FDA proposes fee system for new drug class

The Food and Drug Administration wants some drugmakers to pay a fee for meetings early in the process of developing a new product.

The FDA already collects user fees to cover the cost of reviewing brand-name prescription drugs. The agency said it wants to begin collecting that money earlier for a new class of drugs created by the healthcare reform law.

The law gave the FDA the power to approve drugs known as biosimilars — in essence, generic versions of biological drugs, which are more complex than traditional pharmaceuticals.

Because the FDA could not previously approve biosimilars, only a handful of products have been developed and the industry isn’t quite sure what to expect. Drugmakers are therefore requesting meetings and consultations with agency reviewers while they’re still developing their products.

The FDA wants to begin charging user fees for those meetings because they are “where FDA activities currently are in greatest demand and increased review capacity is needed," according to a notice published Monday.

Under the existing program, brand-name drugmakers pay their user fees when they submit a finished application for the FDA to review. For biosimilars, the agency wants to collect roughly $150,000 per year during the development phase, then subtract the total of those fees from the cost of a final approval decision.