INDUSTRY BUZZ

FDA Watch: Gottlieb Resignation Costs Lab Industry a Valuable Frenemy

Scott Gottlieb, M.D., is resigning as FDA commissioner, the position he’s held since 2017. Although his reign lasted just two years, Gottlieb has been a longtime friend and foe of the lab industry having served as deputy commissioner during the George W. Bush administration. The key question: Will the initiatives and policies he championed during his tenure continue after he’s gone?

Why Gottlieb Is Leaving
The first clue to answering that question is that Gottlieb isn’t being forced out. He’s resigning for personal rather than political reasons, namely his desire to be closer to his wife and three young daughters in Westport, CT.

His Legacy & Impact on Labs
Gottlieb will be remembered for his commitment to making one of the federal government’s most opaque agencies more transparent and his energy in advocating reforms designed to simplify and speed up the cumbersome FDA approval process and ending the “shenanigans” that thwart competition.

Historically, becoming FDA commissioner has proven a less than effective way of winning friends in the lab industry. But Gottlieb was different. What the industry really appreciated (and may sorely miss when he’s gone) was Gottlieb’s willingness to tackle the controversial lab-developed tests (LDTs) issue. “The agency helped support major legislative efforts to secure a more modern framework for the efficient regulation of diagnostic tests,” Gottlieb said in his resignation letter.

Under Gottlieb, the agency has made several proposals to make it easier to bring new tests to market. Specifically, it has worked with industry and Congress to generate support for the VALID Act, a bill aimed at resolving the longstanding controversy around FDA regulation of LDTs that would bring all diagnostics under a single regulatory pathway using more modern and technologically realistic approval criteria.

Meanwhile, the volume of test approvals has increased markedly during Gottlieb’s tenure, including:

  • Two new flu tests;
  • First NGS residual cancer detection test to gain FDA approval;
  • New point-of-care tests for Ebola; and
  • First approved objective blood test for concussion evaluation. 

Under Gottlieb, the FDA also softened its previous resistance to genetic tests, most notably in allowing 23andMe to engage in direct to consumer marketing of its products. So, it’s not that biotechnology stocks fell on the day he announced his resignation.

Of course, lab tests are just part of the story. Gottlieb has also won praise for his determination to speed approval of new generic drugs and the agency’s handling of the opioid crisis. Of course, he’s not without critics. One problem area is his support for e-cigarettes, which the anti-tobacco groups contend has contributed to the growth of vaping among teens. Gottlieb has also managed to tick off the other side by pushing to regulate the amount of nicotine in cigarettes and proposing a ban on menthol cigarettes.

His Successor
Norman Sharpless, M.D., director of the National Cancer Institute has been named acting commissioner. He will oversee the agency until President Trump nominates and the Senate confirms a permanent successor.

New FDA Approvals
Here’s a look at the key FDA approvals announced from late February to late March:

NEW FDA APPROVALS
Manufacturer(s) Product(s)
Roche Diagnostics Clearance for Ventana PD-L1 Assay as first companion diagnostic to identify triple-negative breast cancer patients for the Tecentriq-Abraxane combination
Roche Diagnostics Clearance for Ammonia II assay, enzymatic test measuring ammonia in human plasma run on Roche’s Cobas c systems
Euroimmun (now owned by PerkinElmer) Clearance for Anti-tissue Transglutaminase ELISA (IgA) test kit to detect IgA class antibodies against tissue transglutaminase in human serum and ethylenediaminetetraacetic acid (EDTA) plasma
Euroimmun (now owned by PerkinElmer) Clearance for Anti-tissue Transglutaminase ELISA (IgG) test kit for qualitative determination of IgG class antibodies against tissue transglutaminase in human serum and EDTA plasma to diagnose celiac disease
BioMérieux Clearance for two culture bottle products for recovery and detection of bacteria and yeast from blood:
* BacT/Alert FA Plus Culture Bottles<
* BacT/Alert PF Plus Culture
BioMérieux Clearance for Vitek 2 Gram-negative Susceptibility Card for use with Vitek 2 Systems to determine susceptibility of clinically significant aerobic gram-negative bacilli to antimicrobial agents
T2 Biosystems Breakthrough device designation for T2Resistance Panel
Hitachi Chemical Diagnostics Clearance for Optigen AP 3600 high capacity allergy testing system
GenePOC Clearance for rapid molecular assay to detect group A Streptococcus run on firm’s Revogene instrument
Instrumentation Laboratory 510(k) clearance for Gem Premier ChemStat in vitro diagnostic analyzer incorporating IL’s Intelligent Quality Management module
Beckman Coulter Clearance for MicroScan Dried Gram-Negative MIC/Combo Panels and Dried Gram-Negative Breakpoint Combo panels to determine antimicrobial agent susceptibility to and/or identify species level of aerobic and facultatively anaerobic gram-negative bacilli
CoaguSense Clearance for Prothrombin Time /INR Monitoring System to measure INR units and provide prothrombin time results expressed in seconds
EKF Diagnostics Clearance for use of its Quo-Test A1c System for detecting glycated hemoglobin levels in venous whole-blood samples
Sekisui Diagnostics Clearance for Sekure Acetaminophen L3K Assay to measure acetaminophen in serum, lithium heparin plasma and sodium heparin plasma, and for diagnosis and treatment of acetaminophen overdose toxicity
U&U Medical Technology Clearance for use of its Blood Collection Sets in routine venipuncture procedures
Abbott CLIA waiver for use of its reformulated rapid influenza diagnostic test, BinaxNOW Influenza A & B Card 2, with firm’s Digival diagnostic reader for rapid detection of influenza virus

New CE Marks & Global Certifications
Notable European CE certifications during the period:

NEW CE CERTIFICATIONS IN EUROPE
Manufacturer(s) Product(s)
Bruker CE-IVD marking for FluoroCycler XT PCR system and FluoroType MTBDR 2.0 Liquid Array assay for detecting tuberculosis and antibiotic resistance
Roche CE marking for newly launched Navify Mutation Profiler clinical software
Abbott CE marking for Alinity m molecular diagnostics system and assays
Omega Diagnostics Group CE marking for Visitect CD4 Advanced Disease test for monitoring people living with HIV
Personal Genome Diagnostics CE marking for PGDx Elio Plasma Resolve liquid biopsy
Ortho Clinical Diagnostics CE marking for Vitros XT MicroSlide technology enabling labs to run two tests at the same time
Co-Diagnostics CE-IVD marking for Logix Smart ZDC PCR-based multiplex test for diagnosing Zika virus, dengue fever and chikungunya infection
Oncgnostics Extended CE-IVD marking for GynTect cervical cancer assay to run on Roche’s Cobas z 480 quantitative PCR-based analyzer

Other international clearances announced during the period:

Manufacturer(s) Country(ies) Product(s)
Amoy Diagnostics China National Medical Products Administration (NMPA) approval for BRCA1 and BRCA2 gene mutation detection kit
Thermo Fisher Scientific Japan Ministry of Health, Labour and Welfare expanded approval for Oncomine Dx Target Test CDx System
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