FDA Roundup: March 19, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-march-19-2024
FDA Approves First Gene Therapy for Children with Metachromatic Leukodystrophy
http://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapy-children-metachromatic-leukodystrophy
The new director of the Department of Innovation, Access to Medicines and Health Technologies (IMT), Judit Rius Sanjuan, tells us about the challenges and opportunities they are working on to reduce gaps and inequities in access to medicines and essential technologies, as well as to increase innovation.
Washington DC, 22 November 2022 (PAHO)- From 7-9 November 2022 , the XIII Regional Meeting of the Health Technology Assessment Network of the Americas (RedETSA) was held in the city of Brasilia, Brazil. Representatives from 18 countries discussed the Health Technology Assessment (HTA) process at all stages of the technologies’ life cycle, in order to face the challenges of their incorporation into health systems. The event was organized in conjunction with the III Congress of the Brazilian Health Technology Assessment Network – Rebrats.
Marcelo Queiroga, Minister of Health of Brazil; Socorro Gross Galiano, Representative of the PAHO/WHO Country Office in Brazil; Sandra Barros, Secretary of Science, Technology, Innovation and Strategic Inputs in Health; Vania Canuto, Director of the Department of Management and Incorporation of Health Technologies; and Alexandre Lemgruber, PAHO Regional Advisor on Health Technologies Management attended the opening of the event.
During the XIII Regional Meeting, open scientific conferences were held and organized according to the different stages of health technologies’ life cycle (regulation-evaluation-incorporation-use-monitoring). A total of 311 people participated in person and 228 virtually thanks to the direct transmission of the event. For more information go to https://www.paho.org/en/news/22-11-2022-xiii-regional-meeting-health-technology-assessment-network-americas
Washington, DC, 21 December (PAHO) – In an effort to increase equitable access to COVID-19 therapeutics, the Pan American Health Organization (PAHO) delivered more than 11,000 vials of a medication to improve treatment for severe and critically ill COVID-19 patients in 15 Latin American and Caribbean countries.
Countries that have received the PAHO donation of tocilizumab since mid-September are Belize, Bolivia, Dominica, Dominican Republic, El Salvador, Grenada, Guyana, Haiti, Jamaica, Nicaragua, Peru, St. Lucia, St. Vincent and the Grenadines, Suriname and Venezuela. Panama expects to receive it soon.
The drug, tocilizumab, has been shown to reduce deaths in hospitalized patients with severe or critical COVID-19, who are rapidly deteriorating or need increased levels of oxygen, and who have a significant inflammatory response.
The purchase, worth over US$2 million, was procured by PAHO and supported by the Government of the United States.
For more information go to https://www.paho.org/en/news/21-12-2022-paho-makes-covid-19-therapeutic-available-16-countries
Geneva, 23 January 2023 – WHO is releasing an urgent call to action to countries to prevent, detect and respond to incidents of substandard and falsified medical products.
Over the past four months, countries have reported on several incidents of over-the-counter cough syrups for children with confirmed or suspected contamination with high levels of diethylene glycol (DEG) and ethylene glycol (EG). The cases are from at least seven countries, associated with more than 300 fatalities in three of these countries. Most are young children under the age of five. These contaminants are toxic chemicals used as industrial solvents and antifreeze agents that can be fatal even taken in small amounts, and should never be found in medicines.
Based on country reports, WHO has issued three global medical alerts addressing these incidents. The Medical Product Alert N°6/2022 on 5 October 2022 focused on the outbreak in the Gambia, Medical Product Alert N°7/2022 on 6 November 2022 focused on Indonesia, and Medical Product Alert No1/2023 on 11 January 2023 focused on Uzbekistan.
WHO’s medical product alerts were rapidly disseminated to the national health authorities of all 194 WHO Member States. These medical product alerts requested, inter alia: (a) the detection and removal of contaminated medicines from circulation in the markets, (b) increased surveillance and diligence within the supply chains of countries and regions likely to be affected, (c) immediate notification to WHO if these substandard products are discovered in-country; and otherwise inform the public of the dangers and toxic effects of the substandard medicines at issue.
Since these are not isolated incidents WHO calls on various key stakeholders engaged in the medical supply chain to take immediate and coordinated action.
For more information go to WHO urges action to protect children from contaminated medicines
