||he legal authority for regulating for drug advertising dates from 1962, when Congress granted the Food and Drug Administration (FDA) authority for assuring the dissemination of truthful information about pharmaceutical products. Since then, there have been dramatic changes in the pharmaceutical marketplace:
Once confined largely to journal advertisements and detailing, promotional practices have mushroomed to engender an ever-wider variety of communication channels, many unthought of in 1962,
- Once confined to physicians, the audiences for pharmaceutical promotion have grown to include an increasing number of people, from formulary decision makers to patients. The health care delivery system itself is radically different from 1962,
- Once focused on promoting a limited number of well-known drugs, the pharmaceutical industry now aggressively markets an augmented list of complex chemicals treating many diseases for the first time or with innovative chemical approaches.
In short, the pharmaceutical marketplace, as we enter the new century, has never been more competitive, more diverse, or more promising. And the patient has never been so well educated and so much in need of information. Despite huge increases in patient-oriented information dissemination, levels of undertreatment (through both unrecognized disease and noncompliant behavior) remain in epidemic proportions.
In the 1990s FDA recognized that the combination of help-seeking and reminder broadcast advertising left consumers in a quandary regarding the advertised product. This led to a new policy permitting the broadcast of consumer advertising. Now, the question is whether FDA's requirements for broadcast advertising result in a more informed consumer or an uninformed and confused one? Similarly, with the Division of Drug Marketing, Advertising and Communications' (DDMAC's) review of health professional promotion, we must ask if the resultant materials further the public health goals set forth in legislation.
From a regulatory standpoint, the question that must be addressed in the new century is whether the current regulatory system, designed in the 1960s following enactment of the law, makes sense in an increasingly complex and dynamic pharmaceutical marketplace.
We believe that the underlying premises for promotion regulation (ie, that information should not be false and/or misleading, and that risks should be proactively disclosed) should remain intact. We believe, however, that a new marketplace and a new century require a new way of thinking about how promotion should be regulated.
We believe that drug promotion regulation must make major modifications, entailing significant changes in regulatory approaches. Further, while the basic concepts from the enabling legislation may remain intact, the regulatory framework must be totally rethought. The FDA "style" of regulation must evolve quickly, moving away from "command and control" and strict oversight toward an "incentive" based system providing clear direction for the pharmaceutical industry.
The purpose of this paper is to outline how we believe the drug promotion regulatory system should be redesigned to provide physicians, other health professionals and consumers with truthful and "balanced"
information in the new century. First, we describe the current set of basic legal and regulatory concepts underlying the current regulatory framework. Second, we describe the variety of "cultural" changes that pose new challenges for regulators. Lastly, we propose an innovative framework--much different from what exists now--for pharmaceutical promotion regulation in the new millenium.
The Current Regulatory Scheme
The Food, Drug and Cosmetic Act (the Act) sets forth broad and very vague concepts on how pharmaceutical promotion should be regulated. Under the law, manufacturers, packers, or distributors of pharmaceutical products should not disseminate information that is false or misleading. In addition, a "brief summary" of risk information should be included in promotional material. The premise is that recipients of information about pharmaceuticals should not be misled into making harmful treatment decisions. The law applies only to information issued by regulated entities. It does not extend to other sources of information.
We believe that the basic premise that people--whether prescribers, buyers, or consumers--need truthful and balanced information to use prescription drugs correctly, should remain as the primary goal of drug advertising regulation in the 21st century. It is the obligation of companies that make and market pharmaceuticals to assure the accuracy and balance of the information they disseminate. One might argue, in a world in which so much information is available, that to place special restrictions on manufacturers is unrealistic and unfair. We believe that the responsibility for issuing honest and accurate information should continue to remain with manufacturers, even though the information emanating from drug companies is a diminishing percentage of the total information available about a drug.
It is becoming clearer and clearer that several of the methods used by the FDA to interpret and enforce these basic concepts have become strained by the ever-changing nature of drug marketing. For example, the act specifies that pharmaceutical information should not be false or misleading "in any particular." FDA interprets this as requiring in-depth and exhaustive review of every element of pharmaceutical promotion. With the explosion of information and the development of long and involved web-based interfaces with huge information databases, how will FDA perform the in-depth and exhaustive review of every promotional piece?
Another issue revolves around the sources that FDA uses to evaluate the truthfulness of information. The FDA traditionally utilizes the approved product insert to determine if claims are permissible. Information does not need to be lifted verbatim from the insert, but it must be "consistent" with the label. While labels have become more complex, they still do not provide all of the information provided to prescribers and users.
In 1997, Congress recognized the changing marketplace and dynamic of pharmaceutical information in enacting the FDA Modernization Act. Section 114 of that law provided for health economic information-- information provided to managed care and other purchasers of drugs--to be regulated under a different set of rules. Congress said that there needs to be a more flexible set of regulatory review standards for this audience. We believe that Congress was on the right track. The question is how will FDA regulate different types of claims that do not necessarily convey traditional safety or effectiveness information for different audiences?
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