What This Bill Does
This bill allows drug manufacturers to send prescribing information (the detailed guidance about how to use a drug) to doctors and pharmacists through digital means instead of requiring paper copies. Manufacturers must give doctors and pharmacists the choice to continue receiving paper copies or request them when needed, without any extra charge.
Who It Affects
Drug manufacturers, prescribers (doctors and other healthcare professionals who write prescriptions), and dispensers (pharmacists and others who give out medications).
Key Provisions
- Drug manufacturers may provide required prescribing information only by electronic means if they let prescribers and dispensers choose to receive paper copies instead or request paper labeling as needed (Sec. 2(a))
- Manufacturers must provide requested paper information promptly without charging extra fees (Sec. 2(a))
- The Secretary of Health and Human Services must create final regulations within one year explaining how healthcare professionals can get paper copies directly from manufacturers or distributors if they want them (Sec. 2(b)(1)(B))
- The Secretary must design these regulations to reduce negative economic impacts on prescribers and dispensers (Sec. 2(b)(2))
- The Secretary must hold a public workshop within two years with stakeholders to discuss how to improve the format, accessibility and usability of prescribing information (Sec. 2(c))
What Changes
If this bill becomes law, drug manufacturers will be allowed to stop automatically sending paper prescribing information to doctors and pharmacists, instead using electronic delivery as the default method.
Important Definitions
"Drug" has the meaning given in section 201 of the Federal Food, Drug, and Cosmetic Act (Sec. 2(e)).
Effective Date
The earlier of two years after the law is enacted or when the final regulations go into effect (Sec. 2(d)).
I
118TH CONGRESS
1ST SESSION H. R. 1503
To provide for digital communication of prescribing information for drugs
(including biological products), and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
MARCH 9, 2023
Mrs. HARSHBARGER (for herself and Ms. SHERRILL) introduced the following
bill; which was referred to the Committee on Energy and Commerce
A BILL
To provide for digital communication of prescribing informa-
tion for drugs (including biological products), and for
other purposes.
Be it enacted by the Senate and House of Representa-
1
tives of the United States of America in Congress assembled,
2
SECTION 1. SHORT TITLE.
3
This Act may be cited as the ‘‘Prescription Informa-
4
tion Modernization Act of 2023’’.
5
SEC. 2. DIGITAL COMMUNICATION OF FDA-APPROVED PRE-
6
SCRIBING INFORMATION FOR DRUGS (IN-
7
CLUDING BIOLOGICAL PRODUCTS).
8
(a) IN GENERAL.—Section 502(f) of the Federal
9
Food, Drug, and Cosmetic Act (21 U.S.C. 352(f)) is
10
VerDate Sep 11 2014
04:45 Mar 22, 2023
Jkt 039200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H1503.IH
H1503
kjohnson on DSK79L0C42PROD with BILLS
2
•HR 1503 IH
amended by adding at the end the following: ‘‘Required
1
prescribing information for drugs subject to section
2
503(b)(1) may be made available solely by electronic
3
means provided that the labeling complies with all applica-
4
ble requirements of law, that the manufacturer affords
5
prescribers and dispensers the opportunity to elect to also
6
continue to receive all such information in paper form, or
7
to request paper labeling on an as-needed basis, and after
8
such request, and that the manufacturer promptly pro-
9
vides the requested information without additional cost.’’.
10
(b) RULEMAKING.—
11
(1) IN GENERAL.—Not later than 1 year after
12
the date of the enactment of this Act, the Secretary
13
of Health and Human Services shall issue final reg-
14
ulations to—
15
(A) implement the amendment made by
16
subsection (a); and
17
(B) provide instructions on how health
18
care professionals can receive paper copies of
19
prescribing information directly from the manu-
20
facturer or distributor if desired.
21
(2) ECONOMIC
IMPACTS.—The Secretary of
22
Health and Human Services shall design the regula-
23
tions required by paragraph (1) so as to minimize
24
VerDate Sep 11 2014
04:45 Mar 22, 2023
Jkt 039200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H1503.IH
H1503
kjohnson on DSK79L0C42PROD with BILLS
3
•HR 1503 IH
the adverse economic impacts of such regulations on
1
prescribers and dispensers.
2
(c) PUBLIC WORKSHOP.—Not later than 2 years
3
after the date of the enactment of this Act, the Secretary
4
of Health and Human Services, acting through the Com-
5
missioner of Food and Drugs, shall hold a public workshop
6
with relevant stakeholders to discuss how to continue to
7
optimize the format, accessibility, and usability of pre-
8
scribing information.
9
(d) EFFECTIVE DATE.—The amendment made by
10
subsection (a) shall apply with respect to drugs introduced
11
or delivered for introduction into interstate commerce on
12
or after the sooner of—
13
(1) the date that is 2 years after the date of the
14
enactment of this Act; or
15
(2) the effective date of the final regulations
16
promulgated to implement such amendment.
17
(e) DEFINITION.—In this section, the term ‘‘drug’’
18
has the meaning given to such term in section 201 of the
19
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
20
Æ
VerDate Sep 11 2014
04:45 Mar 22, 2023
Jkt 039200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6301
E:\BILLS\H1503.IH
H1503
kjohnson on DSK79L0C42PROD with BILLS