDA has $270M in GDUFA, PDUFA fees in hand
FDA threatens drugmaker with ban for not paying user fee
New bill could free drug user fees from sequestration, improve oversight

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