Tuesday, 21 April 2020

• Since the spread of COVID-19 in Russia started later than its spread in most other European countries, the Russian Government has only recently started elaborating measures in response to the outbreak, and now the situation is developing swiftly. In this analysis, we describe the most important legislative amendments affecting the pharma industry to-date, including those affecting drug pricing, the online sale of over-the-counter drugs, liability for substandard drugs, import duties, marketing authorization procedures for drugs and medical devices, VATs, state procurement rules, and telemedicine. (Authored by Natalia Gulyaeva)

• According to the new Order SND/354/2020 of 19 April issued by the Spanish Ministry of Health, the pricing authority has 48 hours to set the maximum retail price of surgical masks, nitrile gloves, hygienic masks, antiseptics, hydroalcoholic gels and solutions as well as other (medical and non-medical) devices that are considered essential to minimize the risk of COVID-19 spreading among people. Additional measures relating to labeling and "control actions" of hygienic masks as well as the sale of surgical masks, which are not packaged individually have also been implemented. Read more here. (Authored by Santiago Garrido and Álvaro Abad)

• The U.S. Food & Drug Administration (FDA) continues to emphasize that there are no scientifically proven products that treat or prevent the COVID-19 virus. Yet numerous health and wellness companies are seeking to capitalize on consumer anxiety during the current health crisis with claims that their products do just that. The U.S. Federal Trade Commission (FTC), frequently in partnership with the FDA, has been sending out a flurry of warning letters to stop the rise of coronavirus-related fraud. We analyze those here, concluding that, given their “exacting” and heightened scrutiny of the marketplace, companies making any type of representations about their products and COVID-19 must exercise considerable care in the substance of those claims or risk the consequences. (Authored by Julia Anne Matheson)

Monday, 20 April 2020

• On 10 April 2020, the European Commission, the EMA, and the European medicines regulatory network published a notice providing guidance to stakeholders regarding regulatory expectations for medicinal products for human use during the COVID-19 pandemic. The guidance provided covers marketing authorizations, manufacturing and importation of active pharmaceutical ingredients (APIs) and finished products, quality variations, and labeling and packaging requirements. The guidance is published in the form of a Q&A document. It is intended to introduce flexibility to facilitate the movement of medicinal products within the EU during the period of the COVID-19 crisis. The document also provides an overview of existing flexibility measures that may be employed. Read more here. (Authored by EA Wright)

• On 15 April 2020, the European Commission issued guidelines regarding COVID-19 in vitro diagnostic tests. The guidelines offer an overview of the different types of test and their purposes as well as the relevant EU regulatory framework. They also include considerations regarding test performance as well as the validation of that performance and provide elements that the EU Member States and stakeholders must take into consideration when defining national strategies. The guidelines provide that the relevant regulatory framework for COVID-19 related in vitro diagnostic tests is the Directive on in vitro diagnostic medical devices 98/79/EC. Read more here. (Authored by Fabien Roy)

• In light of the challenges posed by the COVID-19 pandemic to the usual channels of manufacture and distribution of medical devices, healthcare institutions have begun to manufacture medical devices and their accessories and to reprocess used medical devices. On 9 April 2020, the Belgian Federal Agency of Medicines and Health Products (AFMPS) issued a Circular providing the framework for collaboration between health care institutions and external companies intended to address the existing shortages in essential materials. The intended purpose of the Circular is to establish the conditions and the means with which healthcare institutions may respond to emergency shortages of essential materials either, through manufacturing medical devices or, by subcontracting the manufacture and reprocessing of medical devices to third parties. Read more here. (Authored by EA Wright)

• The U.S. Food and Drug Administration (FDA) issued new guidance to expand the availability of telethermographic systems during the COVID-19 public health emergency. Fever is a common symptom of COVID-19 and telethermographic systems can assess surface skin temperature, which is then used to estimate body temperature during the triage process. The advantage of these systems is their potential use in high throughput areas (e.g., airports, businesses, warehouses, and factories). FDA’s enforcement policy applies to telethermographic systems that are intended for adjunctive diagnostic screening during the COVID-19 pandemic. As part of an effort to address public health concerns raised by the shortage of temperature measurement products, FDA does not intend to enforce the following regulatory requirements for telethermographic systems: submission of a 510(k) premarket notification, Reports of Corrections and Removals requirements, Registration and Listing requirements, the Quality System Regulation, and Unique Device Identification requirements. FDA believes devices included in this enforcement policy will not create undue risk where performance and labeling elements are met and where an elevated body temperature measurement is confirmed with secondary evaluation methods. FDA intends for this policy to remain in effect only for the duration of the COVID-19 public health emergency. (Authored by Christine Zimmerman)

• U.S. President Trump signed an Executive Order on Preventing Hoarding of Health and Medical Resources to Respond to the Spread of COVID-19 (EO) on 23 March 2020. The EO delegates presidential authority under the Defense Production Act (DPA)1 to prevent hoarding of health and medical resources necessary to respond to the COVID-19 outbreak to Secretary of Health and Human Services (HHS) Alex Azar. This delegation of authority includes the power to identify “scarce materials or materials the supply of which would be threatened” by hoarding and authority to gather information about how such supplies are distributed throughout the nation. Attorney General Barr’s remarks at the press conference announcing the EO indicate that the Department of Justice (DOJ) will cooperate with HHS to identify instances of hoarding and price gouging and bring enforcement actions where warranted. Read more here. (Authored by Megan Dixon)

Daily reports for the week of 13 - 17 April are online here.

Daily reports for the week of 6 - 10 April are online here.

Daily reports for the week of 30 March - 3 April are online here.

Daily reports for the week of 23 - 27 March are online here.