instruction:
In this task, you are given text for US Congressional and California state bills, your task is to generate a summary for this bill.
question:
SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Drug Competition Act of 2002''.

SEC. 2. FINDINGS.

    Congress finds that--
            (1) prescription drug prices are increasing at an alarming 
        rate and are a major worry of many senior citizens and American 
        families;
            (2) there is a potential for companies with patent rights 
        regarding brand name drugs and companies which could 
        manufacture generic versions of such drugs to enter into 
        financial deals that could tend to restrain trade and greatly 
        reduce competition and increase prescription drug expenditures 
        for American citizens; and
            (3) enhancing competition among these companies can 
        significantly reduce prescription drug expenditures for 
        Americans.

SEC. 3. PURPOSES.

    The purposes of this Act are--
            (1) to provide timely notice to the Department of Justice 
        and the Federal Trade Commission regarding agreements between 
        companies with patent rights regarding brand name drugs and 
        companies which could manufacture generic versions of such 
        drugs; and
            (2) by providing timely notice, to enhance the 
        effectiveness and efficiency of the enforcement of the 
        antitrust and competition laws of the United States.

SEC. 4. DEFINITIONS.

    In this Act:
            (1) ANDA.--The term ``ANDA'' means an Abbreviated New Drug 
        Application, as defined under section 201(aa) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 321(aa)).
            (2) Assistant attorney general.--The term ``Assistant 
        Attorney General'' means the Assistant Attorney General in 
        charge of the Antitrust Division of the Department of Justice.
            (3) Brand name drug.--The term ``brand name drug'' means a 
        drug approved under section 505(c) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 355(c)).
            (4) Brand name drug company.--The term ``brand name drug 
        company'' means the party that received Food and Drug 
        Administration approval to market a brand name drug pursuant to 
        an NDA, where that drug is the subject of an ANDA, or a party 
        owning or controlling enforcement of any patent listed in the 
        Approved Drug Products With Therapeutic Equivalence Evaluations 
        of the Food and Drug Administration for that drug, under 
        section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355(b)).
            (5) Commission.--The term ``Commission'' means the Federal 
        Trade Commission.
            (6) Generic drug.--The term ``generic drug'' means a 
        product that the Food and Drug Administration has approved 
        under section 505(j) of the Federal Food, Drug, and Cosmetic 
        Act (21 U.S.C. 355(j)).
            (7) Generic drug applicant.--The term ``generic drug 
        applicant'' means a person who has filed or received approval 
        for an ANDA under section 505(j) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355(j)).
            (8) NDA.--The term ``NDA'' means a New Drug Application, as 
        defined under section 505(b) et seq. of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 355(b) et seq.)

SEC. 5. NOTIFICATION OF AGREEMENTS.

    (a) In General.--
            (1) Requirement.--A generic drug applicant that has 
        submitted an ANDA containing a certification under section 
        505(j)(2)(vii)(IV) of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 355(j)(2)(vii)(IV)) and a brand name drug company 
        that enter into an agreement described in paragraph (2), prior 
        to the generic drug that is the subject of the application 
        entering the market, shall each file the agreement as required 
        by subsection (b).
            (2) Definition.--An agreement described in this paragraph 
        is an agreement regarding--
                    (A) the manufacture, marketing or sale of the brand 
                name drug that is the subject of the generic drug 
                applicant's ANDA;
                    (B) the manufacture, marketing or sale of the 
                generic drug that is the subject of the generic drug 
                applicant's ANDA; or
                    (C) the 180-day period referred to in section 
                505(j)(5)(B)(iv) of the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 355(j)(5)(B)(iv)) as it applies 
                to such ANDA or to any other ANDA based on the same 
                brand name drug.
    (b) Filing.--
            (1) Agreement.--The generic drug applicant and the brand 
        name drug company entering into an agreement described in 
        subsection (a)(2) shall file with the Assistant Attorney 
        General and the Commission the text of any such agreement, 
        except that the generic drug applicant and the brand-name drug 
        company shall not be required to file an agreement that solely 
        concerns--
                    (A) purchase orders for raw material supplies;
                    (B) equipment and facility contracts;
                    (C) employment or consulting contracts; or
                    (D) packaging and labeling contracts.
            (2) Other agreements.--The generic drug applicant and the 
        brand name drug company entering into an agreement described in 
        subsection (a)(2) shall file with the Assistant Attorney 
        General and the Commission the text of any other agreements not 
        described in subsection (a)(2) between the generic drug 
        applicant and the brand name drug company which are contingent 
        upon, provide a contingent condition for, or are otherwise 
        related to an agreement which must be filed under this Act.
            (3) Description.--In the event that any agreement required 
        to be filed by paragraph (1) or (2) has not been reduced to 
        text, both the generic drug applicant and the brand name drug 
        company shall file written descriptions of the non-textual 
        agreement or agreements that must be filed sufficient to reveal 
        all of the terms of the agreement or agreements.

SEC. 6. FILING DEADLINES.

    Any filing required under section 5 shall be filed with the 
Assistant Attorney General and the Commission not later than 10 
business days after the date the agreements are executed.

SEC. 7. DISCLOSURE EXEMPTION.

    Any information or documentary material filed with the Assistant 
Attorney General or the Commission pursuant to this Act shall be exempt 
from disclosure under section 552 of title 5, and no such information 
or documentary material may be made public, except as may be relevant 
to any administrative or judicial action or proceeding. Nothing in this 
section is intended to prevent disclosure to either body of Congress or 
to any duly authorized committee or subcommittee of the Congress.

SEC. 8. ENFORCEMENT.

    (a) Civil Penalty.--Any brand name drug company or generic drug 
applicant which fails to comply with any provision of this Act shall be 
liable for a civil penalty of not more than $11,000, for each day 
during which such entity is in violation of this Act. Such penalty may 
be recovered in a civil action brought by the United States, or brought 
by the Commission in accordance with the procedures established in 
section 16(a)(1) of the Federal Trade Commission Act (15 U.S.C. 56(a)).
    (b) Compliance and Equitable Relief.--If any brand name drug 
company or generic drug applicant fails to comply with any provision of 
this Act, the United States district court may order compliance, and 
may grant such other equitable relief as the court in its discretion 
determines necessary or appropriate, upon application of the Assistant 
Attorney General or the Commission.

SEC. 9. RULEMAKING.

    The Commission, with the concurrence of the Assistant Attorney 
General and by rule in accordance with section 553 of title 5 United 
States Code, consistent with the purposes of this Act--
            (1) may define the terms used in this Act;
            (2) may exempt classes of persons or agreements from the 
        requirements of this Act; and
            (3) may prescribe such other rules as may be necessary and 
        appropriate to carry out the purposes of this Act.

SEC. 10. SAVINGS CLAUSE.

    Any action taken by the Assistant Attorney General or the 
Commission, or any failure of the Assistant Attorney General or the 
Commission to take action, under this Act shall not bar any proceeding 
or any action with respect to any agreement between a brand name drug 
company and a generic drug applicant at any time under any other 
provision of law, nor shall any filing under this Act constitute or 
create a presumption of any violation of any antitrust or competition 
laws.

SEC. 11. EFFECTIVE DATE.

    This Act shall--
            (1) take effect 30 days after the date of enactment of this 
        Act; and
            (2) shall apply to agreements described in section 5 that 
        are entered into 30 days after the date of enactment of this 
        Act.

            Passed the Senate November 18, 2002.

            Attest:

                                                  JERI THOMSON,

                                                             Secretary.
answer:
Drug Competition Act of 2002 - (Sec. 5) Requires a generic drug applicant that has submitted an Abbreviated New Drug Application (ANDA) and a brand name drug company that enter into an agreement, prior to the generic drug entering the market, regarding the manufacture, marketing, or sale of the brand name or the generic drug, or regarding the 180-day semi-exclusivity period referred to in the Federal Food, Drug, and Cosmetic Act as it applies to such ANDA or any other ANDA based on the same brand name drug, to each file such agreement and any related agreements with the Assistant Attorney General and the Federal Trade Commission (FTC). Makes an exception for agreements that solely concern purchase orders for raw material supplies, equipment and facility contracts, or employment or consulting contracts. Requires such agreements to be filed not later than ten business days after the date they are executed.(Sec. 7) Exempts any such information or documentary material filed from disclosure under the Freedom of Information Act. Prohibits such information or material from being made public, except as relevant to any administrative or judicial action or proceeding.(Sec. 8) Subjects an applicant or company to a civil penalty of up to $11,000 for each day such entity fails to comply with this Act, recoverable in a civil action brought by the United States or the FTC. Authorizes a U.S. district court to order compliance and grant equitable relief.


question:
SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Educational Empowerment Act''.

SEC. 2. DESIGNATION OF EDUCATIONAL EMPOWERMENT ZONES.

    (a) In General.--Chapter 1 of the Internal Revenue Code of 1986 is 
amended by adding at the end the following new subchapter:

             ``Subchapter X--Educational Empowerment Zones

        ``Sec. 1400E. Designation of educational empowerment zones.

``SEC. 1400E. DESIGNATION OF EDUCATIONAL EMPOWERMENT ZONES.

    ``(a) Designation.--
            ``(1) Educational empowerment zone.--For purposes of this 
        title, the term `educational empowerment zone' means any area--
                    ``(A) which is nominated by one or more local 
                governments and the State or States in which it is 
                located for designation as an educational empowerment 
                zone (hereinafter in this section referred to as a 
                `nominated area'), and
                    ``(B) which the Secretary of Health and Human 
                Services and the Secretary of Education (hereinafter in 
                this section referred to as the `Secretaries 
                concerned') jointly designate as an educational 
                empowerment zone.
            ``(2) Number of designations.--The Secretaries concerned 
        may designate not more than 30 nominated areas as educational 
        empowerment zones.
            ``(3) Areas designated based on degree of poverty, etc.--
        Except as otherwise provided in this section, the nominated 
        areas designated as educational empowerment zones under this 
        subsection shall be those nominated areas with the highest 
        average ranking with respect to the criteria described in 
        subsection (c)(3). For purposes of the preceding sentence, an 
        area shall be ranked within each such criterion on the basis of 
        the amount by which the area exceeds such criterion, with the 
        area which exceeds such criterion by the greatest amount given 
        the highest ranking.
            ``(4) Limitation on designations.--
                    ``(A) Publication of regulations.--The Secretaries 
                concerned shall prescribe by regulation no later than 4 
                months after the date of the enactment of this 
                section--
                            ``(i) the procedures for nominating an area 
                        under paragraph (1)(A).
                            ``(ii) the parameters relating to the size 
                        and population characteristics of an 
                        educational empowerment zone, and
                            ``(iii) the manner in which nominated areas 
                        will be evaluated based on the criteria 
                        specified in subsection (c).
                    ``(B) Time limitations.--The Secretaries concerned 
                may designate nominated areas as educational 
                empowerment zones only during the 24-month period 
                beginning on the first day of the first month following 
                the month in which the regulations described in 
                subparagraph (A) are prescribed.
                    ``(C) Procedural rules.--The Secretaries concerned 
                shall not make any designation of a nominated area as 
                an educational empowerment zone under paragraph (2) 
                unless--
                            ``(i) a nomination regarding such area is 
                        submitted in such a manner and in such form, 
                        and contains such information, as the 
                        Secretaries concerned shall by regulation 
                        prescribe, and
                            ``(ii) the Secretaries concerned determine 
                        that any information furnished is reasonably 
                        accurate.
            ``(5) Nomination process for indian reservations.--For 
        purposes of this subchapter, in the case of a nominated area on 
        an Indian reservation, the reservation governing body (as 
        determined by the Secretary of the Interior) shall be treated 
        as being both the State and local governments with respect to 
        such area.
    ``(b) Period for Which Designation is in Effect.--Any designation 
of an area as an educational empowerment zone shall remain in effect 
during the period beginning on the date of the designation and ending 
on the earliest of--
            ``(1) December 31, 2007,
            ``(2) the termination date designated by the State and 
        local governments in their nomination, or
            ``(3) the date the Secretaries concerned revoke such 
        designation.
    ``(c) Area and Eligibility Requirements.--
            ``(1) In general.--The Secretary of Commerce may designate 
        a nominated area as an educational empowerment zone under 
        subsection (a) only if the area meets the requirements of 
        paragraphs (2) and (3) of this subsection.
            ``(2) Area requirements.--For purposes of paragraph (1), a 
        nominated area meets the requirements of this paragraph if--
                    ``(A) the area is within the jurisdiction of one or 
                more local governments,
                    ``(B) the boundary of the area is continuous, and
                    ``(C) the area does not include an empowerment zone 
                (as defined in section 1393(b)) other than such a zone 
                designated under section 1391(g).
            ``(3) Eligibility requirements.--For purposes of paragraph 
        (1), a nominated area meets the requirements of this paragraph 
        if the State and the local governments in which it is located 
        certify that the nominated area satisfies such conditions as 
        the Secretary of Education deems appropriate.
            ``(4) Consideration of dropout rate, etc.--The Secretary of 
        Education, in setting forth the conditions for eligibility 
        pursuant to paragraph (3), shall take into account the extent 
        to which an area has low-income families, a high dropout rate, 
        a high rate of teen pregnancy, and large school class size.
    ``(d) Coordination With Treatment of Enterprise Communities.--For 
purposes of this title, if there are in effect with respect to the same 
area both--
            ``(1) a designation as an educational empowerment zone, and
            ``(2) a designation as an enterprise community,
both of such designations shall be given full effect with respect to 
such area.
    ``(e) Definitions and Special Rules.--For purposes of this 
subchapter, rules similar to the rules of paragraphs (2), (3), (5), and 
(7) of section 1393 shall apply.''.
    (b) Clerical Amendment.--The table of subchapters for chapter 1 is 
amended by adding at the end the following new item:

                              ``Subchapter X. Educational Empowerment 
                                        Zones.''.

SEC. 3. CREDIT FOR DONATIONS TO SCHOOL DISTRICTS IN EDUCATIONAL 
              EMPOWERMENT ZONES.

    (a) In General.--Subpart B of part IV of subchapter A of chapter 1 
of the Internal Revenue Code of 1986 is amended by inserting after 
section 30A the following new section

``SEC. 30B. CONTRIBUTIONS TO SCHOOL DISTRICTS IN EDUCATIONAL 
              EMPOWERMENT ZONES.

    ``(a) Allowance of Credit.--There shall be allowed as a credit 
against the tax imposed by this chapter for the taxable year an amount 
equal to the amount of qualified educational empowerment zone 
contributions made by the taxpayer during such year.
    ``(b) Maximum Credit.--The amount of the credit allowed by 
subsection (a)--
            ``(1) in the case of an individual, shall not exceed 
        $2,000, and
            ``(2) in the case of any other taxpayer, shall not exceed 
        $10,000.
    ``(c) Definition of Qualified Educational Empowerment Zone 
Contributions.--For purposes of this section, the term `qualified 
educational empowerment zone contributions' means cash contributions 
made to any school district located in an educational empowerment zone 
(as designated under section 1400E) if such contributions--
            ``(1) but for subsection (d), would be allowable as a 
        deduction under section 170, and
            ``(2) are used for any of the following purposes by the 
        school district:
                    ``(A) Hiring new teachers.
                    ``(B) Increasing teacher salaries.
                    ``(C) Training teachers.
    ``(d) Denial of Double Benefit.--No deduction shall be allowed 
under this chapter for any contribution taken into account in computing 
the credit under this section.
    ``(e) Election.--This section shall apply to any taxpayer for any 
taxable year only if such taxpayer elects (at such time and in such 
manner as the Secretary may by regulations prescribe) to have this 
section apply for such taxable year.
    ``(f) Application With Other Credits; Carryover of Excess Credit.--
The credit allowed by subsection (a) for any taxable year shall not 
exceed the excess (if any) of--
            ``(1) the regular tax for the taxable year reduced by the 
        sum of the credits allowable under subpart A and the preceding 
        sections of this subpart, over
            ``(2) the tentative minimum tax for the taxable year.
If the credit under subsection (a) exceeds the limitation of the 
preceding sentence, such excess shall be added to the credit allowable 
under subsection (a) for the succeeding taxable year.''.
    (b) Clerical Amendment.--The table of sections for subpart B of 
part IV of subchapter A of chapter 1 of such Code is amended by 
inserting after the item relating to section 30A the following new 
item:

        ``Sec. 30B. Contributions to school districts in educational 
                            empowerment zones.''.
    (c) Effective Date.--The amendments made by this section shall 
apply to taxable years beginning after December 31, 2003.

SEC. 4. TEACHER LOAN FORGIVENESS PROGRAM.

    Part B of title IV of the Higher Education Act of 1965 is amended 
by inserting after section 428K (20 U.S.C. 1078-11) the following new 
section:

``SEC. 428L. LOAN FORGIVENESS FOR MATHEMATICS AND SCIENCE TEACHERS.

    ``(a) Purpose.--It is the purpose of this section to encourage more 
individuals to enter and stay in the field of teaching mathematics, 
science, and related fields.
    ``(b) Program.--
            ``(1) In general.--The Secretary shall carry out a program 
        of assuming the obligation to repay, pursuant to subsection 
        (c), a loan made, insured, or guaranteed under this part or 
        part D (excluding loans made under sections 428B and 428C or 
        comparable loans made under Part D) for any new borrower after 
October 12, 1998, who--
                    ``(A) has been employed as a full-time teacher for 
                3 consecutive complete school years in a school that is 
                located in an educational empowerment zone, as such 
                term is defined in section 1400E of the Internal 
                Revenue Code of 1986;
                    ``(B) is a fully qualified teacher; and
                    ``C) is not in default on a loan for which the 
                borrower seeks forgiveness.
            ``(2) Award basis; priority.--
                    ``(A) Award basis.--Subject to subparagraph (B), 
                loan repayment under this section shall be on a first-
                come, first-served basis and subject to the 
                availability of appropriations.
                    ``(B) Priority.--The Secretary shall give priority 
                in providing loan repayment under this section for a 
                fiscal year to student borrowers who received loan 
                repayment under this section for the preceding fiscal 
                year.
            ``(3) Regulations.--The Secretary is authorized to 
        prescribe such regulations as may be necessary to carry out the 
        provisions of this section.
    ``(c) Loan Repayment.--
            ``(1) Eligible amount.--The amount the Secretary may repay 
        on behalf of any individual under this section shall not 
        exceed--
                    ``(A) 80 percent of the sum of the principal 
                amounts outstanding of the individual's qualifying 
                loans at the end of 3 consecutive complete school years 
                of service described in subsection (b)(1)(A);
                    ``(B) an additional 10 percent of such sum at the 
                end of each of the next 2 consecutive complete school 
                years of such service; and
                    ``(C) a total of more than $10,000.
            ``(2) Construction.--Nothing in this section shall be 
        construed to authorize the refunding of any repayment of a loan 
        made under this part or part D.
            ``(3) Interest.--If a portion of a loan is repaid by the 
        Secretary under this section for any year, the proportionate 
        amount of interest on such loan which accrues for such year 
        shall be repaid by the Secretary.
            ``(4) Double benefits prohibited.--No borrower may, for the 
        same service, receive a benefit under both this section and 
        subtitle D of title I of the National and Community Service Act 
        of 1990 (42 U.S.C. 12601 et seq.). No borrower may receive a 
        reduction of loan obligations under both this section and 
        section 428J or 460.
    ``(d) Repayment to Eligible Lenders.--The Secretary shall pay to 
each eligible lender or holder for each fiscal year an amount equal to 
the aggregate amount of loans which are subject to repayment pursuant 
to this section for such year.
    ``(e) Application for Repayment.--
            ``(1) In general.--Each eligible individual desiring loan 
        repayment under this section shall submit a complete and 
        accurate application to the Secretary at such time, in such 
        manner, and containing such information as the Secretary may 
        require.
            ``(2) Conditions.--An eligible individual may apply for 
        loan repayment under this section after completing the required 
        number of years of qualifying employment.
            ``(3) Fully qualified teachers.--An application for loan 
        repayment under this section shall include such information as 
        is necessary to demonstrate that the applicant--
                    ``(A) if teaching in a public elementary or 
                secondary school (other than as a teacher in a public 
                charter school), has obtained State certification as a 
                teacher (including certification obtained through 
                alternative routes to certification) or passed the 
                State teacher licensing exam and holds a license to 
                teach in such State; and
                    ``(B) if teaching in--
                            ``(i) an elementary school, holds a 
                        bachelor's degree and demonstrates knowledge 
                        and teaching skills in reading, writing, 
                        mathematics, science, and other areas of the 
                        elementary school curriculum; or
                            ``(ii) a middle or secondary school, holds 
                        a bachelor's degree and demonstrates a high 
                        level of competency in all subject areas in 
                        which he or she teaches through--
                                    ``(I) a high level of performance 
                                on a rigorous State or local academic 
                                subject areas test; or
                                    ``(II) completion of an academic 
                                major in each of the subject areas in 
                                which he or she provides instruction.
    ``(f) Evaluation.--
            ``(1) In general.--The Secretary shall conduct, by grant or 
        contract, an independent national evaluation of the impact of 
        the program assisted under this section.
            ``(2) Competitive basis.--The grant or contract described 
        in subsection (b) shall be awarded on a competitive basis.
            ``(3) Contents.--The evaluation described in this 
        subsection shall--
                    ``(A) determine the number of individuals who were 
                encouraged by the program assisted under this section 
                to pursue teaching careers;
                    ``(B) determine the number of individuals who 
                remain employed in teaching mathematics, science, or 
                related fields as a result of participation in the 
                program;
                    ``(C) identify the barriers to the effectiveness of 
                the program;
                    ``(D) assess the cost-effectiveness of the program; 
                and
                    ``(E) identify the number of years each individual 
                participates in the program.
            ``(4) Interim and final evaluation reports.--The Secretary 
        shall prepare and submit to the President and the Congress such 
        interim reports regarding the evaluation described in this 
        subsection as the Secretary deems appropriate, and shall 
        prepare and so submit a final report regarding the evaluation 
        by January 1, 2006''.
answer:
Educational Empowerment Act - Amends the Internal Revenue Code to allow a tax credit for qualified educational empowerment zone contributions. Allows the designation of up to 30 such zones. Bases designations on the degree of poverty.Establishes a teacher loan forgiveness program for mathematics and science teachers.


question:
SECTION 1. SHORT TITLE AND PURPOSE

    (a) Short Title.--This Act may be cited as the ``Safe Medications 
Act of 1993''.
    (b) Purpose.--It is the purpose of this Act to have the Secretary 
of Health and Human Services create a data bank for reports of errors 
in the prescribing, dispensing, and administration of drugs, to 
establish a program using such data to assist in preventing such 
errors, and to educate and inform health care professionals of the 
deaths that may occur in the course of drug therapy.

SEC. 2. REPORTING.

    (a) In General.--Any pharmacy, hospital, long-term care facility, 
physician's office, or other health care facility, as defined by the 
Secretary of Health and Human Services by regulation, in which an error 
occurs in the prescribing, dispensing, or administration of a drug to 
an individual which results in the individual's death shall report such 
error and resulting death to the Secretary of Health and Human Services 
under section 3. Such a report shall be made not later than 10 working 
days after the date of the discovery of the error resulting in such 
death.
    (b) Report Requirements.--Each report of an error in the 
prescribing, dispensing, or administration of a drug to an individual 
shall contain--
            (1) an identification of the person making the report, 
        including the address and telephone number of such person, and 
        the name and address of the facility in which the error 
        occurred,
            (2) the brand names of the drugs involved, the generic 
        names of the drugs, the manufacturers of the drugs, the labeler 
        of the drug if different from the manufacturer, the dosage form 
        of the drugs, the strength of the drugs, and the type and size 
        of the containers,
            (3) the lot number of the drugs, if available,
            (4) a description of the error,
            (5) information on the patient for whom the drug was 
        prescribed, dispensed, or administered, including the patient's 
        age and sex,
            (6) the diagnosis for which the drug was prescribed, 
        dispensed, or administered,
            (7) the date and time the death, and
            (8) when and how the error was discovered.

SEC. 3. DATA BANK.

    (a) Establishment.--The Secretary of Health and Human Services, 
acting through the Commissioner of Food and Drugs, shall establish a 
data bank to receive reports under section 2 of errors resulting in 
deaths.
    (b) Secretarial Action.-- The Secretary shall review information 
reported to the data bank on an ongoing basis to determine trends 
relating to drugs and shall report such information to the compilers of 
the official compendia on an ongoing basis for consideration of 
revision of the packaging and labeling requirements or other standards 
for drugs for dissemination of information to physicians, pharmacists, 
and other health professionals involved in the prescribing, dispensing, 
and administration of drugs to patients. Such reporting of aggregate 
data shall be done in a manner which assists such health professionals 
in identifying and reducing patterns and incidents of inappropriate and 
misuse associated with certain drugs.
    (c) Confidentiality.-- The identity of a person making a report to 
the data bank, the deceased, or the individual believed to have caused 
the error shall be considered as privileged and confidential 
information for purposes of any law requiring disclosure of 
information.
    (d) Shared Information.--The Secretary shall share the reported 
information with licensing, accreditation, and inspection organizations 
for their followup with the appropriate organization to ensure that 
there has not been underreporting of medication errors related to 
deaths.
    (e) Enforcement.--Whoever with false pretenses reports to the data 
bank, requests information from the data bank, or unlawfully gains 
access to the data bank shall be fined not more than $15,000 or 
imprisoned for not more than 3 years, or both, except that if a person 
commits a violation of this subsection after a conviction for a 
violation of this subsection has become final, such person shall be 
fined not more than $25,000 or imprisoned for not more than 3 years, or 
both.

SEC. 4. PENALTIES.

    (a) Imposition of Fine.--Any institution that does not make a 
report as required by section 2 shall be subject to a fine of $15,000 
for each report not made. Within 60 days of a conviction under this 
subsection, a person shall submit to the Secretary of Health and Human 
Services a plan for the reporting to the data bank of drug prescribing, 
dispensing, and administration errors.
    (b) Mandatory Exclusion from Medicare and State Health Care 
Programs.--Section 1128(a) of the Social Security Act (42 U.S.C. 1320a-
7(a)) is amended by adding at the end the following new paragraph:
            ``(3) Failure to report deaths resulting from errors in the 
        prescribing, dispensing, and administration of drugs.--Any 
        individual or entity that has failed to meet the requirements 
        of section 2 of the Safe Medications Act of 1993.''.

SEC. 5. AUTHORIZATION.

    There are authorized to be appropriated to carry out this Act and 
the amendment made by this Act such sums as may be necessary.
answer:

Safe Medications Act of 1993 - Requires any health care facility in which an error in the prescribing, dispensing, or administration of a drug results in an individual's death, to report such error and resulting death to a data bank to be established by the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs.  Requires the Secretary to review reported information to determine trends relating to drugs and to report to compilers of the official compendia for consideration of revisions of packaging and labeling requirements and dissemination to health professionals. 
Imposes fines for reporting to or requesting information from the data bank under false pretenses and for gaining access to the data bank unlawfully.  Prescribes penalties for failing to make required reports. 
Amends the Social Security Act to exclude any individual or entity from Medicare and State health care programs for noncompliance with this Act. 
Authorizes appropriations.