II 

117TH CONGRESS 

1ST SESSION S. 2257 

To provide Federal support for nonprofit generic and essential medicine 

and device manufacturers to increase the availability of drugs and devices 

in order to reduce drug or device shortages and drug and device costs. 

IN THE SENATE OF THE UNITED STATES 

JUNE 24, 2021 

Ms. ROSEN introduced the following bill; which was read twice and referred 

to the Committee on Finance 

A BILL 

To provide Federal support for nonprofit generic and essential medicine and device manufacturers to increase the 

availability of drugs and devices in order to reduce drug 

or device shortages and drug and device costs. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Expanding Access to 

5 Affordable Prescription Drugs and Medical Devices Act’’. 


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1 SEC. 2. SUPPORTING NONPROFIT GENERIC AND ESSENTIAL 

2 MEDICINES AND DEVICE MANUFACTURERS. 

3 (a) IN GENERAL.—Part P of title III of the Public 

4 Health Service Act (42 U.S.C. 280g et seq.) is amended 

5 by adding at the end the following: 

6 ‘‘SEC. 399V–7. SUPPORTING NONPROFIT GENERIC AND ES7 SENTIAL MEDICINES AND DEVICE MANUFAC8 TURERS. 

9 ‘‘(a) IN GENERAL.—The Secretary shall award coop10 erative agreements and low interest revolving loans to, and 

11 waive user fees with respect to, nonprofit entities to sup12 port the manufacture and distribution within the United 

13 States of eligible drugs and eligible devices. 

14 ‘‘(b) TERMS OF COOPERATIVE AGREEMENTS AND

15 LOANS.— 

16 ‘‘(1) COOPERATIVE AGREEMENTS.— 

17 ‘‘(A) INITIAL AWARDS.—Each cooperative 

18 agreement awarded under this section shall be 

19 for an initial period determined by the Sec20 retary, not to exceed 5 years, and shall be in an 

21 amount determined by the Secretary, not to ex22 ceed $5,000,000. 

23 ‘‘(B) SUBSEQUENT AWARDS.—An entity 

24 receiving a cooperative agreement under this 

25 section may apply for additional awards with 

26 respect to other eligible drugs or eligible devices 


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1 under this subsection. The Secretary may 

2 award additional cooperative agreements to 

3 such entities, for periods not to exceed 5 years, 

4 in amounts not to exceed $5,000,000. 

5 ‘‘(C) EXTENSIONS.—The Secretary may 

6 extend the initial time period of a cooperative 

7 agreement awarded under subparagraph (A) or 

8 (B), but the total award amount of the original 

9 award plus any extension may not exceed 

10 $5,000,000. 

11 ‘‘(2) LOW INTEREST REVOLVING LOANS.—Each 

12 loan awarded under this section shall be for a period 

13 determined by the Secretary, with an interest rate 

14 not greater than the Federal Reserve benchmark in15 terest rate plus 3 percent, and in an amount not 

16 greater than $5,000,000. 

17 ‘‘(c) APPLICATIONS.— 

18 ‘‘(1) IN GENERAL.—To be eligible to receive a 

19 cooperative agreement or loan under this section, an 

20 entity shall— 

21 ‘‘(A) be an organization that— 

22 ‘‘(i) manufactures, or facilitates the 

23 manufacture of, finished drug products or 

24 devices in the United States; 


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1 ‘‘(ii) is an organization described in 

2 paragraph (3) or (4) of section 501(c) of 

3 the Internal Revenue Code of 1986 and ex4 empt from tax under section 501(a) of 

5 such Code; and 

6 ‘‘(iii) is based in the United States; 

7 ‘‘(B) demonstrate expertise in the process 

8 of drug or device manufacturing, and the ability 

9 to fully comply with all applicable State and 

10 Federal requirements; 

11 ‘‘(C) agree to ensure that— 

12 ‘‘(i) the highest total compensation of13 fered to any employee of such entity is not 

14 more than 40 times greater than the total 

15 compensation offered to the lowest-com16 pensated employee, including any self-em17 ployed independent contracted workers on 

18 an hourly wage, of such entity; 

19 ‘‘(ii) among drugs that may be self20 administered by patients and remaining 

21 after application of clause (iii), other than 

22 such drugs that are not required to be dis23 tributed through pharmacies— 

24 ‘‘(I) the entity shall report to the 

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1 riers faced in making the drug widely 

2 available through retail pharmacies; 

3 and 

4 ‘‘(II) the entity shall, on an an5 nual basis and in a manner prescribed 

6 by the Secretary, make publicly avail7 able complete information on the 

8 availability of the drug from retail 

9 pharmacies; and 

10 ‘‘(iii) if the Secretary identifies a need 

11 to supplement the strategic national stock12 pile under section 319F–2, the Secretary 

13 has priority access to purchase, at the av14 erage cost price offered to other pur15 chasers, a quantity of the drug or device 

16 equivalent to at least 25 percent of the en17 tity’s production, or such percentage of 

18 such supply as the Secretary, in consulta19 tion with the entity, determines appro20 priate, consistent with public health needs, 

21 until the need has been met; 

22 ‘‘(D) include a timeline for any drugs or 

23 devices manufactured by the entity that are ex24 pected to come to market within the duration of 

25 the cooperative agreement or loan, with at least 


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1 one such drug or device expected to come to 

2 market within 5 years of starting the coopera3 tive agreement or loan; and 

4 ‘‘(E) submit an application at such time, 

5 in such manner, and containing such additional 

6 information as the Secretary may require. 

7 ‘‘(2) PRIORITY.—In awarding cooperative 

8 agreements and loans under this section, the Sec9 retary shall give priority to applications from entities 

10 that are expected to manufacture and take to mar11 ket eligible drugs or eligible devices at a price that 

12 is lower than existing treatments for the same dis13 ease or condition that such drug or device is in14 tended to treat, or to entities that are expected to 

15 manufacture any eligible drug or eligible device iden16 tified as a public health priority by the Secretary. 

17 ‘‘(3) CALCULATION OF WAGES.—For purposes 

18 of paragraph (1)(C)(i) to calculate employee com19 pensation with respect to part-time employees, the 

20 Secretary shall calculate the compensation such em21 ployees would receive if they were to work full-time 

22 at their existing hourly wages. 

23 ‘‘(4) REPORT.—The Secretary shall report to 

24 Congress annually regarding barriers reported by 

25 entities regarding availability of drugs described in 


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1 paragraph (1)(C)(ii) (other than such drugs that are 

2 not required to be distributed through pharmacies) 

3 through retail pharmacies and regulatory or legisla4 tive recommendations to improve public access to 

5 such drugs. 

6 ‘‘(d) DEFINITIONS.—For purposes of this section— 

7 ‘‘(1) the term ‘eligible device’ means a device— 

8 ‘‘(A)(i) that is approved under section 515 

9 of the Federal Food, Drug, and Cosmetic Act, 

10 cleared under section 510(k) of such Act, or au11 thorized under section 513(f)(2) of such Act; 

12 ‘‘(ii) for which the device manufacturer ap13 plying for a cooperative agreement under sub14 section (a) or a low interest revolving loan 

15 under subsection (b) has submitted an applica16 tion under section 515 of the Federal Food, 

17 Drug, and Cosmetic Act, or a notification under 

18 section 510(k) or 513(f)(2) of such Act; or 

19 ‘‘(iii) that is urgently needed to meet a 

20 public health need, as determined by the Sec21 retary, and for which the device manufacturer 

22 applying for a cooperative agreement under 

23 subsection (a) or a low interest revolving loan 

24 under subsection (b) has provided a timeline for 

25 submission of an application under section 515 


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1 of the Federal Food, Drug, and Cosmetic Act, 

2 or a notification under section 510(k) or 

3 513(f)(2) of such Act; and 

4 ‘‘(B) that the Secretary has deemed essen5 tial on the basis of— 

6 ‘‘(i) there being 2 or fewer active 

7 manufacturers of the device or a substan8 tially similar device; 

9 ‘‘(ii) the device having been on the de10 vice shortage list under section 506J(g) of 

11 the Federal Food, Drug, and Cosmetic Act 

12 at any time in the past 5 years; 

13 ‘‘(iii) similar devices have increased in 

14 cost more than the rate of inflation over 

15 the most recent 5-year period; 

16 ‘‘(iv) the device meeting an otherwise 

17 unmet critical public health need; or 

18 ‘‘(v) other factors, as determined by 

19 the Secretary; and 

20 ‘‘(2) the term ‘eligible drug’ means a drug— 

21 ‘‘(A)(i) that is approved by the Food and 

22 Drug Administration under section 505 of the 

23 Federal Food, Drug, and Cosmetic Act or li24 censed under section 351 of this Act; 


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1 ‘‘(ii) for which the drug manufacturer ap2 plying for a cooperative agreement under sub3 section (a) or a low interest revolving loan 

4 under subsection (b) has submitted an applica5 tion under subsection (b)(2) or (j) of section 

6 505 of the Federal Food, Drug, and Cosmetic 

7 Act or under section 351(k) of this Act; or 

8 ‘‘(iii) that is urgently needed to meet a 

9 public health need, as determined by the Sec10 retary, and for which the drug manufacturer 

11 applying for a cooperative agreement under 

12 subsection (a) or a low interest revolving loan 

13 under subsection (b) has provided a timeline for 

14 submission of an application under subsection 

15 (b) or (j) of section 505 of the Federal Food, 

16 Drug, and Cosmetic Act or under subsection (a) 

17 or (k) of section 351 of this Act; and 

18 ‘‘(B) that the Secretary has deemed essen19 tial on the basis of— 

20 ‘‘(i) there being 2 or fewer active 

21 manufacturers of the drug; 

22 ‘‘(ii) the drug having been on the drug 

23 shortage list under section 506E of the 

24 Federal Food, Drug, and Cosmetic Act at 

25 any time in the past 5 years; 


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1 ‘‘(iii) alternative treatments for the 

2 disease or condition the drug is intended to 

3 treat costing more than $50 per 1-month 

4 supply according to the public list price; 

5 ‘‘(iv) the drug meeting an otherwise 

6 unmet critical public health need; or 

7 ‘‘(v) other purposes, as determined by 

8 the Secretary. 

9 ‘‘(e) USE OF FUNDS.—A recipient of an award under 

10 this section may use funds for start-up, research and de11 velopment, or expansion costs associated with the manu12 facture of eligible drugs or eligible devices, in accordance 

13 with the terms of the applicable cooperative agreement or 

14 loan. 

15 ‘‘(f) REPORT.—Not later than 3 years after the date 

16 of enactment of the Expanding Access to Affordable Pre17 scription Drugs and Medical Devices Act and annually 

18 thereafter, the Secretary shall submit a report to Congress 

19 on, with respect to the applicable reporting period— 

20 ‘‘(1) the number of grants and loans awarded 

21 under the program; 

22 ‘‘(2) the drugs and devices that came to market 

23 with support from grants or loans under the pro24 gram; 


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1 ‘‘(3) a cost-savings analysis for all federally2 funded health programs, based on savings that were 

3 realized due to a drug or device whose manufacturer 

4 was supported by a grant under this section; and 

5 ‘‘(4) a cost-savings analysis for consumer out6 of-pocket and insurance premium spending, based on 

7 savings that were realized due to a drug or device 

8 whose manufacturer was supported by a grant under 

9 this section, and any impact on consumer access to 

10 the drug or device. 

11 ‘‘(g) WAIVER OF USER FEES WITH RESPECT TO EN12 TITIES NOT RECEIVING AN AWARD.— 

13 ‘‘(1) IN GENERAL.—With respect to an entity 

14 that is an organization described in paragraph (2), 

15 the Secretary shall waive the following fees that 

16 would otherwise be applicable during the period dur17 ing which such entity is so exempt and is manufac18 turing such product: 

19 ‘‘(A) Fees under paragraphs (1) and (2) of 

20 section 736(a) of the Federal Food, Drug, and 

21 Cosmetic Act. 

22 ‘‘(B) Fees under paragraphs (2) and (3) of 

23 section 738(a) of the Federal Food, Drug, and 

24 Cosmetic Act. 


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1 ‘‘(C) Fees under paragraphs (3), (4), and 

2 (5) of section 744B(a) of the Federal Food, 

3 Drug, and Cosmetic Act. 

4 ‘‘(D) Fees under paragraphs (1)(A), 

5 (1)(B), (2), and (3) of section 744H of the 

6 Federal Food, Drug, and Cosmetic Act. 

7 ‘‘(2) ENTITY DESCRIBED.—An entity described 

8 in this paragraph is an entity that— 

9 ‘‘(A) is described in paragraph (3) or (4) 

10 of section 501(c) of the Internal Revenue Code 

11 of 1986 and exempt from tax under section 

12 501(a) of such Code; 

13 ‘‘(B) manufactures an eligible drug or eli14 gible device; and 

15 ‘‘(C) is not currently receiving a loan or 

16 cooperative agreement under this section. 

17 ‘‘(h) FUNDING.— 

18 ‘‘(1) AUTHORIZATION OF APPROPRIATIONS.— 

19 To carry out this section, there are authorized to be 

20 appropriated such sums as may be necessary for 

21 each of fiscal years 2022 through 2031. 

22 ‘‘(2) LOAN REPAYMENTS.—In addition to any 

23 amounts appropriated under paragraph (1), the Sec24 retary of the Treasury shall transfer to the Sec25 retary of Health and Human Services annually an 


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1 amount equal to the amount received for the pre2 vious year in payments on loans awarded under this 

3 section for purposes of carrying out the program 

4 under this section with respect to loans.’’. 

5 (b) CBO REPORT.—Not later than 1 year after the 

6 date of enactment of this Act, the Director of the Congres7 sional Budget Office shall submit budget-neutral or cost8 savings policy options to Congress showing ways to cap9 ture the savings from nonprofit drug and device manufac10 turers supported by the program under section 399V–7 

11 of the Public Health Service Act, as added by subsection 

12 (a). Such options shall direct at least half of such savings 

13 to create a mandatory funding stream to support grants 

14 and low-interest loans similar to grants and loans offered 

15 under section 399V–7 of the Public Health Service Act, 

16 as added by subsection (a), and any remaining portion of 

17 such savings toward ensuring the solvency of the Medicare 

18 program under title XVIII of the Social Security Act (42 

19 U.S.C. 1395 et seq.) and reducing out-of-pocket and pre20 mium costs under such program. 

21 (c) PRIORITY REVIEW.— 

22 (1) NDAS.—The Secretary of Health and 

23 Human Services may grant priority review, as de24 scribed in the Manual of Policies and Procedures of 

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1 fied in the letters described in section 101(b) of the 

2 Prescription Drug User Fee Amendments of 2017, 

3 for any application that includes a commitment to a 

4 specific price that represents a significant cost re5 duction compared to similar treatments on the mar6 ket, if the sponsor is a qualified drug or device man7 ufacturing organization (as defined in section 

8 501(s)(4) of the Internal Revenue Code of 1986). 

9 (2) ANDAS.—Section 505(j)(11)(A) of the 

10 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

11 355(j)(11)(A)) is amended— 

12 (A) in clause (i), by striking ‘‘; or’’ and in13 serting a semicolon; 

14 (B) in clause (ii), by striking the period 

15 and inserting ‘‘; or’’; and 

16 (C) by adding at the end the following: 

17 ‘‘(iii) for which the sponsor is a qualified drug 

18 or device manufacturing organization (as defined in 

19 section 501(s)(4) of the Internal Revenue Code of 

20 1986), and commits to a specific price that rep21 resents a significant cost reduction compared to 

22 similar treatments on the market.’’. 

23 (3) BIOSIMILAR BIOLOGICAL PRODUCTS.—The 

24 Secretary of Health and Human Services may grant 

25 priority review for any application under section 


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1 351(k) of the Public Health Service Act (42 U.S.C. 

2 262(k)) that includes a commitment to a specific 

3 price that represents a significant cost reduction 

4 compared to similar treatments on the market, if the 

5 sponsor is a qualified drug or device manufacturing 

6 organization (as defined in section 501(s)(4) of the 

7 Internal Revenue Code of 1986). 

8 (4) BREAKTHROUGH DEVICES.—Section 

9 515B(b)(2) of the Federal Food, Drug, and Cos10 metic Act (21 U.S.C. 360e–3(b)(2)) is amended— 

11 (A) in subparagraph (C), by striking ‘‘; or’’ 

12 and inserting a semicolon; 

13 (B) by redesignating subparagraph (D) as 

14 subparagraph (E); and 

15 (C) by inserting after subparagraph (C) 

16 the following: 

17 ‘‘(D) for which the sponsor is a qualified drug 

18 or device manufacturing organization (as defined in 

19 section 501(s)(4) of the Internal Revenue Code of 

20 1986), and commits to a specific price that rep21 resents a significant cost reduction compared to 

22 similar treatments on the market; or’’. 


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1 SEC. 3. ADDITIONAL RULES FOR TAX-EXEMPT STATUS OF 

2 CERTAIN DRUG AND MEDICAL DEVICE MANU3 FACTURERS. 

4 (a) IN GENERAL.—Section 501 of the Internal Rev5 enue Code of 1986 is amended by adding at the end the 

6 following new subsection: 

7 ‘‘(s) ADDITIONAL REQUIREMENTS FOR CERTAIN

8 DRUG OR MEDICAL DEVICE MANUFACTURERS.— 

9 ‘‘(1) TREATMENT AS CHARITABLE ORGANIZA10 TION.—A qualified drug or medical device manufac11 turing organization shall be treated as an organiza12 tion organized and operated exclusively for chari13 table purposes under subsection (c)(3) if— 

14 ‘‘(A) such organization meets the require15 ments under paragraph (4), 

16 ‘‘(B) no part of the net earnings of such 

17 organization inures to the benefit of any private 

18 shareholder or individual, 

19 ‘‘(C) no substantial part of the activities of 

20 such organization is carrying on propaganda, or 

21 otherwise attempting, to influence legislation 

22 (except as otherwise provided in subsection (h)), 

23 and 

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1 ical campaign on behalf of (or in opposition to) 

2 any candidate for public office. 

3 ‘‘(2) TREATMENT AS SOCIAL WELFARE ORGANI4 ZATION.—A qualified drug or medical device organi5 zation shall be treated as an organization organized 

6 and operated primarily to promote social welfare 

7 under subsection (c)(4) if— 

8 ‘‘(A) such organization meets the require9 ments under paragraph (4), and 

10 ‘‘(B) no part of the net earnings of such 

11 organization inures to the benefit of any private 

12 shareholder or individual. 

13 ‘‘(3) QUALIFIED DRUG OR MEDICAL DEVICE

14 MANUFACTURING ORGANIZATION.—For purposes of 

15 this section— 

16 ‘‘(A) IN GENERAL.—The term ‘qualified 

17 drug or medical device manufacturing organiza18 tion’ means an organization that is organized 

19 and operated exclusively for the production of 

20 drugs or devices. 

21 ‘‘(B) SPECIAL RULE.—An organization 

22 shall not fail to be treated as a qualified drug 

23 or medical device manufacturing organization 

24 solely because such organization provides public 

25 health education, conducts public health 


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1 screenings, or conducts other related charitable 

2 activities. 

3 ‘‘(4) REQUIREMENTS.—The requirements of 

4 this paragraph are as follows: 

5 ‘‘(A) ORGANIZATION AND OPERATION.— 

6 The organization is organized as a nonprofit 

7 corporation under State law and is compliant 

8 with the laws of the State pertaining to oper9 ation as a pharmaceutical or medical device 

10 manufacturer. 

11 ‘‘(B) DRUGS AND DEVICES.—Each drug or 

12 device manufactured by the organization— 

13 ‘‘(i) furthers a public health objective 

14 (as determined by the Secretary, in con15 sultation with the Secretary of Health and 

16 Human Services), such as addressing bar17 riers related to availability, shortage, or 

18 price, and 

19 ‘‘(ii) meets such other requirements, 

20 as determined by the Secretary, in con21 sultation with the Secretary of Health and 

22 Human Services. 

23 ‘‘(C) LIST PRICE.— 

24 ‘‘(i) IN GENERAL.—The organization 

25 establishes a public list price for each drug 


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1 or device manufactured by the organization 

2 in accordance with clause (ii) and charges 

3 no more than such public list price. 

4 ‘‘(ii) MAXIMUM LIST PRICE.—The 

5 amount of the public list price established 

6 under this clause with respect to any drug 

7 or device shall not be more than 120 per8 cent of the sum of— 

9 ‘‘(I) the production costs for the 

10 drug or device, 

11 ‘‘(II) an amount calculated to re12 cover up to the previous 5 years of 

13 qualified research expenses (as de14 fined in section 41) attributable to the 

15 drug or device over a 5-year period, 

16 ‘‘(III) the regulatory costs associ17 ated with developing and maintaining 

18 a marketed drug or device, 

19 ‘‘(IV) the anticipated costs (not 

20 greater than the usual and customary 

21 rates) of storing, warehousing, and 

22 distributing the drug or device, plus 

23 ‘‘(V) interest on loans directly fi24 nancing the development or produc25 tion of the drug or device. 


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1 ‘‘(D) COMPENSATION.— 

2 ‘‘(i) IN GENERAL.—The organization 

3 meets the requirements of clauses (ii), (iii), 

4 and (iv). 

5 ‘‘(ii) COMPENSATION AMOUNT.— 

6 ‘‘(I) IN GENERAL.—The highest 

7 total remuneration offered to any em8 ployee of the organization or of an ap9 plicable independent contractor of the 

10 organization is not more than 40 

11 times greater than the total remu12 neration offered to the lowest-com13 pensated employee of the organization 

14 or of any applicable independent con15 tractor of the organization. For pur16 poses of this clause, the compensation 

17 provided to a part-time hourly em18 ployee shall be determined by applying 

19 such employee’s hourly wage to the 

20 number of hours of a full-time em21 ployee. 

22 ‘‘(II) APPLICABLE INDEPENDENT

23 CONTRACTOR.—The term ‘applicable 

24 independent contractor’ means, with 

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1 pendent contractor that has less than 

2 2 employees and the contract for 

3 which specifies an hourly rate. 

4 ‘‘(iii) COMPENSATION OF OTHER

5 INDEPENDENT CONTRACTORS.—In the 

6 case of any independent contractor of the 

7 organization that is not an applicable inde8 pendent contractor, the organization— 

9 ‘‘(I) compensates any work done 

10 at a fair market rate, and 

11 ‘‘(II) keeps such financial infor12 mation as required by the Secretary 

13 with respect to amounts paid to such 

14 independent contractors. 

15 ‘‘(iv) PROHIBITION ON OUTSIDE COM16 PENSATION.—The organization does not 

17 permit employees to be compensated from 

18 any other person for work related to the 

19 organization. 

20 ‘‘(E) BOARD OF DIRECTORS.—The organi21 zation— 

22 ‘‘(i) maintains an independent board 

23 of directors, and 

24 ‘‘(ii) maintains a clear financial sepa25 ration from— 


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1 ‘‘(I) entities with which the orga2 nization conducts business, and 

3 ‘‘(II) entities from which the or4 ganization purchases goods or serv5 ices. 

6 ‘‘(5) OTHER DEFINITIONS.—For purposes of 

7 this subsection— 

8 ‘‘(A) DRUG.—The term ‘drug’ means any 

9 drug that is approved under section 505 of the 

10 Federal Food, Drug, and Cosmetic Act (21 

11 U.S.C. 355) or licensed under section 351 of 

12 the Public Health Service Act (42 U.S.C. 262). 

13 ‘‘(B) DEVICE.—The term ‘device’ means 

14 any device that is approved under section 515 

15 of the Federal Food, Drug, and Cosmetic Act 

16 (21 U.S.C. 360e), cleared under section 510(k) 

17 of such Act (21 U.S.C. 360(k)), or authorized 

18 under section 513(f)(2) of such Act (21 U.S.C. 

19 360c(f)(2)). 

20 ‘‘(6) REGULATIONS.—The Secretary shall issue 

21 such regulations and guidance as may be necessary 

22 to carry out the provisions of this subsection, includ23 ing guidance relating to determining acceptable 

24 methods for making the calculation under paragraph 

25 (4)(C)(ii).’’. 


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1 (b) TREATMENT AS A PUBLIC CHARITY.—Section 

2 509(a) of the Internal Revenue Code of 1986 is amended 

3 by striking ‘‘and’’ at the end of paragraph (3), by striking 

4 the period at the end of paragraph (4) and inserting ‘‘, 

5 and’’, and by inserting after paragraph (4) the following 

6 new paragraph: 

7 ‘‘(5) an organization which meets the require8 ments of subparagraphs (A), (B), (C), and (D) of 

9 section 501(s)(1).’’. 

10 (c) EFFECTIVE DATE.—The amendments made by 

11 this section shall apply to taxable years beginning after 

12 the date of the enactment of this Act. 

13 (d) SENSE OF THE SENATE.—It is the sense of the 

14 Senate that nothing in the amendments made by this sec15 tion shall be construed to prevent an organization that 

16 manufactures drugs or medical devices and that is other17 wise described in paragraph (3) or (4) of section 501(c) 

18 of the Internal Revenue Code of 1986 from being treated 

19 as an organization that is so described. 

Æ 


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