[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3870 Introduced in House (IH)]






108th CONGRESS
  2d Session
                                H. R. 3870

  To amend the Public Health Service Act, the Federal Food, Drug, and 
 Cosmetic Act, and the Controlled Substances Import and Export Act to 
  provide grants to States to establish prescription drug monitoring 
  programs, to impose requirements respecting Internet pharmacies, to 
  require manufacturers to implement chain-of-custody procedures, to 
    restrict an exemption respecting the importation of controlled 
          substances for personal use, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 2, 2004

 Mr. Norwood (for himself and Mr. Strickland) introduced the following 
    bill; which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
  To amend the Public Health Service Act, the Federal Food, Drug, and 
 Cosmetic Act, and the Controlled Substances Import and Export Act to 
  provide grants to States to establish prescription drug monitoring 
  programs, to impose requirements respecting Internet pharmacies, to 
  require manufacturers to implement chain-of-custody procedures, to 
    restrict an exemption respecting the importation of controlled 
          substances for personal use, 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 ``Prescription Drug Abuse Elimination 
Act of 2004''.

SEC. 2. PRESCRIPTION DRUG MONITORING PROGRAM.

    Part P of title III of the Public Health Service Act (42 U.S.C. 
280g et seq.) is amended by adding after section 399N the following:

``SEC. 399O. PRESCRIPTION DRUG MONITORING PROGRAM.

    ``(a) Prescription Drug.--For purposes of this section, the term 
`prescription drug' means--
            ``(1) a drug that is included in schedule II, III, or IV of 
        section 202(c) of the Controlled Substances Act; or
            ``(2) a drug that is--
                    ``(A) subject to section 503(b) of the Federal 
                Food, Drug, and Cosmetic Act; and
                    ``(B) identified for purposes of this section by 
                the Secretary as potentially subject to abuse, 
                diversion, and misuse.
    ``(b) Grants.--The Secretary shall make a grant to each State that 
submits an application in accordance with subsection (k) for the 
purpose of establishing a prescription drug monitoring program 
described in this section.
    ``(c) Reporting Requirements.--A funding agreement for a grant 
under this section is that the State involved shall comply with the 
following:
            ``(1) The State shall require dispensers to report each 
        dispensing in the State of a prescription drug to an ultimate 
        user or research subject.
            ``(2) A State may exclude from the reporting requirement of 
        this section--
                    ``(A) the direct application of a prescription drug 
                to the body of an ultimate user or research subject;
                    ``(B) the dispensing of a prescription drug in a 
                quantity limited to an amount adequate to treat the 
                ultimate user or research subject involved for 48 hours 
                or less; or
                    ``(C) the application or dispensing of a 
                prescription drug in accordance with an exclusion 
                identified by the Secretary under subsection (i)(2).
            ``(3) Subject to paragraph (5), the information to be 
        reported under this section with respect to the dispensing of a 
        prescription drug shall include the following:
                    ``(A) Drug Enforcement Administration Registration 
                Number of the dispenser.
                    ``(B) Drug Enforcement Administration Registration 
                Number and name of the practitioner who prescribed the 
                drug.
                    ``(C) Name, address, and telephone number of the 
                ultimate user or research subject.
                    ``(D) Identification of the drug by a national drug 
                code number.
                    ``(E) Quantity dispensed.
                    ``(F) Estimated number of days for which such 
                quantity should last.
                    ``(G) Number of refills ordered.
                    ``(H) Whether the drug was dispensed as a refill of 
                a prescription or as a first-time request.
                    ``(I) Date of the dispensing.
                    ``(J) Date of origin of the prescription.
            ``(4) The State shall specify an electronic format for the 
        reporting of information under this section and may waive the 
        requirement of such format with respect to an individual 
        dispenser.
            ``(5) The State may meet the requirements of paragraphs (3) 
        and (4) by requiring that information be reported under this 
        section in accordance with the current version of the 
        telecommunications format for controlled substances of the 
        American Society for Automation in Pharmacy.
    ``(d) Database.--A funding agreement for a grant under this section 
is that the State involved shall comply with the following:
            ``(1) The State shall establish and maintain an electronic 
        database containing the information reported to the State under 
        this section.
            ``(2) The database must be searchable by any field or 
        combination of fields.
            ``(3) The State shall include reported information in the 
        database in a timely and efficient manner, with appropriate 
        safeguards for ensuring the accuracy and completeness of the 
        database.
            ``(4) The State shall take appropriate security measures to 
        protect the integrity of, and access to, the database.
    ``(e) Required Availability of Information.--Subject to subsection 
(g), a funding agreement for a grant under this section is that the 
State involved, with respect to the database established by the State 
under subsection (d), shall comply with the following:
            ``(1) The State, taking into consideration the criteria 
        established by the Secretary under subsection (i)(1), shall 
        notify appropriate authorities responsible for drug diversion 
        investigation if information in the database indicates a 
        potential unlawful diversion or misuse of a prescription drug.
            ``(2) The State shall provide for sharing of information on 
        a specific individual in the database with each State that--
                    ``(A) maintains a database established under 
                subsection (d); and
                    ``(B) agrees to use the information in accordance 
                with the requirements of this section.
            ``(3) The State shall automatically share information 
        reported to the State under this section with another State 
        if--
                    ``(A) such other State maintains a database under 
                subsection (d); and
                    ``(B) the information concerns--
                            ``(i) the dispensing of a prescription drug 
                        to an ultimate consumer or research subject who 
                        resides in such other State; or
                            ``(ii) the dispensing of a prescription 
                        drug prescribed by a practitioner whose 
                        principal place of business is located in such 
                        other State.
    ``(f) Optional Availability of Information.--Subject to subsection 
(g), a funding agreement for a grant under this section is that the 
State involved, with respect to the database established by the State 
under subsection (d), may choose to comply with any of the following:
            ``(1) On request, the State may make available information 
        on a specific individual from the database to any dispenser or 
        practitioner who certifies that the requested information is 
        for the purpose of providing pharmaceutical or medical 
        treatment, or evaluating the need for such treatment, with 
        respect to a bona fide patient.
            ``(2) On request, the State may make available information 
        on a specific individual from the database to any local, State, 
        or Federal law enforcement authority responsible for 
        prescription drug diversion investigation that requests the 
        information and certifies that--
                    ``(A) the requested information relates to an 
                active criminal investigation or proceeding involving 
                the unlawful diversion or misuse of a prescription 
                drug; and
                    ``(B) the authority has reasonable cause to 
                conclude that such information will further the purpose 
                of the investigation or assist in the proceeding.
            ``(3) On request, the State may make available information 
        on a specific individual from the database to any health care 
        professional licensing authority that requests the information 
        and certifies that the requested information relates to an 
        active investigation or proceeding involving the unlawful 
        diversion or misuse of a prescription drug, and the authority 
        has reasonable cause to conclude that such information will 
        further the purpose of the investigation or assist in the 
        proceeding. Information made available to a health care 
        professional licensing authority under this paragraph shall be 
        limited to those individuals licensed, regulated, or 
        disciplined by the authority.
            ``(4) The State may make available information on a 
        specific individual from the database to dispensers, 
        practitioners, law enforcement authorities responsible for 
        prescription drug diversion investigation, and health care 
        professional licensing authorities in accordance with 
        paragraphs (1), (2), and (3), irrespective of whether such 
        dispensers, practitioners, or authorities are from another 
        State.
            ``(5) On request, the State may make available information 
        on a specific individual from the database to that specific 
        individual with appropriate identification and procedures.
    ``(g) Limitation.--With respect to information in a database 
established under subsection (d), a funding agreement for a grant under 
this section is that--
            ``(1) the State involved shall limit the release of 
        information pursuant to subsections (e) and (f) to the minimum 
        necessary to accomplish the intended purpose of such release;
            ``(2) after the passage of 18 months from the date of the 
        dispensing of a drug, the State involved will make information 
        on such dispensing available only to the extent required by 
        court order; and
            ``(3) except as inconsistent with the provisions of this 
        section, the State involved will comply with section 264(c) of 
        the Health Insurance Portability and Accountability Act of 1996 
        (Public Law 104-191; 110 Stat. 2033) (concerning the 
        confidentiality of individually identifiable health 
        information) and any regulation promulgated under such section.
    ``(h) Quality Improvement Program.--A funding agreement for a grant 
under this section is that the State involved shall operate a 
continuous quality improvement program to ensure the State's compliance 
with this section and to improve the State's prescription drug 
monitoring program.
    ``(i) Authority of Secretary.--
            ``(1) National criteria.--The Secretary shall establish 
        criteria for determining whether information in a database 
        established under subsection (d) indicates a potential unlawful 
        diversion or misuse of a prescription drug.
            ``(2) Exclusions.--The Secretary may identify instances (in 
        addition to those described in subparagraphs (A) and (B) of 
        subsection (c)(2)) in which a State may exclude from the 
        reporting requirement of this section the application or 
        dispensing of a prescription drug.
    ``(j) Advisory Council.--A funding agreement for a grant under this 
section is that the State involved shall comply with the following:
            ``(1) The State shall establish an advisory council to 
        assist in the establishment and implementation of a 
        prescription drug monitoring program under this section.
            ``(2) The State shall ensure that the membership of the 
        advisory council includes the following:
                    ``(A) A representative of the primary State agency 
                responsible for law enforcement.
                    ``(B) A representative of the primary State agency 
                responsible for health care.
                    ``(C) A health care practitioner with a specialty 
                in pain medicine licensed in the State to prescribe 
                drugs.
                    ``(D) A pharmacist licensed in the State.
                    ``(E) A prosecutor experienced in criminal 
                prosecution of drug diversion cases.
                    ``(F) A member representing the public at large.
    ``(k) Application.--For purposes of subsection (b), an application 
is in accordance with this subsection if--
            ``(1) the application contains each funding agreement in 
        this section;
            ``(2) with respect to such funding agreements, the 
        application provides assurances of compliance satisfactory to 
        the Secretary; and
            ``(3) the application is in such form, is made in such 
        manner, and contains such information as the Secretary 
        determines to be necessary to carry out this section.
    ``(l) Definitions.--For purposes of this section:
            ``(1) The term `bona fide patient' means an individual who 
        is a patient of the dispenser or practitioner involved.
            ``(2) The term `dispense' means to deliver a prescription 
        drug to an ultimate user or research subject by, or pursuant to 
        the lawful order of, a practitioner, irrespective of whether 
        the dispenser uses the Internet or other means to effect such 
        delivery.
            ``(3) The term `dispenser' means a physician, pharmacist, 
        or other individual who dispenses a prescription drug to an 
        ultimate user or research subject.
            ``(4) The term `ultimate user' means a person who has 
        lawfully obtained, and who possesses, a prescription drug for 
        his or her own use, for the use of a member of his or her 
        household, or for the use of an animal owned by him or her or 
        by a member of his or her household.
    ``(m) Authorization of Appropriations.--
            ``(1) In general.--There is authorized to be appropriated 
        to carry out this section $10,000,000 for fiscal year 2005 and 
        each subsequent fiscal year.
            ``(2) Startup grants.--For the purpose of awarding grants 
        under this section to assist with the initial costs of 
        establishing a prescription drug monitoring program, there is 
        authorized to be appropriated $25,000,000 for the period of 
        fiscal years 2005 through 2009. Such authorization of 
        appropriations is in addition to the authorization of 
        appropriations in paragraph (1).''.

SEC. 3. INTERNET PHARMACIES.

    (a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by inserting after section 503A 
the following:

``SEC. 503B. INTERNET SALE OF PRESCRIPTION DRUGS.

    ``(a) In General.--
            ``(1) Prohibitions.--Subject to paragraph (2), it is a 
        violation of this section--
                    ``(A) for any person to sell a prescription drug in 
                interstate commerce through an Internet site--
                            ``(i) if the Internet site is an illegal 
                        Internet pharmacy under subsection (b);
                            ``(ii) if the person fails to comply with 
                        the treating provider verification requirements 
                        of subsection (c);
                            ``(iii) if the person fails to submit the 
                        notices required by subsection (d); or
                            ``(iv) if the person fails to comply with 
                        the reporting requirements applicable to the 
                        person under a State prescription drug 
                        monitoring program established with a grant 
                        under section 399O of the Public Health Service 
                        Act; or
                    ``(B) for any person to own or operate an illegal 
                Internet pharmacy in interstate commerce.
            ``(2) Exception.--Any person who sells a prescription drug 
        through an Internet site, or who owns or operates an Internet 
        pharmacy, is deemed to meet the requirements of this section 
        for purposes of such sale, ownership, or operation if the 
        Internet site or Internet pharmacy is certified by the National 
        Association of Boards of Pharmacy's Verified Internet Pharmacy 
        Practice Sites program.
    ``(b) Internet Pharmacy Requirements.--
            ``(1) In general.--For purposes of this section:
                    ``(A) The term `Internet pharmacy' means an 
                Internet site that is used primarily to sell 
                prescription drugs in interstate commerce.
                    ``(B) The term `illegal Internet pharmacy' means an 
                Internet pharmacy that fails to comply with this 
                subsection.
            ``(2) Requirements.--An Internet pharmacy shall provide to 
        any individual who accesses the pharmacy the following 
        information:
                    ``(A) The street address and telephone number of--
                            ``(i) the Internet pharmacy's place of 
                        business; and
                            ``(ii) the Internet pharmacy's supervising 
                        pharmacist.
                    ``(B) All States in which the Internet pharmacy is 
                licensed or otherwise authorized to dispense 
                prescription drugs.
                    ``(C) If the Internet pharmacy makes referrals to, 
                or solicits on behalf of, a practitioner or a group of 
                practitioners for prescription services--
                            ``(i) the name, street address, and 
                        telephone number of such practitioner or group; 
                        and
                            ``(ii) each State in which each 
                        practitioner involved is licensed or otherwise 
                        authorized to prescribe drugs.
                    ``(D) A statement that the Internet pharmacy will 
                dispense prescription drugs only upon a showing of a 
                prescription.
    ``(c) Treating Provider Verification Requirements.--The treating 
provider verification requirements of this subsection are as follows:
            ``(1) In general.--Subject to paragraph (2), a person may 
        sell a prescription drug in interstate commerce through an 
        Internet site only if--
                    ``(A) the sale is in accordance with a prescription 
                of the treating provider of the patient involved;
                    ``(B) the seller verifies the prescription in 
                accordance with paragraph (3);
                    ``(C) the seller maintains a record of direct 
                communications in accordance with paragraph (4); and
                    ``(D) the seller complies with the prohibition of 
                paragraph (5) against alteration of the prescription.
            ``(2) Limitation.--The treating provider verification 
        requirements of this subsection apply with respect to a 
        prescription drug only if--
                    ``(A) the prescription drug is included in schedule 
                II, III, or IV of section 202(c) of the Controlled 
                Substances Act; or
                    ``(B) the Secretary for purposes of this section 
                identifies the prescription drug as potentially subject 
                to abuse, diversion, and misuse.
            ``(3) Verification requirement.--
                    ``(A) Requirement.--A seller verifies a 
                prescription in accordance with this paragraph if--
                            ``(i) the patient involved or the patient's 
                        treating provider presents the prescription, 
                        directly or by facsimile or electronic mail, to 
                        the seller; or
                            ``(ii) the seller verifies the prescription 
                        by direct communication with the treating 
                        provider involved.
                    ``(B) Information.--When seeking verification of a 
                prescription under subparagraph (A)(ii), a seller shall 
                provide to the treating provider the following 
                information:
                            ``(i) Patient's full name and address.
                            ``(ii) Identification of the drug by a 
                        national drug code number.
                            ``(iii) Quantity to be dispensed.
                            ``(iv) Date of patient request.
                            ``(v) Date and time of verification 
                        request.
                            ``(vi) Name of contact person at seller's 
                        company, including facsimile and telephone 
                        number.
                    ``(C) Verification events.--A prescription is 
                verified under subparagraph (A)(ii) only if one of the 
                following occurs:
                            ``(i) The treating provider confirms the 
                        prescription is accurate by direct 
                        communication with the seller.
                            ``(ii) The treating provider informs the 
                        seller that the prescription is inaccurate and 
                        provides the accurate prescription.
                            ``(iii) The treating provider fails to 
                        communicate with the seller within 48 hours, or 
                        a similar time as defined by the Commissioner 
                        of Food and Drugs, after receiving from the 
                        seller the information described in 
                        subparagraph (B).
                    ``(D) Invalid prescription.--If a treating provider 
                informs a seller before the deadline under subparagraph 
                (C)(iii) that the prescription is inaccurate or 
                expired, the seller shall not fill the prescription. 
                The treating provider shall specify the basis for the 
                inaccuracy or invalidity of the prescription. If the 
                prescription communicated by the seller to the treating 
                provider is inaccurate, the treating provider shall 
                correct it.
            ``(4) Record requirement.--A seller shall maintain a record 
        of all direct communications with a treating provider regarding 
        the sale of a prescription drug, including verification of the 
        prescription involved.
            ``(5) No alteration.--A seller may not alter a prescription 
        for a prescription drug. Notwithstanding the preceding 
        sentence, if the same prescription drug is manufactured by the 
        same company and sold under multiple labels to individual 
        providers, the seller may fill the prescription with a 
        prescription drug manufactured by that company under another 
        label.
            ``(6) Definitions.--In this subsection:
                    ``(A) The term `direct communication' includes 
                communication by telephone, facsimile, or electronic 
                mail.
                    ``(B) The term `seller' means a person that sells a 
                prescription drug in interstate commerce through an 
                Internet site.
                    ``(C) The term `treating provider' means--
                            ``(i) a health care provider who has 
                        performed a documented patient evaluation of 
                        the individual involved (including a patient 
                        history and physical examination) to establish 
                        the diagnosis for which the prescription drug 
                        involved is prescribed, has discussed with the 
                        individual his or her treatment options and the 
                        risks and benefits of treatment, and maintains 
                        contemporaneous medical records on the 
                        individual;
                            ``(ii) a health care provider who is 
                        providing care in consultation with a health 
                        care provider described in clause (i) and who 
                        has access to the medical records of the 
                        patient involved; or
                            ``(iii) a health care provider who is 
                        providing care as part of an on-call or cross-
                        coverage arrangement with a health care 
                        provider described in clause (i).
    ``(d) State Notice Requirements.--A person that sells a 
prescription drug in interstate commerce through an Internet site shall 
provide to each State authority that licenses or otherwise authorizes 
the person to dispense the prescription drug the following information:
            ``(1) A statement that the person is selling prescription 
        drugs through an Internet site.
            ``(2) The name, Internet address, street address, and 
        telephone number of the person's business for selling such 
        drugs.
    ``(e) Definition.--In this section, the term `prescription drug' 
means a drug subject to section 503(b).''.
    (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 sale of a prescription drug, or the ownership or 
operation of an illegal Internet pharmacy, in violation of section 
503B.''.
    (c) Links to Illegal Internet Pharmacy.--Section 302 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 332) is amended by adding at 
the end the following:
    ``(c) In the case of a violation of section 503B relating to an 
illegal Internet pharmacy, the district courts of the United States and 
the United States courts of the Territories shall have jurisdiction to 
order a provider of an interactive computer service to remove, or 
disable access to, a site violating such section, or a link to a site 
violating such section, that resides on a computer server that such 
provider controls or operates. Such relief shall--
            ``(1) be available only after provision to the provider of 
        notice and an opportunity to appear;
            ``(2) not impose any obligation on the provider to monitor 
        its service or to affirmatively seek facts indicating activity 
        violating section 503B;
            ``(3) specify the provider to which the relief applies; and
            ``(4) specifically identify the location of the site or 
        link to be removed, or to which access is to be disabled.''.

SEC. 4. DISTRIBUTION AND LABELING OF DRUGS.

    (a) Drug Pedigree Amendments.--Paragraph (1) of section 503(e) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(e)) is 
amended--
            (1) in subparagraph (A), by striking ``Each person who is 
        engaged in the wholesale distribution of a drug subject to 
        subsection (b) and who is not the manufacturer or an authorized 
        distributor of record of such drug shall'' and inserting 
        ``Subject to subparagraph (C), each person who is engaged in 
        the wholesale distribution of a drug subject to subsection (b) 
        shall''; and
            (2) by adding after subparagraph (B) the following:
    ``(C) Subparagraph (A) applies to the manufacturer of a drug or the 
authorized distributor of record of a drug only if--
            ``(i) the drug is included in schedule II of section 202(c) 
        of the Controlled Substances Act; or
            ``(ii) the Secretary designates the drug for purposes of 
        this subparagraph, taking into consideration the impact to 
        public health that would result from counterfeiting or 
        diversion of the drug, the price of the drug, the volume of the 
        drug, the dosage form of the drug, the clinical uses of the 
        drug, the history of counterfeiting or diversion of the drug, 
        and whether products similar to the drug have a history of 
        counterfeiting or diversion.''.
    (b) Chain-Of-Custody Requirements.--Chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) (as amended by section 
3) is amended--
            (1) in section 502, by adding at the end the following:
    ``(w) If it is a drug with respect to which the manufacturer, 
importer, distributor, or retailer fails to comply with the chain-of-
custody requirements of section 503C.''; and
            (2) by inserting after section 503B the following:

``SEC. 503C. CHAIN-OF-CUSTODY REQUIREMENTS.

    ``(a) In General.--Not later than January 1, 2006, the Secretary 
shall promulgate chain-of-custody requirements applicable to each 
manufacturer, importer, distributor, and retailer of a prescription 
drug.
    ``(b) Manufacturers.--The chain-of-custody requirements promulgated 
under this section shall require each manufacturer of a prescription 
drug--
            ``(1) to incorporate a unique identifier into the packaging 
        or labeling of the drug;
            ``(2) to track the drug through the point of delivery to 
        the retailer of the drug; and
            ``(3) to maintain, either directly or through a contractor, 
        a database on the movement of the drug.
    ``(c) Importers, Distributors, and Retailers.--The chain-of-custody 
requirements promulgated under this section shall require each 
importer, distributor, and retailer of a prescription drug to assist in 
the tracking of the drug under this section by reporting the receipt of 
the drug to the manufacturer.
    ``(d) Prescription Drug.--In this section, the term `prescription 
drug' means a drug subject to section 503(b).
    ``(e) Effective Date.--The chain-of-custody requirements 
promulgated by the Secretary under this section shall take effect on 
January 1, 2008.''.
    (c) Grants for Community Pharmacists.--The Secretary of Health and 
Human Services may make grants to community pharmacists to assist such 
pharmacists to comply with tracking requirements imposed on such 
pharmacists by drug manufacturers, importers, or distributors as a 
result of the amendments made by subsection (b).

SEC. 5. RESTRICTION ON PERSONAL USE EXEMPTION FOR IMPORTING CONTROLLED 
              SUBSTANCES.

    Paragraph (2) of section 1006(a) of the Controlled Substances 
Import and Export Act (21 U.S.C. 956(a)) is amended by striking ``may 
not import the controlled substance'' and all that follows and 
inserting ``may not import the controlled substance into the United 
States--
            ``(1) in an amount that exceeds 50 dosage units of the 
        controlled substance; or
            ``(2) in the case of a controlled substance in schedule II, 
        III, or IV, more than 1 time during any 30-day period.''.

SEC. 6. WORKING GROUP ON PHARMACEUTICAL COUNTERFEITING.

    (a) Establishment.--The Secretary of Health and Human Services (in 
this section referred to as the ``Secretary''), acting through the 
Commissioner of Food and Drugs, shall convene a working group (in this 
section referred to as the ``working group'') to conduct a study and 
submit a report on pharmaceutical counterfeiting.
    (b) Members.--The Secretary shall invite to serve as members of the 
working group representatives of the following:
            (1) Domestic regulatory agencies.
            (2) Domestic and international law enforcement officials.
            (3) Multinational organizations, such as the World Trade 
        Organization and the World Health Organization.
            (4) The United States Trade Representative.
            (5) The pharmaceutical industry.
            (6) Trade associations.
    (c) Study.--The study conducted by the working group on 
pharmaceutical counterfeiting shall consider the following:
            (1) How to enhance supply-chain security.
            (2) Consumer education on counterfeiting issues.
            (3) Employing technology designed to frustrate organized 
        and sophisticated criminals intent on compromising the world's 
        drug supply.
            (4) How industry could assist law enforcement by analyzing 
        suspected counterfeit drugs to determine authenticity.
            (5) How industry can collaborate on issues related to 
        pharmaceutical counterfeiting without revealing trade secrets 
        or other confidential information.
    (d) Report.--Not later than 2 years after the date of the enactment 
of this Act, the working group shall submit a report to the Congress on 
the results of the study conducted under this section, including 
recommendations on measures to reduce or eliminate problems associated 
with pharmaceutical counterfeiting.

SEC. 7. BASELINE RESEARCH ON PRESCRIPTION DRUG ABUSE.

    (a) Research.--The Secretary of Health and Human Services shall 
conduct research on issues related to prescription drug abuse, 
including the following:
            (1) Enhancing existing public use surveys and other sources 
        so as to provide appropriate baseline data and data on the 
        natural history and context of prescription drug use in order 
        to evaluate the extent and nature of potential problems and 
        guide corrective actions which reduce the problems without 
        unintentionally hindering patient access.
            (2) The phenomenon of iatrogenic addiction, including the 
        actual incidence and prevalence of iatrogenic addiction, the 
        factors that modulate the risk of such addiction, and the 
        extent to which concern about iatrogenic addiction impacts 
        health care delivery.
            (3) Development of postapproval surveillance approaches 
        that can detect and address potential risks of abuse and 
        misuse, including risks in diverse patient populations that did 
        not previously appear at risk for diversion or abuse, and in 
        geographic regions that have been relatively absent from risk.
            (4) Methods to better translate new ideas about 
        terminology, diagnosis, and management of addiction diseases 
        into clinical practice at the primary care and specialist 
        levels.
            (5) Reliable, useful assessment tools for addiction in the 
        clinical setting of initial and ongoing treatment of conditions 
        requiring the use of controlled substances.
            (6) Development of better methods of ensuring patient 
        adherence to prescribed drug regimens.
            (7) Relative contributions of genetic, psychosocial, 
        environmental, and behavioral factors to addiction to 
        prescription opioids.
    (b) Report.--Not later than 2 years after the date of the enactment 
of this Act, the Secretary of Health and Human Services shall submit to 
the Congress a report on the results of the research conducted under 
this section.

SEC. 8. DATABASE FOR DRUG ABUSE MORTALITY REPORTING.

    Section 505 of the Public Health Service Act (42 U.S.C. 290aa-4) is 
amended--
            (1) in subparagraph (B) of subsection (c)(1), by striking 
        ``, as indicated in reports by coroners''; and
            (2) by adding at the end the following:
    ``(e) With respect to the activities of the Administrator under 
subsections (a) and (c)(1)(B) relating to the collection of data on the 
number of deaths occurring as a result of substance abuse, the 
Administrator--
            ``(1) shall expand and intensify collection activities to 
        maintain a comprehensive, national database on such deaths; and
            ``(2) shall require medical examiners, coroners, and other 
        appropriate persons to report to the Administrator for purposes 
        of collecting data on such deaths.''
                                 <all>