[Congressional Record Volume 153, Number 158 (Thursday, October 18, 2007)]
[Senate]
[Pages S13087-S13088]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. FEINGOLD:
  S. 2192. A bill to establish a user fee for follow-up reinspections 
under the Federal Food, Drug, and Cosmetic Act; to the Committee on 
Health, Education, Labor and Pensions.
  Mr. FEINGOLD. Mr. President, today I am introducing a bill that would 
charge a reinspection fee for goods that fail FDA inspection for good 
manufacturing practices. Currently, businesses do not have to pay for 
the second inspection if they fail. Essentially, then, the FDA is 
absorbing this extra cost. This Nation faces difficult enough choices 
without subsidizing private companies that fail basic inspections. I am 
pleased to credit the administration for identifying this proposed 
savings of an estimated $23 million per year in its fiscal year 2008 
budget. Over 5 years, this could save as much as $115 million.
  We must ensure that U.S. taxpayer money is being used efficiently and 
effectively, and this measure would help in our ongoing efforts to 
streamline government programs and reduce the Federal budget deficit. 
FDA Commissioner Andrew von Eschenbach testified about these fees 
before the House Agriculture, Rural Development, and FDA Appropriations 
Subcommittee in 2006. He believes, and I agree, that the reinspection 
fee will motivate businesses to comply with long-established health and 
safety standards. Businesses that do not meet federal standards should 
bear the burden of the reinspection, rather than getting a free pass at 
the taxpayer's expense.
  One of the main reasons I first ran for the U.S. Senate was to 
restore fiscal responsibility to the federal budget. I have worked 
throughout my Senate career to eliminate wasteful spending and to 
reduce the budget deficit. Unless we return to fiscally responsible 
budgeting, Congress will saddle our Nation's younger generations with 
an enormous financial burden for years to come. This bill is one small 
step in that direction.
  I ask unanimous consent the the text of the bill be printed in the 
Record.

[[Page S13088]]

  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                S. 2192

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. ESTABLISHMENT OF USER FEE FOR FOLLOW-UP 
                   REINSPECTIONS.

       (a) In General.--The Secretary shall assess and collect a 
     user fee from each manufacturer of a food, drug, device, 
     biological product, or animal drug for which a follow-up 
     reinspection is required to ensure correction of a violation, 
     found by the Secretary during initial inspection of the 
     manufacturer, of a Good Manufacturing Practices requirement 
     under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 
     et seq.).
       (b) Payment of Fee.--The user fee required by subsection 
     (a) shall be due from a manufacturer upon the reinspection of 
     the manufacturer as described in subsection (a).
       (c) Amount of User Fee.--The amount of the user fee 
     required under subsection (a) shall be established by the 
     Secretary.
       (d) Definitions.--For purposes of this section--
       (1) the terms ``animal drug'', ``device'', ``drug'', and 
     ``food'' have the meanings given those terms in section 201 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321);
       (2) the term ``biological product'' has the meaning given 
     the term in section 351 of the Public Health Service Act (42 
     U.S.C. 262); and
       (3) the term ``Secretary'' means the Secretary of Health 
     and Human Services.
                                 ______