```

[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 2137 Placed on Calendar Senate (PCS)]

                                                      Calendar No.  436
108th CONGRESS
  2d Session
                                S. 2137

 To authorize the Secretary of Health and Human Services to promulgate 
regulations for the reimportation of prescription drugs, and for other 
                               purposes.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                            February 26, 2004

 Mr. Dorgan (for himself, Ms. Snowe, Ms. Stabenow, Mr. McCain, and Mr. 
 Daschle) introduced the following bill; which was read the first time

                            February 27, 2004

            Read the second time and placed on the calendar

_______________________________________________________________________

                                 A BILL

 
 To authorize the Secretary of Health and Human Services to promulgate 
regulations for the reimportation of prescription drugs, 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 ``Pharmaceutical Market Access Act of 
2003''.

SEC. 2. FINDINGS.

    Congress finds that--
            (1) Americans unjustly pay up to 1000 percent more to fill 
        their prescriptions than consumers in other countries;
            (2) the United States is the largest market for 
        pharmaceuticals in the world, yet American consumers pay the 
        highest prices for pharmaceuticals in the world;
            (3) an unaffordable drug is neither safe nor effective;
            (4) allowing and structuring the importation of 
        prescription drugs ensures access to affordable drugs, thus 
        providing a level of safety to American consumers that 
        consumers do not currently enjoy;
            (5) according to the Congressional Budget Office, American 
        seniors alone will spend $1,800,000,000,000 on pharmaceuticals 
        over the next 10 years; and
            (6) allowing open pharmaceutical markets could save 
        American consumers at least $635,000,000,000 each year.

SEC. 3. PURPOSES.

    The purposes of this Act are--
            (1) to give all Americans immediate relief from the 
        outrageously high cost of pharmaceuticals;
            (2) to reverse the perverse economics of American 
        pharmaceutical markets;
            (3) to allow the importation of drugs (excluding 
        pharmaceutical narcotics) only if the drugs and the facilities 
        in which the drugs are manufactured are approved by the Food 
        and Drug Administration; and
            (4) to require that imported prescription drugs be packaged 
        and shipped using counterfeit-resistant technologies approved 
        by the Bureau of Engraving and Printing, similar to the 
        technologies used to secure United States currency.

SEC. 4. IMPORTATION OF PRESCRIPTION DRUGS.

    Section 804 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
384) is amended--
            (1) in subsection (a)--
                    (A) by striking ``The Secretary'' and inserting 
                ``Not later than 181 days after the date of enactment 
                of the Pharmaceutical Market Access Act of 2003, the 
                Secretary''; and
                    (B) by striking ``pharmacists and wholesalers'' and 
                inserting ``pharmacists, wholesalers, and qualifying 
                individuals'';
            (2) in subsection (b)--
                    (A) by striking paragraph (1) and inserting the 
                following:
            ``(1) require that each covered product imported under that 
        subsection complies with sections 501, 502, and 505 and other 
        applicable requirements of this Act; and'';
                    (B) in paragraph (2), by striking ``, including 
                subsection (d); and'' and inserting a period; and
                    (C) by striking paragraph (3);
            (3) in subsection (c), by inserting ``by pharmacists and 
        wholesalers (but not qualifying individuals)'' after 
        ``importation of covered products'';
            (4) in subsection (d)--
                    (A) by striking paragraphs (3) and (10);
                    (B) in paragraph (5), by striking ``, including the 
                professional license number of the importer, if any'';
                    (C) in paragraph (6)--
                            (i) in subparagraph (C), by inserting ``(if 
                        required under subsection (e))'' before the 
                        period;
                            (ii) in subparagraph (D), by inserting 
                        ``(if required under subsection (e))'' before 
                        the period; and
                            (iii) in subparagraph (E), by striking 
                        ``labeling'';
                    (D) in paragraph (7)--
                            (i) in subparagraph (A), by inserting ``(if 
                        required under subsection (e))'' before the 
                        period; and
                            (ii) by striking subparagraph (B) and 
                        inserting the following:
                    ``(B) Certification from the importer or 
                manufacturer of the product that the product meets all 
                requirements of this Act.''; and
                    (E) by redesignating paragraphs (4) through (9) as 
                paragraphs (3) through (8), respectively;
            (5) by striking subsection (e) and inserting the following:
    ``(e) Testing.--
            ``(1) In general.--Subject to paragraph (2), regulations 
        under subsection (a) shall require that testing referred to in 
        paragraphs (5) through (7) of subsection (d) be conducted by 
        the importer of the covered product, unless the covered product 
        is a prescription drug subject to the requirements of section 
        505B for counterfeit-resistant technologies.
            ``(2) Exception.--The testing requirements of paragraphs 
        (5) through (7) of subsection (d) shall not apply to an 
        importer unless the importer is a wholesaler.'';
            (6) in subsection (f), by striking ``or designated by the 
        Secretary, subject to such limitations as the  Secretary 
determines to be appropriate to protect the public health'';
            (7) in subsection (g)--
                    (A) by striking ``counterfeit or''; and
                    (B) by striking ``and the Secretary determines that 
                the public is adequately protected from counterfeit and 
                violative covered products being imported pursuant to 
                subsection (a)'';
            (8) in subsection (i)(1)--
                    (A) by striking subparagraph (A) and inserting the 
                following:
                    ``(A) Study.--
                            ``(i) In general.--The Secretary shall 
                        conduct, or contract with an entity to conduct, 
                        a study on the imports permitted under 
                        subsection (a), including consideration of the 
                        information received under subsection (d).
                            ``(ii) Evaluation.-- In conducting the 
                        study, the Secretary or entity shall--
                                    ``(I) evaluate the compliance of 
                                importers with regulations under 
                                subsection (a), and the incidence of 
                                shipments under that subsection, if 
                                any, that have been determined to be 
                                misbranded or adulterated; and
                                    ``(II) determine how that 
                                compliance contrasts with the incidence 
                                of shipments of prescription drugs 
                                transported within the United States 
                                that have been determined to be 
                                misbranded or adulterated.''; and
                    (B) in subparagraph (B), by striking ``Not later 
                than 2 years after the effective date of final 
                regulations under subsection (a),'' and inserting ``Not 
                later than 18 months after the date of enactment of the 
                Pharmaceutical Market Access Act of 2003,'';
            (9) in subsection (k)(2)--
                    (A) by redesignating subparagraphs (D) and (E) as 
                subparagraphs (E) and (F), respectively; and
                    (B) by inserting after subparagraph (C) the 
                following:
                    ``(D) Qualifying individual.--The term `qualifying 
                individual' means an individual who is not a pharmacist 
                or a wholesaler. ''; and
            (10) by striking subsections (l) and (m).

SEC. 5. USE OF COUNTERFEIT-RESISTANT TECHNOLOGIES TO PREVENT 
              COUNTERFEITING.

    (a) Misbranding.--Section 502 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the 
following:
    ``(w) If it is a drug subject to section 503(b), unless the 
packaging of the drug complies with the requirements of section 505B 
for counterfeit-resistant technologies.''.
    (b) Requirements.--Title V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by inserting after section 505A 
the following:

``SEC. 505B. COUNTERFEIT-RESISTANT TECHNOLOGIES.

    ``(a) Incorporation of Counterfeit-Resistant Technologies Into 
Prescription Drug Packaging.--The Secretary shall require that the 
packaging of any drug subject to section 503(b) incorporate--
            ``(1) overt optically variable counterfeit-resistant 
        technologies that are described in subsection (b) and comply 
        with the standards of subsection (c); or
            ``(2) technologies that have an equivalent function of 
        security, as determined by the Secretary.
    ``(b) Eligible Technologies.--Technologies described in this 
subsection--
            ``(1) shall be visible to the naked eye, providing for 
        visual identification of product authenticity without the need 
        for readers, microscopes, lighting devices, or scanners;
            ``(2) shall be similar to the technologies used by the 
        Bureau of Engraving and Printing to secure United States 
        currency;
            ``(3) shall be manufactured and distributed in a highly 
        secure, tightly controlled environment; and
            ``(4) should incorporate additional layers of nonvisible 
        covert security features up to and including forensic 
        capability.
    ``(c) Standards for Packaging.--
            ``(1) Multiple elements.--For the purpose of making it more 
        difficult to counterfeit the packaging of drugs subject to 
        section 503(b), a manufacturer of the drugs shall incorporate 
        the technologies described in subsection (b) into multiple 
        elements of the physical packaging of the drugs, including 
        blister packs, shrink wrap, package labels, package seals, 
        bottles, and boxes.
            ``(2) Labeling of shipping container.--
                    ``(A) In general.--A shipment of a drug described 
                in subsection (a) shall include a label on the shipping 
                container that incorporates the technologies described 
                in subsection (b), so that officials inspecting the 
                packages will be able to determine the authenticity of 
                the shipment.
                    ``(B) Chain-of-custody procedures.--
                            ``(i) In general.--A manufacturer of a drug 
                        described in subsection (a) shall ensure that 
                        chain-of-custody procedures apply to a label 
                        required under subparagraph (A).
                            ``(ii) Required procedures.--Chain-of-
                        custody procedures required under clause (i) 
                        shall include--
                                    ``(I) procedures applicable to 
                                contractual agreements for the use and 
                                distribution of the labels;
                                    ``(II) methods to audit the use of 
                                the labels; and
                                    ``(III) database access for the 
                                relevant governmental agencies for 
                                audit or verification of the use and 
                                distribution of the labels.''.

                                                       Calendar No. 436

108th CONGRESS

  2d Session

                                S. 2137

_______________________________________________________________________

                                 A BILL

 To authorize the Secretary of Health and Human Services to promulgate 
regulations for the reimportation of prescription drugs, and for other 
                               purposes.

_______________________________________________________________________

                           February 27, 2004

            Read the second time and placed on the calendar
```