H.B. 120

1

INFORMATION ON PHARMACEUTICAL PRODUCTS
2 2013 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor: Paul Ray
5 Senate Sponsor: ____________
6
7 LONG TITLE
8 General Description:
9 This bill amends the Division of Occupational and Professional Licensing Act related to
10 commercial and academic detailing for prescription drugs and devices.
11 Highlighted Provisions:
12 This bill:
13 . defines terms;
14 . creates standards for providing educational information to health care providers
15 about prescription drugs and devices;
16 . expands the application of federal regulations that apply to a pharmaceutical
17 manufacturer's drug representatives to other health care providers who make
18 educational statements about a prescription drug or device;
19 . creates certain exceptions to the application of the federal regulations; and
20 . makes it unprofessional conduct to violate the federal regulations.
21 Money Appropriated in this Bill:
22 None
23 Other Special Clauses:
24 None
25 Utah Code Sections Affected:
26 ENACTS:
27 58-1-501.7, Utah Code Annotated 1953

28
29 Be it enacted by the Legislature of the state of Utah:
30 Section 1. Section 58-1-501.7 is enacted to read:
31 58-1-501.7. Standards of conduct for prescription drug education -- Academic
32 and commercial detailing.
33 (1) For purposes of this section:
34 (a) "Academic detailing":
35 (i) means a health care provider who is:
36 (A) licensed under this title to prescribe or dispense a prescription drug or device; and
37 (B) employed by someone other than a pharmaceutical manufacturer to disseminate
38 educational information about prescription drugs or devices to other health care providers
39 across a broad range of interventions in an effort to better align clinical practice with scientific
40 research; and
41 (ii) does not include a health care provider who:
42 (A) is disseminating educational information about a prescription drug or device as
43 part of teaching or supervising students or graduate medical education students at an institution
44 of higher education or through a medical residency program; or
45 (B) is disseminating educational information about a prescription drug or device to a
46 patient or a patient's representative.
47 (b) "Commercial detailing" means an educational practice employed by a
48 pharmaceutical manufacturer in which clinical information and evidence about a prescription
49 drug or device is shared with health care professionals.
50 (c) "Manufacture" is as defined in Section 58-37-2 .
51 (d) "Pharmaceutical manufacturer" is a person who manufactures a prescription drug or
52 device.
53 (2) (a) The provisions of this section apply to an academic detailer beginning July 1,
54 2013.
55 (b) An academic detailer and a commercial detailer who educate another health care
56 provider about prescription drugs or devices through written or oral educational material is
57 subject to federal regulations regarding:
58 (i) labeling and false and misleading advertising in 21 C.F.R., Part 201 (2007);

59 (ii) prescription drug advertising in 21 C.F.R., Part 202 (2007); and
60 (iii) the federal Office of the Inspector General's Compliance Program Guidance for
61 Pharmaceutical Manufacturers issued in April 2003, as amended.
62 (c) It is unprofessional conduct for a health care provider licensed under this title to
63 violate the provisions of this section.




Legislative Review Note
as of 2-6-13 8:59 AM

Office of Legislative Research and General Counsel

[Bill Documents]