Drugs

FDA Grants, Denies Kaiser 2009 REMS Petition

David McFarland

— 2 min read
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FDA has responded to a Kaiser Permanente petition submitted more than 14 years ago (12/2009) asking the agency to revise its standards, procedures, and guidelines for developing, implementing, and evaluating risk evaluation and mitigation strategies (REMS). The FDA response says Kaiser specifically asked the agency to:

  • increase the transparency and opportunity for comment by healthcare providers and other members of the public in the development process for REMS that include elements to assure safe use (ETASU);
  • make summary data collected by REMS programs and findings from assessments of REMS programs publicly available so healthcare providers and patients have an opportunity to review the information objectively and use it in making healthcare decisions;
  • regularly evaluate the ETASU required as part of a REMS program to assess their effectiveness and include healthcare providers in the evaluation process;
  • ensure that drug companies do not use requirements in REMS programs to give preferential treatment to certain healthcare providers; and
  • guard the confidentiality of protected health information (PHI) by ensuring (a) that collection of PHI is required only when essential to an effective REMS; (b) that PHI and provider information disclosed for a REMS shall only be used to satisfy the REMS requirements; (c) that no patients or providers are requested to authorize disclosure of PHI for any purpose beyond the immediate requirements of the REMS; and (d) that the identity of all entities to whom PHI and provider information has been disclosed and the reasons for each disclosure are known.

FDA says that many of Kaiser’s requests in the petition have been implemented in the years since it was filed. It granted the request for transparency and the inclusion of public input into REMS to the extent that the agency has convened and continues to convene advisory committees to obtain expert and public input into the development of REMS programs when appropriate. It denies the request for public input on every potential REMS with ETASU before they are approved.

FDA denies the request to make summary REMS assessment data publicly available but says it will continue to post all approved REMS on the agency Web site to ensure transparency about applicable requirements.

The request that FDA regularly evaluate ETASU to assess REMS program effectiveness is granted. The request to ensure that REMS do not prevent specific entities from participating in REMS is granted to the extent that FDA will continue to impose in REMS only those requirements that are necessary to assure safe use and does not limit the specific entities that can participate in the REMS beyond their ability to fulfill those requirements.

To the extent that the petition seeks FDA involvement in the business contracts between applicants and wholesalers, distributors, and pharmacies, the response says, that request is denied. To the extent that the petition asks that FDA only require the collection of PHI when necessary to fulfill the REMS, the request is granted, and to the extent that the petition requests action by FDA in the implementation of HIPAA, the request is denied.

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