The FDA has laid out the user fees that generic drug and API makers must pay to help the agency step up the pace of generic drug approvals and cover some costs of plant inspections. The fees, due March 4, include a $15,000 premium for foreign plants to cover the extra costs of their oversight.
The rates are:
- $175,389 for a U.S. finished drug form facility
- $190,389 for a foreign finished drug form facility
- $26,458 for a domestic API plant
- $41,458 for a foreign API plant
The FDA warns in an FAQ that those companies that don't pay within 20 days of the deadline risk having imports of their products cut off. They can also face having products considered misbranded, which can result in prosecution if the FDA wants to take that route. The FAQ also provides more specifics, like whether a plant making both finished products and APIs must pay two fees (yes); and whether two plants at the same site must each pay a fee (it depends).
For the first time, generic drugs are covered under a user fee program similar to the one branded drugmakers have been paying for years. Branded makers pay a variety of application and other fees, which according to an Aug. 1 Federal Register posting can range from about $100,000 for product fees to nearly $2 million for an application requiring clinical data. There are some exceptions.
Passage of the Generic Drug User Fee Act did many things, but of wide interest is that it gives the agency more leverage to inspect the manufacturing plants of foreign companies, or to block their products if they refuse. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, last year told Congress that there are now more foreign drugmakers than U.S. drugmakers for it to inspect. Currently, U.S. plants are inspected at least every two years, while foreign plants might go up to 9 years, on average, without an inspector showing up. Under the new law, the FDA can address that disparity by having the authority to put its attention to whatever products appear to present the most risk. It also puts the responsibility on drug manufacturers to audit their suppliers to ensure that their APIs meet U.S. standards.