¹ The Internet is a “network of networks—a decentralized, self-maintaining series of redundant links among computers and computer networks, capable of rapidly transmitting communications without direct human involvement or control.” American Libraries Ass'n v. Pataki, 969 F. Supp. 160, 164 (S.D.N.Y. 1997). The World Wide Web, the best-known category of Internet communication, consists of a “vast number of documents stored in different computers all over the world.” Reno v. ACLU, 117 S. Ct. 2329, 2335 (1997). It allows users to search for and retrieve information stored in remote computers and, in some cases, to communicate back to designated sites. See id. Web pages, or sites, are more elaborate Web documents that have their own addresses and often allow viewers or visitors to communicate with the pages’ producers. See id.

“Access to most Web pages is freely available, but some allow access only to those who have purchased the right from a commercial provider.” Id. From the readers’ viewpoint, the Web is comparable to “both a vast library including millions of readily available and indexed publications and a sprawling mall offering goods and services.” Id. From the publishers’ point of view, the Web “constitutes a vast platform from which to address and hear from a world-wide audience of millions of readers, viewers, researchers, and buyers.” Id. According to one report, the Web contained more than 200 million “home” pages by September 30, 1997. See Hoag Levins, 71,000 New Net Users Every Day: New International Study, EDITOR & PUBLISHER, Oct. 18, 1997, available in 1997 WL 9873846. Home pages are web sites set up by corporations, individuals, institutions and organizations from which a user can access stored information about their products or activities. See Reno, 117 S. Ct. at 2335 & n.9. The terms “Web page” and “Web site” are used interchangeably throughout this Note.

² Navigation buttons or bars are icons users click on that allow them to jump to other sections of a Web page to view different text or graphics. See Reno, 117 S. Ct. at 2335.

³ These links are codings hidden behind electronic text or graphics (usually highlighted in blue) which, when clicked on, will connect a user to a different Web page that may or may not be published by the same entity that provides the link. See id.

⁴ See Joann Muller, Computers/Software: Outlook ‘98, BOSTON GLOBE, Jan. 4, 1998, at C7 (citing research conducted by International Data Corporation (IDC), a “highly respected” Massachusetts market research firm, and noting that almost two-thirds of the 1997 online purchasing consisted of industrial transactions between corporations). Internet use reports vary widely because there is no standard method of measuring Internet traffic. For example, IDC placed the number of people using the Internet at approximately 60 million by the end of 1997. See Levins, supra note 1. Computer Industry Almanac Inc., however, arrived at 99.96 million users for the same year. See Martyn Williams, Global Internet Users at 100 Million Says Latest Estimate, NEWSBYTES, Jan. 13, 1998, available in LEXIS, News Library, Asapii File. Furthermore, Computer Intelligence found that only 36.9 million personal computers were regularly accessing the Internet as of January 5, 1998. See Larry Lange, News, ELECTRONIC ENGINEERING TIMES, Jan. 5, 1998, at 18, available in LEXIS, Cmpcom Library, Comm File. This last study was unclear as to whether users accessing the Internet via Macintosh computers were counted. See id. IDC predicts that there will be 100 million Internet users by the end of 1998. See Muller, supra, at C7.

⁵ See, e.g., Mary J. Cronin, To Sell or Not to Sell on the World Wide Web, FORTUNE, June 9, 1997, at 144, 144 (discussing security issues surrounding a water filtration company). See generally Excite Site Offers Credit Card Guarantee, L.A. TIMES, Sept. 2, 1997, at D14 (noting that consumers fear making purchases online); Michael E. Kanell, Security Issues May Be Stalling Commerce on Net, ATLANTA J. & CONST., Sept. 28, 1997, at 8, available in LEXIS, News Library, Atljnl File (same).

⁶ See Daniel A. Kracov & David J. Bloch, FDA Regulation May Inhibit Positive Uses of Internet, LEGAL BACKGROUNDER, Oct. 4, 1996, available in LEXIS, Genfed Library, Wlf File (discussing FDA's “deliberate” approach to regulation of Internet marketing).

⁷ In 1995, half of all U.S. corporate advertisers expected to develop Web pages and spend as much as $150 million for online advertising. See Consider a Few Internet Stats …, HEALTH INDUSTRY TODAY, July 1996, available in LEXIS, Market Library, Iacnws File [hereinafter Few Internet Stats]. However, while pharmaceutical companies like Roche and Schering-Plough are spending more than $1 million per year to advertise online, see Michael Wilke, Drug Companies Boost Online Media Buying: Roche Will Spend SI Million-Plus, ADVERTISING AGE, Jan. 19, 1998, available in LEXIS, Fedcom Library, Adage File, general corporate interest in the Internet seems to have grown more skeptical. See Martin Stone, Internet Spending Will Decline in 1998, Jan. 7, 1998, NEWSBYTES, available in 1998 WL 5028259. The number of chief information officers planning significant increases in Internet spending dropped from 65% in 1997 to 31% in 1998. See id. (citing an “anecdotal” survey conducted by Deloitte Consulting of approximately 500 North American chief information officers).

⁸ To date, the Food and Drug Administration (FDA) has indicated its disapproval of certain companies’ Web pages via warning letters. See discussion infra notes 47-57 and accompanying text (discussing FDA warning letters to various medical and pharmaceutical companies).

⁹ See discussion infra notes 43-46, 71-76 and accompanying text. James O'Reilly's writings on food and drug law discuss the division of powers between FDA and the Federal Trade Commission (FTC).

1 JAMES T. O'REILLY, FOOD AND DRUG ADMINISTRATION § 15.10 (2d ed. Supp. 1993) (footnotes omitted); see also Kracov & Block, supra note 6 (discussing problems with FDA oversight over marketing of medical products on the Internet).

¹⁰ Labeling requires “full disclosure” via a copy of the FDA-approved package insert delineating the drug's uses, risks and characteristics, while advertising requires only a “brief summary” of the package insert. See Kracov & Block, supra note 6.

¹¹ See id.

¹² “[A]t any given time ‘tens of thousands of users are engaging in conversations on a huge range of subjects.’ It is ‘no exaggeration to conclude that the content on the Internet is as diverse as human thought.'” Reno v. ACLU, 117 S. Ct. 2329, 2335 (1997) (quoting ACLU v. Reno, 929 F. Supp. 824, 835, 842 (E.D. Pa. 1996)).

¹³ FDA recently relaxed its regulation of broadcast prescription drug advertisements. See Lisa Seachrist, FDA Eases Restrictions on TV Ads for Prescription Drugs, BIOWORLD TODAY, Aug. 11, 1997, at 1, 1. The agency issued a draft “Guidance” on August 8, 1997, that “allows pharmaceutical and biotechnology companies to directly advertise their products to consumers without devoting air time to listing all of the side effects found in the package insert.” Id. FDA now requires that broadcast advertisements mention only major side-effects and drug interactions and refer consumers to another source offering complete package insert information. See id. This other source may be one develof the following: (1) a toll-free number the consumer can call to receive mailed or faxed copies of the information; (2) an Internet address where the information can be read or downloaded; (3) a specific print advertisement that contains the information; or (4) a statement that the information is available from physicians or pharmacists. See id. FDA, however, still prefers to review and approve all prescription drug advertisements. See id.

¹⁴ See James G. Dickinson, Why the FDA Should Leave the Internet Alone, MED. MARKETING & MEDIA, Feb. 1997, available in LEXIS, Busfin Library, Abi File (discussing a petition by the Internet Medical Information Association (IMIA) to FDA that noted that because of rapid change on the Internet, “the procedural requirements of notice-and-comment rulemaking would likely mean that the final regulation would be rendered obsolete by the time of its publication“).

¹⁵ “[T]he Internet provides significant access to all who wish to speak in the medium, and even creates a relative parity among speakers.” Reno, 117 S. Ct. at 2340 n.30.

¹⁶ See discussion infra note 49.

¹⁷ See, e.g., Daniel A. Kracov & David J. Bloch, Supreme Court's Decision Requires FDA to Reconsider Free Speech Issues, July 26, 1996, available in LEXIS, Genfed Library, WLF File (arguing that FDA will now have to consider all restrictions on speech more seriously in light of 44 Liquormart, Inc. v. Rhode Island, 517 U.S. 484 (1996), which invalidated a state law prohibiting advertisement of retail prices for alcoholic beverages anywhere but at the point of purchase).

¹⁸ See, e.g., Nancy Turett, The World Wide Web: The Ultimate Communications Platform, HEALTHCARE PR & MARKETING NEWS, Oct. 1996, available in 1996 WL 8580477 (stating that the Internet can help consumers “reach new heights of understanding that are not possible with a brochure or a television advertisement“); TTie Internet: Will FDA Restrain Itself on ‘Web’ or Just Industry?, MED. DEVICE APPROVAL LETTER, NOV. 1996, available in LEXIS, Market Library, lac News (reporting that “drug and device manufacturers, AIDS activists and Internet information providers” told FDA at an October 16, 1996, hearing to refrain from regulating dissemination of offlabel use information via industry Web pages); see also Pamela Weintraub, You ‘ve Got a Medical Problem, But Your Doctor Doesn't Know All the Treatments Available—Or Your HMO Won't Tell You, REDBOOK, NOV. 1997, at 124, 124 (reporting that Health and Human Services Secretary, Donna Shalala, said that the U.S. government is “committed to using the new technology, including the World Wide Web and the Internet, to provide health information to the public“).

¹⁹ The “learned intermediary” doctrine was developed as an exception for prescription drug makers to the common law duty of manufacturers to warn users of known dangers inherent in the use of their products. See Reaves v. Ortho Pharm. Corp., 765 F. Supp. 1287, 1288-89 (E.D. Mich. 1991). The doctrine allows drug makers to assume that patients rely on physicians to evaluate the benefits and risks of using prescription drugs. See id. at 1289. Under the doctrine, the drug makers’ only duty to warn of risks and harmful side-effects associated with their products is to the prescribing physicians, who act as learned intermediaries for their patients. See id. Prescription drug manufacturers thus discharge their duty by properly warning the prescribing physicians of the dangers associated with the use of the prescription drugs. See id.; Bravman v. Baxter Healthcare Corp., 984 F.2d 71, 75 (2d Cir. 1993). A few courts have held that makers of oral contraceptives may not escape liability under the learned intermediary exception because: (1) women receive information on the products directly from the manufacturer (by FDA mandate); (2) companies market noncurative oral contraceptives directly to consumers; and (3) women often take these products for extended periods of time without medical assessment. See Reaves, 765 F. Supp. at 1289-90 (referring to In re Certified Questions, 358 N.W.2d 873 (Mich. 1984) and two subsequent federal district court opinions, Stephens v. G.D. Searle & Co., 602 F. Supp. 379 (E.D. Mich. 1985) and Odgers v. Ortho Pharmaceutical Corp., 609 F. Supp. 867 (E.D. Mich. 1985), both purporting to apply Michigan law). The Reaves court declined to adopt this interpretation of Michigan law and held that Michigan's highest court would apply the learned intermediary rule to oral contraceptive manufacturers. See id. at 1291.

²⁰ See generally Reno, 117 S. Ct. at 2334-35 (discussing Internet subscriptions).

²¹ In Reno, the court stated that:

Id. at 2337.

²² See infra note 132 and accompanying text.

²³ See generally American Libraries Ass'n v. Pataki, 969 F. Supp. 160, 167 (S.D.N.Y. 1997) (invalidating, on Commerce Clause grounds, a New York statute making it a crime to knowingly use a computer to disseminate obscene material to minors). The American Libraries court analyzed the challenged state statute under the Commerce Clause for two reasons: (1) the Internet is “analogous to a highway or railroad” and thus similar to an instrument of interstate commerce, see id. at 161; and (2) “[t]he unique nature of the Internet highlights the likelihood that a single actor might be subject to haphazard, uncoordinated, and even outright inconsistent regulation by states that the actor never intended to reach and possibly was unaware were being accessed,” id. at 168—exactly the “menace” the framers of the Constitution were addressing when they wrote the Commerce Clause in an effort to prevent “overreaching by the individual states that might jeopardize the growth of the nation—and in particular, the national infrastructure of communications and trade—as a whole.” Id. at 169. Pointing to “dormant” Commerce Clause cases, the American Libraries court held that the New York Internet obscenity statute contravened the Commerce Clause for three reasons: (1) it represented an “unconstitutional projection of New York law into conduct that occurs wholly outside New York“; (2) although the state's asserted interests were substantial, “the burdens on interstate commerce resulting from the Act clearly exceed any local benefit derived from it“; and (3) the Internet “is one of those areas of commerce that must be marked off as a national preserve to protect users from inconsistent legislation that, taken to its most extreme, could paralyze development of the Internet altogether.” Id. (citation omitted). For recent Supreme Court treatment of preemption in the health product field not relating to state Internet laws, see Medtronic, Inc. v. Lohr, 116 S. Ct. 2240, 2244 (1996).

Of course, thorough consideration of possible preemption of state laws affecting the Internet is impossible without considering the jurisdictional questions posed by Internet activity. Although the Supreme Court has yet to address the issue, several courts have held that the mere posting of a Web page alone, or the posting of an e-mail message on an Internet service provider's electronic bulletin board, constitutes neither purposeful availment by the posting party of the laws of every state in which the page might be accessed nor minimum contacts with every such state. See. e.g., Cybersell, Inc. v. Cybersell, Inc., 130 F.3d 414, 440 (9th Cir. 1997) (holding that a Florida corporation's use of plaintiffs trademark on Internet site did not support exercise of personal jurisdiction in Arizona where defendant conducted no commercial activity over the Internet in Arizona but merely posted on the Web an essentially passive home page referring site visitors to defendant's Florida address and telephone number); Bensusan Restaurant Corp. v. King, 126 F.3d 25, 29 (2d Cir. 1997) (holding that a Missouri jazz club owner's creation of a Web site did not constitute commission of a tortious act in New York despite the fact that the defendant's Web site contained a link to the plaintiffs Web site for the plaintiffs New York jazz club of the same name); Mallianckordt Med., Inc. v. Sonus Pharm., Inc., No. CIV.A-97-1732(PLF), 1998 WL 6546, at *7 (D.D.C. Jan. 5, 1998) (finding that the court had no jurisdiction over the defendant where the defendant had no contacts with the District of Columbia (D.C.) other than: (1) its prior involvement in FDA-related litigation, which necessarily occurred in D.C; and (2) an e-mail message it sent from Seattle to Virginia via a private subscriber service that was later posted on a bulletin board maintained by that service).

²⁴ See discussion supra note 4. Study results vary widely because researchers have yet to agree on a method for measuring the number of Internet users. See Levins, supra note 1.

²⁵ See Reaching the People: The Internet: A Remedy for New Marcom Efforts, PR NEWSWIRE, Jan. 26, 1998, available in LEXIS, Market News, Iacnws (citing study by Find/SVP and noting that the largest “healthcare [information] retriever” group in the United States comprises users age 50-59).

²⁶ See Few Internet Stats, supra note 7.

²⁷ See Wilke, supra note 7. As of July 1, 1996, 330 medical companies and 16 pharmaceutical companies had placed sites on the Web. See Few Internet Stats, supra note 7. Upjohn Co., among the first pharmaceutical companies to set up a Web site to promote prescription drugs, launched its site in June 1995 to promote its minoxidil hair growth product. See id. The Web address is http://www.igroup.com/rogaine. See id. Schering-Plough was also one of the first pharmaceutical companies to use the Web to advertise prescription drugs. See id. The address for its nonsedating antihistamine Claritin is http://www.allergy-relief.com. See id. In all media, the pharmaceutical industry spent $600 million in 1997 to advertise prescription drugs to the general public. See Frank H. Boehm, Creating a Revolution in the Waiting Room, TENNESSEAN, Jan. 6, 1998, at 7A, available in LEXIS, News Library, Tennes File.

²⁸ See Curt Werner, Cyberspace Marketing Quickly Gaining Favor Among Manufacturers, HEALTH INDUSTRY TODAY, July 1996, at 1,1.

²⁹ See id. Medtronic, Inc., a multiproduct device manufacturer, spent $250,000 to produce 600 screens for its various divisions and estimates that typical interactive Web pages cost about $200,000 per year to set up and maintain. See id. “The $200,000 a year is what a fully loaded sales rep would make anyway… . Besides, you can't just add sales people. Customers want access in other ways and at their convenience. There is a value to time. We couldn't afford not to go on the Web.” Id. (quoting a Medical Marketing Association attendee). Note, however, that pharmaceutical companies, finding they are not very good at developing sites that are catchy enough to draw repeat visitors, are shifting their online advertising spending away from building multimillion-dollar sites toward purchasing advertising on established health-related sites such as Time Inc.'s and America Online's Thrive (www.thriveonline.com), Medscape (www.medscape.com) and Onhealth.com (www.onhealth.com). See Wilke, supra note 7. Such advertising, often called “banner” advertising because it usually runs in shallow horizontal boxes at the top or bottom of a Web page, can be very profitable. See Jeffery D. Zbar, Agency Tests Online Sales with Corporate Gift Catalog, SUNSENTINEL (Fort Lauderdale), Oct. 6, 1997, at 12, available in LEXIS, News Library, Curnews File (noting that such advertising has a positive impact on the intent to purchase). Bristol-Myers, for example, added 30,000 new names to its customer database in one month by running advertisements on financial Web sites and billing its product as “the tax headache medicine.” See Internet Proves Fine Marketing Tool, Bus. DAY (South Africa), Nov. 25, 1997, at 16. The company offered free samples to users who clicked on the advertisements and typed in their names and addresses. See id. The shift toward simpler Web sites to support banner advertisements on other companies’ contentrelated sites (by providing detailed labeling information) mimics print and broadcast model advertising and perhaps better captures audience interest. See Zbar, supra.

³⁰ See Richard Raysman & Peter Brown, Regulating Internet Advertising, N.Y. L.J., May 1996, at 3, 3. Prescription drugs may also be available to Internet users. The Pharmaceutical Care Management Association has petitioned FDA to investigate reports of Internet sales of prescription drugs by mail without a prescription from retail pharmacies in Mexico. See NewsBites, DRUG STORE NEWS, Aug. 4, 1997 (Rx Pharmacy), at 19.

³¹ See Raysman & Brown, supra note 30, at 3.

³² See Stephen D. Moore, European Drug Firms Join Patients in Tapping Internet for Treatment, WALL ST. J. EUR., June 7, 1996, at 1. Researchers at the German pharmaceutical company E. Merck KGaA recently reported data on a new experimental cancer drug at a conference in Washington, D.C., and then posted a summary of their presentation on the Internet two days later. See id. Brian Gazzard, a British AIDS researcher, says patients should be as well-informed as their doctors so they can take or leave the doctors’ advice about treatment options. See id. Internet discussions between patients, however, can potentially unblind smaller clinical trials when patients who are not supposed to know whether they are receiving a drug or a placebo are able to discern which they are receiving from discussions with other trial participants. See id.

³³ See Caswell O. Hobbs, The FDA and the Federal Trade Commission, in FOOD AND DRUG LAW 425 (Richard M. Cooper ed., 1991); Reichertz, Peter S., Legal Issues Concerning the Promotion of Pharmaceutical Products on the Internet to Consumers, 51 FOOD & DRUG L.J. 355, 356 (1996)Google Scholar.

³⁴ See 21 U.S.C. §§ 351-352, 393 (1994); see also Memorandum of Understanding Between the FTC and the FDA, 36 Fed. Reg. 18,539, 18,539 (1971) [hereinafter FTC-FDA Memorandum] (establishing a joint effort between FTC and FDA to protect consumers against deceptive labeling and advertising of foods, drugs, devices and cosmetics).

³⁵ See 15 U.S.C. §§ 41, 52-53 (1994) (describing FTC's creation and its authority to act against anyone it believes to be violating the advertising restrictions); see also FTC-FDA Memorandum, 36 Fed. Reg. at 18,539 (explaining that FTC, not FDA, has the authority over OTC drugs and medical devices).

³⁶ See 21 U.S.C. § 352(n); 21 C.F.R. § 202.1(e) (1997).

³⁷ 21 C.F.R. § 202.1(1)(1).

³⁸ See 21 U.S.C. § 352(n) (1994).

³⁹ See 21 C.F.R. § 202.1(e)(5)(ii).

⁴⁰ Reichertz, supra note 33, at 358.

⁴¹ 21 C.F.R. § 202.1(1)(2).

⁴² See id. at § 202.1(e); see also Reichertz, supra note 33, at 357 (stating that the full disclosure policy requires “a copy of the approved package insert to accompany” any prescription drug).

⁴³ See Kracov & Bloch, supra note 6; Reichertz, supra note 33, at 357; see also Vinod Menon, Internet Drug Promos: Is It Really Advertising?, ASHEVILLE ClTIZEN-TlMES, Jan. 5, 1998, at D3, available in LEXIS, News Library, Ashcty File (reporting that FDA recommendations were still in the drafting stage and would in any event be subject to revision after public comment). 44 The five “Centers” of FDA are: the Center for Biologies Evaluation, the Center for Drug Evaluation and Research, the Center for Devices and Radiological Health, the Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine. See Michael Brannon, Organizing and Reorganizing FDA, in FOOD AND DRUG LAW, supra note 33, at 130.

⁴⁵ See Kracov & Bloch, supra note 6 (citing Promotion of FDA-Regulated Medical Products on the Internet, 61 Fed. Reg. 48,707 (1996)); see also Reichertz, Peter S., Understanding Government Regulation of the Marketing and Advertising of Medical Devices. Drugs, and Biologies: The Challenges of the Internet, 52 FOOD & DRUG L.J. 303, 307 (1997)Google Scholar (noting that FDA will issue a draft Guidance on Internet promotion for comment, addressing more specific issues). See generally Advertising and Promotion, 61 Fed. Reg. 52,800 (1996) (announcing the publication of two guides to clarify how sponsors of drugs, medical devices and other biological products should disseminate information about unapproved uses of those products to health care professionals).

⁴⁶ See Kracov & Bloch, supra note 6. In a survey conducted by CenterWatch, an organization that provides information about clinical trials to medical professionals and patients via the Internet, 97% of 521 patients and consumers who visited CenterWatch's Web page while seeking clinical trial information believe the Internet is the most valuable source for such information. See U.S. Consumers and Clinical Trials on Internet, MARKETLETTER, Jan. 6, 1997, available in 1997 WL 7972051 [hereinafter Clinical Trials on the Internet]. Additionally, the participants stated that FDA should not review the clinical trial information if an institutional review board has already approved it for Internet listing. See id.

⁴⁷ The Federal Food, Drug and Cosmetic Act permits FDA to use warning letters instead of seizures or injunctions for minor violations of the Act. See Scott Bass, Enforcement Powers of the Food and Drug Administration, in FOOD AND DRUG LAW, supra note 33, at 72. See generally Joel E. Hoffman, The Food and Drug Administration's Administrative Procedures, in FOOD AND DRUG LAW supra, at 39 (outlining the transformation of FDA over the past century and noting that the agency has emerged as the “model of a modern major regulator“).

⁴⁸ Performance claims are an advertising issue and thus, under current regulations, fall under FDA jurisdiction if they relate to prescription drugs or devices and FTC jurisdiction if they concern OTC drugs or devices. See 21 U.S.C. § 351(n) (1994); see also Memorandum of Understanding Between the FTC and the FDA, 36 Fed. Reg. 18,539, 18,539 (1971) (stating that FTC has jurisdiction over advertising of cosmetics, foods, devices and nonprescription drugs).

⁴⁹ See Curt Werner, FDA Turning Wary Eye on Internet Abusers, HEALTH INDUSTRY TODAY, Sept. 1996, at 7, 7. When promotional material exceeds the scope of a product's FDA clearance, it is usually identifying, discussing or referring to uses for which the product has not received FDA approval (but for which physicians may legally use it). See Elyse Tanouye, Staffers of Drug Maker Say It Pushed Product for Unapproved Uses, WALL ST. J., Sept. 15, 1997, at Al. These uses are called “unapproved” or “off-label” uses. See id. See generally Reichertz, supra note 33, at 356-63 (discussing FDA and FTC guidelines for prescription drug promotions and product claims, respectively). Former Rhone-Poulenc Rorer employees are currently suing the company for damages incurred when it coerced them to expand off-label promotion—often through arranging and paying for lectures on unapproved uses—and then to destroy evidence of such promotion. See Tanouye, supra, atAl.

⁵⁰ See Werner, supra note 49, at 7; VidaMed, WARNING LETTER BULL., Aug. 26, 1996, available in 1996 WL 11225417 (reporting an FDA warning letter to VidaMed Inc., which promoted its Transurethral Needle Ablation System (TUNA) without marketing clearance); Spotlight on Foreign Companies, US Medical Web Page Promo, WARNING LETTER BULL., July 1, 1996, available in 1996 WL 8733978 [hereinafter Spotlight on Foreign Companies] (reporting an FDA warning letter to U.S. Medical Products Inc., which promoted its Consensus Knee System for uses beyond its marketing clearance). Other companies that received letters aimed at their Web page materials: Liposome Co., American Biogenetic Sciences, Harrier, Byron Medical, Gynecare, Amazonic Herbals, Inc., Palomar Medical Technologies/Spectrum Medical Technologies and Immunex. See Ronald M. Schwartz, FDA Issues Warning on Wayward Website, AM. DRUGGIST, Feb. 1997, available in 1997 WL 7972051 (reporting that Liposome Co. failed to update its Website after approval of a competing product, erroneously implied that its own product was the only available therapy for a specific type of infection); Byron Medical, WARNING LETTER BULL., June 30, 1997, available in 1997 WL 11868815 (reporting an FDA warning letter to Byron Medical for its unauthorized promotion of its Accelerator Aspirator); FDA, WARNING LETTER BULL., Apr. 21, 1997, available in 1997 WL 8657821 (reporting an FDA warning letter to Harrier for its unauthorized promotion of Bioptron Lamp); American Biogenetic Sciences, WARNING LETTER BULL., Mar. 24, 1997, available in 1997 WL 8657683 (reporting an FDA warning letter to American Biogenetic Sciences, which promoted . the Thrombus precursor protein (TpP) for unauthorized uses); Gynecare, WARNING LETTER BULL., Mar. 24, 1997, available in 1997 WL 8657685 (reporting an FDA warning letter to Gynecare for its unauthorized promotion of Uterine Balloon Therapy); FDA Warns Herbal Manufacturer About Therapeutic Claims on Internet, FOOD LABELING NEWS, Feb. 6, 1997 (reporting an FDA warning letter to Amazonic Herbals, Inc., which made unlicensed remarks regarding an herbal product on its Web site); Reichertz, supra note 45, at 305-06 (discussing warning letters to Palomar Medical Technologies/Spectrum Medical Technologies, Immunex and other companies previously mentioned).

⁵¹ See VidaMed, supra note 50. VidaMed touted its TUNA product as an alternative treatment for benign prostatic hyperplasia. See id.; Werner, supra note 49, at 7. FDA also questioned Vida- Med's announcement on its Web page that it had applied for the clearance (called a 510(k) or premarket notification). See Werner, supra, at 7.

⁵² See VidaMed, supra note 50.

⁵³ See id.; Werner, supra note 49, at 7.

⁵⁴ See Werner, supra note 49, at 7 (quoting the Warning Letter to VidaMed).

⁵⁵ Id. (quotations omitted); see also Reichertz, supra note 45, at 308 (noting that an agency spokesperson indicated that companies should use a “reasonable and rational approach” in applying the regulations to promoting products via the Internet).

⁵⁶ See Werner, supra note 49, at 7; Spotlight on Foreign Companies, supra note 50. U.S. Medical Products’ Web site material promoted the company's Consensus Knee System in forms suitable for “cemented use” and “press fit” when the product's FDA clearance covered only cemented use. See id.

⁵⁷ See Werner, supra note 49, at 7. Papnet had used the Internet to promote its test to detect precancerous cells in routine Pap smears and its software program for reading the Pap smears. See id.

⁵⁸ See Reichertz, supra note 33, at 358 n.18.

⁵⁹ See id. at 357.

⁶⁰ See Device Information on Internet Home Pages Likely Constitutes Labeling, THE GRAY SHEET, F-D-C Rep., Inc., No. 22, July 15, 1996, at I & W-5, I & W-5 to -6 [hereinafter Device Information]. Byrom L. Tart's Internet address is bxt@fdadr.cder.fda.gov. See generally Advertising and Promotion, 60 Fed. Reg. 62,471 (1995) (discussing FDA-approved labeling).

⁶¹ Pharmaceutical Companies Await FDA Before Launching Web Sites, HEALTHCARE PR & MARKETING NEWS, June 13, 1996, available in 1996 WL 8580356 (quoting FDA public health adviser Melissa Moncavage). Indeed, IMIA submitted a Citizen Petition requesting that FDA establish a formal guideline that permits “voluntary self-denomination of the regulatory category of information to be disseminated by FDA regulated companies.” Reichertz, supra note 45, at 307.

⁶² A listserv or mail exploder is an e-mail group in which subscribers can send messages to a common e-mail address, which then forwards the messages to the group's other subscribers. See Reno v. ACLU, 117 S. Ct. 2329, 2334 (1997). Newsgroups allow subscribers to post messages for discussion among members. See id. at 2335. Virtual chat rooms, by allowing users to type messages that appear almost immediately on the recipients’ screens, provide dialogue capabilities that are very close to telephone and face-to-face communications. See id.

⁶³ See 21 U.S.C. §§331,355(1994).

⁶⁴ See Advertising and Promotion, 60 Fed. Reg. at 62,472; see also Reichertz, supra note 45, at 307 (discussing a report indicating that FDA's draft Guidance, when it appears, will address Web links but will otherwise give general rather than specific guidance to enable flexibility in its application and to avoid hindering scientific exchange).

⁶⁵ See Device Information, supra note 60, at I & W-6. If pharmaceutical companies engage in “framing,” the popular Internet practice in which sites “erect” on-screen borders that remain constant as visitors jump between screens and even between sites, they will further blur the issue of who owns or sponsors the framed content, thereby putting themselves at still greater risk of violating FDA regulations. See generally Rebecca Quick, ‘Framing’ Muddies Issue of Content Ownership: Technology Lets Sites Alter Presentation of Others’ Web Pages, WALL ST. J., Jan. 30, 1997, at B8.

⁶⁶ See Greg Borzo, Drug Ads Casting Wider Net, Finding a Home on the Web, AM. MED. NEWS, NOV. 20, 1995, at 25, 25; Reichertz, supra note 33, at 360. Because Web pages can be updated daily, the prospect of pre-release review by FDA presents serious problems in terms of efficiency and the agency's administrative capacity in general. See Borzo, supra.

⁶⁷ See Werner, supra note 49, at 7.

⁶⁸ See CVM Is Monitoring Online Computer Systems Drug Promotions, Says Keller, FOOD CHEMICAL NEWS, Dec. 4, 1995, at 6, 6 (reporting a statement by Dr. William Keller, director of the Center for Veterinary Medicine Division of Surveillance, that Internet and Web promotional material should be submitted to FDA at the same time it becomes available online).

⁶⁹ See discussion supra note 19; see also Garside v. Osco Drug, Inc., 976 F.2d 77, 80 (1st Cir. 1992) (noting that the learned intermediary doctrine will still shield a manufacturer that fails to adequately warn a physician if the manufacturer can show that the physician would not have heeded the warning).

⁷⁰ See discussion supra note 19; see also Lukaszewicz v. Ortho Pharm. Corp., 510 F. Supp. 960, 964 (E.D. Wis. 1981) (stating that the learned intermediary rule did not apply where federal administrative regulations required that warnings be given to the patient as well as the physician).

⁷¹ See Thomas C. Morrison & Robert W. Lehrburger, FTC Targets Deceptive Cyberspace Advertising, NAT'L L.J., Aug. 12, 1996, at B7 (citing 15 U.S.C. §§ 45, 52 (1994), noting that FTC has already prosecuted “a dozen cases involving alleged online scams and false advertising“).

⁷² See 15 U.S.C. §§ 41, 52-55 (1994); see also Memorandum of Understanding Between the FTC and the FDA, 36 Fed. Reg. 18,589, 18,589 (1971) (stating that FTC has primary responsibility for regulation of the truth or falsity of all advertising (other than labeling) of food, drugs and cosmetics). See generally Hobbs, supra note 33, at 429-30 (discussing the overlapping and concurrent relationship between FTC and FDA over the labeling and advertising of food, drugs, medical devices and cosmetics).

⁷³ See Reichertz, supra note 33, at 362.

⁷⁴ See 15 U.S.C. §§ 45, 52-57; see also 21 C.F.R. § 202.1(e)(5)(ii) (1997) (specifying FDA's power of fair balance with respect to advertisements).

⁷⁵ See Reichertz, supra note 33, at 362.

⁷⁶ See id.

⁷⁷ See id. See generally Morrison & Lehrburger, supra note 71 (noting that FTC had prosecuted “a dozen cases involving alleged online scams and false advertising“).

⁷⁸ See Morrison & Lehrburger, supra note 71, at B7.

⁷⁹ See id.

⁸⁰ See id.

⁸¹ See id.

⁸² See id.

⁸³ See id. atn.15.

⁸⁴ See Charles Boisseau, Internet Rife with Cyberscams, DALLAS MORNING NEWS, Mar. 4, 1995, at 3C, available in 1995 WL 7468700.

⁸⁵ See The National Consumers League Holds a News Conference on Combatting Fraud on the Internet, FDCH POL. TRANSCRIPTS, Feb. 27, 1996, available in LEXIS, News Library, Script File.

⁸⁶ See Life Plus” Ads for Shape Plus and Endogen Referred to FTC, THE TAN SHEET, F-D-C Rep. Inc., No. 30, July 22, 1996, at 6, 6-7, available in LEXIS, Genmed Library, Tan File [hereinafter Life Plus’ Ads].

⁸⁷ See Internet Advertising Now Subject of Self-Regulatory Review; eWatch Helps Ad Industry Monitor Truth and Accuracy, PR NEWSWIRE, Dec. 7, 1995, available in LEXIS, News Library, Wires File [hereinafter Internet Advertising].

⁸⁸ See Life Plus’ Ads, supra note 86, at 6-7.

⁸⁹ See Internet Advertising, supra note 87.

⁹⁰ See 21 U.S.C. §§ 351-353 (1994); see also Memorandum of Understanding Between the FTC and the FDA, 36 Fed. Reg. 18,539, 18,539 (1971) (concluding that FDA will exercise primary jurisdiction over all matters regulating the labeling of food, drugs, devices and cosmetics).

⁹¹ See 21 C.F.R. § 202.1(1)(2) (1997).

⁹² See, e.g., Clinical Trials on the Internet, supra note 46 (reporting a survey of Web page visitors seeking information presented on a specific Web page regarding clinical trials); see also Reichertz, supra note 45, at 307.

⁹³ A browser is a gateway to the Web. Browsers, like Netscape Navigator and Microsoft's Internet Explorer, connect users’ computers to the Web, allowing them to type in Web addresses they wish to visit or linking them to search engines if their searches are not yet focused. See Reno v. ACLU, 117 S. Ct. 2329, 2335 (1997) (discussing Web browsers in general); see also BRUCE JUDSON, NETMARKETING 218 (1996) (describing the basic functions of Netscape).

⁹⁴ A search engine is an Internet navigation service that maintains directories of Web pages and searches the directories for key words depending on users’ research needs, retrieving lists of potential sites for users to visit. See JUDSON, supra note 93, at 110-11. Popular search engines include Alta Vista, Infoseek, Lycos and WebCrawler. See id.

⁹⁵ See 21 C.F.R. § 202.1(k)(2).

⁹⁶ See FDA Must Address Internet Advertising, Former Agency Commissioner Hayes Suggests; Agency's Temple Sees Internet Ads Fitting “Traditional” Mold, THE PINK SHEET, F-D-C Rep., Inc., No. 10, Oct. 23, 1995, at 10, 10.

⁹⁷ See United States v. Sene X Eleemosynary Corp., 479 F. Supp. 970, 979 (S.D. Fla. 1979) (construing the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 352(a) (1979)).

⁹⁸ See Kordel v. United States, 335 U.S. 345, 350 (1948).

⁹⁹ See United States v. Bottles Sterling Vinegar, 338 F.2d 157, 159-60 (3d Cir. 1964) (holding that misleading claims are generally the province of the Federal Trade Commission Act unless they are presented to customers in immediate connection with the products, for example, on labels).

¹⁰⁰ See Reichertz, supra note 33, at 362; see also Raysman & Brown, supra note 30, at 3 (stating that “[advertising on the Internet could mean a new role for the FTC“).

¹⁰¹ The Pharmaceutical Research and Manufacturers of America has suggested that FDA consider user visits to industry Web pages to be unsolicited. See Reichertz, supra note 45, at 307.

¹⁰² See Kracov & Bloch, supra note 6.

¹⁰³ See id.; see also Reichertz, supra note 33, at 362 (recommending application of existing standards to prevent deception). The FTC “fair balance” requirement provides that any promotional claim which relates to effectiveness and/or safety of a drug must be balanced by a presentation of information relating to that drug's contraindications, side-effects, warnings, etc. See 21 C.F.R. § 202.1(e)(5)(ii) (1997). The FTC “prominence and readability” requirement provides that the balancing information must have a “prominence and readability reasonably comparable” to the advertiser's statements regarding the drug's effectiveness. See 21 C.F.R. § 202.1(e)(7)(viii). FTC substantiation requirements provide that advertisers must be able to substantiate their claims at the time they make them, using competent, reliable scientific evidence. See Reichertz, supra note 33, at 362.

¹⁰⁴ See Kracov & Bloch, supra note 6.

¹⁰⁵ See id. (noting the difficult issue of whether manufacturer sites containing links to other sites featuring information regarding off-label or unapproved uses would violate the FDA prohibition against referencing off-label or unapproved uses in advertising and labeling).

¹⁰⁶ See Reichertz, supra note 33, at 360 (describing issues that arise from the international nature of the Internet).

¹⁰⁷ See id.; Kracov & Bloch, supra note 6.

¹⁰⁸ See Kracov & Bloch, supra note 6.

¹⁰⁹ See id.; BARRY R. FURROW ET AL., HEALTH LAW: CASES, MATERIALS AND PROBLEMS 36-38 (2d ed. 1991). The authors discuss the decentralized manner in which clinical policies are formed in the medical profession, stating that such policies “derive from a flow of reports in the literature, at meetings, and in peer discussions.” Id. at 36. They then list among the advantages of this process the benefits of collective wisdom, the fact that “unwarranted bursts of enthusiasm are dampened,” the fact that policies are tested by “the best minds” and the promotion of flexibility by “allowing adaptation to local skills and values.” Id.

¹¹⁰ See Kracov & Bloch, supra note 6.

¹¹¹ Reichertz, supra note 33, at 360-61 (suggesting that FDA monitors only those sites about which it receives complaints because it lacks staff and resources to monitor all health care activity on the Internet and Web).

¹¹² See, e.g., Kracov & Bloch, supra note 6 (explaining how the nature of communication on the Internet is significantly different from the communication that FDA regulations were initially designed to oversee and describing the shortcomings of the existing regulatory scheme for international oversight).

¹¹³ See id.

¹¹⁴ Id.

¹¹⁵ This includes material appearing in chat rooms, on listservs, in newsgroup discussions or in online versions of journals or periodicals. See id.

¹¹⁶ See generally Kracov & Bloch, supra note 6 (asserting that imposing the current regulatory framework for medical promotional activities on the Internet will invite First Amendment challenges).

¹¹⁷ Cf. Bransburg v. Hayes, 408 U.S. 665, 704 (1972) (noting that “freedom of the press is a fundamental personal right which is not confined to newspapers and periodicals. It necessarily embraces pamphlets and leaflets… . The press in its historic connotation comprehends every sort of publication which affords a vehicle of information and opinion“). In fact, FDA's admonishment of Vidamed, see VidaMed, supra note 50, for announcing to the public that it had applied for a certain regulatory approval is questionable under Bransburg.

¹¹⁸ See Bolger v. Youngs Drug Prod. Corp., 463 U.S. 60, 66-67 (1983) (identifying three criteria that must be met for speech to be treated as presumptively commercial: (1) whether the communication is an advertisement; (2) whether the communication makes reference to a specific product; and (3) whether the speaker has an economic motivation for the communication).

¹¹⁹ 447 u.s. 557, 564 (1980); see also Association of Nat'l Advertisers, Inc. v. Lungren, 44 F.3d 726, 729 (9th Cir. 1994), cert, denied, 116 S. Ct. 62 (1995) (applying the “more relaxed inquiry” of intermediate scrutiny to restrictions on commercial speech).

¹²⁰ 116 S. Ct. 1495(1996).

¹²¹ First, for commercial speech to be protected by the First Amendment, it must “concern lawful activity and not be misleading.” Central Hudson, 447 U.S. at 566. Second, the asserted government interest in regulating it must be substantial. See id. Third, “[i]f both inquiries yield positive answers,” the challenged regulation, to survive, must directly advance the asserted government interest. Id. Finally, the asserted regulation must also be “not more extensive than is necessary to serve that interest.” Id. The fourth prong of the Central Hudson test is sometimes referred to as a “narrow tailoring” requirement. See Bad Frog Brewery, Inc. v. New York State Liquor Auth., No. 97-7949, 1998 U.S. App. LEXIS 525, at *38-39 (2d Cir. Jan. 15, 1998). Some members of the Supreme Court appear to apply an even stricter test to future government burdens on commercial speech. See 44 Liquormart, 116 S. Ct. 1495, 1509 (1996) (Stevens, J., plurality) (using the language “significantly advances” in discussing Central Hudson's third prong as applied to the “complete suppression of truthful, nonmisleading information“). The circuit courts that have addressed this issue since 44 Liquormart agree that the Supreme Court, at minimum, has strengthened the third and fourth prongs of the Central Hudson test. See Bad Frog, 1998 U.S. App. LEXIS 525, at *37^»0 (stating that “[i]n its most recent commercial speech decisions, the Supreme Court has placed renewed emphasis on the need for narrow tailoring of restrictions on commercial speech” and relying on Edenfield v. Fane, 507 U.S. 761, 771 (1993), to require that the regulation before it “directly and materially advance[]” the state's interests); Nordyke v. Santa Clara County, 110 F.3d 707, 712 (9th Cir. 1997) (noting that, “[djespite the diminishing enthusiasm on the part of the Supreme Court concerning the legitimacy of the third and fourth parts of the Central Hudson test, their repudiation has not occurred“); Valley Broad. Co. v. United States, 107 F.3d 1328, 1334 (9th Cir. 1997) (“While 44 Liquormart fails to present a coherent framework for reviewing these claims, one point is clear: the government's asserted interest in reducing demand for casino gambling seems less likely to succeed following the Court's decision.“); Anheuser-Busch, Inc. v. Schmoke, 101 F.3d 325, 328-29 (4th Cir. 1996) (recognizing that 44 Liquormart appears to indicate that some members of the Supreme Court favor strengthening Central Hudson's third and fourth prongs, but distinguishing the regulation in the case before it as a mere “time, place, and manner” restriction, unlike the total ban on advertising in 44 Liquormart).

¹²² 44 Liquormart, 116 S. Ct. at 1505 (citing Virginia Bd. of Pharmacy v. Virgina Citizens Consumer Council, Inc., 425 U.S. 748, 765 (1976)).

¹²³ See id.

¹²⁴ See id. at 1509-10.

¹²⁵ Cf. Bad Frog, 1998 U.S. App. LEXIS 525, at *35 (holding that the New York State Liquor Agency's statewide ban on Bad Frog's labels did not directly advance the state's asserted interest of protecting children from exposure to vulgarity because it was only one small step toward achieving this goal, when no other steps had been taken).

¹²⁶ See Kracov & Bloch, supra note 6.

¹²⁷ “We know that the actively engaged patient, the informed patient, has better treatment compliance and better treatment outcomes.” Boehm, supra note 27 (quoting Dr. Steven Miles of the Center for Bioethics at the University of Minnesota); see also Tyler L. Chin, Managed Care Patient Education at the Crossroads, HEALTH DATA MGMT., Nov. 16, 1997, available in 1997 WL 8748976 (discussing results of a study in which seriously ill patients who were given computers and modems, enabling them to use educational software and access online medical discussion groups, experienced fewer hospital admissions and reduced lengths of stay than those who were not given computers and modems).

¹²⁸ 116 S. Ct. at 1512 (noting that “[t]he text of the First Amendment makes clear that the Constitution presumes that attempts to regulate speech are more dangerous than attempts to regulate conduct“). The paternalistic nature of Rhode Island's regulation offended the Court. See id. at 1507. In response to the regulation, the Court stated the following: “The First Amendment directs us to be especially skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good. That teaching applies equally to state attempts to deprive consumers of accurate information about their chosen products.” Id. at 1508.

¹²⁹ Washington Legal Found, v. Kessler, 880 F. Supp. 26 (D.D.C. 1995).

¹³⁰ See id.

¹³¹ See id. at 27-28. No subsequent activity has occurred in this case except for an order requiring the FDA commissioner to appear for a deposition, FDA Deposition Rebuff, NAT'L L.J., Dec. 16, 1996, at A10, and a denial of mandamus petition. See DC Circuit Denies Kessler's Petitions for Writ of Mandamus, PHARM. LITIG. REP., Jan. 1997, available in LEXIS, News Library, Andrws File.

¹³² See Reynolds Holding & Ramon G. McLeod, Court Protects Free Speech on Internet; ‘Decency’ Law Discarded by Federal Panel, SAN FRAN. CHRON., June 13, 1996, at Al. For example, the Electronic Frontier Foundation (EFF) is an influential Internet advocacy group that works to promote civil liberties in electronic communications. See John Barlow, A Not Terribly Brief History of the Electronic Frontier Foundation (visited Mar. 20, 1998) <http://www.eff.org/pub/EFF/history.eff>. EFF, which was founded in San Francisco by Grateful Dead lyricist John Perry Barlow, devotes a special section of its Web page to issues relating to freedom of speech and the Telecommunications Act of 1996. See Blue Ribbon Campaign (visited Mar. 20,1998) <http://www.eff.org/blueribbon.html>.

¹³³ See, e.g., Andrew C. Barrett, Multiple Broadband Wires to the Home: Future or Folly?, 44 COMMLAW CONSPECTUS 163-64 (1996) (noting that “convergence” refers to “the ability of a single communication service provider, such as a cable television company, to provide voice telephony, video and data (e.g., facsimile) services simultaneously over a single wire“). Andrew Barrett served on the Federal Communications Commission from September 8, 1989, to March 31, 1996. See id. He is now the managing director of the global telemedia group at Edelman Public Relations Worldwide. See id.

¹³⁴ This includes material appearing on manufacturer-sponsored Web pages or sites. 21 C.F.R. § 202(1)(1)(2) (1997); see also supra notes 10-11 and accompanying text (discussing FDA labeling requirements).

¹³⁵ This includes material appearing on sites produced by medical journals or the general press. 21 C.F.R. § 202(1)(1)(2); see also supra notes 71-77 and accompanying text (discussing FTC requirements and possible FDA and FTC regulation of drug and medical supply promotion on the Internet).

¹³⁶ This includes material appearing in articles written by medical journal or general press staff and appearing on sites produced by medical journals or the general press.

¹³⁷ This includes material appearing on or in non-industry-sponsored listservs, newsgroups or chat rooms.

¹³⁸ See discussion supra note 65.

¹³⁹ See, e.g., Odgers v. Ortho Pharm. Corp., 609 F. Supp. 867, 879 (E.D. Mich. 1985); Stephens v. G.D. Searle & Co., 602 F. Supp. 379, 380 (E.D. Mich. 1985); Lukaszewicz v. Ortho Pharm. Corp., 510 F. Supp. 960, 965, modified, 532 F. Supp. 211, 212 (E.D. Wis. 1981); see also discussion supra note 19 (stating that a few courts have held that makers of oral contraceptives may not escape liability under the “learned intermediary” exception because the product is marketed directly to consumers).

¹⁴⁰ See Moore, supra note 32, at 1.

¹⁴¹ Id. (quoting Brian Gazzard, British AIDS researcher and founder of Information Exchange, a European cybercafe for people who are HIV-positive). Brian Gazzard believes doctors should “act a bit more like lawyers” by giving patients advice which they can take or leave. Id.

¹⁴² See id.

¹⁴³ Frontier Media Group and VirSci Corp. have formed a watchdog group, the Internet Healthcare Coalition, to guard against the spread of misinformation on the Internet. See Kristen Hallam, The Pulse, NASHVILLE BANNER, Nov. 11, 1997, at Bl, available in 1997 WL 14342606. Representatives from pharmaceutical companies Glaxo Wellcome and SmithKline Beecham, the British Medical Association and The New England Journal of Medicine are among the coalition's directors. See id.

¹⁴⁴ See Moore, supra note 32, at 1.

¹⁴⁵ See id. (reporting that the chief executive of the charity British Association of Cancer United Patients has said that the United Kingdom's National Health Service so constrains physicians’ practices that they no longer “have the time to discuss all different treatment options in detail with patients“).