Ethics: 2009-2

 

 

 

ADVISORY OPINION 2009-2

 

Drug Maker’s Communications with the Pharmaceutical and Therapeutics Committee to Get a Drug Placed on the Preferred-Drug List

 

Introduction

 

            The Citizen’s Ethics Advisory Board issues this advisory opinion at the request of Cynthia Isales, an assistant general counsel with the Office of State Ethics.  She was recently asked how the Code of Ethics for Lobbyists (“Code”) applies to a drug maker’s communications with members of the Pharmaceutical and Therapeutics Committee (“P&T Committee”) to get a drug placed on the state’s preferred-drug list.   

 

Facts

 

            Under federal law, states are permitted to establish drug formularies (lists of drugs) to limit the number of drugs that may be used under their Medicaid programs.[1]  As a condition of adopting a formulary, a state must satisfy certain requirements, one of which is that the formulary be developed by a committee “consisting of physicians, pharmacists, and other appropriate individuals appointed by the Governor of the State . . . .”[2]

 

In response, the Connecticut General Assembly established the P&T Committee,[3] which now has fourteen unpaid members, each of whom is appointed by the Governor, including five physicians, four pharmacists, two visiting nurses, a state-employed clinician, a representative of drug manufacturers, and a consumer representative.[4]  The P&T Committee is “within” the Department of Social Services[5] and serves an advisory role in the department’s adoption of a preferred-drug list,[6] namely, a “listing of prescription products recommended by the [P&T Committee] as efficacious, safe, and cost effective choices when prescribing for Medicaid patients.”[7]

 

            The preferred-drug list is overseen by a contractor hired by the Department of Social Services.  The contractor subcontracts with another firm to, among other things, negotiate supplemental rebates with various drug makers.  The subcontractor then presents its recommendations for inclusion on the preferred-drug list to the P&T Committee at its quarterly meetings.  The P&T Committee evaluates the drugs in terms of their “clinical efficacy, safety, and cost”[8]; and at the meetings’ close, the committee chairperson drafts a letter to the Commissioner of Social Services outlining the committee’s recommendations as to what should be added to or removed from the preferred-drug list.  Based on those recommendations, the Commissioner of Social Services decides which drugs make the list.[9] 

 

Question

 

            We consider whether a drug maker is “lobbying,” as defined in the Code, if it communicates with members of the P&T Committee to get a drug placed on the preferred-drug list.  

 

Conclusion

 

We conclude that, in engaging in such activity, the drug maker is soliciting others (members of the P&T Committee) to communicate with an executive branch official (the Commissioner of Social Services), for the purpose of influencing administrative action.  Thus, the drug maker is “lobbying”—unless, that is, its communications fit within one of the exceptions to the definition of that term.[10]          

 

Analysis

                       

Under the Code, “lobbying” is defined, in relevant part, as “communicating directly or soliciting others to communicate with any official or his staff in the . . . executive branch of government . . . for the purpose of influencing any . . . administrative action . . . .”[11]  

 

            Applying this definition to the facts at hand leads us to the following three-part inquiry: In communicating with members of the P&T Committee to get a drug placed on the preferred-drug list, is a drug maker either (1) communicating directly with an executive branch official or his staff, or (2) soliciting others to communicate with an executive branch official or his staff, (3) for the purpose of influencing administrative action? 

 

1.         Communicating Directly With an Executive Branch “Official or His Staff”

 

A.        Official”

 

            To answer whether a drug manufacturer, in engaging in such activity, is communicating directly with an executive branch “official or his staff,” we turn first to the term “official.”  Although this term is not defined in the Code, the term “public official” is, and since the Code’s inception, the two have been deemed synonymous.[12]  The term “public official” includes, among others, “any person appointed to any office of the . . . executive branch of state government by the Governor,” but excludes “a member of an advisory board.”[13]    

 

            Because members of the P&T Committee are appointed by the Governor to an executive branch office[14]—meaning they satisfy the definition of “public official” insofar as their appointment is concerned—we must determine whether they also satisfy the definition of “member of an advisory board.”  If so, they are not “public officials.” 

 

The term “member of an advisory board,” broken down into its three parts, includes, among others, any person

 

(1)  appointed by a public official as a member of a committee, commission or council established to advise, recommend or consult with a public official or branch of government or committee thereof and

 

(2)  who receives no public funds other than per diem payments or reimbursement for his actual and necessary expenses incurred in the performance of his official duties and

 

(3)  who has no authority to expend any public funds or to exercise the power of the state.[15]

 

After reviewing the P&T Committee’s enabling statute (§ 17-274d), it is clear that committee members meet the definition of “member of an advisory board.”  First, they are appointed by the Governor (a public official[16]) as members of a committee established to consult with,[17] and make recommendations to,[18] the Department of Social Services, an executive branch agency.  Second, they are neither compensated for their service as committee members, nor reimbursed for expenses incurred in performing committee duties.  Third, the P&T Committee, to which no state funds are appropriated, has no independent authority to expend state funds; and it does not exercise the power of the state, but rather acts solely in an advisory capacity to the Department of Social Services concerning the state’s preferred-drug list.  Thus, members of the P&T Committee are “members of an advisory board,” not “public officials.”[19]    

 

Naturally, therefore, in communicating with the P&T Committee to get a drug placed on the preferred-drug list, a drug maker is not communicating directly with an executive branch “public official.”  That leaves the question of whether, in communicating with the P&T Committee for that purpose, a drug maker is communicating directly with the “staff” of an executive branch public official, specifically the Commissioner of Social Services.[20]  In other words: Are members of the P&T Committee considered “staff” of the Commissioner of Social Services?     

 

B.        Staff”

 

The term “staff” is not defined in the Code, but it has been defined by way of advisory opinion in relation to another Code provision, General Statutes § 1-96 (e).  Under this provision, registered client lobbyists generally are required to file an itemized statement of each expenditure of ten dollars or more made “for the benefit of a public official in the legislative or executive branch, a member of his staff or immediate family . . . .”[21]  In defining the term “staff,” the former State Ethics Commission (“former Commission”) stated:

 

Since the purpose of [§ 1-96 (e)] is to disclose expenditures made by a registrant for the benefit of public officials, who are often in a position to favor the registrant, and of those influential with an official, “staff” should not be read to include all those employed in the same department or agency as the official.  The term should be restricted to employees who meet the traditional definition of “staff” and who are close enough to the official to influence his decisions.[22]

 

Thus, in its broadest (traditional) sense, the term “staff” would include all employees in the same department or agency as the public official; while in its narrowest sense, it would include only those employees in the department or agency close enough to the public official to influence his or her decisions.  In either sense, the term “staff” is limited to “employees,” namely, those who work “for another in return for financial or other compensation.”[23] 

 

Because members of the P&T Committee are not compensated for their service, they are not “employees” of the Department of Social Services.  It follows that they are not (under either definition of the term) “staff” of the Commissioner of Social Services.  Therefore, in communicating with members of the P&T Committee to get a drug placed on the preferred-drug list, the drug maker is not communicating directly with the “staff” of an executive branch public official.

 

            Accordingly, the answer to the first part of our three-part inquiry is that the drug maker is not communicating directly with an executive branch “official” or “his staff.”   

 

2.         Soliciting Others to Communicate With an Executive Branch Official or His Staff

           

However, as noted above, “lobbying” includes not only communicating directly with an executive branch official or his staff, but also soliciting others to communicate with an executive branch official or his staff.     

 

For example, in Advisory Opinion No. 2001-25, the former Commission concluded that an organization’s mailing asking for signatures for a petition to oppose certain legislation was “clearly a solicitation of others to communicate with state legislators . . . .”  It concluded likewise in Advisory Opinion No. 99-6, which involved an organization’s proposed ad campaign.  In that campaign, the organization would request that individuals contact it to help end homelessness, and if an individual did so, he or she would be “asked to contact their representatives in the General Assembly . . . .”  According to the former Commission, this constituted “solicitations of other persons to communicate with a public official . . . .” 

 

The question here is whether, in communicating with members of the P&T Committee to get a drug placed on the preferred-drug list, the drug maker is “soliciting” them to communicate with an executive branch public official or his staff.  The term “solicit” is not defined in the Code, so we look to its dictionary definition, which is “[t]o seek to obtain by persuasion, entreaty, or formal application.”[24]  So: Is the drug maker seeking to persuade members of the P&T Committee to communicate with an executive branch official or his staff? 

 

We answer that question in the affirmative, and a brief review of the facts will show why.  As noted above, at its quarterly meetings, the P&T Committee evaluates drugs in terms of their clinical efficacy, safety, and cost.  Its chairman then writes a letter to the Commissioner of Social Service outlining the committee’s recommendations as to what should be added to or removed from the preferred-drug list.  Relying on that information, the Commissioner of Social Services determines which drugs make the list.  Thus, the sole reason for the drug maker to communicate with members of the P&T Committee—who have absolutely no decision-making authority when it comes to the preferred-drug list—is to persuade them to communicate to the Commissioner of Social Services—the decision-maker—that its drug should be placed on the preferred-drug list. 

 

Therefore, the answer to part two of our inquiry is that, in communicating with members of the P&T Committee to get a drug placed on the preferred-drug list, the drug maker is soliciting others (members of the P&T Committee) to communicate with an executive branch official (the Commissioner of Social Services).

 

3.         For the Purpose of Influencing Administrative Action

           

            But why?  If its purpose is to influence administrative action, then it is “lobbying.”  “Administrative action” is defined as

 

any action or nonaction of any executive agency of the state with respect to the proposal, drafting, development, consideration, amendment, adoption or repeal of any rule, regulation or utility rate, and any action or nonaction of any executive agency or quasi-public agency, as defined in section 1-79, regarding a contract, grant, award, purchasing agreement, loan, bond, certificate, license, permit or any other matter which is within the official jurisdiction or cognizance of such an agency.[25]

 

            Here, the drug maker is attempting to influence action of an executive branch agency—the Department of Social Services—with respect to a matter that is within its official jurisdiction: the placement of drugs on the state’s preferred-drug list.  Thus, in answer to part three of our inquiry, the drug maker’s purpose is to influence administrative action.

 

            To sum up, in communicating with members of the P&T Committee to get a drug placed on the preferred-drug list, the drug maker (while not communicating directly with an executive branch official or his staff) is soliciting others to communicate with an executive branch official, for the purpose of influencing administrative action.  Thus, the drug maker is “lobbying”—unless, that is, its communications fit within one of the statutory or regulatory exceptions to the definition of that term.[26] 

 

 

By order of the Board,

 

 

 

 

Dated____2/26/09_______                                                ________/s/_________________           

Robert Worgaftik, Chairperson

 

 



[1]See 42 U.S.C. § 1396r-8 (d) (4).

[2]42 U.S.C. § 1396r-8 (d) (4) (A). 

[3]Public Acts 2002, No. 02-1, § 121.  

[4]General Statutes § 17b-274d (b).

[5]General Statutes § 17b-274d (a).

[6]See General Statutes § 17b-274d (e).

[7]https://www.ctdssmap.com/CTPortal/Pharmacy%20Information/tabid/63/Default.aspx.

 

[8]General Statutes § 17b-274d (i).

[9]See General Statutes § 17b-274d (e).

[10]See General Statutes § 1-91 (k) and § 1-92-42a of the Regulations of Connecticut State Agencies.   

[11]General Statutes § 1-91 (k). 

[12]See, e.g., Advisory Opinion No. 79-17 (“That Code includes in its definition of lobbying ‘communicating with any official . . . in the legislative . . . branch of government for the purpose of influencing any legislative . . . action.’ . . .  A member of the General Assembly is a ‘public official.’”  [Citation omitted; emphasis added.]); Advisory Opinion No. 85-7 (“‘Lobbying means communicating directly, or soliciting others to communicate, with any official or his staff for the purpose of influencing administrative or legislative action . . . . Once an organization . . . communicates with a Connecticut public official or staff for the purposes of influencing legislative action . . . .” [Citation omitted; emphasis added.]); Advisory Opinion No. 96-11 (“[t]he Code . . . require[s] registered lobbyists to report . . . expenditures made or received . . . for ‘lobbying,’ i.e., communicating directly with public officials or soliciting others to do so” [emphasis added]; Advisory Opinion No. 99-6 (“disclosure is required of solicitations of other persons to communicate with a public official for the purpose of influencing any legislative act” [emphasis added]).     

[13]General Statutes § 1-91 (p).

[14]The P&T Committee was established “within” the Department of Social Services, an executive branch agency.  General Statutes § 17b-274d (a).

[15]General Statutes § 1-91 (m).

[16]The definition of “public official” in § 1-91 (p) includes state-wide elected officers, such as the Governor.  

[17]Under the P&T Committee’s enabling statute, the “Department of Social Services, in consultation with the [P&T] Committee, may adopt preferred drug lists”; (emphasis added) General Statutes § 17-274d (e); and the “Department of Social Services . . . shall in consultation with the [P&T] Committee, expand the preferred drug list . . . .”  (Emphasis added.)  General Statutes § 17-274d (e).

[18]The P&T Committee’s enabling statute provides that “the [P&T] Committee may also make recommendations to the department regarding the prior authorization of any prescribed drug.”  (Emphasis added.)  General Statutes § 17-274d (j).     

[19]This means, among other things, that members of the P&T Committee are not subject to the Code of Ethics for Public Officials.  However, they are subject to an ethics policy established by the Department of Social Services.

[20]The Commissioner of Social Services is a “public official” by virtue of being appointed to that position by the Governor.  See General Statutes § 1-91 (p).

[21](Emphasis added.)  General Statutes § 1-96 (e).

[22](Emphasis added.)  Advisory Opinion No. 78-30.  The former Commission went on to say: “Thus, in a small agency, such as a State commission, all the employees of the commission would normally be considered ‘staff.’  In a large department, ‘personal staff’ and those chiefly responsible for carrying out the operations of the department would be considered ‘staff.’”  Id.

[23]The American Heritage Dictionary of the English Language (New College Ed. 1981). 

[24]The American Heritage Dictionary of the English Language (New College Ed. 1981).

[25](Emphasis added.)  General Statutes § 1-91 (a).

[26]See General Statutes § 1-91 (k) and § 1-92-42a of the Regulations of Connecticut State Agencies.

 

 



Content Last Modified on 2/26/2009 8:35:07 PM