The moral from Sorrell: educate, don't legislate.

Author:Gooch, George R.
Position:Legal decisions on the use of prescriber-identifying data for marketing purposes
 
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ABSTRACT

This Article argues that in response to the United States Supreme Court's 2011 decision in Sorrell v. IMS Health Inc., state legislators should refrain from enacting prescription confidentiality laws and instead implement policies supporting academic detailing, a form of continuing medical education in which trained health professionals such as physicians, registered nurses, advanced practice nurses, and pharmacists provide evidence-based information about prescription drugs to prescribers.

According to Sorrell, pharmaceutical companies may freely use physicians' prescribing data to better promote, or "detail," products to physicians without government interference. While pharmaceutical companies may profit from detailing drugs to physicians, detailing increases health care costs for patients and negatively affects patient health outcomes. These problems motivated Maine, New Hampshire, and Vermont to enact prescription confidentiality laws that banned the use of information about the prescribing habits of physicians to help market drugs to physicians.

Recent state attempts to stop drug detailing to physicians have been found to violate the First Amendment. This Article provides a history and background on the pharmaceutical-detailing process and analyzes recent legal decisions relating to prescription confidentiality. It concludes that academic detailing is a viable solution to the negative effects of pharmaceutical detailing and is consistent with the First Amendment.

CONTENTS INTRODUCTION I. HISTORY AND BACKGROUND A. The History of Drug Detailing B. Physician Resistance to Pharmaceutical Detailing and the American Medical Association's Response C. Pharmaceutical Detailing Today II. IMS HEALTH INC. LITIGATION IN THE FIRST CIRCUIT A. Some Clarification on Parties to the IMS Health Inc. Cases B. New Hampshire's Prescription Confidentiality Law C. Maine's Prescription Confidentiality Law D. The First Circuit's Decision in the IMS Health Cases III. VERMONT'S PRESCRIPTION CONFIDENTIALITY LAW AND THE SUPREME COURT'S DECISION IN SORRELL V. IMS HEALTH INC A. How Vermont's Prescription Confidentiality Law Differs from Maine and New Hampshire's Laws B. Vermont's Prescription Confidentiality Law in the Lower Courts C. The Supreme Court's Decision D. "Heightened" Judicial Scrutiny and the First Amendment E. Protecting Physician Privacy under Heightened Scrutiny F. Containing Prescription Drug Costs under Heightened Scrutiny G. Promoting Public Health under Heightened Scrutiny H. The Majority Provides Some Guidance IV. GOVERNMENT RESPONSES TO PHARMACEUTICAL DETAILING A. Enacting Legislation Banning the Use of Prescriber-Identifying Data Will Likely Fail Under the First Amendment B. Giving Physicians More Privacy Options Is Irrelevant to the Courts C. Telling Physicians to Close Their Doors Will Not Solve Anything V. ACADEMIC DETAILING IS THE BEST RESPONSE TO SORRELL A. What Is Academic Detailing? B. Federal Initiatives for Academic Detailing Programs C. Legal Advantages of Academic Detailing D. Protecting Physician Privacy with Academic Detailing and the PDRP E. Reducing Prescription Drug Costs with Academic Detailing F. Academic Detailing Programs' Costs Weighed against Profits G. Promoting Public Health with Academic Detailing H. Prescriber-Identifying Data Can Improve Academic Detailing CONCLUSION INTRODUCTION

Physicians often work upwards of eighty hours each week. (1) Between seeing patients, filling out paperwork, and managing a practice, physicians have little time to research the drugs they prescribe. Although physicians can seek drug information from any number of sources--including colleagues, journal articles and advertisements, direct mail, commercial sources, Medicare updates, conferences, and continuing medical education activities (2)--they rely on information from pharmaceutical sales representatives (drug reps). (3) Drugs reps are mindful of physicians' limited time and offer them succinct drug information. (4) This direct-to-physician marketing is hugely successful; indeed, it is a highly profitable form of advertising for drug companies. (5) While research shows that physicians understand the conflict of interest between marketing and patient care, they nevertheless frequently communicate with drug reps. (6) In 2005, the average primary care physician interacted with twenty-eight drug reps each week; the average specialist interacted with fourteen. (7)

Drug reps promote their products to physicians in offices and hospitals through a process called detailing. Detailing is a marketing technique used to educate physicians about a pharmaceutical company's products in hopes that physicians will prescribe them more. (8) Drug reps, also known as detailers, bring physicians drug samples and medical studies explaining the advantages of their company's products. (9)

Detailers can market a particular drug more effectively when they have information about doctors' unique prescribing practices, or "prescriber-identifying data." Using prescriber-identifying data, detailers can target physicians who adopt new drugs quickly, regularly prescribe competitors' drugs, or prescribe large quantities of drugs for particular conditions. (10) Because detailing is an expensive process, pharmaceutical companies typically use it to promote expensive brand-name, patent-protected drugs. (11) Once a brand-name drug's patent expires, cheaper, generic alternatives are manufactured and sold. (12) Because of their lower profit margins, generic drugs are not marketed by drug reps. (13)

Pursuant to federal law, pharmacies receive prescriber-identifying data when processing prescriptions. (14) Several pharmacies sell this information to data miners, also known as health information organizations (HIOs) or prescription drug intermediaries (PDIs). HIOs and PDIs are firms that analyze prescriber-identifying data to create reports on prescriber behavior. (15) The Health Insurance Portability and Accountability Act (HIPAA) mandates that this prescriber-identifying data contain no patient identifiers such as names, addresses, and social security numbers. (16) Some integrated health care organizations such as Kaiser Permanente restrict use of prescription data because they object to influencing prescribing patterns to promote more costly, brand-name drugs when cheaper generics are often equally effective. (17) Only a small fraction of pharmacies, however, restrict the use of prescriber data. (18)

HIOs combine the prescription information from pharmacies with physicians' demographic, practice, and contact information from the American Medical Association's (AMA) Masterfile to create reports on physician prescribing patterns. (19) HIOs lease these reports, subject to nondisclosure agreements, to pharmaceutical manufacturers, medical researchers, and government agencies. (20) "Detailers, who represent drug manufacturers, then use these reports to refine their marketing tactics and increase [pharmaceutical] sales." (21)

Some physicians welcome detailers, claiming that detailers provide them with studies relevant to their practices, useful free drug samples, and targeted data about the prescribing patterns of other physicians. (22) Generally, these physicians claim they are immune to detailers' influence and see no conflicts of interest. (23) Other physicians, however, object that detailing intrudes into their prescribing decisions. (24) These physicians insist that detailers should be restricted from using their prescribing patterns for direct-to-physician marketing purposes. (25)

Studies show that detailing influences requests to add brand-name medications to hospitals' formularies, thus increasing prescribing costs that add to the burgeoning cost of health care in the United States. (26) In 2010, health-care expenditures in the United States surpassed $2.5 trillion, more than three times the $724 billion spent in 1990 and eight times the $255 billion spent in 1980. (27) Prescription drugs account for about ten percent of these increasing costs. (28) Between 2002 and 2005, the pharmaceutical industry spent $7 billion annually detailing brand-name drugs to physicians. (29) Aggressive marketing campaigns by large drug companies and the billions spent in direct-to-consumer drug advertising lead to increased drug costs that are passed along to patients. (30)

Detailing can also adversely affect health outcomes. Although the Food and Drug Administration (FDA) requires pharmaceutical companies to engage in extensive drug testing to ensure that drugs are both safe and effective, (31) a drug's long-term effects are sometimes unknown until the drug has been on the market for several years. (32) When detailers market to "early adopters," i.e., physicians who prescribe new drugs earlier than other physicians, (33) the number of patients taking a drug with potentially unknown side effects increases. (34)

In response to these concerns, some states have enacted legislation banning the use of prescriber-identifying data for marketing purposes, (35) and at least twenty-five other states have considered similar legislation. (36) Implementation of these statutes has been unsuccessful, however, with the most recent blow coming from a 6-3 Supreme Court decision, Sorrell v. IMS Health Inc., ruling that a Vermont law banning the use of prescriber-identifying data for marketing purposes violated the Free Speech Clause of the First Amendment. (37)

Rather than banning the use of prescriber-identifying data, other states have incorporated detailing programs of their own to balance the information physicians receive from the pharmaceutical industry. (38) This practice is known as academic detailing, "a form of continuing medical education in which a trained health professional such as a physician or pharmacist visits physicians in their offices to provide evidence-based information." (39)

In the wake of Sorrell, with patients' health and wallets...

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