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

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

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.

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