Judge Permits Spread of Unapproved Uses Literature

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An MD&DI October 1998 Column

WASHINGTON WRAP-UP

A federal judge strikes FDA's objection to manufacturers disseminating previously published materials on device or drug uses unapproved by FDA.

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James G. Dickinson

According to a recent judicial opinion, a simple disclaimer such as "Use not approved by FDA" is all companies need to use to hand out appropriately published materials about FDA-unapproved uses of drugs or devices to medical practitioners or to sponsor seminars and speakers on such unapproved uses.

This decision was handed down on July 30 in a 54-page opinion by District of Columbia federal judge Royce C. Lamberth. The four-year-old First Amendment case against FDA was filed by the Washington Legal Foundation (WLF). The group challenged FDA's published guidances about ways medical device and drug companies could support scientific and educational activities directed at health-care providers.

Lamberth granted WLF's arguments for a summary judgment and preliminary injunction against FDA. He enjoined FDA from prohibiting, restricting, sanctioning, or otherwise limiting manufacturers from giving medical professionals materials previously published in "bona fide peer-reviewed professional journals" or in "bona fide independent" textbooks, and from "suggesting content or speakers to an independent program provider in connection with a continuing medical education seminar program or other symposium...."

Lamberth agreed with FDA on one point, however. Such communications are not pure free speech when regulated companies get involved, but commercial speech subject to a lesser degree of First Amendment protection. As such, the government has a substantial interest in it and may impose minimal limits on its expression. FDA's guidances, however, were excessive.

Lamberth's order and opinion are more liberal than the provision in Congress's recently passed Modernization Act. The provision allows a manufacturer to hand out such materials only if it has filed for FDA approval of new labeling that covers the unapproved uses in question. The Health Industry Manufacturers Association (HIMA) criticized that part of the act as being so restrictive that it would "result in few, if any, scientific or medical journal articles being disseminated." HIMA believes FDA should assume—as Judge Lamberth's opinion does—that peer-reviewed articles in scientific or medical journals are scientifically sound.

Whether the judge's interpretation of Congress's intent in the act will be sustained at the appellate level—assuming, as nearly everyone does, that FDA will appeal—remains to be seen. Courts may have a difficult time weighing congressional intent in the Modernization Act. The wording in many of the committee reports is astonishingly ambiguous and loose, and the philosophies of the many lawmakers who briefly coalesced to pass the act are diverse.

Although he threw out FDA's guidance document, Lamberth invited the agency to "require any pharmaceutical or medical device manufacturer that sponsors or provides financial support for the dissemination or redistribution of articles or reference textbooks or for seminars or symposia that included references to uses of drugs or medical devices other than those approved by FDA to disclose (i) its interest in such drugs or devices, and (ii) the fact that the use discussed has not been approved by FDA."

FDA has 60 days to file an appeal. Given the loose wording of the Modernization Act, however, the agency may decide to proceed instead with the rulemaking Lamberth suggested.

Another reason that FDA should avoid spending taxpayers' money on an appeal is the common sense of Lamberth's written opinion. In it, he says what has long been obvious to everyone except FDA: medical practitioners are capable of deciding for themselves what is believable about unapproved-use information. "Despite the FDA's occasional statements in its briefs to the contrary," he chides, "physicians are a highly educated, professionally trained and sophisticated audience."

At another point in his opinion, Lamberth noted, "to endeavor to support a restriction upon speech by alleging that the recipient needs to be shielded from that speech for his or her own protection, which is the gravamen of FDA's claim here, is practically an engraved invitation to have the restriction struck."

Lamberth also took FDA to task for its self-importance. "In asserting that any and all scientific claims about safety, effectiveness, contraindications, side effects and the like regarding medical [devices] are misleading until the FDA has had the opportunity to evaluate them, FDA exaggerates its overall place in the universe," he wrote. (It should be noted that, throughout his opinion, Lamberth uses the word drugs for both drugs and medical devices, since the lawsuit covered both kinds of products equally. In his first footnote, Lamberth says the term drugs should be understood to encompass both prescription drugs and medical devices. The term devices has been substituted here for drugs for ease of reading.)

One of FDA's claims was that it is not the unapproved-use information itself that is objectionable, but the manner in which it may be promoted. Lamberth observed that it really makes little difference how the information gets into the physicians' hands: "Why the ability of a doctor to critically evaluate the scientific findings depends upon how the article got into the physician's hands, or whether a manufacturer suggests speakers or content for a continuing medical education seminar, is unclear to this court."

In short, Lamberth rejected FDA's primary claim that the government has a substantial interest in preventing doctors from being misled by unapproved-use information supplied by firms with a vested interest in that information. However, Lamberth accepted FDA's secondary claim that it needs to limit this commercial speech to provide manufacturers an incentive to do the clinical studies necessary to admit the use to the approved labeling. His opinion endorsed FDA's argument that "if the manufacturer's ability to disseminate any information on a new use of a previously approved device is made wholly contingent upon FDA approval of that use, the manufacturer will be encouraged, if not compelled, to gain FDA approval."

The opinion slaps down a suggestion by WLF that after a device is approved and marketed, the approval of subsequent uses is discretionary rather than mandatory. "Fundamental to this entire litigation," writes Lamberth, "is the fact that the rules that physicians must follow in prescribing, and those that device manufacturers must follow in labeling, marketing and promoting are different. The fact that physicians may prescribe and do prescribe off-label, and that those prescriptions may often be the standard of care, does not mean that manufacturers are not required by statute to get all new devices evaluated for safety and efficacy for use under the conditions prescribed, recommended or suggested in the labeling. There is no support for the contention that this approval process is discretionary to the extent that manufacturers may elect not to submit the new use for FDA approval and still label the device for that use."

FDA is receiving public comments until October 19 on CDRH's new model for the development and review of Class III medical devices. The model contains three tracks: (1) expedited review for devices that offer significant advantages over current therapy, (2) standard review for most devices, and (3) streamlined review for devices that are very well understood by both the sponsor and FDA. The deadline is given in a July 21 Federal Register notice, which steers inquirers to CDRH Facts-On-Demand at 800/899-0381 or 301/827-0111 and to the CDRH home page.

General hospital devices manufactured at Baxter Healthcare's Cleveland, MS, facility were adulterated because of the company's failure to validate its EtO sterilization processes, wrote FDA New Orleans district director James Garnet in a warning letter on July 2.

The company did not perform enough qualification runs under the same conditions as routine runs, sufficiently document sterilization validation, or adequately validate that EtO did not adversely affect packaging, the letter stated.

Baxter spokesperson Debra Spak said on July 21 that the company is finalizing its response to the letter, which she characterized as a disagreement over the meaning of worst case.

Efforts by the Department of Health and Human Services to shift the categorization of commercial test systems regulated under the Clinical Laboratory Improvement Amendments (CLIA) from CDC to FDA are supported by HIMA, states a July 17 letter from HIMA to HHS Secretary Donna Shalala. CDC apparently adopted the function because of lack of sufficient funds at FDA, the letter said. The transfer would allow FDA to consider CLIA regulations during product reviews.

Steris Corp. (Mentor, OH) distributed adulterated biological monitoring kits, alleges a four-page July 8 warning letter. The letter stated that the kits were affected by changed stability tests and inadequate assurance of conformance with specifications.

The warning letter was written after two GMP inspections (last fall and this spring) and a written response from the firm that was "not adequate to correct all of the violative conditions pointed out to you," according to the letter.

A Steris spokesman said the tests in question were provided by a third party, and the company is confident it will resolve FDA's concerns.

Four companies have sought exemptions from premarket notification for Class II devices, FDA said in a July 21 Federal Register notice. The notice solicits public comment on the firms' petitions. The four companies are Sandhill Scientific (Highlands Ranch, CO), for a gastrointestinal motility monitoring system; Welch Allyn (Skaneateles Falls, NY), for an ophthalmoscope; Computerized Medical Systems (St. Louis), for radiation therapy simulation systems with respect only to the radiation oncologist data entry workstation; and Chemicon International (Temecula, CA), for cytomegalovirus serological reagents.

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