US Codex
Pub. L.
Notes

Title I — Fees Relating to Drugs

115th Congress · Approved Aug 18, 2017 · 131 Stat. 1005 · Lineage

TITLE I Fees Relating to Drugs

SEC. 101. Short Title; Finding.

(a)
Short Title.— This title may be cited as the “Prescription Drug User Fee Amendments of 2017”.
(b)
Finding.— The Congress finds that the fees authorized by the amendments made in this title will be dedicated toward expediting the drug development process and the process for the review of human drug applications, including postmarket drug safety activities, as set forth in the goals identified for purposes of part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record.

SEC. 102. Authority to Assess and Use Drug Fees.

(a)
Types of Fees.—
(1)
In general.— Section 736(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(a)) is amended—
(A)
in the matter preceding paragraph (1), by striking “ fiscal year 2013” and inserting “ fiscal year 2018”;
(B)
in the heading of paragraph (1), by striking “ and supplement”;
(C)
in paragraph (1), by striking “ or a supplement” and “ or supplement” each place either appears;
(D)
in paragraph (1)(A)—
(i)
in clause (i), by striking “ (c)(4)” and inserting “ (c)(5)”; and
(ii)
in clause (ii), by striking “ A fee established” and all that follows through “ are required.” and inserting the following: “ A fee established under subsection (c)(5) for a human drug application for which clinical data (other than bioavailability or bioequivalence studies) with respect to safety or effectiveness are not required for approval.”;
(E)
in the heading of paragraph (1)(C), by striking “ or supplement”;
(F)
in paragraph (1)(F)—
(i)
in the heading, by striking “ or indication”; and
(ii)
by striking the second sentence;
(G)
by striking paragraph (2) (relating to a prescription drug establishment fee);
(H)
by redesignating paragraph (3) as paragraph (2);
(I)
in the heading of paragraph (2), as so redesignated, by striking “ Prescription drug product fee” and inserting “ Prescription drug program fee”;
(J)
in subparagraph (A) of such paragraph (2), by amending the first sentence to read as follows: “ Except as provided in subparagraphs (B) and (C), each person who is named as the applicant in a human drug application, and who, after September 1, 1992, had pending before the Secretary a human drug application or supplement, shall pay the annual prescription drug program fee established for a fiscal year under subsection (c)(5) for each prescription drug product that is identified in such a human drug application approved as of October 1 of such fiscal year.”;
(K)
in subparagraph (B) of such paragraph (2)—
(i)
in the heading of subparagraph (B), by inserting after “ Exception” the following: “ for certain prescription drug products”; and
(ii)
by striking “ A prescription drug product shall not be assessed a fee” and inserting “ A prescription drug program fee shall not be assessed for a prescription drug product”; and
(L)
by adding at the end of such paragraph (2) the following:

“(C) Limitation.—A person who is named as the applicant in an approved human drug application shall not be assessed more than 5 prescription drug program fees for a fiscal year for prescription drug products identified in such approved human drug application.”

(2)
Conforming amendment.— Subparagraph (C) of section 740(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–12(a)(3)) is amended to read as follows:

“(C) Limitation.—An establishment shall be assessed only one fee per fiscal year under this section.”

(b)
Fee Revenue Amounts.— Subsection (b) of section 736 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h) is amended to read as follows:

“(b) Fee Revenue Amounts.—

“(1) In general.—For each of the fiscal years 2018 through 2022, fees under subsection (a) shall, except as provided in subsections (c), (d), (f), and (g), be established to generate a total revenue amount under such subsection that is equal to the sum of—

“(A) the annual base revenue for the fiscal year (as determined under paragraph (3));

“(B) the dollar amount equal to the inflation adjustment for the fiscal year (as determined under subsection (c)(1));

“(C) the dollar amount equal to the capacity planning adjustment for the fiscal year (as determined under subsection (c)(2));

“(D) the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(3));

“(E) the dollar amount equal to the additional direct cost adjustment for the fiscal year (as determined under subsection (c)(4)); and

“(F) additional dollar amounts for each fiscal year as follows:

“(i) $20,077,793 for fiscal year 2018.

“(ii) $21,317,472 for fiscal year 2019.

“(iii) $16,953,329 for fiscal year 2020.

“(iv) $5,426,896 for fiscal year 2021.

“(v) $2,769,609 for fiscal year 2022.

“(2) Types of fees.—Of the total revenue amount determined for a fiscal year under paragraph (1)—

“(A) 20 percent shall be derived from human drug application fees under subsection (a)(1); and

“(B) 80 percent shall be derived from prescription drug program fees under subsection (a)(2).

“(3) Annual base revenue.—For purposes of paragraph (1), the dollar amount of the annual base revenue for a fiscal year shall be—

“(A) for fiscal year 2018, $878,590,000; and

“(B) for fiscal years 2019 through 2022, the dollar amount of the total revenue amount established under paragraph (1) for the previous fiscal year, not including any adjustments made under subsection (c)(3) or (c)(4).”

(c)
Adjustments; Annual Fee Setting.— Subsection (c) of section 736 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h) is amended to read as follows:

“(c) Adjustments; Annual Fee Setting.—

“(1) Inflation adjustment.—

“(A) In general.—For purposes of subsection (b)(1)(B), the dollar amount of the inflation adjustment to the annual base revenue for each fiscal year shall be equal to the product of—

“(i) such annual base revenue for the fiscal year under subsection (b)(1)(A); and

“(ii) the inflation adjustment percentage under subparagraph (B).

“(B) Inflation adjustment percentage.—The inflation adjustment percentage under this subparagraph for a fiscal year is equal to the sum of—

“(i) the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 years of the preceding 4 fiscal years, multiplied by the proportion of personnel compensation and benefits costs to total costs of the process for the review of human drug applications (as defined in section 735(6)) for the first 3 years of the preceding 4 fiscal years; and

“(ii) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of the process for the review of human drug applications (as defined in section 735(6)) for the first 3 years of the preceding 4 fiscal years.

“(2) Capacity planning adjustment.—

“(A) In general.—For each fiscal year, after the annual base revenue established in subsection (b)(1)(A) is adjusted for inflation in accordance with paragraph (1), such revenue shall be adjusted further for such fiscal year, in accordance with this paragraph, to reflect changes in the resource capacity needs of the Secretary for the process for the review of human drug applications.

“(B) Interim methodology.—

“(i) In general.—Until the capacity planning methodology described in subparagraph (C) is effective, the adjustment under this paragraph for a fiscal year shall be based on the product of—

“(I) the annual base revenue for such year, as adjusted for inflation under paragraph (1); and

“(II) the adjustment percentage under clause (ii).

“(ii) Adjustment percentage.—The adjustment percentage under this clause for a fiscal year is the weighted change in the 3-year average ending in the most recent year for which data are available, over the 3-year average ending in the previous year, for—

“(I) the total number of human drug applications, efficacy supplements, and manufacturing supplements submitted to the Secretary;

“(II) the total number of active commercial investigational new drug applications; and

“(III) the total number of formal meetings scheduled by the Secretary, and written responses issued by the Secretary in lieu of such formal meetings, as identified in section I.H of the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017.

“(C) Capacity planning methodology.—

“(i) Development; evaluation and report.—The Secretary shall obtain, through a contract with an independent accounting or consulting firm, a report evaluating options and recommendations for a new methodology to accurately assess changes in the resource and capacity needs of the process for the review of human drug applications. The capacity planning methodological options and recommendations presented in such report shall utilize and be informed by personnel time reporting data as an input. The report shall be published for public comment no later than the end of fiscal year 2020.

“(ii) Establishment and implementation.—After review of the report described in clause (i) and any public comments thereon, the Secretary shall establish a capacity planning methodology for purposes of this paragraph, which shall—

“(I) replace the interim methodology under subparagraph (B);

“(II) incorporate such approaches and attributes as the Secretary determines appropriate; and

“(III) be effective beginning with the first fiscal year for which fees are set after such capacity planning methodology is established.

“(D) Limitation.—Under no circumstances shall an adjustment under this paragraph result in fee revenue for a fiscal year that is less than the sum of the amounts under subsections (b)(1)(A) (the annual base revenue for the fiscal year) and (b)(1)(B) (the dollar amount of the inflation adjustment for the fiscal year).

“(E) Publication in federal register.—The Secretary shall publish in the Federal Register notice under paragraph (5) of the fee revenue and fees resulting from the adjustment and the methodologies under this paragraph.

“(3) Operating reserve adjustment.—

“(A) Increase.—For fiscal year 2018 and subsequent fiscal years, the Secretary may, in addition to adjustments under paragraphs (1) and (2), further increase the fee revenue and fees if such an adjustment is necessary to provide for not more than 14 weeks of operating reserves of carryover user fees for the process for the review of human drug applications.

“(B) Decrease.—If the Secretary has carryover balances for such process in excess of 14 weeks of such operating reserves, the Secretary shall decrease such fee revenue and fees to provide for not more than 14 weeks of such operating reserves.

“(C) Notice of rationale.—If an adjustment under subparagraph (A) or (B) is made, the rationale for the amount of the increase or decrease (as applicable) in fee revenue and fees shall be contained in the annual Federal Register notice under paragraph (5) establishing fee revenue and fees for the fiscal year involved.

“(4) Additional direct cost adjustment.—

“(A) In general.—The Secretary shall, in addition to adjustments under paragraphs (1), (2), and (3), further increase the fee revenue and fees—

“(i) for fiscal year 2018, by $8,730,000; and

“(ii) for fiscal year 2019 and subsequent fiscal years, by the amount determined under subparagraph (B).

“(B) Amount.—The amount determined under this subparagraph is—

“(i) $8,730,000, multiplied by

“(ii) the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All Items; Annual Index) for the most recent year of available data, divided by such Index for 2016.

“(5) Annual fee setting.—The Secretary shall, not later than 60 days before the start of each fiscal year that begins after September 30, 2017—

“(A) establish, for each such fiscal year, human drug application fees and prescription drug program fees under subsection (a), based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection; and

“(B) publish such fee revenue and fees in the Federal Register.

“(6) Limit.—The total amount of fees charged, as adjusted under this subsection, for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of human drug applications.”

(d)
Fee Waiver or Reduction.— Section 736(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(d)) is amended—
(1)
in paragraph (1)—
(A)
by inserting “ or” at the end of subparagraph (B);
(B)
by striking subparagraph (C); and
(C)
by redesignating subparagraph (D) as subparagraph (C);
(2)
by striking paragraph (3) (relating to use of standard costs);
(3)
by redesignating paragraph (4) as paragraph (3); and
(4)
in paragraph (3), as so redesignated—
(A)
in subparagraphs (A) and (B), by striking “ paragraph (1)(D)” and inserting “ paragraph (1)(C)”; and
(B)
in subparagraph (B)—
(i)
by striking clause (ii);
(ii)
by striking “ shall pay” through “ (i) application fees” and inserting “ shall pay application fees”; and
(iii)
by striking “ ; and” at the end and inserting a period.
(e)
Effect of Failure To Pay Fees.— Section 736(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(e)) is amended by striking “ all fees” and inserting “ all such fees”.
(f)
Limitations.— Section 736(f)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(f)(2)) is amended by striking “ supplements, prescription drug establishments, and prescription drug products” and inserting “ prescription drug program fees”.
(g)
Crediting and Availability of Fees.— Section 736(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(g)) is amended—
(1)
in paragraph (3)—
(A)
by striking “ 2013 through 2017” and inserting “ 2018 through 2022”; and
(B)
by striking “ and paragraph (4) of this subsection”; and
(2)
by striking paragraph (4).
(h)
Orphan Drugs.— Section 736(k) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(k)) is amended by striking “ product and establishment fees” each place it appears and inserting “ prescription drug program fees”.

SEC. 103. Reauthorization; Reporting Requirements.

Section 736B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h–2) is amended—
(1)
in subsection (a)(1)—
(A)
in the matter before subparagraph (A), by striking “ 2013” and inserting “ 2018”; and
(B)
in subparagraph (A), by striking “ Prescription Drug User Fee Amendments of 2012” and inserting “ Prescription Drug User Fee Amendments of 2017”;
(2)
in subsection (b), by striking “ 2013” and inserting “ 2018”; and
(3)
in subsection (d), by striking “ 2017” each place it appears and inserting “ 2022”.

SEC. 104. Sunset Dates.

(a)
Authorization.— Sections 735 and 736 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g; 379h) shall cease to be effective October 1, 2022.
(b)
Reporting Requirements.— Section 736B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h–2) shall cease to be effective January 31, 2023.
(c)
Previous Sunset Provision.— Effective October 1, 2017, subsections (a) and (b) of section 105 of the Food and Drug Administration Safety and Innovation Act (Public Law 112–144) are repealed.

SEC. 105. Effective Date.

The amendments made by this title shall take effect on October 1, 2017, or the date of the enactment of this Act, whichever is later, except that fees under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act shall be assessed for all human drug applications received on or after October 1, 2017, regardless of the date of the enactment of this Act.

SEC. 106. Savings Clause.

Notwithstanding the amendments made by this title, part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, as in effect on the day before the date of the enactment of this title, shall continue to be in effect with respect to human drug applications and supplements (as defined in such part as of such day) that on or after October 1, 2012, but before October 1, 2017, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2018.