[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3677 Introduced in House (IH)]







106th CONGRESS
  2d Session
                                H. R. 3677

   To amend the Federal Food, Drug, and Cosmetic Act to restrict the 
 authority of the Food and Drug Administration to issue clinical holds 
regarding investigational drugs or to deny patients expanded access to 
                              such drugs.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           February 16, 2000

Mr. Burton of Indiana (for himself, Mr. Barr of Georgia, Mr. Barton of 
    Texas, Mr. Doolittle, Mr. Gilman, Mr. Horn, Mr. Jones of North 
 Carolina, Mr. LaHood, Mr. McHugh, Mr. McIntosh, Mrs. Meek of Florida, 
     Mr. Paul, Mr. Ryun of Kansas, Mr. Scarborough, and Mr. Stump) 
 introduced the following bill; which was referred to the Committee on 
                                Commerce

_______________________________________________________________________

                                 A BILL


 
   To amend the Federal Food, Drug, and Cosmetic Act to restrict the 
 authority of the Food and Drug Administration to issue clinical holds 
regarding investigational drugs or to deny patients expanded access to 
                              such drugs.

    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 ``Thomas Navarro FDA Patient Rights 
Act''.

SEC. 2. INVESTIGATIONAL NEW DRUGS; RESTRICTIONS ON AGENCY AUTHORITY 
              REGARDING CLINICAL HOLDS ON TRIALS AND EXPANDED ACCESS 
              FOR PATIENTS.

    (a) Clinical Holds.--Section 505(i)(3) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355(i)(3)) is amended by adding at the end 
the following subparagraph:
                    ``(D) The Secretary may not under clause (i) or 
                (ii) of subparagraph (B) place a clinical hold on an 
                investigation of a drug on the basis that the Secretary 
                has determined that--
                            ``(i) there is another drug (including 
                        another investigational drug) that is or may be 
                        a safe and effective therapy for the disease or 
                        condition involved; or
                            ``(ii) there is a comparable or 
                        satisfactory alternative therapy available for 
                        a patient who is receiving or will receive the 
                        drug as a clinical subject in the 
                        investigation, except that such restriction on 
                        the authority of the Secretary applies only if 
                        the patient declares in writing that the 
                        patient is aware of the comparable or 
                        satisfactory alternative therapy, is aware of 
                        the risk involved in receiving the drug in the 
                        investigation, and chooses to receive the drug 
                        notwithstanding such risk and notwithstanding 
                        the comparable or satisfactory alternative 
                        therapy.''.
    (b) Expanded Access.--
            (1) Individual patient access.--Section 561(b)(1) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb(b)(1)) 
        is amended by inserting before the semicolon the following: ``, 
        except that such conditions for the receipt by the person of 
        the investigational drug do not apply if the person declares in 
        writing that the person is aware that there is a comparable or 
        satisfactory alternative therapy, is aware of the risk involved 
        in receiving the investigational drug, and chooses to receive 
        the drug notwithstanding such risk and notwithstanding the 
        comparable or satisfactory alternative therapy''.
            (2) Treatment application.--Section 561(c)(2) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb(c)(2)) 
        is amended by inserting before the semicolon the following: ``, 
        except that such condition for the receipt by a patient of an 
        investigational drug does not apply if the patient declares in 
        writing that the patient is aware that there is a comparable or 
        satisfactory alternative therapy, is aware of the risk involved 
        in receiving the investigational drug, and chooses to receive 
        the drug notwithstanding such risk and notwithstanding the 
        comparable or satisfactory alternative therapy''.
                                 <all>