[Congressional Record Volume 153, Number 1 (Thursday, January 4, 2007)]
[Senate]
[Pages S64-S66]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. KOHL (for himself and Mr. Leahy):
  S. 25. A bill to amend the Federal Food, Drug, and Cosmetic Act to 
establish requirements for certain petitions submitted to the Food and 
Drug Administration, and for other purposes; to the Committee on 
Health, Education, Labor, and Pensions.
  Mr. KOHL. Mr. President, I rise today on the first day of this new 
Congress to introduce the Citizen Petition Fairness and Accuracy Act of 
2007. This legislation will help speed the introduction of cost-saving 
generic drugs by preventing abuses of the Food and Drug Administration 
citizen petition process.
  Consumers continue to suffer all across our country from the high--
and ever rising--cost of prescription drugs. A recent independent study 
found that prescription drug spending has more than quadrupled since 
1990, and now accounts for 11 percent of all health care spending. At 
the same time, the pharmaceutical industry is one of the most 
profitable industries in the world, returning more than 15 percent on 
their investments.
  One key method to bring prescription drug prices down is to promote 
the introduction of generic alternatives to expensive brand name drugs. 
Consumers realize substantial savings once generic drugs enter the 
market. Generic drugs cost on average 63 percent less than their brand-
name equivalents. One study estimates that every 1 percent increase in 
the use of generic drugs could save $4 billion in health care costs.
  This is why I have been so active in pursuing legislation designed to 
combat practices which impede the introduction of generic drugs. The 
legislation I introduce today, which I first introduced last year with 
Senator Leahy in last Congress, targets one particularly pernicious 
practice by brand name drug companies to impede or block the marketing 
of generic drugs--abuse of the FDA citizen petition process.
  FDA rules permit any person to file a so-called ``citizen petition'' 
to raise concerns about the safety or efficacy of a generic drug that a 
manufacturer is seeking FDA approval to bring to market. While this 
citizen petition process was put in place for a laudable purpose, 
unfortunately in recent years it has been abused by frivolous petitions 
submitted by brand name drug manufacturers (or individuals acting at 
their behest) whose only purpose is to delay the introduction of 
generic competition. The FDA has a policy of not

[[Page S65]]

granting any new generic manufacturer's drug application until after it 
has considered and evaluated any citizen petitions regarding that drug. 
The process of resolving a citizen petition (even if ultimately found 
to be groundless) can delay the approval by months or years. Indeed, 
brand name drug manufacturers often wait to file citizen petitions 
until just before the FDA is about to grant the application to market 
the new generic drug solely for the purpose of delaying the 
introduction of the generic competitor for the maximum amount of time 
possible. This gaming of the system should not be tolerated.
  In recent years, FDA officials have expressed serious concerns about 
the abuse of the citizen petition process. In 2005, FDA Chief Counsel 
Sheldon Bradshaw noted that ``[t]he citizen petition process is in some 
cases being abused. Sometimes, stakeholders try to use this mechanism 
to unnecessarily delay approval of a competitor's products.'' He added 
that he found it ``particularly troublesome'' that he had ``seen 
several examples of citizen petitions that appear designed not to raise 
timely concerns with respect to the legality or scientific soundness of 
approving a drug application, but rather to delay approval by 
compelling the agency to take the time to consider the arguments raised 
in the petition, regardless of their merits, and regardless of whether 
the petitioner could have made those very arguments months and months 
before.''
  And a simple look at the statistics gives credence to these concerns. 
Of the 21 citizen petitions for which the FDA has reached a decision 
since 2003, 20--or 95 percent of them--have been found to be without 
merit. Of these, ten were identified as ``eleventh hour petitions'', 
defined as those filed less than 6 months prior to the estimated entry 
date of the generic drug. None of these ten ``eleventh hour petitions'' 
were found to have merit, but each caused unnecessary delays in the 
marketing of the generic drug by months or over a year, causing 
consumers to spend millions and millions of dollars for their 
prescription drugs than they would have spent without these abusive 
filings.
  Despite the expense these frivolous citizen petitions cause consumers 
and the FDA, under current law the government has absolutely no ability 
to sanction or penalize those who abuse the citizen petition process, 
or who file citizen petitions simply to keep competition off the 
market. Our legislation will correct this obvious shortcoming and give 
the Department of Health and Human Services--the FDA's parent agency 
the power to sanction those who abuse the process.
  Our bill will, for the first time, require all those who file citizen 
petitions to affirm certain basic facts about the truthfulness and good 
faith of the petition, similar to what is required of every litigant 
who makes a filing in court. The party filing the citizen petition will 
be required to affirm that the petition is well grounded in fact and 
warranted by law; is not submitted for an improper purpose, such as to 
harass or cause unnecessary delay in approval of competing drugs; and 
does not contain any materially false, misleading or fraudulent 
statement. The Secretary of the Department of Health and Human Services 
is empowered to investigate a citizen petition to determine if it has 
violated any of these principles, was submitted for an improper 
purpose, or contained false or misleading statements. Further, the 
Secretary is authorized to penalize anyone found to have submitted an 
abusive citizen petition. Possible sanctions include a fine up to one 
million dollars, a suspension or permanent revocation of the right of 
the violator to file future citizens' petition, and a dismissal of the 
petition at issue. HHS is also authorized to refer the matter to the 
Federal Trade Commission so that the FTC can undertake its own 
investigation as to the competitive consequences of the frivolous 
petition and take any action it finds appropriate. Finally, the bill 
directs the HHS that all citizen petitions be adjudicated within six 
months of filing, which will put an end to excessive delays in bringing 
needed generic drugs to market because of the filings of these 
petitions.
  While our bill will not have any effect on any person filing a truly 
meritorious citizen petition, this legislation will serve as a strong 
deterrent to attempts by brand name drug manufacturers or any other 
party that seeks to abuse the citizen petition process to thwart 
competition. It will thereby remove one significant obstacle exploiting 
by brand name drug companies to prevent or delay the introduction of 
generic drugs. I urge my colleagues to support this legislation.
  I ask unanimous consent that the text of the bill be printed in the 
Record.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                 S. 25

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

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Citizen Petition Fairness 
     and Accuracy Act of 2007''.

     SEC. 2. CITIZEN PETITIONS AND PETITIONS FOR STAY OF AGENCY 
                   ACTION.

       Section 505(j)(5) of the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 355(j)(5)) is amended by adding at the end the 
     following:
       ``(G)(i) Notwithstanding any other provision of law, any 
     petition submitted under section 10.30 or section 10.35 of 
     title 21, Code of Federal Regulations (or any successor 
     regulation), shall include a statement that to the 
     petitioner's best knowledge and belief, the petition--
       ``(I) includes all information and views on which the 
     petitioner relies, including all representative data and 
     information known to the petitioner that is favorable or 
     unfavorable to the petition;
       ``(II) is well grounded in fact and is warranted by law;
       ``(III) is not submitted for an improper purpose, such as 
     to harass or cause unnecessary delay (including unnecessary 
     delay of competition or agency action); and
       ``(IV) does not contain a materially false, misleading, or 
     fraudulent statement.
       ``(ii) The Secretary shall investigate, on receipt of a 
     complaint, a request under clause (vi), or on its own 
     initiative, any petition submitted under such section 10.30 
     or section 10.35 (or any successor regulation), that--
       ``(I) does not comply with the requirements of clause (i);
       ``(II) may have been submitted for an improper purpose as 
     described in clause (i)(III); or
       ``(III) may contain a materially false, misleading, or 
     fraudulent statement as described in clause (i)(IV).
       ``(iii) If the Secretary finds that the petitioner has 
     knowingly and willingly submitted the petition for an 
     improper purpose as described in clause (i)(III), or which 
     contains a materially false, misleading, or fraudulent 
     statement as described in clause (i)(IV), the Secretary may--
       ``(I) impose a civil penalty of not more than $1,000,000, 
     plus attorneys fees and costs of reviewing the petition and 
     any related proceedings;
       ``(II) suspend the authority of the petitioner to submit a 
     petition under such section 10.30 or section 10.35 (or any 
     successor regulation), for a period of not more than 10 
     years;
       ``(III) revoke permanently the authority of the petitioner 
     to submit a petition under such section 10.30 or section 
     10.35 (or any successor regulation); or
       ``(IV) dismiss the petition at issue in its entirety.
       ``(iv) If the Secretary takes an enforcement action 
     described in subclause (I), (II), (III), or (IV) of clause 
     (iii) with respect to a petition, the Secretary shall refer 
     that petition to the Federal Trade Commission for further 
     action as the Federal Trade Commission finds appropriate.
       ``(v) In determining whether to take an enforcement action 
     described in subclause (I), (II), (III), or (IV) of clause 
     (iii) with respect to a petition, and in determining the 
     amount of any civil penalty or the length of any suspension 
     imposed under that clause, the Secretary shall consider the 
     specific circumstances of the situation, such as the gravity 
     and seriousness of the violation involved, the amount of 
     resources expended in reviewing the petition at issue, the 
     effect on marketing of competing drugs of the pendency of the 
     improperly submitted petition, including whether the timing 
     of the submission of the petition appears to have been 
     calculated to cause delay in the marketing of any drug 
     awaiting approval, and whether the petitioner has a history 
     of submitting petitions in violation of this subparagraph.
       ``(vi)(I) Any person aggrieved by a petition filed under 
     such section 10.30 or section 10.35 (or any successor 
     regulation), including a person filing an application under 
     subsection (b)(2) or (j) of this section to which such 
     petition relates, may request that the Secretary initiate an 
     investigation described under clause (ii) for an enforcement 
     action described under clause (iii).
       ``(II) The aggrieved person shall specify the basis for its 
     belief that the petition at issue is false, misleading, 
     fraudulent, or submitted for an improper purpose. The 
     aggrieved person shall certify that the request is submitted 
     in good faith, is well grounded in fact, and not submitted 
     for any improper purpose. Any aggrieved person who knowingly 
     and intentionally violates the preceding sentence shall be 
     subject to the civil penalty described under clause (iii)(I).

[[Page S66]]

       ``(vii) The Secretary shall take final agency action with 
     respect to a petition filed under such section 10.30 or 
     section 10.35 (or any successor regulation) within 6 months 
     of receipt of such petition. The Secretary shall not extend 
     such 6-month review period, even with consent of the 
     petitioner, for any reason, including based upon the 
     submission of comments relating to a petition or supplemental 
     information supplied by the petitioner. If the Secretary has 
     not taken final agency action on a petition by the date that 
     is 6 months after the date of receipt of the petition, such 
     petition shall be deemed to have been denied on such date.
       ``(viii) The Secretary may promulgate regulations to carry 
     out this subparagraph, including to determine whether 
     petitions filed under such section 10.30 or section 10.35 (or 
     any successor regulation) merit enforcement action by the 
     Secretary under this subparagraph.''.
                                 ______