Washington Legal Foundation v. Friedman

Decision Date30 July 1998
Docket NumberCivil Action No. 94-1306(RCL).
Citation13 F.Supp.2d 51
PartiesWASHINGTON 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.
CourtU.S. District Court — District of Columbia

Richard A. Samp, Washington Legal Foundation, Washington, DC, Thomas William Queen, Bertram Walter Rein, Daniel E. Troy, Wiley, Rein & Fielding, Washington, DC, for Plaintiff.

Daniel Franklin Van Horn, U.S. Attorney's Office, Washington, DC, Gerald Cooper Kell, U.S. Department of Justice, Office of Consumer Litigation, Washington, DC, for Defendants.

Charles Douglas Welty, Welty & Blair, P.C., Arlington, VA, for Movants.


LAMBERTH, District Judge.

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.


Plaintiff Washington Legal Foundation ("WLF") is a nonprofit 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 ¶ 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 device1 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, 69 S.Ct. 106, 93 L.Ed. 52 (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 ¶ 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 ¶ 2; 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 ¶ 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. "[M]ore 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")....

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