First Substitute H.B. 120

Representative Paul Ray proposes the following substitute bill:

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.
11 Highlighted Provisions:
12 This bill:
13 . defines terms;
14 . creates standards for providing educational information to health care providers
15 about prescription drugs;
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;
19 . creates certain exceptions to the application of the federal regulations; and
20 . creates a private right of action if the federal regulations are violated.
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; and
37 (B) employed by someone other than a pharmaceutical manufacturer to disseminate
38 educational information about prescription drugs to other health care providers across a broad
39 range of interventions in an effort to better align clinical practice with scientific research; and
40 (ii) does not include a health care provider who:
41 (A) is disseminating educational information about a prescription drug as part of
42 teaching or supervising students or graduate medical education students at an institution of
43 higher education or through a medical residency program; or
44 (B) is disseminating educational information about a prescription drug to a patient or a
45 patient's representative.
46 (b) "Commercial detailing" means an educational practice employed by a
47 pharmaceutical manufacturer in which clinical information and evidence about a prescription
48 drug is shared with health care professionals.
49 (c) "Manufacture" is as defined in Section 58-37-2 .
50 (d) "Pharmaceutical manufacturer" is a person who manufactures a prescription drug.
51 (2) (a) The provisions of this section apply to an academic detailer beginning July 1,
52 2013.
53 (b) An academic detailer and a commercial detailer who educate another health care
54 provider about prescription drugs through written or oral educational material is subject to
55 federal regulations regarding:
56 (i) labeling and false and misleading advertising in 21 C.F.R., Part 201 (2007);

57 (ii) prescription drug advertising in 21 C.F.R., Part 202 (2007); and
58 (iii) the federal Office of the Inspector General's Compliance Program Guidance for
59 Pharmaceutical Manufacturers issued in April 2003, as amended.
60 (c) A person who is injured by a violation of this section has a private right of action
61 against the person who violated this section.

[Bill Documents]