FDA WATCH

FDA Watch: Congress Kills Trump Plan to ‘Recalibrate’ User Fees

Instead of the budget cuts the President asked for, the newly approved federal government spending plan increases FDA funding by $103 million, $4.665 billion in total. That includes $2.759 billion for FDA discretionary spending, $39 million above FY 2016 outlays. The extra discretionary money will be spent on, among other things:

  • Supplemental medical product safety and Precision Medicine initiatives authorized by the 21st Century Cures Act: $10.9 million;
  • Response to Zika, Ebola and other emerging health threats: $10 million; and
  • Foreign high-risk inspections: $2.5 million.

From the diagnostic industry perspective, the most significant aspect of the spending plan may be what it does not include, namely, the Trump 2018 budget proposal plan to "recalibrate" medical product user fees by doubling the fees pharmaceutical and medical device companies pay the FDA to review their products. While the concept of making the "industries that benefit from FDA approval pay for their share" rings fair, raising user fees 100 percent threatened to chill new product development especially by biotech and other smaller, entrepreneurial firms operating on tight margins. The proposal also drew criticism for ignoring painstakingly negotiated FDA revenue targets and the consensus that user fees are a supplemental rather than primary funding source of FDA review activities.

Notable New 510(k) Marketing Clearances
As we highlighted in LIR‘s April issue, the FDA broke new ground by authorizing 23andMe to engage in direct-to-consumer (DTC) marketing of its Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or conditions. Another big development: Royal Phillips got the green light to market its IntelliSite Pathology Solution, which the company claims to be the first and only digital pathology solution in the U.S. to receive clearance for primary diagnostic use by pathology labs. FDA approval "opens a complete new dimension towards computational pathology which aims to increase accuracies and ultimately enhance patient care," according to a company statement.

The Latest Zika Test
Emergency Use Authorization (EUA) of in vitro diagnostics for the Zika virus continues to sizzle with the approval of Nanobiosym’s test for qualitative detection of Zika RNA in human serum based on the company’s Gene-Radar portable platform. This is the 17th EUA that the FDA has issued for Zika tests since the start of 2016. (See LIR, March 2017 for a listing of the previous 16 tests, including subsequent expansions of the scope of approval.)

Here’s a rundown of all the notable diagnostic approvals in the past month.

Manufacturer(s) Product(s)
Royal Philips Approval to market IntelliSite Pathology Solution, which the company claims is the first and only digital pathology solution in the U.S. to receive clearance for primary diagnostic use
Alere Approval to market Alere™ Reader, a diagnostic analyzer that can be used in both point-of-care and laboratory settings
Nanobiosym Emergency Use Authorization for Gene-Radar Zika virus test
23andMe Approval to market Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or conditions
Becton, Dickinson and Company Approval of BD FACSVia™ system for identifying and counting rWBCs in leucoreduced blood products
Great Basin Scientific Approval of Bordetella Direct, sample-to-result molecular test to detect Bordetella pertussis, the bacteria that causes whooping cough
Qiagen Approval of ipsogen® JAK2 RGQ PCR Kit (ipsogen JAK2 assay), test detecting the JAK2 V617F/G1849T allele in genomic DNA extracted from EDTA whole blood
Myriad Genetics Approval of BRACAnalysis CDx for use as complementary diagnostic to identify ovarian cancer patients with germline BRCA mutations likely to benefit from treatment with Zejula
Siemens Healthineers Pre-market approval Versant HCV Genotype 2.0 assay identifying all 6 hepatitis C virus genotypes

New CE Marks
BioGx was the most active firm of the month, securing CE approval for four different tests. Here’s a listing of notable diagnostic products receiving CE marking for Europe during the month:

Manufacturer(s) Product(s)
BioGx BioGx Mycoplasma-Ureaplasma, test using ThinPrep or universal transport media samples to diagnose genital infection
BioGx BioGx Pneumocystis jirovecii, test using pretreated sputum samples to diagnose pneumonia caused by the eponymous fungus
BioGx BioGx Mycobacterium tuberculosis Complex, test using pretreated sputum and bronchoalveolar lavage samples to diagnose tuberculosis infection
BioGx BioGx Bordetella Speciation plus Toxin, test using nasopharyngeal swabs or nasal wash samples to diagnose Bordetella species
GenMark Diagnostics ePlex Blood Culture Identification fungal pathogen panel
Curetis Multiplex PCR-based assay for severe intra-abdominal infections
Great Basin Scientific Stool-based bacterial pathogens detection panel
Vela Diagnostics Sentosa SA HBV Quantitative PCR Test to detect Hepatitis B virus DNA
Singulex Sgx Clarity® system, fully-automated in vitro diagnostics platform
Roche Liat System point-of-care platform, which performs real-time PCR in tube-based format, using spatial thermal cycling generating results within 20 minutes
Roche Assay for Clostridium difficile
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