[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 2464 Introduced in Senate (IS)]







108th CONGRESS
  2d Session
                                S. 2464

 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
            sale of prescription drugs through the Internet.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              May 20, 2004

Mr. Coleman (for himself, and Mrs. Feinstein) introduced the following 
  bill; which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
            sale of prescription drugs through the Internet.

    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 ``Internet Pharmacy Consumer 
Protection Act'' or the ``Ryan Haight Act''.

SEC. 2. 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:

``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 or that provide an Internet 
                information location tool within the meaning of section 
                231(e)(5) of the Communications Act of 1934 (47 U.S.C. 
                231(e)(5)).
            ``(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 or practice medicine; 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 displayed in a clear and prominent place and manner, 
                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 sell such a drug, if--
                    ``(A) for purposes of such dispensing or sale, the 
                purchaser communicated with the person through the 
                Internet;
                    ``(B) the patient for whom the drug was dispensed 
                or purchased did not, when such communications began, 
                have a prescription for the drug that is valid in the 
                United States;
                    ``(C) pursuant to such communications, the person 
                provided for the involvement of a practitioner, or an 
                individual represented by the person as a practitioner, 
                and the practitioner or such individual issued a 
                prescription for the drug that was purchased;
                    ``(D) the person knew, or had reason to know, that 
                the practitioner or the individual referred to in 
                subparagraph (C) did not, when issuing the 
                prescription, have a qualifying medical relationship 
                with the patient; and
                    ``(E) the person received payment for the 
                dispensing or sale of 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 1 in-person 
                medical evaluation of the patient has been conducted by 
                the practitioner.
                    ``(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.
            ``(3) Rules of construction.--
                    ``(A) Individuals represented as practitioners.--A 
                person who is not a practitioner (as defined in 
                subsection (e)(1)) lacks legal capacity under this 
                section to have a qualifying medical relationship with 
                any patient.
                    ``(B) Applicability of requirements.--Paragraph (2) 
                may not be construed as having any applicability beyond 
                this section, and does not affect any State law, or 
                interpretation of State law, concerning the practice of 
                medicine.
                    ``(C) Standard practice of pharmacy.--Paragraph (1) 
                may not be construed as prohibiting any conduct that is 
                a standard practice in the practice of pharmacy.
    ``(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.--
                    ``(A) Venue.--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.
                    ``(B) Service of process.--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) Effect of section.--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) Additional action.--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) Interactive Computer Service; Advertising.--No provider of an 
interactive computer service, as defined in section 230(f)(2) of the 
Communications Act of 1934 (47 U.S.C. 230(f)(2)), or of advertising 
services shall be liable under this section for dispensing or selling 
prescription drugs in violation of this section on account of another 
person's selling or dispensing such drugs, provided that the provider 
of the interactive computer service or of advertising services does not 
own or exercise corporate control over such person.
    ``(e) Definitions.--For purposes of this section:
            ``(1) Practitioner.--The term `practitioner' means a 
        practitioner referred to in section 503(b)(1) with respect to 
        issuing a written or oral prescription.
            ``(2) Prescription drug.--The term `prescription drug' 
        means a drug that is subject to section 503(b)(1).
            ``(3) Qualifying medical relationship.--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 or selling of a prescription drug in violation 
of section 503B.''.
    (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)), 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 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 (21 U.S.C. 371(a)). The preceding sentence may 
not be construed as affecting the authority of such Secretary to 
promulgate such a final rule.

SEC. 3. REPORTS REGARDING INTERNET-RELATED VIOLATIONS OF FEDERAL AND 
              STATE LAWS ON DISPENSING OF DRUGS.

    (a) In General.--The Secretary of Health and Human Services 
(referred to in this section as the ``Secretary'') shall, pursuant to 
the submission of an application meeting the criteria of the Secretary, 
award a grant or contract to the National Clearinghouse on Internet 
Prescribing (operated by the Federation of State Medical Boards) for 
the purpose of--
            (1) identifying Internet sites that appear to be in 
        violation of Federal or State laws concerning the dispensing of 
        drugs;
            (2) reporting such sites to State medical licensing boards 
        and State pharmacy licensing boards, and to the Attorney 
        General and the Secretary, for further investigation; and
            (3) submitting, for each fiscal year for which the award 
        under this subsection is made, a report to the Secretary 
        describing investigations undertaken with respect to violations 
        described in paragraph (1).
    (b) Authorization of Appropriations.--For the purpose of carrying 
out subsection (a), there is authorized to be appropriated $100,000 for 
each of the fiscal years 2004 through 2006.
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