Receiving information about harm is not always the end of an organization's responsibility. FDA's December 20, 2016 combination-product rule gave that ethical question a concrete regulatory form: constituent-part applicants must share specified safety information with one another. The subject was authorized products combining two or more types among drugs, devices and biological products, not every commercial relationship in healthcare. [2016-30485][E9-23519]

The October 1, 2009 proposal had recognized that a product's reporting framework should preserve the distinctive characteristics of its constituent parts. Its proposed approach combined application-based reporting with supplementary requirements. Read as ethical context, that reasoning resists allowing an administrative category to obscure another part's risks. It remains agency policy rationale, not evidence that a patient was protected in practice. [2016-30485][E9-23519]

The final sharing duty covered information received about specified deaths, serious injuries or adverse experiences and set five calendar days from receipt for exchange among constituent-part applicants. Sending it only to FDA could no longer substitute for that exchange. Separate FDA reporting duties remained. Responsibility to another applicant and responsibility to the regulator were therefore different obligations, rather than competing destinations for a single concern. [2016-30485][E9-23519]

These obligations also had a timetable. January 19, 2017 was the rule's effective date and the compliance date for existing application-based duties; listed additional provisions, including section 4.103 sharing, had an 18-month compliance deferral. Respect for patients calls for precision about that interval, not premature reassurance. The proposal and final rule are one evidentiary chain and offer no independent demonstration of achieved safety benefits. [2016-30485][E9-23519]

Source documents

  1. Postmarketing Safety Reporting for Combination Productshttps://www.govinfo.gov/content/pkg/FR-2016-12-20/html/2016-30485.htm
  2. Postmarketing Safety Reporting for Combination Productshttps://www.govinfo.gov/content/pkg/FR-2009-10-01/html/E9-23519.htm