Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

FDA USER FEES OF $ 1.4 BIL. OVER FIVE YEARS

This article was originally published in The Tan Sheet

Executive Summary

FDA USER FEES OF $ 1.4 BIL. OVER FIVE YEARS are proposed by Vice President Gore in his "reinventing government" report, formally entitled the "National Performance Review." Released Sept. 7, the report proposes to raise $ 1.44 bil. during fiscal 1994-1999 via "user fees on FDA's inspection and approval processes," on the premise that "food, drug and medical device manufacturing, processors and suppliers should be required to pay for FDA services." Looking to FDA for increased revenues through user fees is not a new idea. The Clinton Administration had proposed to raise $ 1.02 bil. over four years (FY 1994-97) in the President's spring deficit reduction plan, "A Vision of Change for America." Facing congressional objections to the earlier proposal, the Clinton Administration agreed not to seek expanded user fees for deficit reduction but to continue with the implementation schedule for the Prescription Drug User Fee Act. The 1992 law calls for industry user fees for prescription drug reviews and Rx-to-OTC switch applications in exchange for setting certain performance goals for FDA. The law authorizes user fees of $ 54 mil. in FY 1994 and a total of $ 300 mil. during the program's first four years. FDA's total budget for FY 1994 is $ 942.3 mil., including the $ 54 mil. in user fees. Although the Vice President's report contains cost estimates for 1994-99, most of the recommendations are not expected to be implemented before 1995. Most of the provisions can be made through executive order, but many, including the user fee proposal, will require legislation. Administration officials said they have not yet decided how the user fees would be allocated among industries regulated by FDA or what fees might be for different types of FDA activities. They suggested the expanded program could include some sort of performance objectives for FDA, in line with the approach of the Prescription Drug User Fee Act and the reinventing government report's emphasis on focusing the federal government on measuring the outcomes of services. Another recommendation in the report that directly affects FDA is a plan to consolidate food safety programs into the agency and to develop a uniform national food safety inspection system. The plan would require moving a number of food safety programs from the Agriculture Department to FDA and expanding agency efforts in this area. One recommendation calls for streamlining the rulemaking procedures of federal agencies like FDA by omitting Office of Management & Budget overview of all but "significant" regulations. An executive order limiting OMB reviews could be issued as soon as the week of Sept. 13. Currently, OMB's Office of Information and Regulatory Affairs reviews all regulations before they are issued by federal agencies. The policy was established in 1981 by President Reagan as part of his antiregulatory program. Critics of OMB reg reviews have argued that they cede too much authority from the agencies to OMB and emasculate the agencies' regulatory power. The Gore report recommends that President Clinton "instruct OIRA to review only significant regulations, not, as under the current process, all regulations." Lengthy OMB reviews "may be appropriate for significant rules, [but] it is a waste of time for others." Limited OMB reviews "will take into account a broad range of costs and benefits, will be more useful and realistic" and "will enhance the planning process and encourage agencies to consult with the public early in the process," the report maintains. By 1999, a total of 252,000 jobs would be eliminated under the Gore plan; more than 2 mil. individuals are cuffently employed by the federal government. Administration officials estimated that at least 700,000 are employed to "run the red tape" of the bureaucracy, or twice as many as are needed.

You may also be interested in...



Supplement GMP Warning Letters Make Modest Debut In 2010

Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC

In Brief

Combe sells most of its OTC brands

People In Brief

Perrigo promotes in pricing, planning

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS081896

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel