ORPHAN DRUG USER FEE POLICY REVIEW?

The US House Appropriations Committee has stated that the Food and Drug Administration orphan drug user fee policy should be reviewed, as user fees on such drugs "may well stifle interest and innovation."

Under the existing system, the FDA is empowered to waive user fees, and in the past has done so for small drugmakers but not for unprofitable products. A Committee bill has also recommended that the FDA should institute a program for the long-term tracking of patients who undergo gene therapy procedures, according to the Pink Sheet.

The Appropriations Committee also noted that the bill HR 4554 gives the agency $914 million for salaries and expenses for fiscal year 1995, compared with $870 million in fiscal 1994, and that $23 million of the hike is generated by higher user fees on prescription medicines. Meantime, speaking to the Drug Information Association, House Energy & Commerce Committee health member Kay Holcombe has said that the FDA's report on the implementation of user fees is a very positive sign that the agency is committed to meeting the "goals that it is committed to meet" under the terms of the user fee act, which was passed in June 1992.