Working With FDA to Develop Policy

Working With FDA to Develop Policy By Bradley Merrill Thompson Epstein Becker & Green P.C. December 6, 2007

Agenda • Stakeholder Objectives • Overview of the Administrative Laws • So What’s Possible? • Some Case Studies

Industry’s Objectives in Policy Making • The right policy prevails—in our eyes • Earliest possible discussion • Informality can be good • A two way street is helpful • An enduring discussion • The right evidence is used • Privacy might be necessary • Rebuttal opportunities • A few bites at the apple is nice • Speed can be good or bad

The Agency’s Objectives • The right policy prevails—in their eyes • Justice • Low personal risk • Using a process that can be defended • Legally • Politically • Efficiency • Informality can be good • Access to the right information • Speed is usually good • Instills confidence • Sets the stage for compliance and enforcement

Objectives behind Administrative Laws-- Rulemaking • Ensure rules are: • Thoughtful • Well-supported by a factual record • Unbiased by special interests • The process is fair for all concerned • Enhanced compliance because those concerned had the opportunity to provide input

Objectives behind Administrative Laws--FACA • Counter the undue influence of special interests by ensuring that the membership of federal advisory committees is balanced • Ensure the committee meetings and minutes are open to the public • There were “too many inactive, meaningless, obsolete and redundant committees” • At the same time, other “committees were so powerful … they, in effect, constituted a fifth arm of government”

Objectives behind Administrative Laws--GGPs • No announcement of policy through speeches and enforcement letters • No policy development without public input • No confusion regarding official policy—sign off • Need for systematic process for keeping guidance up to date • Need for central repository • Clarity regarding the legal effect of guidance

Tensions in Objectives • Speed vs. Openness • Universal fairness vs. informality • Early collaboration vs. universal fairness • Creativity vs. procedural fairness • Privacy vs. fairness • Efficiency vs. fairness

Government in the Sunshine Laws • Federal Rulemaking (APA) • Federal Advisory Committee Act • 21 C.F.R. Part 10 – FDA Administrative Practices • Good Guidance Practices • OMB Regulations and Guidelines

Choice Between Rulemaking and Guidance Development

Federal Rulemaking Types of rulemaking • Formal—trial type • Informal—notice and comment

Notice and Comment Rulemaking Process • Notice of proposed rulemaking in FR (optional) • Proposed rule with explanation published in FR • Comment period (discretionary) • Agency analysis • Final rule published in FR, together with statement of basis and purpose • Judicial review available

Guidance Development • Similar dichotomy to rulemaking • Level 1 is reserved for guidance that: • Plows new ground • Addresses controversial topics • Makes significant policy changes or • Tackles complex science. • Level 2 is used for all other guidance

Guidance Development Process • Similar to rulemaking, but uses FDA’s website instead of FR • Only employs the FR to announce level 1 guidance • Level 1 guidance requires an opportunity for public comment before implementation • Level 2 does not • Meant to be less formal than rulemaking, and to allow early collaboration

Federal Advisory Committee Act FACA requires that advisory committees: • Establish a written charter that explains the mission of the committee • Give timely notice of meetings in the FR • Have fair and balanced membership • Open meetings to the public whenever possible • Have the sponsoring agency prepare minutes of meetings • Provide public access to the information used by the committee • Grant to the federal government the authority to convene and adjourn meetings • Terminate within two years unless the committee charter is renewed or otherwise authorized by statute

No Q.1 -- Does the collection of individuals include non-government personnel? Yes No Q.2 -- Do the individuals have a cohesive group structure or rapport? Yes No No Q.3 -- Is that group structure or rapport a result of FDA effort? Q.4B -- Is group subject to strict FDA management or control? Yes Yes Q.5 -- Does the controlled group render specific advice or recommendations to FDA? No Q.4A -- Does group render specific advice or recommendations to FDA? No Yes Yes FACA does not apply. FACA applies. FACA Applicability

Some Popular Misconceptions Debunked • Informal rulemaking does not preclude contact between the agency and the public • Even clearer before the proposed rule is published • But it is wise to keep records • Also, FDA cannot give advanced notice of what is in a proposed rule (fairness issue) • Guidance develop rules contain absolutely no restrictions on meetings with the public • The FR notices announcing the GGPs explained the goal of facilitating early communication

Wide Range of Options for Meetings • Public meetings, including FDA workshops, conferences etc. (§ 10.65(b)) • Private meetings with specific industry groups on FDA’s premises where summaries are filed with the comments (§10.65(d)) • Industry hosted meetings that FDA attends, like a trade association’s annual meeting (§ 10.65(e) ) • Standards activities organized by appropriate standards development organizations such as AAMI (§ 10.95) • Capitol Hill-convened meetings • Meetings convened by a neutral third party (e.g., FDLI) • Written communication, either e-mail or other correspondence (§10.65(f)) • Discussion as part of an advisory committee meeting

Technologies Available • Telephone conference calls • Video desktop conferencing • Electronic chat rooms • Internet broadcasts of various types

FACA Case Study One Suppose FDA decided to hold a town meeting to provide a one-time forum for any interested party to voice its opinions and concerns to the agency on the appropriate design of a clinical trial to support a PMA. • The time and place of the meeting were determined in advance • The costs of the meeting -- the rental price of the meeting place, for example -- were paid by the agency • FDA publicized its meeting in advance on its website, inviting any parties interested in participating to attend

FACA Case Study One Analysis Quite clearly, this conduct would not trigger FACA. • The agency obviously did not utilize an existing group for advice or recommendations. • Nor did FDA in the scenario establish the group. • The town meeting took place only once, involved a group of participants not designated by the agency -- indeed not identifiable before the event -- and otherwise exhibited no organizational structure. • Simply by holding the meeting the agency did not solicit the collective views, as opposed to the individual views, of those who attended.

FACA Case Study Two Imagine FDA sought to gather the individual views of several recognized experts on the proper design of clinical trials. • FDA decided to hold one long meeting on a single day and have all these experts meet with the agency personnel at once. • At this one-time meeting, FDA personnel questioned the experts, one at a time. • Each expert, in turn, explained to the agency her position regarding the clinical trial question. • FDA personnel kept careful notes of each expert’s view. • No time was reserved for a general discussion session among the experts.

FACA Case Study Two Analysis Does not trigger FACA. • The mere fact that the agency assembled the experts at once does not affect FACA's applicability where, as explained, the experts in no way interact or otherwise function as a unit or a group.

FACA Case Study Three Imagine FDA sought a recommendation from AdvaMed about whether the agency should promulgate a new rule concerning the proper design of clinical trials for PMAs. • To get AdvaMed's advice, the agency convened a series of meetings attended by the agency's own personnel as well as AdvaMed staff • No other medical device group or consumer group was invited to the meetings • Nor were individual company representatives invited. • FDA and AdvaMed staff also happened to discuss the merits of the agency’s policy on some closely-related issues involving PMAs

FACA Case Study Three Analysis FACA would not apply. • Although FDA solicited specific advice respecting a particular policy issue, the advice came from an independent, pre-existing group, not established by the agency. • The important question would be whether FDA so tightly controlled AdvaMed that it utilized AdvaMed for the purpose of obtaining advice. • But the agency exercised no control over AdvaMed, much less tight control. • FDA invited AdvaMed to the meetings, but in no way did the agency shape AdvaMed's composition, management, perspective, deliberations, or agenda.

FACA Case Study Four As in the first case study involving the town meeting, suppose now that the agency's meeting was so successful that FDA decides to institutionalize the event, and conduct it every few months. • Over time, the number of attendees stabilizes to a group of 15 loyal regulars, who develop a sense of group rapport. • FDA decides to use the group, repeatedly, as a sounding board for specific proposals the agency is considering. • Before each meeting FDA sends out an agenda. • At each meeting, those who attend are given a chance to address FDA about their own concerns, but time is always reserved for the agency to tap the views of those in attendance on the agency’s issues. • The group lacks formal organizational structure; it has no chair, no secretary, and no minutes are kept at the meetings.

FACA Case Study Four Analysis FACA may apply. • Although the group has no formal structure, its membership is stable. • The subject of discussion is prepared in advance of the meetings, and addresses topics which FDA itself identifies. • Those topics include specific proposals under consideration at the agency.

FACA Case Study Five Consider again the second case study involving a meeting of experts. Suppose that instead of seeking experts’ individual views, FDA sought the collective view. • The agency still scheduled only one meeting, for the limited purpose of giving experts an opportunity to present their collective view. • The meeting did not provide the experts with an opportunity to discuss the regulatory issue in question. • Instead FDA instructed the experts to meet on their own time, without agency involvement. • At the FDA meeting, the experts presented the agency with a sharply divided report containing the experts’ majority and minority views on the issue under the agency's consideration.

FACA Case Study Five Analysis FACA may apply. • Although no FDA personnel participated in the experts’ prior meetings, and although those meetings produced no consensus view, still the agency established a group composed of non-employees with the specific intent of obtaining advice on a particular question. • The group of experts, who had no organization prior to their enlistment by FDA, met, deliberated and subsequently communicated their collective although divided advice to the agency, all of the agency’s instigation.

FACA Case Study Six Return to the example of where FDA invited AdvaMed. Now suppose that the agency, seeking the advice of the drug and medical device communities generally, created an entirely new group composed of representatives from leading trade associations. • FDA scheduled a series of meetings for the new group's members to discuss whether the agency should promulgate a new rule to prescribe the proper design of a clinical trial, with the intention of relying on the group's advice. • FDA designated the representative of one of the trade groups to serve as the group’s Secretary, and another to be its spokesman.

FACA Case Study Six Analysis FACA would apply. • FDA's conduct now satisfies every item on the checklist of criteria for triggering the act. • The agency: • established the group • appointed all of its members • gave it an organizational structure, and • directed it to consider a substantive policy issue and to advise the agency about whether to respond to that issue. • Although FDA could have solicited advice from individual group members speaking on behalf of their respective trade associations without “utilizing” those groups, the agency instead decided to establish a group.

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Working With FDA to Develop Policy