Governance and DQA Compliance

The FDA has released   material its October  meeting.

The FDA material references initiation and cessation studies. The overwhelming number of these studies were reviewed in detail by the  CRE DQA petition.

 Should not the CRE DQA petition be reviewed by TPSAC as part of its review of the studies identified by FDA?

Is the TPSAC going  to  submit  a  report  which complies with the DQA or is going to ignore the statute and send a report which the FDA can not use?

What is the role of the non-voting tobacco representatives in the preparation of the report?

Should there be an interim report?  Should there be an extension of the deadline for issuance of the TPSAC report?

These  and other questions regarding committee governance would be addressed if the FDA complies with the peer review guidelines issued  by OMB pursuant to the DQA ; the said guidelines were declared to be “binding”  by the DC Circuit.

 The TPSAC review is a “peer review” as defined in the OMB peer review guidelines.

 OMB peer review guidelines  require that agencies post certain information regarding their peer review agendas and plans on their data[information] quality  website and “establish a mechanism for allowing the public to comment on the adequacy of the peer review plans.”[1]

Agencies are directed to place  peer review agendas and plans on their data  quality websites.  The details of the agency’s peer review plan are supposed to be included along with the agenda.[2]   At present, however, there is no information — either agenda or plan — regarding the menthol peer review on the peer review portion of the FDA data quality website.

FDA must  include the menthol peer review agenda and plan on the peer review section of its information quality website and establish and specify a mechanism for allowing public comment on the adequacy of the plan. Other agencies have followed OMB’s directive; for example  in the peer review section of its DQA website preceding the agenda items, EPA expressly acknowledges this public comment requirement, stating:  “Agencies must allow public comment on the adequacy of their Peer Review Plans.”  However, the EPA website does not specify a mechanism for providing public comments on the plans. EPA should also be encouraged to offer a listserve that will advise interested parties when entries are added or updated.[3]

We also request that FDA ensure in its  charges to TPSAC  for the menthol peer review  to comply with the DQA peer review guidance. The peer review charge is a critical component of the peer review, especially since peer reviewers are guided by the charge and  sometimes confine their review only to those questions or topics specified in the charge.  In addition, the peer review guidance recognizes that it is particularly important that peer reviewers be charged “with reviewing scientific and technical matters, leaving policy determinations for the agency” and that they “shall be informed of applicable access, objectivity, reproducibility and other quality standards under the Federal laws governing information access and quality.”[4] The preamble to the peer review Bulletin provides additional, more specific guidance on charging the peer reviewers in such a manner as to avoid allowing policy to intrude on scientific facts and judgments.[5]

As we recently noted in comments to OIRA on its draft report to Congress on regulations,[6]the peer review guidance is not clear with regard to requiring the posting of the charge as part of the peer review plan for public comment.  Unless the charge is made publicly available as part of the posted plan, the direction to provide a mechanism that will allow the public to comment on the peer review plan is undermined.  The charge is one of the most essential elements of the peer review plan. 

 Posting of a draft peer review charge for public comment is necessary in order to comply with the President’s open government principles and OMB’s December 8, 2009 “Open Government Directive.”[7]  The last section of the Directive (sec. 4(a)) requires a review of OMB policies, such as guidance issued under the PRA, as is the information quality guidance, to determine whether it is necessary to clarify or propose revisions to such policies in order to comply with the openness principles.  We believe that it is clear that posting of a draft charge to peer reviewers for public comment prior to review, especially in the case of peer review of a “highly influential scientific assessment,” is necessary in order to implement the President’s “transparency, participation, and collaboration” principles. 

[2]  70 Fed. Reg. at 2673 1st col. (“[F]or each entry on the agenda, the agency shall describe the peer review plan.”)  The guidance specifies the minimum contents for the peer review plan.  70 Fed. Reg. at 2676 3d col.-2677, 2672.

[3]  70 Fed. Reg. at 2673 1st & 2d cols.

[4] 70 Fed. Reg. at 2675 1st & 2d cols.

[5]  Id. at 2669 1st col.  The guidance preamble states in part:  “Peer reviewers can make an important contribution by distinguishing scientific facts from professional judgments.  Furthermore, where appropriate, reviewers should be asked to provide advice on the reasonableness of judgments made from the scientific evidence.  However, the charge should make clear that the reviewers are not to provide advice on the policy (e.g., the amount of uncertainty that is acceptable or the amount of precaution that should be embedded in an analysis).  Such considerations are the purview of the government.  [Footnote omitted]  The charge should ask that peer reviewers ensure that scientific uncertainties are clearly identified and characterized.  Since not all uncertainties have an equal effect on the conclusions drawn, reviewers should be asked to ensure that the potential implications of the uncertainties for the technical conclusions drawn are clear.”

[6]  Docket No. OMB-2009-0017 in regulations.gov.

[7]   http://www.whitehouse.gov/omb/assets/memoranda_2010/m10-06.pdf.