[House Report 116-55]
[From the U.S. Government Publishing Office]


116th Congress     }                               {      Rept. 116-55
                        HOUSE OF REPRESENTATIVES
 1st Session       }                               {            Part 3

======================================================================



 
 CREATING AND RESTORING EQUAL ACCESS TO EQUIVALENT SAMPLES ACT OF 2019

                                _______
                                

                  May 16, 2019.--Ordered to be printed

                                _______
                                

    Mr. Nadler, from the Committee on the Judiciary, submitted the 
                               following

                          SUPPLEMENTAL REPORT

                        [To accompany H.R. 965]

         CORRECTION--CONGRESSIONAL BUDGET OFFICE COST ESTIMATE

    Pursuant to clause 3(a)(2) of rule XIII of the Rules of the 
House of Representatives for the 116th Congress, the Committee 
on the Judiciary is filing this supplemental report to correct 
an error in the report to accompany H.R. 965, the Creating and 
Restoring Equal Access to Equivalent Samples Act of 2019 (H. 
Rept. 116-55, Part 2).

                                     U.S. Congress,
                               Congressional Budget Office,
                                       Washington, DC, May 8, 2019.
Hon. Jerrold Nadler,
Chairman, Committee on the Judiciary,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for H.R. 965, the CREATES 
Act of 2019.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Ellen Werble.
            Sincerely,
                                                Keith Hall,
                                                          Director.
    Enclosure

cc:
        Honorable Doug Collins
        Ranking Member

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
        
    H.R. 965 would create a private right of action that would 
allow developers of generic drugs or biosimilar products to 
bring civil lawsuits against manufacturers of brand-name drugs 
if sufficient quantities of reference samples of a branded 
product are not made available for premarket testing. (To 
obtain marketing approval of their products from the Food and 
Drug Administration (FDA), developers of generic or biosimilar 
drugs currently must purchase reference samples to conduct the 
testing required to demonstrate that their drugs meet the FDA's 
approval criteria.)
    The bill also would remove a statutory requirement that 
manufacturers of generic or biosimilar versions of certain 
drugs that carry a significant risk of serious side effects use 
the same risk management system as the brand-name reference 
drug to ensure safe use of the product. Instead, it would 
provide the FDA with more discretion to allow those 
manufacturers to use comparable safety systems on a case-by-
case basis.
    CBO expects that the bill's provisions would allow generic 
drugs (including biosimilar versions of biologics) to enter the 
market earlier, on average, than they would under current law. 
Because of the earlier entry of lower-priced generic drugs, CBO 
estimates, enacting the legislation would reduce federal 
spending on prescription drugs and subsidies for health 
insurance. In total, CBO estimates that enacting H.R. 965 would 
decrease the deficit by $3.9 billion over the 2019-2029 period. 
That amount includes a $3.3 billion reduction in direct 
spending and a $0.6 billion increase in revenues.
    CBO also estimates that implementing H.R. 965 would 
decrease spending subject to appropriation by $118 million over 
the 2019-2024 period, assuming appropriation actions consistent 
with the bill. That decrease would result primarily because 
lower estimated drug prices would reduce costs for 
discretionary health programs.
    The estimated budgetary effect of H.R. 965 is shown in 
Table 1. The effects of the legislation fall primarily within 
budget functions 550 (health), and 570 (Medicare).

                                                                        TABLE 1.--ESTIMATED BUDGETARY EFFECTS OF H.R. 965
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                             By fiscal year, millions of dollars--
                                                             -----------------------------------------------------------------------------------------------------------------------------------
                                                                2019      2020      2021      2022      2023      2024      2025      2026      2027      2028      2029    2019-2024  2019-2029
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Decreases (-) in Direct Spending
 
Estimated Outlaysa..........................................         0         0       -47      -179      -310      -365      -424      -450      -478      -542      -503       -901     -3,299
    On-budget...............................................         0         0       -47      -178      -308      -363      -423      -448      -476      -540      -501       -897     -3,284
    Off-budgetb.............................................         0         0         *        -1        -2        -2        -2        -2        -2        -2        -2         -5        -15
 
                                                                                      Increases in Revenues
 
Estimated Revenues..........................................         0         0         9        31        56        70        76        85        91        95        99        165        609
    On-budget...............................................         0         0         6        22        40        50        55        63        68        71        74        119        448
    Off-budget..............................................         0         0         2         9        16        20        21        22        23        24        25         46        161
 
                                                          Net Decrease (-) in the Deficit From Changes in Direct Spending and Revenues
 
Effect on the Deficit.......................................         0         0       -55      -210      -366      -435      -500      -535      -568      -637      -602     -1,066     -3,908
    On-budget...............................................         0         0       -53      -200      -348      -414      -477      -511      -544      -611      -575     -1,015     -3,732
    Off-budget..............................................         0         0        -3        -9       -17       -21       -23       -24       -25       -26       -27        -51       -175
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Increases or Decreases (-) in Spending Subject to Appropriation
 
Estimated Authorization.....................................         0         1        -7       -23       -41       -47      n.e.      n.e.      n.e.      n.e.      n.e.       -118       n.e.
Estimated Outlays...........................................         0         1        -7       -23       -41       -47      n.e.      n.e.      n.e.      n.e.      n.e.       -118       n.e.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Components may not sum to totals because of rounding; n.e. = not estimated; * = between -$500,000 and zero.
a. Budget authority equals outlays.
b. Includes off-budget effects on the operating costs of the U.S. Postal Service.

                         Previous CBO Estimate

    On April25, 2019, CBO transmitted a cost estimate for H.R. 
965, the CREATES Act of 2019, as ordered reported by the House 
Committee on Energy and Commerce on April 3, 2019 (https://
www.cbo.gov/publication/55181). While there are differences in 
the language, CBO's estimates of the budgetary effects for the 
two versions are the same.
    The CBO staff contact for this estimate is Ellen Werble. 
The estimate was reviewed by Leo Lex, Deputy Assistant Director 
for Budget Analysis.

                                  [all]