1.
This Act may be cited as the
Internet Pharmacy Consumer Protection
Act
or the Ryan Haight Act
.
2.
Internet sales of prescription drugs
(a)
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:
503B.
Internet sales of prescription drugs
(a)
Requirements regarding information on Internet site
(1)
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)
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)
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)
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)
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)
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)
(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)
(1)
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)
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)
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)
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)
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)
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)
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)
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.