Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

SENATE-PASSED FDA APPROPRIATIONS BILL STRIKES WITHHOLDING OF $ 167 MIL. THAT ADMINISTRATION WOULD HAVE RAISED FROM USER FEES, AT SEN. HATCH's URGING

Executive Summary

The Senate FY 1992 appropriations bill for FDA will not require the agency to submit a specific funding request for the portion of funds that the Bush Administration proposed to raise from user fees. The Agriculture/FDA appropriations bill cleared the Senate on July 30 by a 92-7 vote. During floor debate on the bill (HR 2698), the Senate gave voice vote approval to Sen. Hatch's (R-Utah) amendment to delete a provision to reserve $ 167 mil. of FDA funds until a specific appropriations request is forwarded to Congress ("The Pink Sheet" July 29, T&G-1). The $ 167 mil. is the difference between the total $ 739 mil. in FY 1992 appropriations for FDA provided in the Senate bill and the Administration's request for $ 572 mil. in appropriations. The Administration had proposed a total budget of $ 770.2 mil. for FDA, but that included $ 197 mil. from user fees on regulated industries. Hatch said he understands the "political point" of the requirement; that is, to underscore the Congress' displeasure that the Administration has repeatedly included user fee funds in its budget before the fees are authorized by law. But Hatch said the "real point" is that "FDA needs additional funding to get the job done." The withholding issue still remains to be worked out between the House and Senate when the bill goes to conference. The House- passed appropriations bill also has a provision to withhold the $ 188.8 mil. difference between its $ 762 mil. budget appropriation for the agency and the Administration's appropriations request unless FDA makes a specific request for the funds. Let "us not 'play chicken' with the Administration funds to operate FDA," Hatch urged in his address on the Senate floor. "Let us send a strong message . . . that we will not accept the Administration's user fee facade. But, let us not take a chance on sacrificing the agency in the bargain." Hatch said he had been told by FDA that if it did not receive the $ 167 mil., the agency would be forced to implement an immediate hiring freeze, eliminate overtime, and possibly furlough employees. The Senate bill still contains provisions that require the Administration declare a funding "emergency" in order to get $ 45.4 mil. of the proposed FDA funds, and that hold $ 51.5 mil. in funding until the last day of FY 1992. Those stipulations arose because the Senate Appropriations Committee allocated about $ 500 mil. less to its Agriculture subcommittee than did the House Appropriations Committee, a difference reflecting in-fighting between Senate Appropriations Committee Chairman Byrd (D-W.Va.) and House Appropriations Committee Chairman Whitten (D-Miss.). Since then, the two have worked out a compromise under which the Senate will agree to add back at least some of the funds to programs in the Ag/FDA bill. Senate Agriculture/FDA Subcommittee Chairman Burdick (D-N.D.) told the Senate that if the reallocation "does occur, I believe that the conferees should also do all that we can to provide for a significant increase in funding for the FDA." House and Senate Appropriations Committee members are expected to begin their Ag/FDA conference in early September. Others differences to be resolved include whether money should be earmarked for FDA's effort to develop a consolidated agency campus. The House bill specifically provides $ 2 mil. for site selection and planning and allows FDA to accept donations of land in Maryland's Montgomery and Prince George's Counties ("The Pink Sheet" June 24, p. 6). The Senate Appropriations Committee, in the report accompanying its bill, states that it "does not concur" with the House, and further "notes that funds have been provided for this activity in another appropriations bill." That bill is the Department of Treasury, Postal Service and General Government FY 1992 bill (HR 2622), also awaiting House-Senate conference. It provides $ 200 mil. for both planning and construction of a single campus in Maryland. The Appropriations/Treasury subcommittee includes Sen. Mikulski (D-Md.), a vigorous advocate for home-state federal employees.

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth

UsernamePublicRestriction

Register

LL1126230

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