[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 399 Introduced in Senate (IS)]







109th CONGRESS
  1st Session
                                 S. 399

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


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           February 16, 2005

 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, 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 ``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 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;
                    ``(B) the person dispenses the drug to the 
                purchaser by mailing or shipping the drug to the 
                purchaser; and
                    ``(C) 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--
                            ``(i) are not intended to be accessed by 
                        purchasers or prospective purchasers; or
                            ``(ii) 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 (C) 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.
                            ``(ii) Each State in which the person is 
                        authorized by law to dispense prescription 
                        drugs.
                            ``(iii) The address and telephone number of 
                        each place of business of the person with 
                        respect to sales of prescription drugs through 
                        the Internet, other than a place of business 
                        that does not mail or ship prescription drugs 
                        to purchasers.
                            ``(iv) The name of each individual who 
                        serves as a pharmacist for prescription drugs 
                        that are mailed or shipped pursuant to the 
                        site, and each State in which the individual is 
                        authorized by law to dispense prescription 
                        drugs.
                            ``(v) 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.--Except as provided in paragraph (2), 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) Exceptions.--Paragraph (1) does not apply to--
                    ``(A) the dispensing or selling of a prescription 
                drug pursuant to telemedicine practices sponsored by--
                            ``(i) a hospital that has in effect a 
                        provider agreement under title XVIII of the 
                        Social Security Act (relating to the Medicare 
                        program); or
                            ``(ii) a group practice that has not fewer 
                        than 100 physicians who have in effect provider 
                        agreements under such title; or
                    ``(B) the dispensing or selling of a prescription 
                drug pursuant to practices that promote the public 
                health, as determined by the Secretary by regulation.
            ``(3) 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--
                            ``(i) at least one in-person medical 
                        evaluation of the patient has been conducted by 
                        the practitioner; or
                            ``(ii) the practitioner conducts a medical 
                        evaluation of the patient as a covering 
                        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.
                    ``(C) Covering practitioner.--With respect to a 
                patient, a practitioner is a covering practitioner for 
                purposes of this section if the practitioner conducts a 
                medical evaluation of the patient at the request of a 
                practitioner who has conducted at least one in-person 
                medical evaluation of the patient and is temporarily 
                unavailable to conduct the evaluation of the patient. A 
                practitioner is a covering practitioner without regard 
                to whether the practitioner has conducted any in-person 
                medical evaluation of the patient involved.
            ``(4) Rules of construction.--
                    ``(A) Individuals represented as practitioners.--A 
                person who is not a practitioner (as defined in 
                subsection (d)(1)) lacks legal capacity under this 
                section to have a qualifying medical relationship with 
                any patient.
                    ``(B) 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) Applicability of requirements.--Paragraph (3) 
                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) 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) General Definitions.--For purposes of this section:
            ``(1) The term `practitioner' means a practitioner referred 
        to in section 503(b)(1) with respect to issuing a written or 
        oral prescription.
            ``(2) The term `prescription drug' means a drug that is 
        subject to section 503(b)(1).
            ``(3) The term `qualifying medical relationship', with 
        respect to a practitioner and a patient, has the meaning 
        indicated for such term in subsection (b).
    ``(e) Internet-Related Definitions.--
            ``(1) In general.--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) Authority of secretary.--The Secretary may by 
        regulation modify any definition under paragraph (1) to take 
        into account changes in technology.
    ``(f) 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.''.
    (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) 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) Reports Regarding Internet-Related Violations of State and 
Federal Laws on Dispensing of Drugs.--
            (1) In general.--The Secretary of Health and Human Services 
        (referred to in this subsection as the ``Secretary'') shall, 
        pursuant to the submission of an application meeting the 
        criteria of the Secretary, make an award of a grant or contract 
        to the National Clearinghouse on Internet Prescribing (operated 
        by the Federation of State Medical Boards) for the purpose of--
                    (A) identifying Internet sites that appear to be in 
                violation of State or Federal laws concerning the 
                dispensing of drugs;
                    (B) 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
                    (C) 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 subparagraph (A).
            (2) Authorization of appropriations.--For the purpose of 
        carrying out paragraph (1), there is authorized to be 
        appropriated $100,000 for each of the fiscal years 2005 through 
        2007.
    (e) 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>