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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Pharmaceutical Market Access Act of 
2003''.

SEC. 2. FINDINGS.

    The Congress finds as follows:
            (1) Americans unjustly pay up to 1000 percent more to fill 
        their prescriptions than consumers in other countries.
            (2) The United States is the world's largest market for 
        pharmaceuticals yet consumers still pay the world's highest 
        prices.
            (3) An unaffordable drug is neither safe nor effective. 
        Allowing and structuring the importation of prescription drugs 
        ensures access to affordable drugs, thus providing a level of 
        safety to American consumers they do not currently enjoy.
            (4) According to the Congressional Budget Office, American 
        seniors alone will spend $1.8 trillion dollars on 
        pharmaceuticals over the next ten years.
            (5) Allowing open pharmaceutical markets could save 
        American consumers at least $635 billion of their own money 
        each year.

SEC. 3. PURPOSES.

    The purposes of this Act are as follows:
            (1) To give all Americans immediate relief from the 
        outrageously high cost of pharmaceuticals.
            (2) To reverse the perverse economics of the American 
        pharmaceutical markets.
            (3) To allow the importation of drugs only if the drugs and 
        the facilities where they are manufactured are approved by the 
        Food and Drug Administration, and to exclude pharmaceutical 
        narcotics.
            (4) To require that imported prescription drugs be packaged 
        and shipped using counterfeit-resistant technologies approved 
        by the Bureau of Engraving and Printing (technologies similar 
        to those 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 180 days after the date of the 
                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 amending paragraph (1) to read as follows:
            ``(1) require that each covered product imported pursuant 
        to such 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 amending subparagraph (B) to read 
                        as follows:
                    ``(B) Certification from the importer or 
                manufacturer of such 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 amending subsection (e) to read as follows:
    ``(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 amending subparagraph (A) to read as 
                follows:
                    ``(A) In general.--The Secretary shall conduct, or 
                contract with an entity to conduct, a study on the 
                imports permitted pursuant to subsection (a), including 
                consideration of the information received under 
                subsection (d). In conducting such study, the Secretary 
                or entity shall evaluate the compliance of importers 
                with regulations under subsection (a), and the 
                incidence of shipments pursuant to such subsection, if 
                any, that have been determined to be misbranded or 
                adulterated, and determine how such 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 the 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) 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; deeming drugs and devices to be 
misbranded) is amended by adding at the end the following:
    ``(w) If it is a drug subject to section 503(b), unless the 
packaging of such 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 that 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 non-visible 
        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), manufacturers 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.--Shipments of drugs 
        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. 
        Chain of custody procedures shall apply to such labels and 
        shall include procedures applicable to contractual agreements 
        for the use and distribution of the labels, methods to audit 
        the use of the labels, and database access for the relevant 
        governmental agencies for audit or verification of the use and 
        distribution of the labels.''.

            Passed the House of Representatives July 25 (legislative 
      day, July 24), 2003.

            Attest:

                                                 JEFF TRANDAHL,

                                                                 Clerk.

Summary: Pharmaceutical Market Access Act of 2003 - (Sec. 4) Amends the Federal Food, Drug and Cosmetic Act to direct the Secretary of Health and Human Services to promulgate regulations allowing qualifying individuals to import covered products (in addition to pharmacists and wholesalers, whom current law authorizes to import such products).

Amends provision pertaining to record keeping regarding imported covered products. States that the Secretary shall not have to store records in cases in which qualifying individuals have imported a covered product.

Amends provisions regarding the importation of covered products, including to remove language directing the Secretary to require that a foreign seller specify the original source of the product and the amount of each lot of the product originally received. Amends provisions regarding the testing of imported covered products. Declares that specified tests, including ones involving authenticity and degradation of products, shall not be required unless the importer is a wholesaler. Requires such tests to be conducted by the importer unless a product is a prescription drug subject to the provisions of this Act pertaining to counterfeit-resistant packaging. (Currently either the importer or the manufacturer may conduct such tests). Eliminates the sunset date current law establishes for the provisions pertaining to the importation of covered products. (Sec. 5) Classifies prescription drugs as misbranded if they do not incorporate specified counterfeit-resistant technologies in packaging.