Legal Reviews. Throughout the FDA review process at both the district and headquarters level, the particulars of the case are reviewed from
a legal perspective to make sure evidence is available to support the charges. However, the formal review by FDA lawyers does
not occur until a case is forwarded to the OGC. In most instances, OGC review is the last step in the review process. In the
case of warning letters, OGC approves or rejects recommendations from the local districts or centers. For civil and criminal
sanctions, OGC lawyers forward approved recommendations to the DOJ.
At the OGC stage of the review the company should use company lawyers or outside counsel to communicate with OGC lawyers.
While other senior management may participate in the discussions with OGC, company lawyers will need to address the legal
matters with the OGC lawyers. The discussions should focus on determining FDA's legal course, presenting additional information
or data to negate some or all of the charges, or voluntarily committing to corrective actions that obviate the need for litigation.
Companies may invoke attorney-client privilege to protect information related to disputed issues from disclosure to the FDA
(or during civil litigation, such as lawsuits by shareholders or patients). If so, the company must decide how to use any
information reported under privilege during FDA's dispute resolution process. Companies must decide whether or not to waive
attorney-client privilege if the agency requests protected information. They must consider the benefits to be gained from
voluntary disclosures against the risk of an unfavorable ruling by FDA.
Control The Environment During FDA MeetingsIt is not uncommon for some senior management to have difficulty understanding what is important to FDA, and others may feel
uncomfortable dealing with the agency (especially when they do not fully understand its processes). Regardless of the reason
for an FDA meeting, careful planning is needed to ensure that the appropriate FDA staff attend and that key topics are discussed.
Planning includes establishing strategy and specific objectives, as well as ground rules for meeting. Management should verify
that every attendee knows ahead of time what he or she is expected to contribute to the meeting. Those who are making formal
presentations should have their materials completed well in advance, and practice sessions can confirm that the materials
are appropriate and the proper message is delivered. Simulated question and answer sessions may also be helpful.
Requests for FDA meetings should clearly state the reason for the meeting, outlining specific objectives and listing the names
and titles of company representatives (including consultants). If the company desires certain FDA officials to be present,
the request should include this information. The company should avoid the temptation to introduce issues not identified in
the meeting request. For meetings requested by a company, FDA usually allows the company to set the agenda. The company should
allocate enough time to address each of the meeting’s objectives. The agenda should clearly identify the issues to be addressed,
as well as pertinent background information. It is important to confirm that the company's understanding of the issue is correct.
Once the issue is agreed upon, the company should present its rationale and the support for its position.
During the formal presentations and the subsequent discussions, management should judge the effectiveness of the discussions
and listen for signals or messages that are being delivered by FDA. Frequently FDA officials will not come right out and say
they disagree with the materials presented; silence or no comment should not be interpreted as agreement. Companies may leave
meetings believing they were successful because FDA did not object, while FDA officials may leave the same meeting with the
impression that management "does not get it." Therefore, before the meeting is completed, management should elicit from FDA
a response to the issue.
Rather than soliciting open-ended questions and comments, it is usually advisable to restate the company's conclusion and
then ask FDA attendees if they agree. This should keep FDA responses directed at the specific issues of concern to the company.
It also is prudent to ask FDA attendees if they have any other concerns that have not been communicated to the company.
Finally, at any FDA meeting to discuss disputed issues, it is vital that company representatives remain controlled and professional
at all times. Showing frustration or open hostility will never help the company's position, and may damage its credibility.
If the company still disagrees with FDA's position (after the presentation and discussions), the company should end the meeting
by restating its conclusions in a deliberate manner with the supporting rationale. Meetings do not always conclude with a
resolution of the disputed issue, but no meeting should finish until everyone agrees that they have a common understanding
about what remains unresolved. If possible, both parties should agree upon the next steps to reach a resolution.
Establish Credibility with FDANo dispute can be successfully resolved unless the company establishes credibility with FDA officials. Building credibility
takes considerable effort and will not happen overnight. The company must communicate early, often, and effectively. FDA expects
companies to respond to the issue and to understand FDA's position. Empathizing with FDA's position does not mean agreeing
with FDA's position, but understanding why FDA is concerned. Credibility means being accountable for the actions of the company
and not making excuses. One common mistake made by management is offending FDA reviewers by making excuses such as saying
the issue was the fault of someone else or "that’s never happened before."
Credibility also means demonstrating integrity by always providing FDA with information that is truthful, accurate, and complete.
FDA expects all communications to exhibit these qualities. Credibility means making commitments to achieve timely corrective
actions, showing reasonable progress against a planned schedule, and notifying FDA in advance when schedules cannot be met.
Credibility means learning from the experiences of the company and others in industry by not having recurring issues that
could have been prevented. Credibility also means boasting loudly and proudly about correcting issues and implementing global
improvements. Credibility means having the confidence to disagree with FDA when the company believes it has a valid position
and is capable of presenting its rationale and support in a professional manner. Finally, credibility is established when
the actions and decisions of the company clearly show a commitment to complying with cGMPs and FDA sees positive progress.
ConclusionThere are now new and improved opportunities for dealing with FDA-483 obserations and other disuputes that arise from FDA
inspections. However, until the agency receives comments and finalizes the draft guidance published in August 2003, companies
will still need to deal with disputes according to established FDA procedures and practices.
Successful dispute resolution begins by following the applicable regulations, policies, procedures, and guidance documents
that define the agency's process for handling disagreements about scientific and technical issues. Companies that do not understand
and follow the prescribed process for disputes can not expect to have a favorable outcome. Companies, even if they follow
the process, will not have a positive outcome if they do not provide the agency with the appropriate information at the right
Successful dispute resolution begins with reaching a common understanding of the issue and understanding what information
is needed by officials at each level of review. Companies must decide the optimum timing of FDA meetings and who will represent
the company. Knowledgeable management must be aware of the issues and explain and defend the company’s position in a credible
manner. Finally, successful dispute resolution depends on establishing credibility with FDA by being accountable for company
actions and demonstrating a commitment to comply with the law and regulations. Credibility is established by making global
corrective actions in a timely and reasonable manner and also by giving FDA confidence that the company will perform the right
actions at the right time for the right reasons.
References1. FDA. Formal dispute resolution: scientific and technical issues related to pharmaceutical cGMP, draft guidance for industry
[draft]. 2003 August. Available from URL: www.fda.gov/cder/guidance/5804dft.htm.