FDA May Increase Users Fees

January 2007

Pending approval of Congress, the user fees that pharmaceutical companies pay to the Food and Drug Administration (FDA) to review their products may substantially increase. The fee increase would allow the agency to allocate more money for the monitoring of the safety of drugs after going on the market, in addition to and a new fee for the oversight of television drug ads.

Congress must first approve the five-year deal before it can take effect. However, the FDA is expecting big changes that would result in more authority and responsibilities.

The pharmaceutical fee increase sums up like this:

• The first year of the program would take in $393 million, up from $305 million in 2007.
• An estimated $30 million of the increase would be allocated to drug-safety issues.
• A new fee that could total $6.25 million a year would pay for the FDA to review television ads.
• The FDA would also give drug companies a projected timeline for reviewing new drug applications.

The FDA will hold a public meeting next month to review the fee arrangements.

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