The Statutory Basis for FDA Regulation of Scientific and Educational Information
by Mark E. Boulding
This article first appeared in the Journal of Pharmacy and Law, Vol. 4, No. 2, pages 123-142 (1995). (C) Copyright 1995 Mark E. Boulding
The Food and Drug Administration ("FDA") is the agency responsible for administering the provisions of the Food, Drug, and Cosmetic Act. Among many other things, the FD&C Act regulates the manufacture and marketing of drugs for human use. Over time, FDA has interpreted the provisions of the FD&C Act to give itself increasing authority over the dissemination of information by or on behalf of manufacturers of drugs. In particular, the FDA has in recent years asserted its jurisdiction over scientific and medical exchanges of information (for instance, continuing medical education ("CME") meetings, distribution of textbooks,and enduring materials used in medical education). The Commissioner of the FDA, Dr. David Kessler, summarized the agency's viewpoint in an article in the Journal of the American Medical Association: "[The] definitions of labeling and advertising taken together cover--at least in the FDA's opinion--virtually all information-disseminating activities by or on behalf of a prescription drug manufacturer." Companies and individuals who have nothing to do with the manufacture of drugs, but who are affected by the FDA's aggressive regulatory posture, have sharply criticized the agency's activities.The debate has even moved to the courtroom, where a lawsuit challenging FDA on freedom of speech grounds has caused FDA to request additional comment on at least some aspects of its policies.
Debate over FDA's actions has focused on constitutional and policy objections. Analysis of the more fundamental but less glamorous issue of the limitations of FDA's statutory authority has been largely superficial. With some exceptions,there has been, in my opinion, a failure to concentrate on the specific legal underpinnings of FDA's assertion of jurisdiction. The objective of this article is to examine the precise statutory bases for FDA's recent policies concerning regulation of information and to address the plausibility of these bases given the current state of the law. Because prescription drugs for human use are at the core of the current controversy, they will be the exclusive focus of this article.
To lay a sufficient foundation for this article's analysis, a significant amount of contextual information must be reviewed. What is FDA doing to restrict the dissemination of information about human drugs? What possible justifications exist for FDA's actions in the FD&C Act? Part II of this article summarizes the response to these two questions. Having laid this foundation, Part III then examines the scope of FDA's statutory authority.
A. Recent FDA Actions
As an agency, FDA relies heavily on informal methods of regulation. For much of its policy- making, the agency uses speeches, articles, and draft guidances rather than formal rulemaking procedures. Given this preference on the part of the agency, it should come as no surprise that the recent controversies over regulation of information are based on a series of informal activities by FDA. The first of these was FDA's release, to selected individuals, of a document known as the "Draft Concept Paper." In this document, FDA's Division of Drug Marketing, Advertising, and Communications ("DDMAC") set forth a proposed regulatory scheme applicable to any scientific or medical exchange of information funded by a member of the regulated industry (for instance, a pharmaceutical manufacturer). FDA was concerned that some of these industry-funded activities (including continuing medical education events, seminars on recent developments in therapeutics, and scientific meetings) were largely promotional in nature, with very little medical or scientific content. The Draft Concept Paper generated an enormous number of comments, most of them negative. Companies that specialized in conducting the activities in question discovered that pharmaceutical companies were no longer as willing to fund them for fear of FDA enforcement action. After a year of debate, FDA created a follow-up document that refined the approach of the Draft Concept Paper. This document, titled "Draft Policy Statement on Industry-Supported Scientific and Educational Activities," was published in the Federal Register for public comment.
The Draft Concept Paper and the Draft Policy Statement both began with the basic premise that FDA had complete authority to regulate any informational activity funded directly or indirectly by a member of the regulated industry. The Draft Policy Statement, for example, stated that:
The ostensible purpose of both the Draft Concept Paper and the Draft Policy Statement was to set up a safe harbor from regulation for certain types of industry-funded informational activities of a scientific or educational nature. Those activities that came within the safe harbor would not be subject to FDA regulation, but FDA clearly viewed the safe harbor as a discretionary exception to the agency's general power. Despite the strong adverse reaction to the Draft Concept Paper, FDA attempted to camouflage its newly-aggressive jurisdictional stance as nothing more than a statement of long-standing agency policy.
In addition to the Draft Concept Paper and Draft Policy Statement, FDA also began taking a more restrictive position on the distribution of textbooks and other written materials to physicians when industry funding was involved. The agency had long viewed the unsolicited distribution of journal reprints, even those coming from respected, peer-reviewed journals, as inappropriate when the reprint discussed unapproved uses of a manufacturer's drugs. Textbooks presented a slightly different set of facts. For example, a book might be commonly used in medical schools, and only incidentally discuss a manufacturer's products. In disease areas like cancer or AIDS, any textbook that was medically up-to-date would have to elaborate on the unapproved use of several drugs. Despite these differences from journal article reprints, which normally articulate the specific use of a particular product, the FDA on several occasions refused to allow distribution of textbooks by manufacturers. FDA also announced that it was developing a policy to cover all industry-sponsored "enduring materials," loosely defined as materials of a lasting nature like books, audio or video tapes, and software. FDA officials indicated that the standards for such enduring materials were likely to be similar to those applied to scientific and medical exchanges in the Draft Policy Statement.
FDA's advance into these new areas has not gone unopposed. Significant criticism has come from the press,from the FDA bar,from industry associations,and even from physician groups. In addition, the Washington Legal Foundation, a public interest law firm, has filed a lawsuit challenging FDA's actions on constitutional grounds. This lawsuit recently survived an FDA motion to dismiss (based on procedural grounds).
B. Statutory Bases for FDA's Recent Actions
The scope of FDA activities described in the preceding section leads directly to the question of FDA's statutory authority to regulate manufacturer statements. FDA's discussion of agency authority provides little assistance in this regard. Once FDA believed the activities were promotional in nature, it assumed they were subject to agency jurisdiction. The Agency's clearest statement of this position occurs in its recent Federal Register notice re-opening the comment period for the Draft Policy Statement:
Thus, FDA's belief that pharmaceutical companies were using the means described in the foregoing excerpt to promote their products, coupled with FDA "tradition," was sufficient to justify regulation. Implicit in FDA's language is the view that FDA has general authority to regulate the promotion of drugs and devices. Exploring the basis for the agency's position in the FD&C Act, however, leads not to any literal statement of authority over promotional activities, but rather to a fragmented collection of provisions in an extremely complex statute.
The FD&C Act does provide FDA with some authority over promotional activities, but only through specific statutory mechanisms. The law provides three principal bases for FDA regulation of the information-disseminating activities of drug manufacturers. First, the FD&C Act grants the agency significant power over product labeling, defined as "all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article."If the labeling is "false or misleading in any particular," or fails to bear "adequate directions for use" or "adequate warnings" against dangerous uses, then the product is "deemed misbranded." Second, in the case of prescription drugs, the FD&C Act establishes certain minimum content requirements for advertisements, and gives the FDA rulemaking authority for the purposes of additional control over advertising content. Again, failure to comply with these requirements will cause the product to be deemed misbranded. Third, the FD&C Act prohibits the introduction into interstate commerce of any unapproved new drug. Because statements about the intended use of a product can cause it to be an unapproved new drug, the prohibition on unapproved new drugs can be used to limit a manufacturer's dissemination of information about the product.
These three bases of authority do not relate to information standing alone, but to information (labeling, advertising, or representations about intended use) that relates back to a specific regulated drug, causing it to be either a misbranded drug or an unapproved new drug (or both at once). There are two basic violative acts that may result from marketing a misbranded drug or unapproved new drug. First, the FD&C Act prohibits misbranded drugs from the stream of interstate commerce, no matter when or where that misbranding occurs. Second, the FD&C Act prohibits the introduction (or delivery for introduction) into interstate commerce of an unapproved new drug. The FD&C Act gives FDA a variety of enforcement tools to deal with these (and other) violative acts, including injunctive relief,criminal penalties,and seizure powers.
Once a product is determined to be a misbranded drug or an unapproved new drug, FDA's statutory authority to deal with the violation cannot seriously be questioned. Therefore, for the purposes of analyzing FDA's attempt to regulate scientific and educational activities and materials, it is important to understand the precise legal dimensions of the terms "labeling," "advertising," and "new drug."
Early cases on the FDA's authority over information dissemination by manufacturers were based on the agency's authority over false or misleading labeling. The primary focus of these cases was not on the physical product label,which Section 201(k) of the FD&C Act defines as "a display of written, printed, or graphic matter upon the immediate container of any article," but on materials that may constitute "labeling" even though they do not appear on the "label." The statute defines these materials to include "other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article."
In the fundamental case on the scope of the term "labeling," Kordel v. United States,the U.S. Supreme Court held that the phrase "accompanying such article" was to be given an extremely broad construction. In Kordel, the defendant shipped various health food products and pamphlets concerning the medicinal uses for the products to consumers. FDA charged that these pamphlets caused the products in question to be misbranded drugs. The defendant argued that because the pamphlets were shipped separately they did not "accompany" the products. Therefore, the pamphlets could not be "labeling" for the drug. The Supreme Court disagreed. "Accompanying," the Court held, was not meant to restrict the definition of labeling to materials that physically accompanied the article in question. Instead, the Court said, "[o]ne thing or article is accompanied by another when it supplements or explains it, in the manner that a committee report of the Congress accompanies a bill. No physical attachment one to the other is necessary. It is the textual relationship that is significant." Therefore, printed materials that were shipped entirely separately from the product could nevertheless be "labeling."
Following Kordel, many cases arose that presented slightly varying factual situations. These cases largely involved failed attempts to avoid regulation as a drug by separating the product itself from written materials that explained medicinal uses of the product. Not all these cases were decided in FDA's favor. For example, in United States v. 24 Bottles "Sterling Vinegar & Honey",the Second Circuit declined to find that a book sold in the same store as a product for which the book made medicinal claims was "labeling" for that product. The basis of the decision was the lack of any evidence of "integrated use" of the book and the product. Regardless of FDA's success or failure based on the facts of a particular case, however, the basic principle of Kordel is firmly enshrined in the case law.
FDA's expansion of its labeling authority into new areas in recent years has not been as well supported in the case law as were its initial efforts. Although FDA claimed in the Draft Concept Paper and the Draft Policy Statement that bona fide scientific and educational materials could be labeling, there are no cases that directly address materials of this nature. The precedents, to the extent they exist, come from within FDA. DDMAC, the agency division responsible for oversight of the promotion of prescription drugs, has issued many documents over the years that assert that materials or activities of a claimed scientific or educational nature may be drug labeling. These documents include various types of letters to manufacturers concerning violative materials,reprints of speeches, articles, and informal guidance documents. One reason for the lack of reported court cases is that companies on the receiving end of warning letters from FDA normally negotiate a resolution with the agency. Also, the perceived difficulty of overcoming the courts' deference to FDA on health and safety issues discourages lawsuits against the agency. Indeed, the most serious recent court challenge to FDA's policies, the Washington Legal Foundation lawsuit, avoids the risky issue of FDA's statutory authority and focuses instead on constitutional problems.
FDA gained authority over prescription drug advertising with the passage of the Drug Amendments of 1962. This legislation amended Section 502(n) of the FD&C Act to provide that a prescription drug is misbranded unless all advertising for it lists the established (generic) name of the drug, a quantitative list of ingredients, and a "brief summary relating to side effects, contraindications, and effectiveness." The FD&C Act leaves the specific content of the brief summary up to FDA, which has promulgated extensive regulations on this topic.
Interestingly, despite the FD&C Act's lengthy definitions of "label" and "labeling," the act fails to define the term "advertising." FDA's regulations also fail to define "advertising," but do list examples of the types of advertisements subject to the regulation: "advertisements in published journals, magazines, other periodicals, and newspapers, and advertisements broadcast through media such as radio, televisions, and telephone communication systems." Some FDA representatives have characterized the scope of advertising as "a promotional activity that cannot be regulated as labeling,"but there is no basis for this in the FD&C Act.
The FD&C Act also provides that anything FDA determines to be "labeling" cannot be "advertising" (presumably to avoid conflicting statutory requirements). FDA's advertising regulations contain a list of materials that FDA has determined are "labeling" (and therefore not "advertising"):
This list includes most of the vehicles traditionally used by pharmaceutical companies to sell directly to physicians, and suggests a distinction in FDA's mind between direct sales materials (labeling) and mass-media materials (advertising).
The primary source of authority on the application of FDA's advertising authority comes not from the courts, but from the agency itself. First, the prescription drug advertising regulations specify in great detail what must be contained in a drug's advertising for it not to be misbranded under section 502(n). Although Section 502(n) appears to impose only disclosure requirements, FDA's prescription drug advertising regulations go further, requiring that advertisements not be false or misleading, and that they contain "fair balance" between positive and negative information about the drug. Second, as is the case with labeling, DDMAC has issued letters, speeches, articles, and informal guidance documents on its interpretation of the prescription drug advertising regulations. These materials chiefly relate to various technical aspects of compliance, rather than to broader issues like the scope of the term "advertising."
3. New Drug
In its continuing effort to control the promotion of prescription drugs, FDA has looked beyond the labeling and advertising provisions of the FD&C Act to its new drug authority. This relieves the agency of the burden of proving that the information coming from a manufacturer is actually false or misleading. Instead, to prevail on a new drug charge, the agency need only show that the product in question is an unapproved new drug introduced or delivered for introduction into interstate commerce. A confusing aspect of this type of enforcement action is that a drug can become a new drug by virtue of a new use. In particular, FDA views the information about the drug flowing from the manufacturer as capable of transforming an approved product into an unapproved product if the intent is to use the drug for uses other than those specifically identified in the FDA-approved labeling for the product. FDA uses two different approaches to argue that an already-approved drug is a "new drug": through a straightforward application of the statutory definition, and through a complex application of various provisions of the act that create a situation informally called a "back door" new drug.
a. Definition of "New Drug"
To be a "new drug" under the FD&C Act, a product must first meet the definition of "drug." Section 201(g)(1) defines "drugs" as:
The second part of this definition alone would apply to almost any drug on the market today. Coupled with the other two parts, the definition's reach is very broad. A product that is a "drug" may or may not be a "new drug." Section 201(p) states that the term "new drug" means:
Because of the difficulty involved in demonstrating that a drug developed after enactment of this definition is generally recognized as safe and effective at the time of its introduction, most drugs developed in the last few decades are treated as "new drugs" by their manufacturers and by the FDA. These drugs are marketed on the basis of an FDA-approved new drug application (NDA). Generally speaking, the prescription drugs that are the subject of scientific and educational activities or enduring materials sponsored by manufacturers fall into this category. For FDA to use its new drug authority against these already-approved products, the agency must argue that the manufacturer has specified conditions of use in the drug's labeling that go beyond those approved by FDA in the NDA. No manufacturer of prescription drugs is likely to risk altering the labeling that physically accompanies the product (namely, the product label and the physician prescribing information) to discuss unapproved uses. However, it is possible for the manufacturer to ship other materials that come within FDA's expansive definition of "labeling," and that discuss unapproved uses for the product. According to FDA's interpretation of the FD&C Act, such a product would constitute an unapproved new drug.
b. "Back Door" New Drug
In addition to the direct application of the new drug provisions of the FD&C Act, FDA has advanced another theoretical mechanism for regulating the dissemination of information using its new drug authority. Both the FD&C Act and the agency's regulations require a manufacturer to place adequate directions for use by laypersons on product labeling. Prescription drugs are exempted from this requirement to the extent claimed under Section 505 of the FD&C Act (that is, to the extent they bear directions for uses specifically approved by FDA under that section).FDA's regulations place an obligation on the manufacturer to include in product labeling adequate directions for all the "intended uses" of the product, whether or not specifically approved by FDA. The regulations define "intended use" as
A strict application of this language gives a manufacturer disseminating information about off-label uses a difficult choice: either face a misbranding violation by not amending the product labeling to include adequate directions for the unapproved use,or face a possible new drug violation for adding an unapproved new use to the product labeling. In fact, with prescription drugs, it is a generally accepted principle that adequate directions for use by laypersons cannot be written,so a company adding the unapproved use to a prescription drug label would face both a new drug and a misbranding charge.
III. Scope of FDA Authority
While the preceding explanation of the FDA's statutory authority may seem long, it is in many respects a simplification of years of case law, agency rulemaking and policy making, and manufacturer experience. Having established at least a basic framework, we can proceed to consider the relationship between the FDA's statutory authority and the areas the agency now seeks to regulate: scientific and medical activities and enduring materials. As discussed below, none of the statutory bases gives FDA grounds to assert general regulatory authority over these types of activities. However, FDA may be able to exercise regulatory authority in individual cases where the claim of scientific or educational value is part of a deliberate scheme to circumvent the FD&C Act.
As we have seen, FDA could charge a manufacturer with two types of violations in connection with information-disseminating activities about a particular drug: a new drug charge, or a misbranding charge (based on a violation of either the labeling or advertising provisions of the FD&C Act).
Of these two, FDA's new drug authority appears at first to give the agency the most control over manufacturer scientific and educational activities and enduring materials. By claiming that information referring to an unapproved use can turn an approved new drug into an unapproved new drug, FDA places significant pressure on drug manufacturers to avoid disseminating such information. Because the validity of the information is irrelevant to the "new drug" determination, the threat of enforcement action is even stronger. Furthermore, since FDA does not limit itself to information contained in product labeling, but also takes into account any manufacturer representation, whether made directly or through an agent or representative, the scope of information-disseminating activities affected appears to be virtually unlimited.
There is, however, a significant flaw in FDA's "new drug" argument as applied to information that does not constitute "labeling." A careful reading of the FD&C Act establishes that such information is not relevant to a determination that the product is a "new drug." The phrase "intended use," which is central to FDA's assertion of "new drug" jurisdiction over products that are the subject of non-labeling manufacturer representations, comes from the definition of a "drug": "articles intended for use in the diagnosis, cure, mitigation, or prevention of disease." A "new drug," on the other hand, is "any drug . . . the composition of which is such that such drug is not generally recognized . . . as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof . . . ." This distinction is critical. The FDA's suggestion that an approved new drug becomes an unapproved new drug by virtue of its intended use, as determined by objective intent, ignores the statutory origin of the term "intended use." The only supportable argument on these facts is that manufacturer representations concerning an unapproved "intended use," coupled with a failure to include adequate directions for use, make a product misbranded. Once a product is classified as a drug, therefore, the intended use analysis is wholly irrelevant to a determination whether it is a "new drug."
This definitional distinction has important consequences for prescription drugs marketed on the basis of an approved new drug application (or "NDA"). No manufacturer could successfully contend that these products were not "drugs." The real issue is whether the drug, because of statements made by or on behalf of the manufacturer, violates the new drug approval provisions of the FD&C Act. That analysis, as per the statutory definition of a "new drug," must be based solely on "the conditions prescribed, recommended, or suggested in the labeling" of the drug. Therefore, the inescapable conclusion is that materials that are not labeling cannot transform a "drug" into a "new drug." FDA's attempt to conflate the two concepts by relating "intended uses" to new drugs misses this subtle difference, perhaps deliberately. In any case, the result of the difference is to make the scope of "labeling"--an issue addressed in greater detail below--the limiting factor in determining what materials may cause a product to become an unapproved new drug.
Even if its new drug authority is limited in this regard, FDA can still bring a misbranding charge based on non-labeling information that suggests an intended use for which the drug's label fails to bear adequate directions. Although FDA's regulations exempt prescription drugs from the requirement for adequate directions for use, the exemption is limited to the uses specifically approved by FDA in the drug's NDA. The most significant problem with this authority, at least from the agency's perspective, is that it fails to distinguish between legitimate and non-legitimate off-label uses of approved drugs. Taken to its logical extreme, the theory would prevent the sale of any drug with a generally-accepted off-label use. It might even discourage manufacturers from supporting publication of research into new uses, even in peer-reviewed journals, for fear of triggering a misbranding violation. At least one court has recognized the possible consequences of FDA's expansive reading of "intended use": "[T]his would mean that every merchant who sells carrots to the public with knowledge that some consumers believe the ingestion of carrots prevents eye diseases holds the carrots out for use as a drug, as that term is defined in the [FD&C] Act." These problems perhaps explain why FDA has only infrequently deployed the "squeeze play" against FDA-approved prescription drugs in the courtroom,and why it is not discussed in any detail in either the Draft Concept Paper or the Draft Policy Statement. As a practical matter, the theory works better as a case-by- case enforcement tool than as a foundation for a general assertion of regulatory authority.
In light of the foregoing analysis, the scope of the term "labeling" is critical to understanding FDA's authority over regulation of manufacturer-supported scientific and educational activities and materials concerning already-approved new drugs. The only practical misbranding charge the agency could bring would involve a determination that such activities or materials were false and misleading "labeling." In addition, as discussed above, if the activities or materials are "labeling," they can transform an approved new drug into an unapproved new drug. When it comes to activities like continuing medical education or medical textbook distribution, however, FDA's labeling authority has serious limitations.
First, because labeling is limited to written, printed or graphic material, relying on the labeling authority alone would deprive FDA of authority over oral exchanges of information. In the case of a CME seminar or a meeting on research results, this would probably represent the bulk of the information given out (although FDA could perhaps locate violative handouts or other printed materials). Second, even with respect to written, printed, or graphic materials, there are many grounds on which to distinguish cases that interpret "labeling" broadly, like Kordel and its descendants, from bona fide exchanges of scientific and educational information. Indeed, on closer examination, many of these cases were very fact-specific decisions based on deliberate schemes to circumvent the drug provisions of the FD&C Act.
A review of Kordel, the archetypical fact pattern for these cases, reveals the difference between that case and the areas FDA seeks to regulate today. In Kordel, the manufacturer shipped the product separately from the written materials that explained its medicinal use, then claimed the written materials did not represent labeling. Despite this claim, the product and the written materials were displayed together at the point of sale. The connection of the information to the sale is central to the holding in Kordel. A medical device case decided at the same time as Kordel described this as the integration, by functional standards, of the two transactions--one, the movement of the regulated product in interstate commerce, and two, the movement of the written materials. It is this integration of materials and product that is lacking where company-sponsored scientific and educational materials and activities are concerned. There is no sale of product going on at CME meetings, or in connection with the distribution of independently-prepared educational textbooks. In fact, the health care providers on the receiving end may never have the occasion to prescribe the drugs discussed. The connection between informational materials and product sales is simply to tenuous to support a conclusion that the materials are labeling. Although it is easy to understand the FDA's desire to control statements in this context, especially where it believes them to be misleading, the agency's authority over product labeling authority is not a sufficient basis on which to proceed. As the Second Circuit put it in Sterling Vinegar & Honey, "the [FD&C Act] was not intended to deal generally with misleading claims. . . ."
Another factual distinction between the Kordel line of cases and the materials FDA now seeks to regulate is the audience. In Kordel, the audience consisted of laypersons without much chance of understanding the scientific validity of the claims being made. Therefore, it was appropriate for the Supreme Court to construe the FD&C Act broadly to protect these individuals. The audience for scientific and educational exchanges about prescription drugs, on the other hand, consists largely of physicians and other health care providers. The policy grounds for construing the FD&C Act broadly are significantly eroded in this context. Also, because of the medical validity of many off-label uses, it is unclear what public health purpose is served by construing the FD&C Act to deny physicians access to information about such uses.
In summary, the logic of cases following Kordel is simply not applicable to the types of scientific and educational activities and materials FDA seeks to regulate. It is unlikely that any court would consider these activities and materials as coming within the legal scope of FDA's labeling authority. Therefore, they cannot result in a violation of either the misbranding or new drug provisions of the FD&C Act. It is possible to imagine activities conducted under the banner of science or education that really represent blatant direct selling of drugs, but the risk of such sham activities is not enough to justify regulation of all possible activities, good or bad. Furthermore, the reasoning in Kordel fully supports FDA's ability to take enforcement action on a case-by-case basis against bad actors who attempt to elude the provisions of the FD&C Act by mischaracterization or manipulation.
The last possible basis for FDA authority over scientific and educational information is that the activities or materials involved are "advertising" that fails to meet legal or regulatory requirements, resulting in a misbranding charge. Although the existence of the authority is clear, its utility as an enforcement tool is limited. Because there is no definition of advertising in the FD&C Act or in FDA's regulations, FDA has very little statutory support for claiming that everything a manufacturer says that is not labeling is advertising. Any attempt to sweep bona fide scientific or educational meetings or materials into the category of "advertising" would likely meet resistance in the courts. Furthermore, there are certain kinds of advertising that cannot be regulated by FDA, such as institutional advertising (that is, advertising about the company itself, rather than its products). Saying that an activity is advertising, then, does not necessarily imply that it is prescription drug advertising covered by Section 502(n) of the FD&C Act. Another problem with using the prescription drug advertising provisions of the FD&C Act as enforcement tools is the provision's orientation toward disclosure. Even if FDA could persuade a court that, for example, a recognized oncology text was advertising, it would still confront the possibility that sufficient disclosures accompanying the textbook could ensure compliance with Section 502(n).
Although this article began by proposing three possible bases for FDA authority over scientific and educational activities and materials, in the end the only really viable basis is that the materials or activities are labeling (resulting in a misbranding or new drug charge). FDA's new drug authority does not extend beyond the scope of "labeling," and its advertising authority is too poorly defined and too limited to serve as a useful enforcement tool outside of the area of traditional advertising. Even FDA's labeling authority, however, is not sufficient to support the agency's attempt to assert general jurisdiction over the entire field of industry-supported scientific and educational activities and materials. Limiting FDA in this manner does not strip the agency of authority over improper promotional activities conducted under the guise of science or education. On the contrary, Kordel and similar cases support the ability of the courts to look beyond the characterization of materials to their actual purpose. What these cases do not support is a blanket assertion that any information coming directly or indirectly from a drug manufacturer is subject to FDA regulation.
FDA's regulation of prescription drugs is an important part of the legal structure that protects the health and safety of individuals. The fact that FDA is a health and safety agency does not, however, give the agency the general ability to make policies that exceed the limits set in the FD&C Act. One can imagine an argument that FDA ought to be able to regulate all statements made by prescription drug manufacturers. As the courts have repeatedly held, however, that is not the current law. Instead, as the analysis above demonstrates, FDA is constrained by the specific statutory bases of its labeling and advertising authority. Until interested parties bring the issue of limits to FDA's statutory authority to the courtroom, however, FDA is likely to continue expanding its regulatory frontiers in this and other areas.
This article contains over one hundred endnotes. Rather than slow down readers by linking every reference number in the text to its corresponding endnote, I have only linked those notes that comment on the text. Notes that simply supply reference sources are not linked, but are of course still contained in the complete list which follows.
1. The author would like to thank Lisa Schule, J.D., of Fox, Bennett & Turner for her research assistance with this article. The views expressed are those of the author alone.
2. Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301-395 (1988 and Supp. V 1993) (hereinafter "FD&C Act"); see also 21 C.F.R. Part 5 (1994) (delegating responsibility for administering FD&C Act to FDA).
3. FD&C Act 201, 301-310, 501-511, 525-528, 701-736, 801-803, and 901-903.
4. See David G. Adams, FDA Regulation of Communications on Pharmaceutical Products, 24 Seton Hall L. Rev. 1399, 1400-1401 (1994).
5. See Draft Policy Statement on Industry - Supported Scientific & Educational Activities, 57 Fed. Reg. 56,412 (1992) (hereinafter "Draft Policy Statement").
6. See Citizen Petition Regarding the Food & Drug Administration's Policy on Promotion of Unapproved Uses of Approved Drugs & Devices; Request for Comments, 59 Fed. Reg. 59,820, 59,823 (1994) (hereinafter "Request for Comments").
7. See FDA to Target Scientific and Consumer Materials, FDA Advertising and Promotion, Feb. 1993, at 1.
8. David A. Kessler & Wayne L. Pines, The Federal Regulation of Prescription Drug Advertising and Promotion, 264 JAMA 2409, 2410 (1990) (citations omitted).
9. See, e.g., Letter from Benjamin W. Boley, Attorney, J.B. Lippincott Company, to Dockets Management Branch, FDA (Feb. 16, 1995) (FDA Docket No. 92N-0434) (responding to FDA request for comments on agency policies regarding regulation of scientific and educational activities in 59 Fed. Reg. 59,820 (1994)).
10. See Request for Comments, 59 Fed. Reg. 59,820 (1994).
11. Id. In fact, whole books have been dedicated to the constitutional issues. See Bad Prescription for the First Amendment: FDA Censorship of Drug Advertising and Promotion (Richard T. Kaplar, ed.,1993).
12. See, e.g., Richard M. Cooper, The Food and Drug Administration's Authority to Regulate Miscellaneous Statements by Pharmaceutical Manufacturers, in Promotion of Pharmaceuticals: Issues, Trends, Options (Dev S. Pathak et al., eds., 1992). Cooper discusses the whole range of statements that might be regulated by FDA, including not only scientific and educational materials but also filings with government agencies, press releases, testimony, and other informational activities.
13. See Wayne L. Pines, 1 FDA Advertising and Promotion Manual 113 (Jan. 1995); see also Washington Legal Found. v. Kessler, Civ. No. 94-1306, slip op. at 19 (D.D.C. Mar. 9, 1995).
14. Division of Drug Marketing, Advertising, and Communications, Center for Drug Evaluation and Research, U.S. Food & Drug Admin., Drug Co. Supported Activities in Scientific or Educational Contexts: Draft Concept Paper (October 26, 1991) (hereinafter "Draft Concept Paper").
15. Draft Concept Paper at 2.
16. See Prepared remarks of Michael R. Taylor, FDA Deputy Commissioner for Policy, delivered at the Third National Conference on CME (October 8, 1992) ("When we released the draft concept paper, there was an enormous outpouring of comment from all quarters. . . . The comments and criticisms were intense, often angry. . . .") (reprinted in part in Arthur N. Levine, FDA's Expanding Control Over Drug Promotion, in Bad Prescription, supra note 10, at 31; Steve Taylor, 1,000 Letters to FDA Provoked CME Concept Paper Rewrite, Dickinson's FDA, Feb. 15, 1992, at 8-9 (estimating that 75% of the comments on the Draft Concept Paper were negative).
17. See Dennis K. Wentz et al., Continuing Medical Education: Unabated Debate, 268 JAMA 1118, 1119 (1992).
18. Draft Policy Statement, 57 Fed. Reg. 56,412 (1992).
19. See Draft Concept Paper at 1; Draft Policy Statement, 57 Fed. Reg. 56,412 (1992).
20. Draft Policy Statement, 57 Fed. Reg. 56,412 (1992). As an aside, it is as a general rule worth considering the statutory authority for any agency practice justified only on the basis of "tradition."
21. See Draft Policy Statement, 57 Fed Reg at 56,414 (listing factors that may result in loss of safe harbor).
22. See Levine, supra note 15, at 37 (discussing inconsistencies in FDA's characterization of the Draft Concept Paper).
23. See Request for Comments, 59 Fed. Reg. 59,820, 59,822 (1994).
24. In these areas, the rapid pace of medical innovation means that the most promising therapies are not yet FDA-approved. The frequency and importance of off-label prescribing in these areas has been documented by the federal government. See, e.g., United States General Accounting Office, Off-Label Drugs: Reimbursement Policies Constrain Physicians in their Choice of Therapies (1991). FDA itself recognizes the importance of off-label uses in the practice of medicine. See, e.g., Request for Comments, 59 Fed. Reg. 59,820, 59,821 (1994).
25. See Amended Complaint at 11-15, Washington Legal Found. v. Kessler (D.D.C. 1995) (Civ. No. 94-1306) (listing examples of FDA refusal to allow distribution of major oncology texts).
26. See FDA to Target Scientific and Consumer Materials, FDA Advertising and Promotion, Feb. 1993, at 1.
28. See, e.g., Lisa Bonnell, Off-label Use: the Controversy Drags On, Med Ad News, Feb. 1994, at 66.
29. See, e.g., Bad Prescription for the First Amendment, supra note 10 (collecting articles).
30. See, e.g., Letter from Gerald J. Mossinghoff, President, Pharmaceutical Manufacturers Association, to Dr. David Kessler, Commissioner of Food and Drugs, FDA (Dec. 20, 1991) (commenting on FDA's Draft Concept Paper).
31. See, e.g., Letter from Karen Antman, President, American Society of Clinical Oncology, to Dr. David Kessler, Commissioner of Food and Drugs, FDA, (Feb. 9, 1995) (FDA Docket No. 92N-0434) (responding to FDA request for comments on agency policies regarding regulation of scientific and educational activities in Request for Comments, 59 Fed. Reg. 59,820 (1994)).
32. Washington Legal Found. v. Kessler, Civ. No. 94-1306, slip op. at 19 (D.D.C. Mar. 9, 1995).
33. Request for Comments, 59 Fed. Reg. 59,820, 59,822 (1994).
34. See, e.g., United States v. Articles of Drug, 745 F.2d 105 (1st Cir. 1984) (citing cases on the FD&C Act's complexity).
35. Others have suggested that the FDA's authority to regulate investigational new drugs is a fourth basis, e.g. Cooper, supra note 11, at 101, but this is probably better viewed as a special case of the agency's new drug authority. See FD&C Act 505(i) (investigational new drug regulations operate as exemption from new drug prohibitions of FD&C Act).
36. FD&C Act 201(m).
37. FD&C Act 502(a) and (f).
38. FD&C Act 502(n).
39. FD&C Act 502.
40. FD&C Act 505(a).
41. See 21 C.F.R. 310.3(h)(4)-(5) (1994).
42. FD&C Act 301(a)-(c), (g), (k).
43. FD&C Act 301(d).
44. FD&C Act 302.
45. FD&C Act 303.
46. FD&C Act 304.
47. See, e.g., Kordel v. United States, 335 U.S. 345 (1948). As discussed below, FDA did not gain authority over drug advertising until 1962.
48. FDA has significant practical authority to control the precise appearance and language of drug labels both during the new drug approval process and after approval. See, e.g., FD&C Act 502(e) (label) and 505(b)(1)(F) (approval); 21 C.F.R. Parts 201 (labeling) and 314 (new drug applications) (1994).
49. 335 U.S. 345 (1948).
51. Id. at 347.
53. Kordel, 335 U.S. at 347.
55. Id. at 350.
56. Id. at 348.
57. Kordel, 335 U.S. at 350.
59. See, e.g., United States v. Guardian Chem. Corp., 410 F.2d 157 (2d Cir. 1969); Nature Food Centers v. United States, 310 F.2d 67 (1st Cir. 1962); United States v. 353 Cases Mountain Valley Mineral Water, 247 F.2d 473 (8th Cir. 1957); Alberty Food Products v. United States, 194 F.2d 463 (9th Cir. 1952).
60. 338 F.2d 157, (2d Cir. 1964).
61. Id. at 159.
62. There is case law, however, that establishes that a book can be labeling within the meaning of the FD&C Act. See, e.g., United States v. 250 Jars . . . "Cal's Tupelo Blossom U.S. Fancy Pure Honey," 344 F.2d 288 (6th Cir. 1965); United States v. 8 Cartons, "Plantation 'The Original' . . . Molasses," 103 F. Supp. 626 (W.D.N.Y. 1951).
63. See, e.g., Letter from Janet L. Rose, Director, DDMAC, FDA, to Phillip Tracey, President, Burroughs Wellcome Company (Dec. 2, 1994).
64. See, e.g., Washington Business Information, The Changing Face of FDA Advertising and Marketing Rules: An Executive Report (1994) (collecting speeches by FDA officials).
65. See, e.g., Adams, supra note 3.
66. See, e.g., Letter from Janet L. Rose, Director, DDMAC, FDA, to all new drug application, abbreviated new drug application, and abbreviated antibiotic drug application holders (March 1994).
67. See Amended Complaint, Washington Legal Found. v. Kessler, Civ. No. 94-1306 (D.D.C. Mar. 9, 1995).
68. Pub. L. No. 87-781, 76 Stat. 780, 788-89 (1962) (also known as the Kefauver-Harris Amendments) (codified as amended at 21 U.S.C. 352(n) (1988 and Supp.V 1993)).
69. FD&C Act 502(n).
70. 21 C.F.R. 202 (1994).
71. See 21 C.F.R. 202.1(l)(1) (1994).
72. David Adams, Pharmaceutical Advertising: Education versus Promotion, in Promotion of Pharmaceuticals: Issues, Trends, Options 58 (Dev S. Pathak et al., eds., 1992).
73. FD&C Act 502(n). It would not make much sense, for instance, to require that a brief summary accompany the physician package insert. Cases that predate the mutually exclusive scheme for advertising and labeling often treat the two as similar. See, e.g., Kordel, 335 U.S. at 350 ("Every labeling is in a sense an advertisement"). Even after advertising was added to the FD&C Act, some courts failed to appreciate the change in the law. See, e.g., United States v. 24 Bottles "Sterling Vinegar & Honey," 338 F.2d 157, 159 (2d Cir. 1964) ("Advertising and labeling overlap . . . . They are not identical, however, and material which serves only as an advertisement is not covered by the [FD&C] Act").
74. 21 C.F.R. 202.1(l)(2) (1994). This regulation appears to ignore the FD&C Act's limitation of "labeling" to "written, printed, or graphic matter." See FD&C Act 201(m).
75. Mass media, in this case, refers to publicity and advertising for the consumption of physicians and other health care providers. The advertising of prescription drugs directly to patients is a different issue, with its own complex history.
76. 21 C.F.R. 202.1(e)(5) (1994).
77. See, e.g., Letter from Janet L. Rose, supra note 62.
78. In the case of bona fide scientific or educational activities, FDA would likely find it difficult to demonstrate that the information presented was false or misleading.
79. See FD&C Act 301(d) and 505(a).
80. See 21 C.F.R. 310.3(h)(4)-(5) (1994).
81. See, e.g., Adams, supra note 3, at 1403-1405.
82. FD&C Act 201(g)(1).
83. FD&C Act 201(p).
84. See FD&C Act 505.
85. For example, any of the materials listed in 21 C.F.R. 202.1(l)(2), including brochures, booklets, mailing pieces, and other such materials.
86. FD&C Act 502(f)(1); 21 C.F.R. 201.5 (1994). This interpretation of "adequate direction for use" has been upheld by the courts. See, e.g., United States v. Articles of Drug, 625 F.2d 665 (5th Cir. 1980).
87. FD&C Act 502(f); 21 C.F.R. 201.100 (1994).
88. 21 C.F.R. 201.128 (1994).
90. See Alberty Food Products v. United States, 185 F.2d 321 (9th Cir. 1950); see also 37 Fed. Reg. 16,503 (1972) (interpreting FDA regulations on intended use to prohibit direct and indirect manufacturer communications concerning unapproved uses).
91. See United States v. Evers, 643 F.2d 1043 (5th Cir. 1981).
92. See United States v. El-O-Pathic Pharmacy, 192 F.2d 62, 75 (9th Cir. 1951).
93. See, e.g., United States v. Article of Drug . . . "Mykocert," 345 F. Supp. 571 (N.D. Ill. 1972). Of course, it is then not even necessary to bring the new drug charge, because the product is misbranded regardless of what the manufacturer does. This situation has been referred to as the "squeeze play." See David A. Kessler, Regulating the Prescribing of Human Drugs for Nonapproved Uses under the Food, Drug, and Cosmetic Act, 15 Har. J. on Leg. 693, 741-43 (1978).
94. See, e.g., United States v. Storage Spaces, 777 F.2d 1363 (9th Cir. 1985), cert. denied, 479 U.S. 1086 (1987).
95. FD&C Act 201(g)(1) (emphasis added).
96. FD&C Act 201(p)(1) (emphasis added).
97. See, e.g., United States v. Article of Drug . . . Designated B-Complex Cholinos Capsules, 362 F.2d 923 (3rd Cir. 1966) (radio broadcasts by third party were evidence of "intended use," therefore drug products were misbranded).
98. See FD&C Act 201(p)(1).
99. As a corollary, because of the mutually exclusive definitions of advertising and labeling in the FD&C Act, it is also true that advertising (which is not labeling) cannot transform a "drug" into a "new drug."
100. See 21 C.F.R. 201.100(c) (1994) (exemptions from adequate directions for use for prescription drugs); see also 21 C.F.R. 201.115 (1994) (exempting new drugs from FD&C Act 502(f)(1), but only to the extent to which an exemption is claimed in an NDA).
101. Indeed, FDA's regulations do not even require any manufacturer dissemination of information to find "intended use." The mere fact that a manufacturer knows a drug is being used off-label is sufficient to trigger the regulatory requirement that he provide adequate labeling for that use. See 21 C.F.R. 201.128 (1994).
102. The FDA is clearly aware of the all-encompassing nature of the "adequate directions for use" theory. In the early 1970s, when the agency was considering how to deal with widespread unapproved uses of drugs, this theory was considered an important potential tool for achieving that end. See Notice of Proposed Rulemaking, 37 Fed. Reg. 16,503, 16,504 (1972).
103. Millet, Pit & Seed Co. v. United States, 436 F. Supp. 84, 89 n.4 (E.D. Tenn. 1977). Of course, the court would be less likely to see problems with the theory in egregious cases where FDA for some reason is unable to bring a misbranding charge based on labeling.
104. The most notable exception to this is the series of cases brought against Dr. Evers, which were really about FDA attempting to control physician prescribing practices. See, e.g., United States v. Evers, 643 F.2d 1043 (5th Cir. 1981).
105. United States v. Urbuteit, 335 U.S. 355 (1948).
106. Sterling Vinegar & Honey, 338 F.2d at 159.
107. There are already examples of successful FDA enforcement actions in such cases, indicating that the new regulatory reach FDA seeks to impose is unnecessary to achieve the agency's objectives. See, e.g., Nature Food Centres v. United States, 310 F.2d 67 (1st Cir. 1962) (FDA enforcement action involving a sham "lecture notes" used to promote and sell drugs).
108. Some FDA representatives have supported this claim with legislative history from the original 1938 FD&C Act. See Adams, supra note 71, at 59. Unfortunately for this argument, advertising was not added to the FD&C Act until 13 years later.
109. Kordel, 335 U.S. 345, at 348-49; see also Sterling Vinegar & Honey, 338 F.2d at 158- 59 (with respect to what constitutes labeling, "[t]here is a line to be drawn, and, if the statutory purpose is to be served, it must be drawn in terms of the function served by the writing.")
110. See, e.g., Sterling Vinegar & Honey, 338 F.2d at 158-59 ("labeling does not include every writing which bears some relation to the product").
111. Occasionally, FDA will candidly admit to this kind of regulatory expansionism. See, e.g., Kessler and Pines, supra note 7, at 2411 ("How expansive FDA's reach is remains an unsettled question. . . . Until further judicial decisions or congressional action clarifies the FDA's specific authority in the area of promotion, the FDA will continue to assert broad jurisdiction").
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Most recent update: November 1998