FDA pharmacovigilance approach is strict but flexible

By the end of 2013, FDA approved 1453 drugs. A number of approved drugs grows naturally as medicine evolves, hence pharmacovigilance expands continuously. Regulator’s requirements are not getting softer as the total volume of reports increases.

On November 30^th FDA gravely warned Langhorne, Pennsylvania on postmarketing surveillance malpractice. The main issue is that the company does not have any written procedures for adverse event reporting. Of all reports submitted to FDA by the company, 70% were documented inappropriately.

Nevertheless, the agency is not trying to complicate pharma business. On November 29^th FDA released a final version of Providing Postmarketing Periodic Safety Reports in the ICH E2C(R2) Format guidance. Industry can choose, whether to submit Periodic Benefit-Risk Evaluation Report (PBRER) accepted by ICH or Periodic Safety Update Report (PSUR), the format of postmarketing report accepted by FDA earlier. If a PSUR waiver has been submitted by the pharmaceutical company earlier, there is an option now to submit PBRER. PSUR waiver can be received if an explanation as to why compliance with PSUR requirements is unnecessary or cannot be achieved, and a description of an alternative submission that satisfies the purpose of pharmacovigilance will be provided.

The new guidance states that if such waiver has been already registered and approved, FDA may allow submitting safety reports in ICH format. If a waiver has not been registered yet, the company should apply for it to have an opportunity to use PBRER format. In compliance with this format, an applicant should also submit a list of all individual case safety reports (ICSR) including ICSRs received during periodic safety report application. The narrative that identifies any changes made to the approved U.S. labeling and a copy of the U.S. labeling in effect on the date of submission should also be provided.

Sources
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm530483.htm
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM346564.pdf
http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ManualofPoliciesProcedures/ucm079937.pdf
http://www.sciencedirect.com/science/article/pii/S1359644614001032