Life Science Compliance Update

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July 28, 2011

Institute of Medicine FDA 510K Advisory Committee Fails to Meet US Fair Balanced Standards

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On Friday of this week, the Institute of Medicine will release their recommendations on the FDA 510K process. The IOM recommendations may determine the fate of all future medical device approvals.  Unfortunately the panel has no industry or inventor representation which may constitute a violation of federal laws on fair balance in advisory committees to the federal government.

 Recently, the Washington Legal Foundation (WLF) urged the Food and Drug Administration (FDA) not to use any advice or recommendations provided by the Institute of Medicine committee (the“IOM Committee”) assembled for the purpose of assessing whether changes are need in the 510(k) approval process, the process by which most medical devices reach the market.

In a Citizen Petition filed with FDA, WLF argued that FDA’s use of advice or recommendations from the IOM Committee would violate § 15 of the Federal Advisory

Committee Act (FACA). Section 15(a) provides that an agency may not use any advice or recommendation developed by the committee unless the committee has complied with all the requirements of § 15 – including § 15(b)(1)’s requirement that the committee membership be “fairly balanced.”

WLF charged that the IOM Committee is not fairly balanced, and thus, Section 15(a) of FACA prohibits FDA from “us[ing] any advice or recommendation provided by” any IOM committee that is not “fairly balanced.”

WLF’s Citizen Petition argued that § 15 of FACA does not permit FDA simply to rely on assurances from the IOM that the Committee is fairly balanced, but rather it must determine for itself that the Committee is indeed fairly balanced before it can consider any recommendation from such a committee.

WLF asserted that it is particularly important for FDA to ensure that the Committee meets the fair balance requirement, even if the result is to require the appointment of individuals with conflicts of interest.

“Using advice from a committee that lacks fair balance encroaches upon Congress’ mandate that each Advisory Committee should be representative of a broad range of viewpoints and should include affected individuals,” said WLF Chief Counsel Richard Samp after filing WLF’s Citizen Petition.

“The IOM Committee is not ‘fairly balanced’ under any plausible definition of that term; numerous persons and groups directly affected by the Committee’s work are totally unrepresented on the Committee’s membership,” Samp said.

Background

Courts examining FACA have concluded that the “‘fairly balanced’ requirement was designed to ensure that persons or groups directly affected by the work of a particular advisory committee would have some representation on the committee.

Congress provided a fair degree of guidance regarding what a “fairly balanced” committee entailed and what it hoped to accomplish by requiring fair balance. It stated, for example, that:

  •  Advisory committees should avoid “the charge of favoritism” by ensuring that “a particular region, university, industry, company, or discipline” are not “overrepresented”;
  • Rather than relying on “personal acquaintances,” agency “clientele,” or individuals who are “close” to the agency, an agency should broaden advisory committee membership to include “[i]ndividuals with ideas, knowledgeable people, and affected individuals” (emphasis added);
  • Committee members should “be representative of a broader range of interests . . . than has been the case”; and
  • Agencies should avoid the pre-FACA state of affairs, under which many agencies were “receiving their advice from sources which have special or limiting viewpoints.”

Congress was particularly concerned with the requirement that a broad range of viewpoints be included on advisory committees, even (and especially) unpopular viewpoints. Such diversity of viewpoints is especially important when (as here) the issues being considered by a committee are policy-oriented.

Where the functions to be performed are not “narrow and explicit,” but instead involve “diverse and far-reaching issues that affect others,” broader representation on the committee is required. This is especially true of committees whose purpose is “to study the effects of a particular type of regulation . . . on the public, which is exactly what FDA asked IOM to do regarding the 510(k) program does.

According to their press release, WLF filed its brief with the pro bono assistance of Robert Klepinski, an attorney from Minneapolis, Minnesota.

FDA and IOM Committee for 510(k)

In 2009, FDA commissioned the IOM to conduct a detailed analysis of the § 510(k) system. FDA referred several issues to the IOM Committee, including these principal questions: (1) whether the current § 510(k) process optimally protects patients; and (2) whether it promotes innovation in support of public health.  FDA asked the IOM Committee:

  •  To consider defining the scope and grounds for the exercise of the Center’s authority to fully or partially rescind a 510(k) clearance.
  • To seek greater authority to require post market surveillance studies as a condition of clearance of certain devices.
  • To develop guidance defining “Class IIb” devices for which clinical information, manufacturing information or, potentially, additional evaluation in the postmarket setting would typically be necessary to support a substantial equivalence determination.
  • To clarify when a device should no longer be available for use as a predicate.
  • To consolidate the concepts of “indication for use” and “intended use” into a single term, “intended use.”
  • To consider the possibility of requiring each 510(k) submitter to keep at least one unit of device under review available for CDRH to access upon request.
  • To explore the possibility of pursuing a statutory amendment that would provide the agency with the express authority to consider an off-label use when determining the “intended use” of a device.

FDA has made clear that it intends to act upon any advice and recommendations it receives from the IOM Committee. It should be noted that after these seven additional questions were posed to the Committee, FDA has sought no further input from the medical device industry or patient groups regarding the questions posed. Nor have any of the IOM Committee meetings conducted during this time period been open to the public.

WLF Citizens Petition to FDA

The IOM Committee is composed of twelve members. The composition of the committee is as follows: five doctors, three lawyers, and several academics with a variety of technical backgrounds. Although each member has impressive qualifications, the committee lacks individuals with experience in areas of critical importance to the Committee’s work.

For example, not present on the committee are innovators, inventors or any product developers who are familiar with the clearance process. In particular, the IOM

Committee’s membership includes no one with any experience in seeking to use the 510(k) process to obtain FDA marketing approval for a new medical device.  There are no individuals who routinely prepare § 510(k) applications, or any professionals from the medical device industry.

Even more striking is the fact that committee does not include any representatives of patients and patient advocacy groups that have benefitted from the development of innovative medical devices. Nor does it include any representatives of patients, who have a strong interest in ensuring that the 510(k) program continues to permit the speedy approval of new, life-saving medical products.

Additionally, there are no entrepreneurs, venture capitalists, investment bankers, or angel investors with experience financing medical device innovations, even though one current controversy surrounding the § 510(k) program is its effect on investment in new companies, and even though the second of FDA’s initial two questions to IOM related to the program’s effect on innovation.

In addition to the absence of members with the expertise/backgrounds enumerated above, the IOM Committee does not appear to include members from a wide variety of policy perspectives. The § 510(k) program has been criticized from all sides of the ideological spectrum. Some view the program as too lax from a safety perspective; they charge that the program has allowed medical devices to be marketed with insufficient attention being paid to whether the product is safe for its intended use. Others view the program as overly bureaucratic and one that unnecessarily delays the marketing of innovative products.

The former perspective is well-represented on the Committee. Indeed, one member has worked for 20 years at Public Citizen Litigation Group, a public interest law firm that has been highly critical of the § 510(k) process and has asserted that dangerous medical devices have been allowed to enter the market because devices are approved too quickly.

But no member of the Committee is publicly identified with the latter perspective. The inclusion of a Public Citizen lawyer makes all the more inexplicable the IOM’s failure to include an industry representative or anyone else with practical experience in navigating the § 510(k) program.

The IOM does not contest that such an absence exists. Rather, the IOM evidently takes the position that inclusion of individuals with meaningful experience in the development of innovative medical devices and/or navigating the § 510(k) process would risk violating FACA’s conflict-of-interest requirements.

FACA Conflict-of-Interest Rules

Numerous interested parties have contacted the IOM to express their dismay over the unbalanced nature of the IOM Committee and to urge the IOM to broaden the Committee’s composition. For example, in a February 17, 2010 letter to the IOM, the Medical Device Manufacturers Association (MDMA) stated that “the current makeup of the committee does not adequately reflect all relevant stakeholders in the process” and urged the IOM to “take the necessary steps to ensure the committee’s review of the 510(k) process is fair, balanced and inclusive by including representatives of key stakeholder groups to participate as members of the committee.” Despite such entreaties, the IOM took no steps to balance the IOM Committee’s membership by adding members with backgrounds not represented on the Committee.

WLF argued that the conflict-of-interest rules do not prevent the appointment of committee members with ties to firms doing business in the field, particularly if individuals are from a background that otherwise would go unrepresented on the Committee.

 Moreover, WLF recognized that nothing in FACA authorizes the National Academy of the Sciences (NAS) to ignore the “fairly balanced” requirement in order to avoid conflicts of interest among committee members. Indeed, FACA § 15(b)(1) indicates that in the event of a direct conflict between these two provisions, it is the conflict-of-interest provision that is to give way.

 The Academy’s own internal policies regarding committee selection recognize the need to include individuals with diverse points of view. Those policies explicitly permit committees to include members who are biased or have expressed a strong opinion on a particular issue of interest. According to the Academy guidelines governing the committee appointment process, “[a] point of view or bias is not necessarily a conflict of interest. The IOM recognizes that member bias is not only permissible, it is sometimes necessary.

 According to the NAS Policy on Committee Composition and Balance, “[f]or some studies . . . it may be important to have an ‘industrial’ perspective” if such a perspective is “vital to achieving an informed, comprehensive, and authoritative understanding and analysis of the specific problems and potential solutions to be considered by the committee.” However, the IOM must balance these perspectives to produce an overall objective committee and avoid bias or the perception of bias. If these individuals have conflicts of interest, they may nevertheless be included on the committee to provide needed expertise, knowledge, balance, or perspective. In such cases, the conflict of interest is “unavoidable” and simply must be disclosed.

Consequently, WLF pointed out that “conflict-of-interest rules have not prevented numerous other committees established by the IOM at the behest of FDA from including industry representatives and others from far more diverse backgrounds than IOM Committee members.” In fact, out of ten current or recent FDA sponsored IOM activities, at least half contain members with industry background and at least three committees contain members with disclosed conflicts of interest.

Clearly, individuals with industry background or connections are frequently deemed valuable and necessary for IOM committees to fulfill their functions, despite obvious conflicts of interest. Thus, it is not unusual that individuals with “unavoidable” conflicts of interest are included on IOM committees.

Conclusion

Ultimately, the IOM has explicitly recognized – both in its own internal policies and in its past committee appointment practices – that conflict-of-interest rules do not prevent the appointment of committee members with ties to firms doing business in the field, where such individuals’ backgrounds will provide the committee with expertise in areas that would otherwise be absent. In light of that recognition, the IOM cannot plausibly maintain that conflict-of-interest rules justified its failure to appoint a “fairly balanced” committee in this instance.

Accordingly, WLF first requested that FDA either proceed with its comprehensive review of the § 510(k) program without obtaining any input from IOM, or else request that IOM reconstitute its committee so as to come into compliance with the “fair balance” requirement.

Second, WLF suggested to FDA that it issue guidelines that would help other advisory committees comply with the requirement of “fair balance” and avoid a similar situation where FDA would not be able to use an advisory committee’s report because the committee failed to comply with § 15 of FACA. Finally, WLF requested that FDA issue a guidance document explaining FDA’s obligations under FACA, and what advisory committees must do in order to permit FDA to make use of any advice or recommendations provided to the agency.

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