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FDA to Industry: Keep Your Own Secrets

Medical Device & Diagnostic Industry Magazine MDDI Article Index Originally Published March 2000 WASHINGTON WRAP-UP In a cost-cutting move, FDA makes manufacturers responsible for ensuring the confidentiality of premarket notification applications.  

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

Originally Published March 2000

In a cost-cutting move, FDA makes manufacturers responsible for ensuring the confidentiality of premarket notification applications.


  • Stepped-up FDA Enforcement
  • Pacemaker Lead Clinical Tests
  • Explants Prompt Recall
  • Labeling Copyright Risk
  • More on Device Tracking
  • Another Reprocessor Cited

The FDA budget crunch continues to produce new economies at the agency—and cost-shifting ideas that could transfer to medical device companies expenses presently carried by FDA.

A new example of this was seen in a December 21 Federal Register proposed rule that would transfer to 510(k) device sponsors the responsibility FDA now has for removing ("redacting" in FDA parlance) trade secret, commercial, confidential, copyrighted, and privacy-protected information from 510(k) documents that are released to the public under the Freedom of Information Act (FOIA).

The proposal would remove FDA from the redaction business entirely, leaving companies to determine for themselves what they want released about their products. A company's decision would be subject only to the disclosure requirements of the Food, Drug, and Cosmetic Act (FD&C Act), Section 513(i)(3). There's a lot of latitude there, and even more in the proposed rule, for companies to please themselves. Not only would they have a free hand in writing FOIA-releasable summaries, but FDA proposes to not even look at what information has been redacted. The agency would become involved only if an FOIA requester complained that too much information had been removed from a 510(k).

The primary instrument for extricating FDA from FOIA redactions for 510(k)s would be a new requirement to be included with all 510(k)s, under which companies would have to "submit to FDA, no later than 30 days after the date of an FDA order under Sec. 807.100(a)(1) declaring this device to be substantially equivalent, a redacted copy of the entire premarket notification as required by Sec. 807.95(f)."

The proposed rule would further distance FDA from the redaction process by encouraging sponsors to submit their redacted FOIA summaries to FDA on disk in portable document format (.pdf)—a form that is normally not editable. Thus, if FDA itself wanted to reinstate content that had been redacted by the 510(k) sponsor, this would be an obstruction (not that FDA ever intends to question a redaction unless it gets a complaint from the public).

In the preamble to the proposed rule, FDA claimed that industry would benefit in several ways. First, the rule would permit sponsors to consider and address FOIA disclosure issues during and immediately following the development and assembly of the 510(k), a significant economy. It would also, said FDA, allow sponsors to have a larger voice in determining what information would be protected from disclosure. "Indeed," the preamble elaborated, "this approach recognizes that the firm is in a uniquely well-qualified position to identify trade secret and confidential commercial information relating to its own 510(k) submission. Currently, FDA assumes the entire responsibility for designating what information is considered trade secret or other confidential information in a 510(k) when it cannot locate the current owner of the 510(k) or when the owner fails to respond to predisclosure notification within an appropriate time. Because FDA is unlikely to have all the information that would be available to the submitter, FDA may not identify trade secret and confidential commercial information in the 510(k) in the same way as the 510(k) holder would have done."

Finally, FDA said the funds it currently uses in redacting 510(k) documents for release under FOIA could be better spent in other areas, such as medical device approvals. The agency did not say, however, how much money would be released if the proposal is adopted, and its Freedom of Information Office keeps no statistics on the expense of 510(k) redaction.

However, the proposal included an estimate of the burden to be transferred to industry: 7350 hours annually for some 4423 sponsors. Using hourly expenses of $35, FDA estimated the total annual cost of compliance with the proposed rule at about $125,500.

Jane Henney ended her first year as FDA commissioner in January. The occasion has prompted the various FDA watchers to do what they always do when a commissioner reaches that point: to assess her initial performance.

From a strictly medical device standpoint, the consensus seems to be that Henney, on a scale of 1 to 10, gets about an 8. She achieves this by the simple fact of not being David Kessler, her predecessor who "took science up a notch" at the Center for Devices and Radiological Health and strengthened enforcement in ways that embittered much of the industry. Although Henney had previously been a Kessler protégé as his deputy commissioner for operations, she won confirmation by managing to convince Senate leaders that she would do things a lot differently.

At the one-year point in her tenure, she is given high marks for doing just that. Indeed, she is credited with de-Kesslerizing the internal FDA command deck. She is also admired by many for shunning the media spotlight that shone so brightly on Kessler.

In fact, she has done that so well that some frustrated journalists have taken to calling her "the invisible commissioner"—a description that pleases Henney's Capitol Hill mentors, most of them media hogs themselves who detested Kessler's ability to capture headlines. This certainly satisfies many in the medical device industry when they think about their relations with FDA—something they seem to do with decreasing frequency—because FDA commissioners in the headlines usually means something negative for some element of industry.

When was the last time Tom Brokaw or Peter Jennings opened a report with, "Now some warm words for the medical device industry from FDA..."? Thus, the quieter Jane Henney remains, the more people she pleases. And the higher her approval rating becomes.

None of the foregoing is meant to imply that the less of the limelight an FDA commissioner occupies, the kindlier the agency's cops will get. Actually, the reverse may well be the case this year.

Commissioner Henney's new associate commissioner for regulatory affairs, Dennis Baker, is cranking up his field organization's enforcement activity—despite diminished financial resources received from a Congress that wants FDA to spend as much as possible on product reviews, rather than on too many inspections. Baker told this writer that enforcement had suffered in recent years, as his Office of Regulatory Affairs invested its available resources into agency outreach, education, and voluntary compliance.

Baker characterized these recent efforts as worthwhile, but said that it's now time to achieve "more balance" in field activities. Declining to identify any specific companies or even industries he had in mind, Baker said FDA is worried that there has been a "relaxing" attitude in industry toward good manufacturing practices.

Baker implied that the situation is like that of a highway where there is no visible law enforcement. He likes the high yield and low cost of voluntary compliance, but prosecutions get the most attention.

When a manufacturer includes copyrighted materials in labeling that it submits to FDA as part of a product approval application, is the copyright protection still valid? A recent case in the pharmaceutical arena suggests that it may not be.

In SmithKline Beecham v. Watson Pharmaceuticals in the Southern District of New York federal court, a copyright infringement case, FDA took the highly unusual step of intervening to advance the theory that manufacturers necessarily indulge in a grant of "implied license" to copy their patented materials when they include them in an FDA application.

In a January 19 brief and accompanying correspondence, FDA explained that labeling—including a patient information audiotape—for generic nicotine gum made by Watson is required to be the "same" (though not down to every word) as counterpart materials for the reference product, SKB's Nicorette gum. SKB argued that 1984 amendments to the FD&C Act requiring generic drugs to have the same labeling as their innovator reference product ("predicate" in device parlance) should yield where copyrighted materials are involved.

"That fundamental premise is incorrect," FDA told the court in its brief. "If a pioneer drug manufacturer chooses to submit copyrighted material as part of its proposed labeling, that manufacturer cannot later assert that copyright law forms a basis for preventing the operation of the same-labeling requirement in the Waxman-Hatch Amendments."

Although the same law does not cover devices—which in any case are not required to carry the "same" labeling as a predicate device—the New York case suggests that if a second device manufacturer chose to copy labeling materials that were protected by copyright, FDA could take a consistent view and thus weaken the predicate device maker's copyright.

FDA's brief urged the court to adopt an "implied license" concept to SKB's copyrighted materials when they are within a new drug application. FDA did not compel SKB to use copyrighted materials—the company could have elected to seek FDA approval for amended labeling that Watson could be required to imitate without intruding on the copyright.

Denying an SKB claim that FDA's position created a conflict between the copyright laws and the FD&C Act, FDA contended that "A pioneer manufacturer (such as SmithKline) does not lose its copyright protections in FDA-approved labeling, but it must be understood to have impliedly consented to the use of that labeling by a generic competitor, as mandated by the [statute]."

Confused about medical device tracking requirements? FDA has released a new guidance in an attempt to clarify the types of medical devices that are subject to tracking. The new document, Guidance on Medical Device Tracking, advises industry that replacement-heart-valve tracking is limited to mechanical heart valves only and does not include human allograft heart valves.

Device tracking for infusion pumps, as outlined in the previous guidance, caused confusion within industry, FDA acknowledged in the new document. FDA has reevaluated its position on infusion pumps and is now requiring tracking on all electromechanical infusion pumps that are used outside a user facility. The previous guidance included all infusion pumps except those labeled for use with low-risk fluids.

FDA is also adding abdominal aortic aneurysm stent grafts to the devices that must be tracked. The agency issued tracking orders for these devices on September 28, 1999, which took effect immediately. FDA said that tracking for these devices is required because device failure could pose a serious problem.

FDA has identified in a new guidance document the preclinical tests and clinical design considerations that should be incorporated in 510(k) and PMA submissions for pacemaker leads and lead adaptors. The document, Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions, (in PDF) provides more detail and information than the agency's previous pacemaker guidance.

On nonclinical testing, the guidance identifies issues that sponsors need to address in order to qualify a "new" pacemaker lead and lists tests that can be used to support a submission. Although most permanent pacemaker leads are marketed under 510(k)s, FDA is now considering a proposed rule to move these devices into Class III, requiring PMA applications, an agency source advises.

St. Jude Medical (St. Paul, MN) has initiated a worldwide voluntary recall of its heart valve–replacement and –repair products that use the company's Silzone silver-based, antimicrobial coating on the sewing-cuff fabric. The action followed reports of an unacceptable level of explants as a result of a postoperative complication known as paravalvular leak. Company officials made the decision to recall and cease distribution of the products after consultation with FDA. They are not recommending explant of products with the Silzone coating unless routine patient monitoring reveals specific complications.

The Silzone technology was first introduced in 1997, as a potential means of reducing endocarditis following valve procedures. The company estimates there have been 36,000 implants worldwide of St. Jude Medical's heart valve–replacement and –repair products incorporating the coating. The reported complication does not involve the valve mechanism, only the Silzone-coated sewing-cuff fabric.

The problem was discovered during the Artificial Valve Endocarditis Reduction Trial (AVERT), which was designed as the largest, most rigorous prospective clinical trial ever conducted in the prosthetic-heart-valve industry. The independent, multiyear, multicenter randomized study intended to follow 4000 patients to evaluate the effect of Silzone coating on the valve sewing-cuff fabric in reducing infection following valve-replacement surgery. Based on data from 792 patients enrolled as of January 6, an independent data-safety-monitoring board advised the company on January 21 that further enrollment in the study was suspended because of eight explants for paravalvular leak out of 398 patients in the Silzone arm of the study.

In another indication that FDA is stepping up the pressure on device reprocessors, the agency has released a December 23 warning letter to Phoenix-based Alliance Medical Corp. that cited quality system regulation deviations in the firm's device reprocessing.

In the three-page letter, FDA said the firm had failed to establish and implement a quality policy, establish corrective and preventive action procedures, and document cleaning and maintenance of the facility and process equipment, among other violations.

In November 1999, the agency issued a 10-page warning letter to Vanguard Medical Concepts Inc. (Lakeland, FL) that an official said was the beginning of a crackdown. Both warning letters were issued from FDA's Florida district.

James G. Dickinson is a veteran reporter on regulatory affairs in the medical device industry.

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