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WASHINGTON LEGAL FOUND. v. FRIEDMAN

July 30, 1998

WASHINGTON LEGAL FOUNDATION, Plaintiff,
v.
MICHAEL A. FRIEDMAN, M.D., in his official capacity as Acting Commissioner, Food and Drug Administration and, DONNA SHALALA, in her official capacity as Secretary, Department of Health and Human Services, Defendants.



The opinion of the court was delivered by: LAMBERTH

MEMORANDUM OPINION

 This matter comes before the court on the parties' cross-motions for summary judgment. Upon consideration of the memoranda filed in support of and in opposition to the respective motions, the relevant legal authorities, and the entire record, and finding that there is no genuine issue of material fact, plaintiff's motion for summary judgment will be granted and defendants' cross-motion will be denied.

 I. FACTUAL BACKGROUND

 Plaintiff Washington Legal Foundation ("WLF") is a non-profit public interest law and policy center that defends "the rights of individuals and businesses to go about their affairs without undue influence from government regulators." See Complaint P 5. In this action, WLF seeks to enjoin the Food and Drug Administration, ("FDA") and the Department of Health and Human Services ("HHS") from enforcing policies restricting certain forms of manufacturer promotion of off-label uses for FDA-approved drugs and devices. The policies at issue -- expressed through Guidance Documents -- concern manufacturer distribution of reprints of medical textbooks and peer-reviewed journal articles ("enduring materials"), and manufacturer involvement in continuing medical education seminars and symposia ("CME"). See Final Guidance on Industry-Supported Scientific and Educational Activities, 62 Fed. Reg. 64074 (1997); Advertising and Promotion; Guidances, 61 Fed. Reg. 52800 (1996).

 Plaintiff seeks a declaratory judgment that the FDA policies expressed in the Guidance Documents violate the rights of its members under the First Amendment of the Constitution. It further requests that the court enter preliminary and permanent injunctions against defendants, preventing them from enforcing, relying upon, or otherwise giving effect to the Guidance Documents.

 A. Statutory & Regulatory Framework

 The FDA derives, its authority to regulate various aspects of the medical and pharmaceutical industries from a complex statutory and regulatory scheme, a major portion of which is embodied in the Food, Drug and Cosmetic Act, 21 U.S.C. § 301, et seq. In order for a prescription drug or class III medical device *fn1" to be distributed by a manufacturer in interstate commerce, the manufacturer is required to demonstrate, through a rigorous series of pre-clinical and clinical trials, that the drug or medical device is both safe and effective for each of its intended uses. 21 U.S.C. § 355(a),(b),(j). FDA makes its final approval decisions under the "substantial evidence" standard. See 21 U.S.C. § 355(d).

 As part of the approval process, the FDA also reviews the proposed "labeling" for the drug, which includes, inter alia, all proposed claims about the drug's risks and benefits, as well as adequate directions for use. See, e.g., 21 U.S.C. § 352(f). Labeling is a term of art that encompasses all written, printed or graphic material "(1) upon any [drug or device] or any of its containers or wrappers, or (2) accompanying such [drug or device]." 21 U.S.C. § 321(k) & (m). The most self-evident form of labeling is the package insert that accompanies the drug, but the term has also been construed to include nearly every form of drug company promotional activity, including booklets, pamphlets, mailing pieces, bulletins, and all literature that supplements, explains, or is otherwise textually related to the product. See 21 C.F.R. § 202.1(1)(2) (1997); Kordel v. United States, 335 U.S. 345, 350, 93 L. Ed. 52, 69 S. Ct. 106 (1948); United States v. Vitamin Indus., Inc., 130 F. Supp. 755, 765-66 (D. Neb. 1955). The FDA will only approve the new drug application if the labeling conforms with the uses that the FDA has approved.

 Congress has closely examined whether alternative uses for approved drugs -- treatments not on the approved label -- should be subjected to the same FDA review procedures as the initial claim. In 1962, Congress amended the definition of a "new drug," 21 U.S.C. § 321(p), to make clear that drugs must be demonstrated safe and effective for "use under the conditions prescribed," meaning that all uses for a drug must obtain FDA approval. See also 108 Cong. Rec. S17366 (daily ed. Aug. 23, 1962) (statement of Senator Eastland). Therefore, if a manufacturer wishes to market or promote a product for an unlabeled use, it must resubmit the drug for another series of clinical trials similar to those from the initial approval. Until this subsequent approval has been granted, the unapproved use is considered to be off-label. Off-label uses include treating a condition not indicated on the label, or treating the indicated condition but varying the dosing regimen or the patient population. Manufacturer promotion of off-label uses constitutes misbranding. See 21 U.S.C. § 352.

 Central to this litigation is that what a manufacturer may lawfully claim that a drug does under the statutory and regulatory scheme, and what a physician may prescribe a drug for, do not match. Once a drug has been approved by the FDA for marketing for any use, the actual prescription choices regarding those drugs are left to the discretion of the physician. See, e.g., 59 Fed. Reg. 59820, 59821 (1994) (noting that the agency has restated this policy on numerous occasions). A physician may prescribe an approved drug for any medical condition, irrespective of whether FDA has determined that the drug is safe and effective with respect to that illness. That physicians may presently prescribe off-label is not in dispute. See Defendants' Response to Plaintiff's Statement of Material Facts P 9 (noting that off-label prescribing is appropriate in the context of the physician-patient relationship); see also Deposition of William K. Hubbard, Associate Commissioner for Policy Coordination at 59-61 (March 21, 1996) ("Hubbard Deposition"). The FDA contends that it accepts the practice of off-label use by physicians as part of its enforcement discretion, see Defendants' Response to Plaintiff's Statement of Material Facts P2; Defendants' Reply to Plaintiff's Memorandum in Opposition at 6 ("Defendants' Reply Memorandum"), though it appears to be an open question as to whether the FDA could currently regulate this aspect of the practice of medicine if it wished to do so.

 B. The Pros & Cons of Off-Label Use

 Whether characterized as either "the standard of care" or "treacherous," off-label use of FDA-approved drugs by physicians is an established aspect of the modern practice of medicine. See, e.g., Off-Label Drugs, Reimbursement Policies Constrain Physicians in Their Choice of Cancer Therapies, GAO/PEMD-91-14 at 5 (Sept. 1991) ("GAO Report") (noting that the use of off-label treatments is widespread). The precise extent upon which physicians rely upon off-label uses is disputed by the parties. A study cited by FDA concludes that off-label prescribing for the 64 most frequently prescribed drug products is low -- constituting only 4.7% of all prescriptions for patented drugs, and 2.0% for off-patent drugs. See Off-Label Use Associated With the Prescribing of the Most Frequently Used Drug Products in the United States, 1995 (unpublished draft, May 24, 1996) at 4. However, when one looks to specific areas of medicine, the picture as to off-label use changes dramatically. The General Accounting Office Report looking at anti-cancer drugs found that 25% of anticancer drugs were prescribed off-label and 56% of cancer patients were given at least one drug off-label. See GAO Report at 4. These uses are especially prevalent when the cancer has reached an advanced stage Off-label prescribing is also common in pediatrics, where drug manufacturers are justifiably reluctant to subject children to experimental clinical trials. See Hubbard Deposition at 77. Even the FDA acknowledges that in some specific and narrow areas of medical practice, practitioners consider off-label use to constitute the standard of good medical care. See Defendants' Response to Plaintiff's Statement of Material Facts P 4; Deposition of Byron L. Tart, Director, Promotion and Advertising Policy Staff (March 15, 1996) at 153 ("Tart Deposition") (stating that public health may benefit from off-label uses in some circumstances).

 As off-label uses are presently an accepted aspect of a physician's prescribing regimen, the open dissemination of scientific and medical information regarding these treatments is of great import. The FDA acknowledges that physicians need reliable and up-to-date information concerning off-label uses. "More generically, we certainly believe it's very appropriate for physicians to get information about off-label uses from the many sources that they get them. And, of course, they get them from CME; they get them from on-line databases; they get them through textbooks; they get them through discussions with colleagues; they get them through going to a medical center and grand rounds. . . . FDA does not desire or intend to interfere with that process." Hubbard Deposition at 62-63; Defendants' Memorandum of Points and Authorities in Opposition to Plaintiff's Motion for Summary judgment at 21 ("Defendants' Opposition Memorandum"). The need for reliable information is particularly acute in the off-label treatment area because the primary source of information usually available to physicians -- the FDA approved label -- is absent. See Defendants' Response to Plaintiff's Statement of Material Facts P 12 (noting that labeling is unavailable for off-label uses); Declaration of Robert Temple, M.D. P 8 ("Temple Declaration") (noting that some information concerning new uses will not be reflected in the approved labeling and that "physicians are completely free to consider this information and to rely on it in making treatment decisions").

 It is not the case however, that off-label prescription practices are wholly unproblematic. Off-label uses have, in some circumstances, proven to be harmful. For example, in the 1980's, physicians began to prescribe, off-label, two anti-arrythmic drugs, encainide and flecainide, to treat minor disturbances in patients who had recently had heart attacks. Patients who took these drugs had a two-and-one-half fold increase in mortality, and estimates of the total number of deaths attributable to this off-label "treatment" range from 3,000 to 10,000 patients per year. See Temple Declaration at P 21 (also noting the absence of promotion by sponsors). Even in cases in which the off-label use is not "toxic," prescribing a drug that is merely not effective may be no less harmful, because the ineffective prescription regimen will have been substituted for an effective one. See id. P 22 (addressing another example concerning the off-label use of "calcium channel blockers" which subsequently proved to be ineffective, which meant that patients were being deprived of the more effective on-label treatment).

 In light of the problems that have arisen out of off-label prescription practices, the FDA, consistent with its mission to protect the public health, claims that it must develop solutions. The agency notes that "the ordinary citizen here has little ability to protect himself or herself from the potential harm associated with unproven uses of drugs and devices. For this reason, FDA has been charged with preventing such harm." Defendants' Opposition Memorandum at 20. (citing United States v. Dotterweich, 320 U.S. 277, 280, 88 L. Ed. 48, 64 S. Ct. 134 (1943)).

 C. The Guidance Documents and the Food and Drug Modernization Act

 1. Continuing Medical Education (CME) Guidance

 In the late 1980's, drug and device companies greatly increased the resources devoted to sponsoring CME seminars. Concerns about the promotional practices of drug manufacturers caught the attention of Congress, which conducted hearings in 1990 to investigate the matter. Among the issues addressed in those hearings was manufacturers' promotion of unapproved claims for approved products. See Advertising, Marketing and Promotional Practices of the Pharmaceutical Industry, 1990; Hearing Before the Senate Committee on Labor and Human Resources, 101st Cong. 2, 5, 8-13 (1990) ("Pharmaceutical Hearings").

 In response, FDA developed a Draft Concept Paper that endeavored to identify instances in which the industry could support scientific and educational programs that addressed off-label uses without violating the Food and Drug Act, which proscribes the misbranding of drugs. However, this concept paper, in defendants' words, "generated even more confusion." Defendants' Opposition Memorandum at 14. After meeting with representatives of the drug and device industry and CME providers, FDA published a Draft Policy Statement on Industry Supported Scientific and Educational Activities, 57 Fed. Reg. 56412 (1992) which again attempted to describe elements that would be significant in determining when a manufacturer-supported program inappropriately promoted off-label uses. The focus of FDA'S inquiry was whether the discussion of off-label use was independent of the promotional influence of the sponsoring manufacturer. After receiving and reviewing all comments with regard to the Draft Policy Statement (including a citizen's petition submitted by plaintiff Washington Legal Foundation), the FDA revised its guidance and published the final guidance on December 3, 1997. See 62 Fed. Reg. 64074 (1997).

 In the final guidance, the FDA recognized the importance of supporting the full exchange of views in scientific and educational discussions, "including discussions of unapproved uses." Id. at 64095. The guidance was designed to distinguish between those situations in which CME is "independent from the substantive influence of the supporting company," and therefore not subject to regulation, as opposed to when the manufacturer is in a position to influence the presentation of information, "or otherwise transform an ostensively independent program into a promotional vehicle." Id. The FDA developed twelve factors to consider in evaluating programs and activities to determine "independence" which include: who controls the content and selects presenters and the moderator; whether there is meaningful disclosure as to the company's funding and whether unapproved uses will be discussed; the focus of the program, such as whether the central theme is on one product; the relationship between supporting companies and the CME provider; audience selection; opportunities for meaningful discussion and questioning; dissemination of information; ancillary promotional activities; and any complaints raised by the provider, presenters or attendees regarding attempts by the supporting company to influence content. Id. at 64097-99. Additionally, while not required, a written agreement between the provider and the supporting company "can provide valuable evidence as to whether an activity is independent and non-promotional." Id. at 64099. This written agreement is intended to demonstrate that the sponsoring company has no involvement in the CME seminars such that it might influence the content, and that the provider is solely responsible for designing and conducting the activity.

 2. Enduring Materials Guidance Documents

 The second set of Guidance Documents concern the distribution of enduring materials -- textbook excerpts and article reprints from medical and scientific journals. See 61 Fed. Reg. 52800 (1996). These Guidances restrict manufacturer distribution of enduring materials when the publications address off-label uses for the company's previously approved products. Similar to the CME Guidance, the FDA noted the need to "strike the proper balance between the need for an exchange of reliable scientific data and information within the health care community, and the statutory requirements that prohibit companies from promoting products for unapproved uses." Id.

 As to sponsor/manufacturer distribution of reprints of professional journal articles, the Guidance requires that the principal subject of the article should be the use(s) or indication(s) that has been approved by the FDA, and the article should report the initial study by the FDA on that approved use; that the reprint should be from a bona-fide peer-reviewed journal; that any effectiveness rates, data, analyses, uses, regimens and the like that are different from the approved labeling shall be prominently stated on the face of the reprint; and that the information shall disclose all material facts and shall not be false or misleading. Id. at 52801. It is largely the first requirement with which plaintiff takes issue.

 As to reference texts (medical textbooks and compendia), the work may not have been written, edited, excerpted or published specifically at the request of a drug, device or biologic firm, unless the text was prepared in a manner that results in a balanced presentation; the content may not have been reviewed, edited or significantly influenced by the manufacturer; the text should not be available primarily through the manufacturer -- it should be generally available in other outlets such as bookstores; and, the reference text should not focus on any particular drug and device, "nor should it have a significant focus on unapproved uses of the drug(s), device(s) or biological(s)." Id.

 Notably, these restrictions on the dissemination of enduring materials apply only when the drug manufacturer or sponsor seeks to initiate distribution of the materials. Dissemination of article reprints and reference texts that would otherwise violate the Guidances are permissible when that distribution is responsive to a physician's inquiry. See Tart Deposition at 53-54. The court will return to this point in greater detail in evaluating the merits of the case.

 3. The Food and Drug Modernization Act of 1997

 On November 21, 1997, President Clinton signed into law the Food and Drug Modernization Act of 1997, Pub L. No. 105-115, 111 Stat. 2296 (to be codified at 21 U.S.C. § 551, et seq.). These Amendments differ from the Guidances in that they will permit manufacturer distribution of written information concerning the safety, effectiveness or benefit of an unapproved use of a previously approved drug under specified conditions. The most notable condition is that the manufacturer must submit an application to have the new use approved by the FDA, or certify that such an application will be submitted within six months after the date of the initial dissemination. See § 551(b). The statute also directly addresses physician-initiated inquiries, as it states, "Nothing in section 551 shall be construed as prohibiting a manufacturer from disseminating information in response to an unsolicited request from a health care practitioner." See § 557(a). The legislation does not address CME seminars.

 The 1997 Modernization Act will become effective no later than one year from the date of enactment, or upon the Secretary's issuance of final regulations. See id. § 557(d). Consequently, the October 1996 Guidance Documents will be superseded by statute at that time.

 II. ANALYSIS

 A. Summary Judgment

 Fed. R. Civ. P. 56(c) provides that, "summary judgment shall be rendered forthwith if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law." The rule provides that "the mere existence of some alleged factual dispute between parties will not defeat an otherwise properly supported motion for summary judgment; the requirement is that there be no genuine issue of material fact." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247-248, 91 L. Ed. 2d 202, 106 S. Ct. 2505 (1986); Celotex Corp. v. Catrett, 477 U.S. 317, 323, 91 L. Ed. 2d 265, 106 S. Ct. 2548 (1986).

 B. Classification of Manufacturer Sponsorship of CME Seminars and Distribution of Enduring Materials Under Current First Amendment Jurisprudence

 The threshold question that this court is called upon to answer is how to classify the "speech" at issue. Plaintiff argues that it is scientific and academic speech, which is entitled to the highest level of First Amendment protection. Defendants challenge this assertion by first making a somewhat difficult to discern argument that the Guidance Documents regulate conduct. A closer examination demonstrates that what the FDA is actually contending is that because the federal government has the broad power to regulate the pharmaceutical industry, the Guidances are incidental encroachments upon speech and entirely compatible with the First Amendment. In the alternative, FDA claims that the Guidance Documents at most regulate commercial speech, which is subject to a more relaxed inquiry than core First Amendment speech.

 1. Speech or Conduct?

 FDA's first contention -- that the Guidance Documents are a restraint upon conduct and not upon speech -- may be addressed quickly. There is little question that the relevant "conduct" Is the off-label prescription of drugs by physicians. The distribution of enduring materials and sponsorship of CME seminars addressing and encouraging that conduct is speech. Mailing enduring materials and/or discussing off-label uses is not inherently "treacherous"; it is only treacherous (if at all) to the extent that physicians choose to pay attention to the message communicated and alter their prescription practices accordingly. As plaintiff's counsel aptly noted at oral argument, the activities at issue in this case are only "conduct" to the extent that moving one's lips is "conduct," or to the extent that affixing a stamp and distributing information through the mails is "conduct."

 FDA clearly recognizes the difference between speech and conduct in noting that "throughout its papers WLF repeatedly mistakes actual off-label use by physicians with the promotion of off-label use by manufacturers . . . FDA's concerns are directed only to the latter." Defendants' Reply Memorandum at 6 (emphasis added). See also id. at 20 ("the Guidance Documents apply only to those situations in which manufacturers 'cross the line' between education and promotion"). This court is hard pressed to believe that the agency is seriously contending that "promotion" of an activity is conduct and not speech, or that "promotion" is entitled to no First Amendment protection. There may certainly be a "line" between education and promotion as regards a drug manufacturer's marketing activities, but that is the line between pure speech and commercial speech, not between speech ana conduct Clearly, defendants do not truly subscribe to this point of view, as they note that "it is the promotional connection with the company that is key", followed by a cite to Bolger v. Youngs Drug Products Corp., 463 U.S. 60, 67, 77 L. Ed. 2d 469, 103 S. Ct. 2875 (1983), which, of course, concluded that the promotional activity at issue was to be analyzed as commercial speech. See Defendants' Opposition Memorandum at 21.

 2. Do the Guidance Documents Address Fully Regulable Speech Not Covered by the First Amendment Because the Food and Drug Industry is Extensively Regulated?

 The FDA next asserts that the speech regulated by the Guidance Documents falls outside of the ambit of the First Amendment because of the federal government's extensive power to regulate the pharmaceutical industry through the Pure Food and Drug Act, 21 U.S.C. § 331 et seq. See 62 Fed. Reg. at 64077-78; Defendants' Opposition Memorandum at 19-22. The agency claims that "FDA is well within its statutory authority to take such actions as are necessary to ensure that drugs and devices comply with the approval requirements of the [Food and Drug] Act." Defendants' Reply Memorandum at 8. ("Defendants' Reply Memorandum"). In support of this argument, the FDA first looks to Ohralik v. Ohio State Bar Ass'n, 436 U.S. 447, 456, 56 L. Ed. 2d 444, 98 S. Ct. 1912 (1978), which notes that "numerous examples could be cited of communications that are regulated without offending the First Amendment" such as information about securities, corporate proxy statements, the exchange of price and production information among competitors in antitrust regulation, and employer's threats of retaliation for the labor activities of employees. (citations omitted). FDA also notes Ohralik's pronouncement that "the State does not lose its power to regulate commercial activity deemed harmful to the public whenever speech is a component of that activity." Id. See also Dun & Bradstreet, Inc. v. Greenmoss Builders, Inc., 472 U.S. 749, 759 n.5, 86 L. Ed. 2d 593, 105 S. Ct. 2939 (1985) (noting that certain types of communications may be regulated without offending the First Amendment). The FDA also directs the court's attention to Securities & Exchange Comm'n v. Wall Street Publ'g Inst., Inc., 271 U.S. App. D.C. 110, 851 F.2d 365, 373 (D.C. Cir. 1988), in which this circuit concluded that regulation of the exchange of information in the securities industry was subject only to limited First Amendment scrutiny. In so holding, the Court of Appeals stated that "the government may have the power to regulate Stock Market Magazine, not because the articles are 'commercial speech,' but rather because of the federal government's broad powers to regulate the securities industry." 851 F.2d at 372. The Court of Appeals went on to note that "speech relating to the purchase and sales of securities, in our view, forms a distinct category of communications in which the government's power to regulate is at least as broad as with respect to the general rubric of commercial speech." Id.

 The court finds that the cases relied upon by FDA do not support its position here. First, the argument that a certain subset of speech may be considered completely outside of the First Amendment framework because the speech occurs in an area of extensive government regulation is a proposition whose continuing validity is at best questionable in light of the Supreme Court's most recent commercial speech cases. Ohralik, of course, predated the seminal commercial speech case of Central Hudson Gas and Electric Corp. v. Public Service Comm'n of New York, 447 U.S. 557, 65 L. Ed. 2d 341, 100 S. Ct. 2343 (1980), by three years. Since the Central Hudson decision, the Supreme Court has consistently applied a speech analysis -- whether under the pure speech or commercial speech framework -- to cases involving statutes and/or regulations in areas subject to extensive state or federal regulation. See, e.g., Rubin v. Coors Brewing Co., 514 U.S. 476, 131 L. Ed. 2d 532, 115 S. Ct. 1585 (1995) (alcohol labeling); Turner Broadcasting System, Inc. v. FCC, 512 U.S. 622, 129 L. Ed. 2d 497, 114 S. Ct. 2445 (1994) (telecommunications); Pacific Gas and Electric Co. v. Public Utilities Comm'n of California, 475 U.S. 1, 89 L. Ed. 2d 1, 106 S. Ct. 903 (1986) (utilities); Friedman v. Rogers, 440 U.S. 1, 59 L. Ed. 2d 100, 99 S. Ct. 887 (1979) (optometry). Significantly, even in the attorney conduct area -- the area directly at issue in Ohralik -- the court has recently used the commercial speech framework to uphold a restriction on speech. In Florida Bar v. Went for It, Inc., 515 U.S. 618, 635, 132 L. Ed. 2d 541, 115 S. Ct. 2371 (1995), the Court noted, "particularly because the standards and conduct of state-licenced lawyers have traditionally been subject to extensive regulation by the States, it is all the more appropriate that we limit our scrutiny of state regulation to a level commensurate with the 'subordinate position' of commercial speech in the scale of First Amendment values." (citing Board of Trustees of the State University of New York v. Fox, 492 U.S. 469, 477, 106 L. Ed. 2d 388, 109 S. Ct. 3028 (1984), quoting Ohralik, 436 U.S. at 456). This statement indicates, if not demands, that areas subject to extensive regulation are to be scrutinized as commercial speech, and not beyond First Amendment scrutiny, as defendants argue.

 Any lingering doubt as to whether the government may impose restrictions upon speech without offending the First Amendment merely because it has the authority to regulate the underlying activity was resolved in 44 Liquormart, Inc. v. Rhode Island, 517 U.S. 484, 134 L. Ed. 2d 711, 116 S. Ct. 1495 (1996). In that case, the Supreme Court expressly rejected the concept embodied in Posadas de Puerto Rico Assoc. v. Tourism Co. of Puerto Rico., 478 U.S. 328, 92 L. Ed. 2d 266, 106 S. Ct. 2968 (1986), that because The government had the power to extensively ...


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