State Policy

Many states have enacted or are attempting to enact legislation that will help curtail inappropriate industry marketing activities in order to staunch the rising cost of drugs and to promote appropriate prescribing. Below is a summary of laws currently on the books and bills introduced in different states.1

GO TO:
1. Gifts/Disclosure legislation
[LAWS/BILLS: AZ CA CO CT DC IL MA MI MS NE NH NJ NY OH WA WV WI]
2. Data Mining Legislation
[LAWS/BILLS: CA DC HI IL KA MD MA MO NH RI VT WA]
3. Prescriber Education Legislation
[LAWS/BILLS: DC MA MI NH NY PA WA]
4. Industry Sales Reps and Other Legislation [LAWS/BILLS: HI IA LA MA NY OK SC TN]


GIFTS AND DISCLOSURE LEGISLATION

Several states and the District of Columbia have enacted so-called "sunshine laws" requiring disclosure of industry payments to physicians and soemtimes limiting these payments. Several other states are trying to achieve passage of such bills. Disclosure laws are important first steps toward developing policies not only to detect existing conflicts of interests, but ultimately to prevent them and end inappropriate industry influence on prescribing.

STATES WITH EXISTING LAWS

MINNESOTA

Minnesota was the first state to pass such legislation, in 1993. It requires reporting of payments over $100 to physicians and bans gifts in value of $50 or more. This and the Massachusetts law are the only statutes that include restrictions and make all disclosed data, including all physician-specific data, part of the public record. Unlike other disclosure laws however, it does not require annual summary reports to the state legislature, meaning that the state is under no obligation to analyze the data it collects. In order to be licensed, all wholesale drug distributors, including pharmaceutical manufacturers operating in the state, must comply with the law.

VERMONT

Vermont's law requires disclosure of payments of $25 and over. Due to a trade secret exemption, much of the data reported to the state is not made part of the public record. Annual summary reports by the Attorney General include average payment by prescriber specialty and type of service associated with payments. A penalty of up to $10,000 per violation of the law may be imposed.

MAINE

Maine requires disclosure of payments of $25 and over. Though physician-specific payment information is collected, it is not made publicly available. Payment information is made part of the public record only in the aggregate form. A fine of $1,000 for each violation of the law may be imposed.

DISTRICT OF COLUMBIA

Requires disclosure to the District of all payments of $25 and over, including marketing, advertising and charitable contributions.

WEST VIRGINIA

The weakest of these laws, West Virginia's requires disclosure only of the total number of prescribers who have received payments above $100. No individual physicians are identified. Reporting is required for all marketing expenses, in addition to physician payments. There is no enforcement mechanism and initial compliance has been poor.

MASSACHUSETTS

Massachusetts law includes disclosure provisions and sets limits on certain marketing activities. The law, passed in 2008, establishes a mandatory code of marketing conduct that is "no less restrictive" than the PhRMA and Advanced Medical Technology Association (AdvaMed) codes, effectively banning the provision of non-educational and practice related items, capping the value of educational gift items to physicians at $100 and prohibiting direct industry funding for physician attendance at professional meetings. While establishing the PhRMA Code as a baseline, the law allows the Department of Public Health to go further. Several provisions of the legislation, including limits on CME funding, also go further than the industry code. The MA law also requires disclosure of all payments valued over $50 to a prescriber or health care professional by pharmaceutical and medical device companies to the Commonwealth and is reported via a publicly searchable website. A penalty of up to $5,000 per violation of the law may be imposed.

Link to enacted law: http://www.mass.gov/legis/bills/senate/185/st02/st02863.htm

COLORADO

Amendment 41 to the constitution went into effect Jan 1, 2007, prohibiting state employees (including University of Colorado employees) from accepting any gift above $50. After pushback (state employees thought their kids would no longer be able to accept scholarships), a district judge granted an injunction against the measure in May 2007. The Colorado Supreme Court reversed the district court and ordered the injunction lifted on Feb 25 2008, saying the independent ethics commission must interpret further the amendment before the Supreme Court could rule on its constitutionality. The Ethics Commission ruled on October 7 2008 that scholarships and honoraria were not covered by the amendment. It seems that they may continue to "whittle away" at the provisions in Amendment 41. Currently, the ban on gifts >$50 (minus recent exceptions) still stands.

STATES ATTEMPTING TO PASS LEGISLATION IN 2008

ARIZONA

HB 2562, would prohibit gifts of greater than $50 in value from drug distributors and manufacturers to medical practitioners, and require annual reporting of all payments, reimbursements, honorariums, professional samples and compensation. Gifts from medical device manufacturers are exempted as are samples, publications and educational materials. Sponsor: Rep. Mark Anderson  

Status: Filed 1/18/08; did not pass by end of 2008 session (dead)

Link to bill: http://www.azleg.gov/DocumentsForBill.asp?Bill_Number=HB2562

SB 1250, would require full disclosure of specified prescription marketing costs.  Sponsor: Senator Meg Burton-Cahill

Status: Filed 1/18/08; did not pass by end of 2008 session (dead)

Link to bill: http://www.azleg.gov/DocumentsForBill.asp?Bill_Number=SB1250

CALIFORNIA

AB 2821, would amend the existing Comprehensive Compliance Program  for pharmaceutical companies by establishing a specific gift limit of $250 per physician per year for each  pharmaceutical company and requiring both the public disclosure of gifts of $50 or more and the payment of a disclosure fee to  the Department of Health Care Services (DHCS).  The bill was a priority of the California Public Interest Research Group, but did not get out of committee.  Sponsor: Assm. Fueur

Bill status:  Introduced 2/22/08; died in committee 4/1/08

Bill text: http://www.assembly.ca.gov/acs/acsframeset2text.htm

Bill analysis: http://www.assembly.ca.gov/acs/acsframeset2text.htm

COLORADO

SJR08-027, a pharmaceutical industry-supported resolution, purports to encourage transparency and disclosure when a physician is receiving financial or other compensation for prescribing any product, but appears to be aimed at discouraging prescribing of generic medication. Sponsor: President of the Senate Peter Groff.

Filed and laid over by Senate 4/24/08; Sent to House and laid over 5/2/08 (dead)

http://www.leg.state.co.us/CLICS/CLICS2008A/csl.nsf/fsbillcont3/5760A1C4BA19E969872573E20080C177?Open&file=SJR027_enr.pdf

CONNECTICUT

Attorney General Blumenthal announced legislation on disclosure and held hearings in 2008, but legislation was not introduced.

DISTRICT OF COLUMBIA

B17-0364, among other provisions, the SafeRx Act bans gifts to D.C.'s P&T committee. Sponsor: Councilmember Catania

Status: Filed 9/29/07; passed City Council 7y-6n, 1/8/08; signed into law by mayor as Act A17-0282, 2/1/08; requires review by US Congress

Link to bill: http://www.dccouncil.washington.dc.us/lims/billrecord.asp?strlegno=B17-0364

ILLINOIS

H 872, Would create a Prescription Drug Ethical Marketing Act that would require every manufacturer and labeler in the state to disclose the value, nature, and purpose of any gift, fee, payment, subsidy, or other economic benefit provided in connection with detailing or promotional activities by the company, directly or through its pharmaceutical marketers, to any physician, hospital, nursing home, pharmacist, health benefit plan administrator, or any other person in the State authorized to prescribe or dispense prescription drugs. Requires the Director to report to the Governor and the General Assembly on the disclosures. Provides exceptions to the disclosures. Provides for injunctive relief and civil penalties for failure to disclose. Provides that the civil penalties collected under the Act shall be deposited into the Prescription Drug Ethical Marketing Fund, which is created as a special fund in the State treasury, to be used for enforcement of the Act. Amends the State Finance Act to reflect the creation of the Prescription Drug Ethical Marketing Fund. Sponsor: Rep. Jack Franks

Status: Introduced 2/7/2007 in House, first reading and referred to Rules Committee, 2/15/2007, HouseAssigned to Consumer Protection Committee;  3/23/2007HouseRule 19(a), Re-referred to Rules Committee

Link to bill: http://www.ilga.gov/legislation/billstatus.asp?DocNum=872&GAID=9&GA=95&DocTypeID=HB&LegID=28277&SessionID=51

MASSACHUSETTS

S 2863 (as enacted replaced S2650 and H4974), for details of the law, see above

H 2251, Would provide for the disclosure of certain gifts made by pharmaceutical companies. Sponsor: Rep. Spellane

Filed 1/9/07 and sent to committee 9/12/07; did not pass before end of '07 session; carried over to '08; (died but related provisions enacted as part of S2863)

Link to bill: http://www.mass.gov/legis/bills/house/185/ht02pdf/ht02251.pdf

MICHIGAN

HB 6158, HB 6159, would require a drug manufacturer or wholesale distributor to adopt a comprehensive compliance program complying with the OIG compliance program and PhRMA code described below, file an annual report of compliance, and subject any manufacturer or distributor who did not file the annual report to administrative fines up to $500,000, depending on the nature of the violation. Sponsors: Rep. Mary Valentine, Rep. Mike Simpson.

Filed and referred to the Committee on Health Policy on 6/22/08, 6/26/2008 motion to discharge committee postponed for day, no further action

Link to bills: http://www.legislature.mi.gov/documents/2007-2008/billintroduced/House/htm/2008-HIB-6158.htm

http://www.legislature.mi.gov/documents/2007-2008/billintroduced/House/pdf/2008-HIB-6159.pdf

MISSISSIPPI

HB 990, Would require pharmaceutical companies to report all gifts and other economic benefits provided to physicians and nurse practitioners. Sponsor: Rep. Sherra Hilman Lane

Filed 2/4/08; died; did not pass committee 2/19/08 (died)

Bill as introduced: http://billstatus.ls.state.ms.us/documents/2008/html/HB/0900-0999/HB0990IN.htm

NEBRASKA

LB 675, Would require disclosures by pharmaceutical manufacturing companies.

Status: Filed and sent to committee 1/19/07; indefinitely postponed 5/31/07; did not pass before end of '07 session; carried over to '08; did not pass

Link to bill: http://uniweb.legislature.ne.gov/QS/session.php

NEW HAMPSHIRE

HB 1518, Establishes prescription drug marketing restrictions and disclosures; provides that no pharmaceutical manufacturer agent shall knowingly and willfully offer or give to a health care practitioner or certain other persons a gift of any value; establishes advertising and marketing reporting requirements for manufacturers. Sponsor: Rep. Thomas Donovan 

Status: Filed and sent to committee 1/2/08; failed house 3/5/08

Link to bill: http://www.gencourt.state.nh.us/legislation/2008/HB1518.html

NEW JERSEY

A 754, Would restrict gifts from drug companies to health care professionals and prohibits health care professionals with financial ties to drug companies from serving on health care facility formulary committees. Sponsor: Asm. Prieto

Status: Filed and sent to committee 1/8/08

Link to bill:http://www.njleg.state.nj.us/2008/Bills/A1000/754_I1.PDF

NEW YORK

A 1550, Would require manufacturers and labelers of prescription drugs dispensed in the state that engage in marketing activities in this state to annually report marketing expenses to the Department of Health; imposes a $10,000 civil fine for failure to report.  Sponsor: Asm. Brodsky

Status: Filed 1/10/07; carried over from 2007 and re-sent to committee 1/9/08

Link to bill: http://assembly.state.ny.us/leg/?bn=a1550

A 7468, S2971, Would require pharmaceutical drug manufacturers and wholesalers to annually report, for disclosure to the general public, all of its gifts to health care practitioners that prescribe drugs when such gifts have a certain value. Sponsors:Asm. Gottfried, Sen. Maziarz

Status: Filed 2/16/07; passed Assembly and sent to Senate 6/22/07; carried over and amended 1/9/08

Link to bill: http://assembly.state.ny.us/leg/?bn=a7468

OHIO

HB 39, Would require manufacturers and labelers of dangerous drugs to disclose to the Director of Health the value, nature, and purpose of certain gifts, fees, payments, subsidies, and other economic benefits they provide in connection with pharmaceutical detailing, marketing, or promotion. Sponsor: Rep. Skindell

Status: Filed and sent to committee 2/21/07; did not pass before end of '07 session; carried over to '08

Link to bill: http://www.legislature.state.oh.us/bills.cfm?ID=127_HB_39

WASHINGTON

SB 5917, Would require the disclosure of gifts from pharmaceutical manufacturers to person who can prescribe in the state.  Requires reporting of gifts, grants and gratuities made by companies directly or indirectly to prescribers, purchasers or dispensers in the state. Sponsor: Sen. Kohl-Welles

Status: Filed  2/7/07; favorable committee report; did not pass by end of regular session 3/13/08

Link to bill: http://apps.leg.wa.gov/billinfo/summary.aspx?bill=5917&year=2008

SB 6302, HB 2498, HB 2680, Would establish prescription drug marketing and annual disclosure standards and requirements.  Regulates gifts, grants, and gratuities made by pharmaceutical manufacturing companies, directly or indirectly, to any person or entity authorized to prescribe drugs" with results posted online by the state Board of Pharmacy. Sponsors: Rep. Green, Sen. Kohl-Welles

Status: Filed 1/17/08, 2/5/08; HB 2680 & SB 6320 favorable reports; did not pass by end of regular session 2/29/08

Link to bills: http://apps.leg.wa.gov/billinfo/summary.aspx?bill=6302; http://apps.leg.wa.gov/billinfo/summary.aspx?bill=2498&year=2008 ; http://apps.leg.wa.gov/billinfo/summary.aspx?bill=2680&year=2008

WEST VIRGINIA

HB 4270, SB 441, Would authorize the West Virginia Office of Pharmaceutical Advocate to promulgate legislative rules relating to prescription drug advertising expense reporting. Sponsors: Del. Brown, Sen. Minard

Status: Filed 1/25/08; both favorable committee reports 2/7/08; did not pass by end of regular session 3/8/08; however, rules were issued without the bill being enacted

Link to bills: http://www.legis.state.wv.us/Bill_Text_HTML/2008_SESSIONS/RS/BILLS/hb4270 intr.htm ; http://www.legis.state.wv.us/Bill_Text_HTML/2008_SESSIONS/RS/BILLS/sb441 intr.htm

WISCONSIN

AB 12, Would prohibit prescription drug manufacturers from "giving or offering anything of monetary value to any practitioner to encourage prescribing the manufacturer's drugs;" product samples would be excluded; includes a fine up to $10,000 per violation. Sponsor: Rep. Schneider

Status: Filed and sent to committee 1/12/07; failed to pass 3/21/08

Link to bill: http://nxt.legis.state.wi.us/nxt/gateway.dll/Session Related/bills07/5021/5022?f=templates$fn=document-frameset.htm$q=[field%20folio-destination-name:'ab12']$x=Advanced - 0-0-0-9753

 

DATA MINING LEGISLATION

New Hampshire, Vermont and Maine are the only states to have enacted laws to ban the marketing use of prescriber data or to create mechanisms for prescribers to act to either waive privacy protections or opt in to a state-run system to preserve privacy of prescription data.  The constitutionality of these laws is currently being litigated in federal court, and confusion about the legality of these provisions has no doubt contributed to the difficulty in finally enacting legislations in additional states.  At least 13 states had bills restricting access to prescriber data for marketing purposes this year, none of which were enacted.  In sharp contrast with this trend, a bill was introduced in California to loosen restrictions on using patient data for marketing purposes, but did not pass.

STATES WITH EXISTING LAWS

NEW HAMPSHIRE

The Prescription Privacy Law (2006) prevents patient and prescriber identifying data from being sold or used for advertising, marketing, promotion or any activity intended to influence sales or market share of a pharmaceutical product (http://www.gencourt.state.nh.us/rsa/html/XXX/318/318- 47-f.htm). The law was passed as a consumer protection and public health measure, and seeks to ensure privacy in prescribing. UPDATE: The law was challenged on the absis of commercial free speech by datamining companies IMS Health and Verispan. A US District court agreed with the plaintiffs, but on November 18 this ruling was rejected by a US Court of Appeals, who asserted the activity regulated by the law was conduct, not speech.

VERMONT

As part of a comprehensive package to control the costs of prescription drugs and regulate inappropriate marketing tactics, Vermont recently passed legislation that provides strong privacy protections by limiting the use of personally identifiable prescription information for marketing purposes unless doctors and other health care providers explicitly agree to waive the protections. The law, S.115, includes a physician opt-in provision at the time of licensure or renewal. This provision, managed by the state's professional licensing board, allows a prescriber to choose to have his or her identifying information used for marketing and promotion of prescription drugs. The Vermont Medical Society supports the measure.

MAINE

Maine also passed legislation requiring its Board of Licensure to include confidentiality protection of prescribing data as part of its licensure and license renewal process.7 The Board must inform applicants that their prescription drug information is used for marketing purposes and how the prescribers may "opt out," a weaker alternative to the prescribing data protection systems in Vermont and New Hampshire.

STATES ATTEMPTING TO PASS LEGISLATION IN 2008

CALIFORNIA

AB 1587, Would prohibit a provider of health care, a health care service plan, contractor, or corporation and its subsidiaries and affiliates from intentionally sharing, selling, using for marketing, or otherwise using any medical information, as defined, for any purpose not necessary to provide health care services to a patient.  Sponsor: Assm. De La Torre

Status: Filed; AB 1587 passed Assembly, 70y-6n, 5/27/07; re-sent to Senate committee 1/31/08; hearing 6/24/08

Link to text and status: http://www.leginfo.ca.gov/cgi-bin/postquery?bill_number=ab_1587&sess=CUR&house=B

 SB 843, Would allow, under provisions of the Confidentiality of Medical Information Act, a pharmacy to mail specified written communications to a patient, without the patient's authorization provided that such mailing pertain only to the prescribed course of medical treatment, not mention any other pharmaceutical products, and that it include disclosures regarding whether the pharmacy receives direct or indirect remuneration for making that written communication. Sponsor: Senator Calderon

Status: Filed 2/23/07; did not pass Assembly by deadline 1/31/08

Link to bill: http://www.leginfo.ca.gov/pub/07-08/bill/sen/sb_0801-0850/sb_843_bill_20080107_amended_sen_v97.html

DISTRICT OF COLUMBIA

B17-0364, among other provisions, the SafeRx Act would have prohibited pharmaceutical representatives from data mining, or using area prescribing data and trends as a marketing tool to target specific physicians.  These provisions were deleted from the final bill before passage.  Sponsor: Councilmember David Catania.

Status: Filed 9/29/07; passed City Council 7y-6n, 1/8/08; signed into law by mayor as Act A17-0282, 2/1/08; requires review by US Congress

Link to bill: http://www.dccouncil.washington.dc.us/lims/billrecord.asp?strlegno=B17-0364

HAWAII

 HB 9, SB 822, Would prohibit the sale or transfer of patient prescription information by certain businesses as an unfair and deceptive act in the conduct of trade or commerce. Sponsor: Rep. Takumi

Status: HB 9 - Filed and sent to committee 1/22/0, deferred in House Committee; SB 822 - Filed and held in committee 2/6/07; carried over to '08; did not pass by end of session

Link to bills: http://www.capitol.hawaii.gov/site1/docs/getstatus2.asp?billno=HB9

ILLINOIS

HB1459 - The Prescription Data Privacy Act would amend existing code and law to prohibit the licensure, transfer, use or sale of any records relative to prescription information containing patient-identifiable or prescriber-identifiable data for commercial purposes. Sponsors: Reps. Nekritz, Flowers

Status: Filed and sent to committee 2/21/07; did not pass before end of '07 session; carried over to '08, did not pass in ‘08

Link to bill: http://www.ilga.gov/legislation/95/HB/09500HB1459.htm

KANSAS

SB 229, Would create the Prescription Confidentiality Act, based on the New Hampshire Prescription Confidentiality Act.  Senator Schmidt introduced the bill for Ernie Kutzley, Advocacy Director for AARP Kansas.

Status: Filed and sent to committee 1/31/07; did not pass by end of '07 or '08 session

Link to bill: http://www.kslegislature.org/bills/2008/229.pdf

MARYLAND

HB 50, Would establish a prescriber data-sharing program for certain purposes with requirements, including requiring a pharmaceutical detailer to disclose certain information to a prescriber under certain circumstances.  Sponsor:  Del. Karen Montgomery

Status: Filed and sent to committee 1/9/08;withdrawn, did not pass 2/12/08)

Link to bill: http://mlis.state.md.us/2008rs/billfile/hb0050.htm

MASSACHUSETTS

H 1005, S 1275, S1309, Would prevent the sharing of prescription data and protect the confidentiality of patient prescription records. Sponsors: Rep. Ronald Mariano, Senator Moore

Status: Filed 1/8/07; H 1005 favorable report; resent to Joint committee on Financial Services, 10/3/07; 3/4/08; did not pass by end of session

Links to bills: http://www.mass.gov/legis/bills/house/185/ht01pdf/ht01005.pdf ; http://www.mass.gov/legis/185history/s01275.htm ; http://www.mass.gov/legis/185history/s01309.htm

MISSOURI

H 1328, Would prohibit the use, sale, transfer, or licensing of any prescription information that contains patient- or prescriber- identifiable data for commercial purposes that includes advertising, marketing, promotion, or other activities used to influence sale and market shares of pharmaceuticals; provides exemptions. Sponsor: Rep. Sater

Status: Filed 1/9/08; did not pass by end of session 5/16/08

Link to bill: http://www.house.mo.gov/billtracking/bills081/bills/hb1328.htm

NEW HAMPSHIRE

H 1396, Although not specific to data mining, this bill relates to patient privacy and would tighten rules governing patient records.  Would require that a prescription be ordered pursuant to "a practitioner-patient relationship" by rewriting the definitions of prescription to include the "medical connection between a licensed practitioner and a patient that includes an in-person exam, a history, a diagnosis, a treatment plan" and documentation of all drugs and dosages.  Sponsor: Rep. Rosenwald

Status: Filed and sent to committee 1/2/08, enacted by Legislature and signed by Governor

Link to bill:http://www.gencourt.state.nh.us/legislation/2008/HB1396.html

RIRHODE ISLAND

S 653, Would allow prescription privacy and prohibit patient identifying information from being transferred.  Also addressed the ethical marketing of prescriptions. Sponsor: Sen. Pichardo

Status: Filed  2/15/07; did not pass before end of session 7/2/07; carried over to '08, did not pass by end of session

Link to bill: http://www.rilin.state.ri.us/BillText/BillText07/SenateText07/S0653.htm

VERMONT

H 750, delays until July 1, 2009 implementation of the provisions the 2007 law relating to confidentiality of prescription information and consumer protections. It would clarify the use of records containing prescriber-identifiable information with the prescriber's consent and eliminate certain disclosure requirements. Redefines a "regulated record" as only those prescriptions dispensed in Vermont and written by an in-state prescriber. Extends deadline for a report on the generic drug voucher pilot program. Sponsor: House Comm. on Health Care (Rep. Chen)

Status: Filed 1/30/08; passed House and sent to Senate 2/6/08, House and Senate Agreement: 02/22/2008, Governor signed  03/05/2008

Link to enacted law: http://www.leg.state.vt.us/docs/legdoc.cfm?URL=/docs/2008/acts/ACT089.HTM

WASHINGTON

HB 1850, would limit the sale or use of prescription information. Sponsor: Rep. Pederson

Status: Filed  1/30/07; reintroduced 1/14/08; did not pass by end of regular session 3/13/08

Link to bill: http://apps.leg.wa.gov/billinfo/summary.aspx?bill=1850&year=2007

HB 2664, Would prohibit the sale and use of prescriber-identifiable prescription data for marketing or promotional purposes.  Sponsor: Rep. Pederson

Status: Filed 1/15/08; favorable committee report 2/6/08; did not pass by end of regular session 3/13/08

Link to bill: http://apps.leg.wa.gov/billinfo/summary.aspx?bill=2664&year=2008

SB 6241, Would prohibit the sale and use of prescriber-identifiable prescription data for marketing or promotional purposes absent affirmative authorization by the prescriber. Sponsor: Sen. Fairley

Status: Filed and sent to committee 1/17/08; passed Senate 26y-22n and sent to House, 2/18/08; did not pass House 3/13/08

Link to bill: http://apps.leg.wa.gov/billinfo/summary.aspx?bill=6241&year=2008

 

PRESCRIBER EDUCATION LEGISLATION

Prescriber outreach and education, also known as academic detailing, is the service of sending trained clinicians to prescribers' offices in order to present the best available, objective information on a given clinical topic. It has a proven track record of better aligning prescribing practices with the scientific evidence and thereby improving the quality of patient care while controlling costs.

STATES WITH EXISTING LAWS

Ground-breaking legislation on academic detailing passed in 2007 in Maine and in Vermont following the example of Pennsylvania, which implemented a program through executive authority.  There has been growing legislative momentum in 2008 with new programs authorized or implemented in the District of Columbia, Massachusetts, New Hampshire, and New York.  In addition, a tri-state initiative involving Maine, New Hampshire and Vermont explored the potential for collaboration between prescriber education programs.

STATES ATTEMPTING TO PASS LEGISLATION IN 2008

DISTRICT OF COLUMBIA

B17-0364, Among other provisions, the SafeRx Amendment Act of 2008 establishes licensure qualifications for pharmaceutical detailers and establishes a fee for the issuance of a license to practice pharmaceutical detailing.  Licensure fees will be used to fund an evidence-based "Pharmaceutical Education Program" (academic detailing).

Status: Filed 9/29/07; passed City Council 7y-6n, 1/8/08; signed into law by mayor as Act A17-0282, 2/1/08; requires review by US Congress

Link to bill: http://www.dccouncil.washington.dc.us/lims/billrecord.asp?strlegno=B17-0364

MASSACHUSETTS

Part of the omnibus health care reform legislation, an academic detailing program was included in the FY09 budget (line item 4510-0716) which allocates $500,000 for the operation of  "an evidence-based outreach and education program designed to provide information and education on the therapeutic and cost-effective utilization of prescription drugs" to prescribers

Status: Initially introduced in  H 2197 (Sponsor: Rep. Marzilli), the bill was filed and sent to committee 1/10/07; did not pass before end of '07 session; carried over to '08, included in omnibus health care reform legislation, S 2863

Link to the FY09 conference committee report: http://www.mass.gov/legis/bills/house/185/ht04pdf/ht04900.pdf.  

MICHIGAN

HB 4044 SB 43, Would repeal law providing manufacturer immunity from liability for drugs that have been approved by U.S. Food and Drug Administration. Sponsor: Rep. Mike Simpson

Status: Filed, passed House and sent to Senate 2/22/07; did not pass before end of '07 session; carried over to '08

HB 4045, Would allow lawsuits within three years of repeal of state law that had prohibited suits once drugs were approved by U.S. Food and Drug Administration. Sponsor: Rep, McDowell

Status: Filed, passed House 60y-49n, 2/22/07; held in Senate 12/07; carried over to '08*

Link to bill: http://www.legislature.mi.gov/(S(sta5pvnrheqnvzjwpknm4ejl))/mileg.aspx?page=getObject&objectName=2007-HB-4045

NEW HAMPSHIRE

H 1513, authorizes the creation of a drug education program under the direction of the New Hampshire Medical Society but does not allocate funding. Sponsor: Rep. Rosenwald

Status: Filed and sent to committee 1/2/08; passed house sent to senate 3/5/08; signed by Governor as Chaptered Law: 0119, 5/08

Link to bill: http://www.gencourt.state.nh.us/legislation/2008/HB1513.html

NEW YORK

Public health law §70-a was amended by adding a new section 276-b on prescriber education as part of the 2008 budget bill. The Department of Health and Human Services is to collaborate with an academic institution to "provide prescribers with an evidence-based, non-commercial source of the latest objective information about pharmaceuticals" (academic detailing).

Status: enacted law as part of budget 4/08

A 2274, Would require all pharmaceutical clinical trials and studies to be posted on a website to provide public with full disclosure; provides definitions; requires the commissioner to collect and post; monitor the website for compliance; provides public service announcements; imposes $25k fine for violators; requires annual reporting to the legislature. Sponsor: Asm. Jacobs

Status: Filed  1/16/07; amended, carried over from 2007 and re-sent to committee 1/9/08, reported to Rules Committee 6/3/08

Link to bill: http://assembly.state.ny.us/leg/?bn=a2274

S 1748, Would require all pharmaceutical clinical trials and studies to be posted on website to provide public with full disclosure; provides definitions; requires the Commissioner of Health to collect and post, monitor the website for compliance and provide public service announcements; creates task force on clinical trials and studies. Sponsor: Sen. Sabini

Status: Filed 1/25/07; carried over and re-sent to committee 1/9/08

Link to bill: http://assembly.state.ny.us/leg/?bn=s1748

PENNSYLVANIA

HR 15, Would urge the U.S. Congress and the Department of Health and Human Services to establish and maintain a comprehensive national registry for clinical drug trial results, requiring that all drug trial results, both positive and negative, be disclosed.

Status: Filed and sent to committee 2/1/07; did not pass before end of '07 session; carried over to '08, no further action

Link to bill: http://www.legis.state.pa.us/cfdocs/billinfo/billinfo.cfm?syear=2007&sind=0&body=H&type=R&BN=0015

WASHINGTON

SB 6200, Would create the prescription drug professional education program as the prescription drug evidence-based education act; provides for a fee for each manufacturer of prescription drugs provided to residents through the Medicaid program to cover the costs of administering the program; provides for reduction in health complications and unnecessary costs associated with non-evidence-based drug prescribing; provides for cost containment and use of generic drugs. Sponsor: Sen. Keiser

Status: Filed 12/31/07; did not pass by end of regular session 3/13/08

Link to bill: http://apps.leg.wa.gov/billinfo/summary.aspx?bill=6200&year=2008

 

INDUSTRY SALES REP AND OTHER LEGISLATION

Massachusetts and the District of Columbia were the leaders in 2008 in setting ethical standards for drug marketing carried out by industry salespersons or "detailers".  Legislation was enacted in California to regulate deceptive marketing tactics for Medicare Part D policies, based on a 2007 Maine law.  The D.C. law established licensing and educational requirements, as well as ethical standards, for drug industry salespersons.  Several other states had legislation introduced to regulate direct to consumer advertising or require regulation of industry salespersons, which failed to pass. 

STATES WITH EXISTING LAWS

CALIFORNIA

The law would regulate and restrict on "deceptive marketing" of Medicare products, defining as an unfair business practice for various parties engaged in the solicitation of health insurance policies to engage in cold lead advertising or multiple services, affecting Part D plans. Sponsor: Assemblywoman Patty Berg

Claifornia also views faculty at State universities as state employees, and thus limits their acceptance of gifts and payments from industry via strict conflicts of interest protocol.

DISTRICT OF COLUMBIA

B17-0364, among other provisions, the SafeRx Act requires licensing of pharmaceutical representatives and imposes penalties for "misleading remarks made in sales pitches to doctors," intended to "counteract the influence of pharmaceutical 'detailers.'  Also would require drug-company representatives to have a bachelor's degree, adhere to a code of ethics and ban gifts to the P&T committee.  Sponsor: Councilmember Catania

FLORIDA - Miami Dade County

The county has interpreted language defining lobbyists to include those attempting to influence the actions or decisions of any state official, including employees of state medical institutions. (Jackson Health System reiterates this in their own vendor policy - they require reps to register as a lobbyist in order to register Jackson Health as a detailer.) Lobbyists are required to file annual expense reports with the county delineating what they have spent by category (food, entertainment, travel, publications, research, etc...) Lobbyist names, their companies and in some cases, the subject of lobbying is compiled by quarter and year in a searchable database on the Miami Dade county website (no expense information).

LOUISIANA

Requires any industry reps detailing members of the Medicaid P7T committee to register as lobbyists. Payments over $50 are forbidden. Currently biannual disclosures required, to become monthly disclosures in Feb. 09.

STATES ATTEMPTING TO PASS LEGISLATION IN 2008

HAWAII

HB 11, SB 814, Would require prescription drug advertisements to meet Federal standards, public disclosure of clinical trial information, and drug manufacturers to pay fees to Department of Health to fund a public education initiative on clinical trials and drug safety. Sponsor: Rep. Takumi

Status: Filed and sent to committee 1/22/07; deferred by committee 2/2/07; carried over to '08; not enacted

Link to bill:  http://www.capitol.hawaii.gov/site1/docs/getstatus2.asp?billno=HB11

HB 2445, Would require prescription drug ads to meet federal standards, public disclosure of clinical trial information, and drug manufacturers to pay fees to department of health to fund a public education initiative on clinical trials and drug safety. Sponsor: Rep. Takumi

Status: Filed and sent to committees 1/22/08, not enacted

Link to bill: http://www.capitol.hawaii.gov/site1/docs/getstatus2.asp?billno=HB2445

IOWA

SSB 1037, Would provide for the establishment of a limited drug and device distributor license.

Status: Filed and sent to committee 1/30/07; did not pass before end of '07 session; carried over to '08;  did not pass before end of session

Link to bill: http://coolice.legis.state.ia.us/Cool-ICE/default.asp?Category=billinfo&Service=Billbook&menu=false&ga=82&hbill=SSB1037

LOUISIANA

H 896, Would prohibit the display of any pharmaceutical advertisements in a health care facility. Sponsor: Rep. Walker Hines 

Status: Filed and sent to committee 3/21/08; did not pass before end of session

Link to bill: http://www.legis.state.la.us/billdata/streamdocument.asp?did=471486

MASSACHUSETTS

H 372, Would prohibit certain advertising by pharmaceutical companies. Sponsor: Rep Kathi Reinstein

Status: Filed  1/5/07; did not pass committee 3/20/08)

Link to bill: http://www.mass.gov/legis/bills/house/185/ht00pdf/ht00372.pdf

S 1250, Would require all patients be given full information on drug samples and require marketers to maintain written records identifying the manufacturer and the person who distributes any complimentary starter doses to prescribers, to be made available to the state upon request.  Sponsor: Sen. Moore

Status: Filed  1/9/07; did not pass before end of '07 session; carried over to '08, sent to committee 3/18/08)

Link to bill:http://www.mass.gov/legis/bills/senate/185/st01/st01270.htm

S 1252, S 1274, S 2279, Would require certain health care professionals to file prescription ethics and responsibility confirmation statements. Sponsor: Sen. Moore

Status: Filed 1/10/07; 9/12/07; favorable committee report as S 2279, 2/28/08

Links to bills: http://www.mass.gov/legis/185history/s01252.htmS 2143 http://www.mass.gov/legis/185history/s01274.htm

Non-binding resolution to the U. S. Congress relative to the advertising of drugs by pharmaceutical companies. Sponsor: Sen. Spilka

Status: Filed 1/8/07; did not pass before end of '07 session; ought to pass as amended in committee 3/13/08

NEW YORK

A 1547, Would expose manufacturers of prescription drugs or medical devices, who engage in direct to consumer advertising, to civil liability where adequate warnings are not provided; provides factors that may be considered in determining whether the warnings were adequate. Sponsor: Asm. Brodsky  

Status: Filed 1/10/07; carried over from 2007 and re-sent to committee 1/9/08

Link to bill: http://assembly.state.ny.us/leg/?bn=A01547&sh=t

S 2005, Would require manufacturers engaging in direct to consumer advertising to prescription drugs to clearly state the primary function of the prescription drug in such advertisement.

Status: Filed 1/30/07; carried over and re-sent to committee 1/9/08

Link to bill: http://assembly.state.ny.us/leg/?bn=s2005

A 9399, Would prohibit manufacturers and distributors of prescription drugs from deducting the costs of advertising such drugs to consumers from their corporate or personal income taxes.  Sponsor: Asm. Brodsky

Filed 9/12/07; carried over and re-sent to committee 1/9/08

Link to bill: http://assembly.state.ny.us/leg/?bn=a9399

S 3357, Would require a cost/benefit analysis of pharmaceutical advertising and promotional activities associated with the provision of prescription drugs to citizens in this state. Sponsor: Sen. Krueger

Status: Filed 3/5/07; carried over and re-sent to committee 1/9/08

Link to bill: http://assembly.state.ny.us/leg/?bn=s3357

OKLAHOMA

HB 1938, Would require the registration of pharmaceutical sales representatives with a state commission; specifies fees; provides for registration forms, reports and termination procedures.  Sponsor: Rep. McMullen

Status: Filed 1/22/07; failed; did not pass before end of '07 or '08 sessions

Link to bill: http://webserver1.lsb.state.ok.us/WebBillStatus/main.html

SOUTH CAROLINA

HB 4551, Would provide that beginning July 1, 2008, pharmaceutical companies may not on broadcast or print media based in this State advertise or cause to be advertised prescription medicines or other controlled substances which may be sold only by prescription and to provide civil penalties for violations. Sponsor: Rep. Rice

Status: Filed 1/24/08; did not pass committee by end of '08 session 6/5/08

Link to bill:http://www.scstatehouse.net/cgi-bin/web_bh10.exe

TENNESSEE

SJR 142, Would urge Congress and appropriate federal agencies to recognize problems caused by direct-to- consumer advertising by pharmaceutical companies and to limit it or ban it altogether. Sponsor: Sen. Finney

Status: Filed 5/1/07; passed Senate 23y-0n, 4/5/07; failed; did not pass committee by end of '07-'08 sessions 5/21/08

Link to bill: http://www.legislature.state.tn.us/bills/currentga/asp/WebBillInfo/BillCompanionInfo.aspx?BillNumber=sjr142

 

 

[1: Content in this section written for the Prescription Project by Sharon Anglin Treat, Executive Director of the National Legislative Association on Prescription Drug Prices]