355 



- 12- 



DISRUPTION OF FDA ACTIVrnES 



FDA already is hard pressed to perform its essential functions. As a result, 

 approval of new medicines, for example, often is significantly delayed. H.R. 2147 

 would require FDA to assume broad additional responsibilities in areas in which it has 

 no pertinent experience or expertise -- regulation and policing of the manufacture, 

 labeling and advertising of tobacco products. Food and pharmaceutical regulators 

 would be forced to become tobacco regulators as well. Even with extra funding, 

 engrafting this wholly new set of responsibilities on administrators currently struggling 

 to perform their agency's core functions would be disastrously disruptive. 

 FUNDING MECHANISM A DANGEROUS PRECEDENT 



The funding mechanism provided by H.R. 2147 also would set a dangerous pre- 

 cedent. H.R. 2147 would require each tobacco company to pay an annual fee to defray 

 the cost of implementing the bill. Rep. Synar has suggested that this fee is similar to 

 the system of user fees established by Congress under the Prescription Drug User Fee 

 Act of 1992. But the fees that H.R. 2147 would assess bear little resemblance to those 

 assessed under the Prescription Drug User Fee Act. 



The fees assessed under the Prescription Drug User Fee Act are designed to 

 enable FDA to improve its process in a single area ~ review and approval of 

 applications for new drugs, antibiotics and biological products. The fees cannot be 

 used to support general FDA activities and merely augment, rather than replace, 

 appropriated monies. The fees are assessed only to the extent that total appropriations 

 for FDA salaries and expenses exceed the 1992 appropriations level. 



