Biologics

FDA Improperly Influenced Advisors: Verax

David McFarland

— 2 min read
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Verax Biomedical says FDA improperly influenced members of the Blood Products Advisory Committee at an 11/30/17 meeting in violation of the Federal Advisory Committee Act (FACA), and agency actions taken to implement recommendations from that meeting should be reversed. In a 3/5 petition, Verax asks that FDA: 

  • ·        either revoke its decision to clear a 510(k) submission declaring BioMérieux’ BacBPN culture bottles as “secondary safety measure tests” for testing blood platelets or stay the decision pending FDA action to remedy violations, including vacating the tainted advisory committee recommendations and presenting unbiased questions before a new advisory committee meeting with new members and a fair and balanced presentation and then evaluate the BioMérieux 510(k);
  •          refrain from taking any further action related to any of the votes taken at the advisory committee meeting, including refraining from any additional 510(k) submissions or issuing any further safety measure designation related to bacterial contamination of blood platelets until the advisory committee is brought into compliance with the FACA, and then only consistent with FDA’s prior evidence-based standards; and
  •          not grant any additional 510(k) clearances based on substantial equivalence to the BioMérieux 510(k) as the predicate device, until the FACA violations are remedied, and then only consistent with prior evidence-based standards.

The petition says FDA issued a 2016 draft guidance that described how testing for bacterial contamination using FDA-cleared tests or pathogen reduction using an FDA-approved method could be used to improve patient safety. It says the draft identified three bacterial risk mitigation strategies — secondary rapid testing as a safety measure for dating extension to seven days, secondary culture following primary culture as currently performed in the U.S., or pathogen reduction.

Instead of promptly finalizing the guidance, the petition says, CBER “launched a flawed new process that violated FACA, favoring unproven platelet contamination threat-reduction methodologies including minimal proportion sampling volume for five day dating, large volume delayed sampling for seven day dating, and day 4 secondary culture for seven day dating,” collectively known as delayed large volume culture (DVLC).

Vertax says FDA improperly influenced the Blood Products Advisory Committee meeting by: 

  •          inviting only advocates for DVLC to formally present at the meeting;
  • ·        presenting misstatements and material omissions of fact and data;
  • ·        framing the evidence presented to the committee in a way that directed it to reach the foregone conclusion desired by FDA; and
  •          describing the questions posed to the committee as the agency’s recommendations and providing the answers to the questions ostensibly posed to the committee.

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