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Regulatory Focus™ > News Articles > Updated Draft Guidance Describes Process for Dispute Resolutions for Drug Products

Updated Draft Guidance Describes Process for Dispute Resolutions for Drug Products

Posted 12 March 2013 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) has released a new draft guidance that describes the process by which those in the biopharmaceutical industry can initiate and elevate disputes regarding drug and biological products.

The guidance is intended to apply to FDA's Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), the two centers responsible for the review and evaluation of nearly all of the drug and biological products overseen by FDA.

With thousands of employees between CDER and CBER, it's a difficult job for them to ensure consistency across their various review divisions, sometimes leading to disputes focused on consistency or the application of rules. In other cases, sponsors-and particularly ones operating on the cutting edge of scientific advancement-take issue with a reviewer's assessment of the products, again leading to disputes.

"Because these disputes often involve complex scientific or procedural matters and also may be precedent-setting, it is critical that there be procedures in place to encourage open, prompt discussion of such disputes," FDA explained in its draft guidance, Formal Dispute Resolution: Appeals Above the Division Level, issued 12 March 2013.

New Guidance

The newly revised draft guidance is a re-issue of one released in February 2000, and contains what FDA calls updated procedures and policies. The existing guidance was issued to reflect changes made to 21 CFR 10.75 which for the first time explicitly stated that a sponsor, applicant or manufacturer of a drug could request a review of a scientific controversy by one of FDA's scientific advisory committees.

Dispute resolution procedures are beholden to specific time frame as prescribed under iterations of the Prescription Drug User Fee Act (PDUFA) and the Generic Drug User Fee Act(GDUFA) of 2012.

"For disputes involving human drug applications covered by PDUFA, the PDUFA goal is to respond to an appeal of a dispute above the original signatory authority within 30 calendar days of the center's receipt of the written appeal," FDA explained. That includes new drug applications (NDAs) and Biologics Licensing Applications (BLAs). Nearly identical dispute resolution procedures are in place for generic drugs submitted to the agency via an abbreviated new drug application (ANDA).

Sponsors also have the option of involving the ombudsman of either department, which can be used to facilitate resolution proceedings, though these interactions are not bound by PDUFA or GDUFA time limits.

Dispute Proceedings

For most disputes, sponsors should seek to resolve the dispute at the division level by holding a post-action meeting with the division or by asking the division to reconsider its decision, FDA wrote. This interaction should not include any new information. If new information is necessary, it should be submitted and reviewed by FDA before any dispute proceedings are initiated. FDA will not accept dispute resolution requests while new information is pending.

If a post-action meeting is not used, sponsors should submit a written request to either CBER or CDER containing a complete background of the issue indicating why a review is appropriate. For requests going to CDER, this document should be submitted as an amendment to the original application, with a separate copy going to the CDER Formal Dispute Resolution Project Manager (FDRPM). For requests going to CBER, the request should be submitted to the CBER ombudsman.

The background information in the written request should include a prominent notice that the request is a "Formal Dispute Resolution Request," the application number, the name of the product, the division or office the product was filed with, the product's proposed uses, a "brief but comprehensive statement of each issue to be resolved," a list of documents previously submitted to FDA, the history of the dispute and its review, and contact information for the sponsor.

The appeal may also take the form of a Type A meeting (used to help an otherwise stalled product), which a sponsor may request in writing. And sponsors are still allowed to request that a dispute be reviewed by a scientific advisory committee.

"Because it can take a significant amount of time to schedule an advisory committee meeting, if a sponsor believes that review by an advisory committee is the most appropriate venue for resolution of a scientific controversy, such a request should be made as early in the dispute resolution process as feasible," the guidance explains.

FDA Response

The guidance notes that FDA intends to issue written responses to dispute resolution requests, which will address "all components of the appeal" with explanations. FDA may also, as it does for Citizen Petitions, issue an interim response indicating that it needs more time to address the issues contained within or more information from the sponsor.

The responses are, as explained earlier, due within 30 calendar days.

Decisions to hold or not to hold an advisory committee meeting on a product are also due within 30 days. If such a request is granted, the guidance advises FDA to bring it up for discussion at the next available meeting, though it notes that might not always be feasible if something else is already scheduled.

If denied, sponsors are allowed to appeal additional times, each time to the next-highest management level in the FDA chain of command. This may, if necessary, include the Commissioner of FDA.

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