Nda I

Medical

Pharmacology

Chemistry

Advisory Committee Meeting

Sponsor Revises-

Application Fileable? Yes 4,

Review by CDER

Refuse to FileLetter Issued

Biopharmaceutical

Statistical

Microbiology

Meetings with Sponsor

Reviews Complete & Acceptable?

Additional Info or Revisions

Requested or Submitted _(Amendment)_

Labeling ^xf^^^Ye^^^^InspectionX Review

Acceptable? (1)

NDA Action of Sites Acceptable?

Pending Satisfactory Results

Fig. 7.23. Product Review with Regulatory Authorities r Thoroughly understand NDA/BLA and literature data r Interact frequently with reviewing Division r Prepare for multiple audiences:

c FDA, committee members, competition, & stock analysts r Prepare c Committee briefing package c. Primary and backup slides r Study c Backgrounds of committee members c Past advisory panel hearings c Politics of the open, public forum r Choose best presenters from company and investigators r Practice, practice, practice

Fig. 7.24. Preparing for FDA Advisory Committee Hearings

At the same time the review team at FDA headquarters is reviewing the contents of the submission, FDA inspectors are working in the field. Inspectors will travel to selected clinical sites, manufacturing facilities, and perhaps animal laboratories to ensure that the studies submitted in the submission have been conducted according to FDA compliance requirements and that the manufacturing facility is capable of repeatedly producing a quality product.

Toward the end of the review process, FDA and the sponsor enter into negotiations on the final language of the package insert and the promotional materials that the sponsor wants to use to launch the product. As the package insert is the basis of what the sponsor can, and cannot, advertise and promote, these two activities are closely linked. Once the package insert has been finalized, barring any other issues, the application is ready to be approved by the FDA.

The agency may request that the data in a submission be presented to one of their advisory committees. This is usually done when the product represents an innovative class of drugs, or when the data present the agency with scientific issues that have significant regulatory implications. An advisory committee hearing adds significantly to the workload for both the agency and the sponsor during the product review process. However, it does provide an opportunity for the sponsor to become very familiar with the issues identified by the FDA, which they can hopefully help address.

The FDA has approximately 30 standing advisory committees aligned by product line (i.e., drug, food, biologic, or device) and therapeutic and pharmacologic categories (Fig. 7.24). Committees are composed of predominantly academic and clinical experts (physicians primarily plus nurses, pharmacists, and other technical experts), patient advocates, and industry experts. Credentials of committee members include recognized technical expertise; leaders in their field; independence from the company and product under review (or competitive companies); known reputation for integrity; and known for commitment to public interest. Although FDA may elect to seek guidance from a committee, the advice from the committee is not binding on the agency. Use of the committee process allows FDA to supplement its knowledge with expertise outside the agency and to provide a public forum as an educational tool for all sponsors involved in drug development.

When a sponsor receives even a hint that the data package may be presented to an advisory committee, they should begin preparing for a meeting. This includes preparing a briefing package for the committee and a presentation with primary and back-up slides. Key presenters may come from the sponsor or may be an external expert and should be chosen based on their thorough knowledge of the data in the application as well as the literature and their presentation skills. External medical consultants are often used to provide fresh insights on how the FDA and advisory committee may view the data. As the FDA review proceeds, the issues and questions that the FDA will raise to the committee will become clearer through frequent interactions with the FDA reviewers. The sponsor is well served by anticipating questions from both the FDA and the committee and addressing those in the sponsor presentation.

As mentioned previously, the advisory committee process is a public process. Attendees include FDA representatives, along with competitors, stock analysts, and the general public. The committee may be asked to vote on whether or not a product should be approved and to provide recommendations on additional studies that should be conducted. It is not uncommon to hear recommendations of advisory committees during the evening news or in the next day's paper.

In order to be fully prepared for an advisory committee meeting, it is incumbent on the sponsor to understand the backgrounds and areas of expertise or interest of the committee members. This will help identify in advance what issues they may have so those issues can be addressed in the briefing document and the presentation. Reviewing previous transcripts of the advisory committee hearings can also provide insights into potential issues. If there are political implications with the drug product under review (e.g., early drugs for the treatment of AIDS), it is necessary for the sponsor to understand the political environment that may be created at the meeting as advocates or detractors speak during the public forum section of the meeting. Finally, a well orchestrated advisory committee presentation requires many, many hours of practice by the sponsor to fully understand their data and to represent those data in a polished fashion.

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