Drug Effectiveness Review Project

Pharmaceutical Companies
Dossier Submission
Public Comment Submission
Center Process for Release of Evidence
Annual Conference for Pharmaceutical Companies
Communication with the Center and EPCs

Pharmaceutical Companies
The Center for Evidence-based Policy (CENTER) and the Evidence-based Practice Centers (EPCs) seek a fair and constructive relationship with the pharmaceutical industry. Multiple methods are available to the pharmaceutical industry to inform the process of the Drug Effectiveness Review Project. The goals of the CENTER in relating to the industry include:

Obtaining the best evidence relevant to the key questions identified by the participating organizations for each drug class chosen.
Obtaining this evidence in a timely fashion.
Giving every pharmaceutical company an equal opportunity to provide evidence to the systematic review process.
Providing to participating organizations, policy makers, the public and pharmaceutical companies full disclosure of the source and content of all evidence considered in the systematic review process.
Providing a standardized, efficient, and open process for pharmaceutical company submission of evidence.

Note: All information submitted to the CENTER will be available to the public at cost upon the release of the related final systematic review report or update.

The CENTER will provide the following opportunities for the pharmaceutical industry to interact with the Project.

The primary process for pharmaceutical companies to submit evidence to the Project will be by dossier submission. Submitting a correctly completed dossier will ensure that the evidence submitted by a company will be fully reviewed. Good quality evidence that is relevant to the key questions will be integrated into the Project reports and updates.

The CENTER will make available, at cost, copies of any evidence submitted in the Project dossier process at the time of release of the relevant report or update. This will enable all interested parties to assess the evidence submitted and its use in the systematic review process. Click here for release of evidence process guidlines.
The EPC will make every effort to ensure that all relevant available evidence is considered in the systematic review process by conducting thorough searches of the appropriate databases, review of dossiers, and any other appropriate sources of evidence. The EPC will not accept evidence submitted by pharmaceutical manufacturers outside the dossier process. The EPC will adhere to the timelines articulated in the initial report and update processes in order to provide an efficient and predictable product to local decision makers. Some changes in timelines are inevitable. Contact us if you have any questions. Click here for more information about timelines.
Questions regarding the Project, any specific report, or update should be addressed to the Center for Evidence-based Policy. Substantive communication regarding any evidence will be scheduled in sessions open to the public. EPC staff will not meet with industry representatives regarding substantive issues outside of these public sessions. Click here for information on Communication to the Center.
The CENTER and the Evidence-based Practice Centers will host an annual conference for industry representatives to discuss the process, answer questions, and receive input on how to improve the dossier process. Click here for annual pharmaceutical company conference information.

Note: Multiple strategies will be used to find relevant information.

Dossier Submission

Note: Any dossier submitted with confidential information will be rejected.

The Dossier submission process will include the following steps:

A description of the Drug Effectiveness Review Project dossier submission process will be provided to all pharmaceutical companies licensed to do business in the United States and Canada. This process is unique to the Drug Effectiveness Review Project. It is not the same as that currently used by the State of Oregon or by the Academy of Managed Care Pharmacy.
The CENTER will notify pharmaceutical companies manufacturing or promoting drugs in a class of the initiation of an evidence-based report or an update by certified mail. Notice will be sent to the company CEO and/or company representative designated to receive notice. Key questions in the initial systematic review or update will be provided with the notice.
Companies will have 4-6 weeks from the date notification is mailed to submit a dossier for an initial systematic review.

To be considered, dossiers must be sent to the Center for Evidence-Based Policy, Oregon Health & Science University, 2611 SW 3rd Ave, MQ280, Portland, Oregon 97201-4950.

Notice of this process will also be provided at this web site by clicking here.
Only evidence relevant to the key questions will be considered.
To ensure that their evidence is considered, companies must submit evidence in the format provided by the CENTER including:
- The dossier must be submitted in an electronic format---email, CD etc. Studies referred to in the dossier can be submitted in paper formats. The CENTER will not make copies of copyrighted documents for public distribution without permission of the authors.
- Indicate whether the company asserts their product is superior, equivalent or has unknown performance compared to other products in the class for the issues identified by the key questions contained in the initial systematic review or the update.
- Providing the current label for their product.
- Summarizing the submitted evidence in a table that includes study name/number, indication, population, and duration of exposure, endpoints, location, key results, publication and other information identified in the dossier submission summary. The evidence table should include all studies known to the submitter relevant to the key questions.
- Submitting copies of the full text of any studies including unpublished studies referred to in their dossier. An electronic copy of the bibliography for the dossier is also required. Illegible submissions will be rejected.
Click here for the dossier submission protocol PDF.

Public Comment Submission
Timelines for all the classes currently selected are now available. Timelines list the dates for Key Question posting, dossier submission, draft report posting and estimated final report completion date. Times are approximate. We anticipate changes will occur given the unique features of each drug class.

The dossier submission and the comment submission processes are designed with specific purposes in mind. We encourage submission of any relevant evidence or analysis during the dossier submission process (recall dossiers are available to the public). Electronic submission is now required. The comment process for draft reports is meant to provide an opportunity to comment on the report itself. It is not meant to be a second opportunity to submit a dossier. If dossiers are submitted during the comment process we will submit those dossiers at the next update.

We would like comments to be thoughtful and concise. Commenters must submit a comment within the web site comment process for any information submitted to be considered. You may refer to tables, graphs and publications in your comments. You may submit tables, graphs and publications directly to the Center in electronic formats or on paper in the case of publications. The documents that you send to the CENTER, either electronically or by mail, must be referred to in the comments you submit online. Your web site comments provide context for any separate submissions and allows the EPCs and Participating Organizations to better organize their review of your comments. If the EPC desires more detail we will contact the commenter. Please submit only new information in the comment process. Submitting information we already have, such as the product label, only wastes the time of all involved. Please review the comments protocol on the draft documents page for detailed information.

When your comments are submitted online, they auto-download into an SQL database and are then retrieved by the CENTER staff as an Excel file. Those comments are merged into a readable and organized Word file and then forwarded onto the reviewers in a timely manner via email by the CENTER staff. We will attach to that email the additional electronic copies of tables, publications, and graphs that you will have supplied to our office staff via email. If you are not able to attach electronic copies of the items you refer to in your comments, we either scan them into an electronic document or overnight express them to the reviewers, who are located around the country. Although we would like to discourage the use of paper documents whenever possible - they can delay the reviewing process because of the time spent in transporting them - we realize that it is sometimes necessary.

Regardless of the mode of submission, your comments and any relevant documents must be received by the due date to be included in the packet sent to the EPCs and participating organizations.

There are many commenters who have used the online comment form successfully and with satisfaction. A few submitters have struggled to successfully submit. Instructions regarding the submission process are now available: Instructions for Using the Online Public Comment Form. The process is straightforward and should work for anyone minimally comfortable with computing.

Contact Alison Little (littleal@ohsu.edu) or Maria Galindo Montoya (galindom@ohsu.edu) with questions or concerns.

Center Process for Release of Evidence
All materials submitted to the CENTER will be available to the public upon the release of a final systematic report or update. All evidence included in the report or update will be listed in the report. The CENTER will:

Maintain a file of all accepted dossiers.
Maintain a master copy of all dossiers.
Make copies of dossiers available at cost and upon request at the time of release of the related draft final initial report or draft final update.
Notify the requesting party of the cost of the request within three business days of the request. Cost will include a flat charge, a per-page copying fee and a shipping charge.
Ship dossier to the requesting party within three business days of receipt of payment.

Note: The CENTER will release only the full set of dossiers submitted for a drug class. Individual dossiers will not be copied and released.

Annual Conference for Pharmaceutical Companies
The CENTER and EPCs will organize a conference on an annual basis for pharmaceutical companies and other interested parties. The conference goals will be to describe the current processes related to the Project, answer questions regarding these processes and provide a venue for industry participants to suggest improvements.

The conference will be held at a time and place designated by the CENTER and EPCs. The CENTER will notify pharmaceutical companies licensed to do business in the US and Canada prior to the conference of the time, place, cost and registration process. The Conference will be open to the public. The cost of the conference will be covered solely by registration fees. Any significant balance remaining in the conference account will be returned to participants on a pro rata basis. The CENTER and EPCs reserve the right to cancel the conference if there is not sufficient registration to cover the cost of the conference. Participating organizations will be invited to attend the conference at their expense.

The proposed and actual budget for the conference will be available to the public. The list of attendees at the conference will be available to participants and to the public upon request.

Communication with the Center and EPCs
Pharmaceutical companies desiring to communicate with the CENTER and EPCs regarding the Project should contact the CENTER first. The CENTER will determine the nature of the inquiry and the appropriate next steps. If the contact involves the submission of evidence, the CENTER will provide the information required to integrate that submission into the dossier process. Any communication with the EPCs regarding evidence will be made public. EPC staff will direct pharmaceutical inquiries to the Center.

Alison Little, MD, MPH will be responsible for responding to inquiries from pharmaceutical companies scientific staff. She is available at 503-494-7239, email at littleal@ohsu.edu, FAX at 503-494-3807 and regular mail at Alison Little, MD MPH , Center for Evidence-based Policy, MQ280, 2611 SW 3rd Avenue, Portland, Oregon 97201-4950.

Requests for release of documents to the public evidence should be directed to Maria Galindo Montoya at galindom@ohsu.edu.

Note: Those wishing to have input into the Project cannot be assured their information will be included unless it is submitted according to the processes and guidelines outlined above.