FDA biomarker testing standards are questioned?

At one time, the certification of the food and Drug Administration (FDA) was the highest testing standard of food and drug in the world So many manufacturers in the world pursue FDA certification as the highest honor and guarantee of product quality Recently, Reka varnai, M.D., from the school of medicine of the University of P é CS in Hungary, and others found that the Hungarian product characteristic profile (SMPC) is more authentic, clearer and clinically relevant drug genome information, which will strengthen the implementation of pharmacogenetics, according to a research report published on narure Pharmacogenomics (PGx) is one of the effective tools of precision medicine (PM) It studies the different reactions of different diseases caused by gene variation to drugs, and on this basis, develops new drugs or new medication methods PGx information can be provided in the drug label to inform doctors or patients of the response of different genotypes to the drug by describing the relevant genomic markers, the functional effects of genomic variants, genotype based drug delivery suggestions and other applicable genomic information This may describe the variability of clinical response and drug exposure, the risk of adverse events, genotype specific administration, the mechanism of drug action, polymorphic drug target and disposition gene or trial design features Doctors at the school of medicine, University of page, Hungary, compared the information in the drug labels (July 2019) of the same active substances of SMPC and FDA to assess the role of these biomarkers from the PGx database Of the 264 FDA approved drugs identified, 195 are on the market in Hungary Among them, 165 drugs included 222 biomarkers Metabolic enzymes (46%) and pharmacological targets (41%) The most common areas of treatment were Oncology (37%), followed by infectious diseases (12%) and psychiatry (9%) The most common biomarkers of SMPC in Hungary are CYP2D6, CYP2C19, estrogen and progesterone receptor (ESR, PGs) Through comparison, it is found that the regulations of SPPC in Hungary on 9 kinds of tumor drugs are more strict than that of FDA, and must be tested before treatment Photo source: the number of drugs containing PGx information in the United States and Hungary has increased 57% in the past 26 months, compared with 46% in Hungary Compared with FDA, 20 kinds (10%) of PGx information (such as lidocaine lidocaine, lusotrombopag, mepivacaine, etc.) were completely missing from the drug labels of 30 active ingredients in Hungary Drugs without PGx biomarker information on these labels belong to different treatment fields (2 oncology 23%, anesthesiology 23%, infectious diseases 20%, cardiology 7%, congenital diseases 7%, rheumatism 7%, dermatology 3%, hematology 3%, psychiatry 3% and lung 3%) The researchers tested 72 biomarkers (25%), of which 66 (92%) belonged to the field of oncology Four (1%) biomarkers in the Hungarian drug label were included in the test recommendation category, compared with six (2%) in the United States 51 biomarkers (18%) had information PGx data in Hungarian drug labels, and 77 biomarkers (27%) in the United States However, 14 biomarkers (5%) are missing from the knowledge base of pharmacogenomics in the United States, which indicates that the implementation of PGx information is usually quite delayed This is also true for 62 biomarkers (22%) in SMPC in Hungary According to the comparison results, the United States scored the effect of PGx information on the same overall quality, but with different significance SMPC in Hungary has stricter requirements for cancer drugs than in the United States The strict gene detection before the treatment of Hungarian cancer drugs may be due to the high cost of these target molecules, so the efficacy must be confirmed before the treatment In the United States, the requirement or recommended proportion of PGx detection is higher than other treatment fields in oncology It is worth noting that FDA provides more applicable dose modification information than SMPC in Hungary FDA has recognized genetic differences in drug metabolism, clinically relevant drug drug drug interactions or gene drug interactions for dose adjustment or alternative drug use Given regulators' assessment of the same scientific data produced in the context of increasingly global harmonization, it is not expected that there will be significant differences between countries in drug and diagnostic regulations Despite the international regulatory coordination, the implementation of drug genome information in official drug labeling shows a wide range of geographic diversity The FDA and the European Drug Administration (EMA) jointly conduct scientific assessments of drugs in a variety of ways to ensure that the drug genome strategy is properly applied at all stages of drug development EMA is responsible for centralized marketing authorization applications in the EU and some other countries Once approved by the European Commission, the centralized sales authorization is valid in all EU Member States Reference source: https:// editor in charge | denigui statement: this point of view only represents the author, not the position of yaozhi.com, welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the author and source of the article.