A use outside the approved uses, 'off-label use', is not permitted unless an exception applies. What is involved with off-label use?Ī therapeutic good is registered or listed by the relevant Government Agency for an approved use.
#MEDICAL DEVICE FDA LABEL EXPERT WITNESS CV PROFESSIONAL#
Ideally it should not depend on the country that is manufacturing the vaccine,' said Soumya Swaminathan, chief scientist at the World Health Organization (WHO), in response to a question from Research Professional News. 'The tough question is going to be for the first tens of millions of doses, who should get it. It will be interesting to see what Governments will do in balancing the interest of the patent owner against public health and COVID-19. Therefore, it is extremely important, for example, that any COVID-19 vaccine is beneficial and does not create greater harm than the disease it is used for.įurther, as we have seen in the past with HIV medications, and the competition for scarce resources such as ventilators in the US, equity of access is also an issue, particularly as patents grant monopoly rights. More recently, Johnson & Johnson is facing numerous class action lawsuits in relation to vaginal mesh products, which are alleged to cause pain, bleeding, infection, organ perforation and autoimmune problems.
Sixty years ago, thalidomide, a drug that was prescribed to many pregnant women in order to relieve pregnancy nausea, was withdrawn from the market after thousands of mothers gave birth to disabled babies. There needs to be a balance between expediting making medical products available for COVID-19 and meeting safety and efficacy requirements. Typically, a pharmaceutical company needs many years to collect evidence that confirms the safety, quality and efficacy of a medicine by running clinical trials and doing other research. What are the legal, regulatory and ethical issues of rushing medicines and medical devices to market, including safety, human rights and equity of access? It is not only the product which is regulated, but also the method of manufacture, with the manufacturing required to comply with Good Manufacturing Practice ( GMP). The various regulators around the globe (including the US Food and Drug Administration (FDA), the Therapeutic Goods Administration (TGA) in Australia, and the European Medicines Agency (EMA) ( Government Agencies)) have been working very hard to facilitate and expedite clinical trials, market approvals and emergency use authorisations. Never before has there been such demand for urgent and practical therapeutic goods regulatory advice. There has been a rush to get medicines and medical devices (ie COVID-19 diagnostic test kits, drugs, face masks, ventilators, vaccines and digital thermometers) to clinical trials and to market. Wirth, Of Counsel, Arnall Golden Gregory LLPĬoronavirus Disease 2019 (COVID-19) has significantly impacted the healthcare sector across the globe.
By Alison Choy Flannigan, Partner, Leader – Health & Community, Hall & Wilcox, Australia James Fry, Partner and Head of Life Sciences, Mills & Reeve, UK and Carolina M.
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