[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5217 Introduced in House (IH)]







107th CONGRESS
  2d Session
                                H. R. 5217

  To amend the Federal Food, Drug, and Cosmetic Act to authorize the 
  Secretary of Health and Human Services to grant waivers permitting 
individuals to import prescription drugs from Canada, to amend such Act 
 with respect to the sale of prescription drugs through the Internet, 
                        and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 25, 2002

Mr. Brown of Ohio (for himself, Mr. Allen, Mr. Berry, Mr. Pallone, and 
 Mr. Strickland) introduced the following bill; which was referred to 
                  the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
  To amend the Federal Food, Drug, and Cosmetic Act to authorize the 
  Secretary of Health and Human Services to grant waivers permitting 
individuals to import prescription drugs from Canada, to amend such Act 
 with respect to the sale of prescription drugs through the Internet, 
                        and for other purposes.

    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 ``Affordable Drugs Access Act''.

SEC. 2. WAIVER REQUIREMENT FOR PERSONAL IMPORTATION OF PRESCRIPTION 
              DRUGS FROM CANADA.

    (a) In General.--Chapter VIII of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 381 et seq.) is amended by adding at the end 
the following section:

  ``waiver requirement for personal importation of prescription drugs 
                              from canada

    ``Sec. 805. (a) In General.--With respect to the importation by 
individuals of prescription drugs from Canada, the Secretary shall in 
accordance with this section establish by regulation a waiver of 
prohibitions under this Act that apply to the importation of drugs. 
Such a waiver shall permit an individual to import into the United 
States any prescription drug that--
            ``(1) is imported from Canada for personal use by the 
        individual (not for resale);
            ``(2) is approved by the Secretary under section 505, is 
        manufactured in an establishment registered with the Secretary 
        under section 510, and is not a controlled substance in 
        schedule I, II, or III under section 202(c) of the Controlled 
        Substances Act;
            ``(3) is imported from a Canadian pharmacy that has 
        submitted to the Secretary a registration that identifies the 
        pharmacy and provides documentation that the pharmacy is 
        licensed in Canada;
            ``(4) is imported in a quantity that does not (for that 
        instance of importation) exceed a 90-day supply;
            ``(5) at the time of importation, is accompanied by a copy 
        of a valid prescription for the drug for the individual, issued 
        in the United States by a practitioner in accordance with 
        section 503(b), or is accompanied by documentation that 
        verifies the issuance of such a prescription for the 
        individual;
            ``(6) is in the form of a final finished dosage; and
            ``(7) is imported under such other conditions as the 
        Secretary determines to be necessary to ensure public safety.
    ``(b) Study; Limitation on Waiver Requirement.--
            ``(1) Study.--During the one-year period beginning on the 
        effective date of this section, the Secretary shall conduct a 
        study of prescription drugs imported from Canada under 
        subsection (a), and of prescription drugs that are imported 
        into the United States from other countries for personal use, 
        in order to determine the authenticity and quality of such 
        drugs.
            ``(2) Limitation.--If through the study under paragraph (1) 
        the Secretary determines that drugs imported under subsection 
        (a) present a significant threat to the public health, the 
        following applies:
                    ``(A) The Secretary may, in order to protect the 
                public health, establish one or more conditions for the 
                importation from Canada of prescription drugs for 
                personal use that are different than the conditions 
                described in such subsection, in which case any 
                conflicting condition described in such subsection 
                ceases to apply.
                    ``(B) The Secretary may publish in the Federal 
                Register a statement that, pursuant to this section, 
                the Secretary has determined that waivers under this 
                section should be terminated in order to protect the 
                public health. Effective on the date on which such a 
                statement is so published, this section ceases to have 
                any legal effect.
    ``(c) Authority Regarding Other Countries.--If through the study 
under subsection (b)(1) the Secretary determines that drugs imported 
under subsection (a) do not present a significant threat to the public 
health, or if under authority of subsection (b)(2)(A) the Secretary 
establishes conditions in order to protect the public health, the 
Secretary may, in the case of such countries in addition to Canada as 
the Secretary determines to be appropriate, establish by regulation a 
waiver of prohibitions under this Act that apply to the importation of 
drugs, under which waiver individuals are permitted to import into the 
United States prescription drugs that meet the conditions that apply 
under subsection (a) (or under subsection (b)(2)(A), as the case may 
be). Such regulations may establish country-specific conditions, as 
determined appropriate by the Secretary to protect the public health.
    ``(d) Definition.--For purposes of this section, the term 
`prescription drug' means a drug that is subject to section 503(b).''.
    (b) Assessment Regarding Additional Agency Inspectors at Ports of 
Entry.--The Secretary of Health and Human Services shall conduct an 
assessment to determine the additional number of inspectors that should 
be added for the Food and Drug Administration at ports of entry into 
the United States in order to provide adequate assurance that drugs 
imported into the United States meet the standards of the Federal Food, 
Drug, and Cosmetic Act. Not later than 180 days after the date of the 
enactment of this Act, the Secretary shall submit to the Congress a 
report describing the findings of the assessment.

SEC. 3. CONTROLLED SUBSTANCES; IMPORTATION WITHOUT VALID PRESCRIPTIONS.

    Section 1006(a)(2) of the Controlled Substances Import and Export 
Act (21 U.S.C. 956(a)(2)) is amended by striking ``that exceeds 50 
dosage units'' and all that follows and inserting the following: ``that 
exceeds 10 dosage units of the controlled substance, except that if the 
individual is importing more than one such controlled substance into 
the United States, the combined total number of dosage units of such 
substances imported by the individual may not exceed 10 dosage 
units.''.

SEC. 4. INTERNET SALES OF PRESCRIPTION DRUGS.

    (a) In General.--Chapter 5 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by inserting after section 503A 
the following section:

``SEC. 503B. INTERNET SALES OF PRESCRIPTION DRUGS.

    ``(a) Requirements Regarding Information on Internet Site.--
            ``(1) In general.--A person may not dispense a prescription 
        drug pursuant to a sale of the drug by such person if--
                    ``(A) the purchaser of the drug submitted the 
                purchase order for the drug, or conducted any other 
                part of the sales transaction for the drug, through an 
                Internet site; and
                    ``(B) such site, or any other Internet site used by 
                such person for purposes of sales of a prescription 
                drug, fails to meet each of the requirements specified 
                in paragraph (2) (other than a site or pages on a site 
                that are not intended to be accessed by purchasers or 
                prospective purchasers).
            ``(2) Requirements.--With respect to an Internet site, the 
        requirements referred to in subparagraph (B) of paragraph (1) 
        for a person to whom such paragraph applies are as follows:
                    ``(A) Each page of the site shall include either 
                the following information or a link to a page that 
                provides the following information:
                            ``(i) The name of such person; the address 
                        of the principal place of business of the 
                        person with respect to sales of prescription 
                        drugs through the Internet; and the telephone 
                        number for such place of business.
                            ``(ii) Each State in which the person is 
                        authorized by law to dispense prescription 
                        drugs.
                            ``(iii) The name of each individual who 
                        serves as a pharmacist for purposes of the 
                        site, and each State in which the individual is 
                        authorized by law to dispense prescription 
                        drugs.
                            ``(iv) If the person provides for medical 
                        consultations through the site for purposes of 
                        providing prescriptions, the name of each 
                        individual who provides such consultations; 
                        each State in which the individual is licensed 
                        or otherwise authorized by law to provide such 
                        consultations; and the type or types of health 
                        professions for which the individual holds such 
                        licenses or other authorizations.
                    ``(B) A link to which paragraph (1) applies shall 
                be clearly visible on the page involved, shall not be 
                of a size smaller than other links on the page (if 
                any), and shall include in the caption for the link the 
                words `licensing and contact information'.
    ``(b) Internet Sales Without Appropriate Medical Relationships.--
            ``(1) In general.--A person may not dispense a prescription 
        drug, or arrange the dispensing of such a drug, pursuant to a 
        sale of the drug if--
                    ``(A) for purposes of such sale, the purchaser 
                communicated with the person through the Internet;
                    ``(B) the patient for whom the drug was purchased 
                did not, when such communications began, have a 
                prescription for the drug;
                    ``(C) pursuant to such communications, the person 
                provided for the involvement of a practitioner and the 
                practitioner issued a prescription for the drug that 
                was purchased;
                    ``(D) the person knew, or had reason to know, that 
                the practitioner did not, when issuing the 
                prescription, have a qualifying medical relationship 
                with the patient; and
                    ``(E)(i) the person received payment for the drug 
                from the purchaser; or
                    ``(ii) in the case of arranging the dispensing of 
                the drug, the person received payment for doing so from 
                the person who dispensed the drug.
        For purposes of subparagraph (E), payment is received if money 
        or other valuable consideration is received.
            ``(2) Qualifying medical relationship.--
                    ``(A) In general.--With respect to issuing a 
                prescription for a drug for a patient, a practitioner 
                has a qualifying medical relationship with the patient 
                for purposes of this section if at least one in-person 
                medical evaluation of the patient has been conducted by 
                the practitioner. This subparagraph and subparagraph 
                (B) may not be construed as having any applicability 
                beyond this section.
                    ``(B) In-person medical evaluation.--A medical 
                evaluation by a practitioner is an in-person medical 
                evaluation for purposes of this section if the 
                practitioner is in the physical presence of the patient 
                as part of conducting the evaluation, without regard to 
                whether portions of the evaluation are conducted by 
                other health professionals.
    ``(c) Actions by States.--
            ``(1) In general.--Whenever an attorney general of any 
        State has reason to believe that the interests of the residents 
        of that State have been or are being threatened or adversely 
        affected because any person has engaged or is engaging in a 
        pattern or practice that violates section 301(l), the State may 
        bring a civil action on behalf of its residents in an 
        appropriate district court of the United States to enjoin such 
        practice, to enforce compliance with such section (including a 
        nationwide injunction), to obtain damages, restitution, or 
        other compensation on behalf of residents of such State, to 
        obtain reasonable attorneys fees and costs if the State 
        prevails in the civil action, or to obtain such further and 
        other relief as the court may deem appropriate.
            ``(2) Notice.--The State shall serve prior written notice 
        of any civil action under paragraph (1) or (5)(B) upon the 
        Secretary and provide the Secretary with a copy of its 
        complaint, except that if it is not feasible for the State to 
        provide such prior notice, the State shall serve such notice 
        immediately upon instituting such action. Upon receiving a 
        notice respecting a civil action, the Secretary shall have the 
        right--
                    ``(A) to intervene in such action;
                    ``(B) upon so intervening, to be heard on all 
                matters arising therein; and
                    ``(C) to file petitions for appeal.
            ``(3) Construction.--For purposes of bringing any civil 
        action under paragraph (1), nothing in this chapter shall 
        prevent an attorney general of a State from exercising the 
        powers conferred on the attorney general by the laws of such 
        State to conduct investigations or to administer oaths or 
        affirmations or to compel the attendance of witnesses or the 
        production of documentary and other evidence.
            ``(4) Venue; service of process.--Any civil action brought 
        under paragraph (1) in a district court of the United States 
        may be brought in the district in which the defendant is found, 
        is an inhabitant, or transacts business or wherever venue is 
        proper under section 1391 of title 28, United States Code. 
        Process in such an action may be served in any district in 
        which the defendant is an inhabitant or in which the defendant 
        may be found.
            ``(5) Actions by other state officials.--
                    ``(A) Nothing contained in this section shall 
                prohibit an authorized State official from proceeding 
                in State court on the basis of an alleged violation of 
                any civil or criminal statute of such State.
                    ``(B) In addition to actions brought by an attorney 
                general of a State under paragraph (1), such an action 
may be brought by officers of such State who are authorized by the 
State to bring actions in such State on behalf of its residents.
    ``(d) Definitions.--
            ``(1) Internet-related definitions.--For purposes of this 
        section:
                    ``(A) The term `Internet' means collectively the 
                myriad of computer and telecommunications facilities, 
                including equipment and operating software, which 
                comprise the interconnected world-wide network of 
                networks that employ the transmission control protocol/
                internet protocol, or any predecessor or successor 
                protocols to such protocol, to communicate information 
                of all kinds by wire or radio.
                    ``(B) The term `link', with respect to the 
                Internet, means one or more letters, words, numbers, 
                symbols, or graphic items that appear on a page of an 
                Internet site for the purpose of serving, when 
                activated, as a method for executing an electronic 
                command--
                            ``(i) to move from viewing one portion of a 
                        page on such site to another portion of the 
                        page;
                            ``(ii) to move from viewing one page on 
                        such site to another page on such site; or
                            ``(iii) to move from viewing a page on one 
                        Internet site to a page on another Internet 
                        site.
                    ``(C) The term `page', with respect to the 
                Internet, means a document or other file accessed at an 
                Internet site.
                    ``(D)(i) The terms `site' and `address', with 
                respect to the Internet, mean a specific location on 
                the Internet that is determined by Internet Protocol 
                numbers. Such term includes the domain name, if any.
                    ``(ii) The term `domain name' means a method of 
                representing an Internet address without direct 
                reference to the Internet Protocol numbers for the 
                address, including methods that use designations such 
                as `.com', `.edu', `.gov', `.net', or `.org'.
                    ``(iii) The term `Internet Protocol numbers' 
                includes any successor protocol for determining a 
                specific location on the Internet.
            ``(2) Other definitions.--For purposes of this section:
                    ``(A) The term `practitioner', with respect to the 
                issuance of a prescription for a drug for a patient, 
                means--
                            ``(i) an individual authorized by law to 
                        administer the drug; or
                            ``(ii) an individual who is not so 
                        authorized but represents himself or herself as 
                        an individual who is so authorized.
                    ``(B) The term `prescription drug' means a drug 
                that is subject to section 503(b).
                    ``(C) The term `qualifying medical relationship', 
                with respect to a practitioner and a patient, has the 
                meaning indicated for such term in subsection (b).''.
    (b) Inclusion as Prohibited Act.--Section 301 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 331) is amended by inserting after 
paragraph (k) the following:
    ``(l) The dispensing of a prescription drug in violation of section 
503B, or arranging for the dispensing of such a drug in violation of 
such section.''.
    (c) Internet Sales of Prescription Drugs; Consideration by 
Secretary of Practices and Procedures for Certification of Legitimate 
Businesses.--In carrying out section 503B of the Federal Food, Drug, 
and Cosmetic Act (as added by subsection (a) of this section), the 
Secretary of Health and Human Services shall take into consideration 
the practices and procedures of public or private entities that certify 
that businesses selling prescription drugs through Internet sites are 
legitimate businesses, including practices and procedures regarding 
disclosure formats and verification programs.
    (d) Effective Date.--The amendments made by subsections (a) and (b) 
take effect upon the expiration of the 60-day period beginning on the 
date of the enactment of this Act, without regard to whether a final 
rule to implement such amendments has been promulgated by the Secretary 
of Health and Human Services under section 701(a) of the Federal Food, 
Drug, and Cosmetic Act. The preceding sentence may not be construed as 
affecting the authority of such Secretary to promulgate such a final 
rule.
                                 <all>