Monday, 8 June 2020

• On June 4, 2020, the U.S. Food and Drug Administration (FDA) updated the Compliance Program Guidance Manual (CPGM) to include a program for “Inspections of CDER-led or CDRH-led Combination Products.” FDA’s CPGM provides instructions to FDA personnel, including FDA investigators, for conducting activities to evaluate compliance. The new compliance program (7356.000) “focuses on inspections of combination product manufacturers of CDER or CDRH-led single-entity and co-packaged finished combination products that include both drug and device or biological product and device constituent parts,” and aims to clarify and explain the application of cGMP requirements to combination products laid out in January 2017 final guidance, including application of the “streamlined approach” to cGMP compliance set forth in the final guidance. Online here is our team's analysis of the new FDA inspection program released for “streamlined approach” for combination product cGMP. (Authored by Jim Johnson)

• The U.S. Food and Drug Administration (FDA) has updated its previous March 2020 guidance detailing its enforcement policy for specific non-invasive remote monitoring devices to include additional device types. FDA intends to exercise enforcement discretion for modifications to particular remote monitoring devices, which measure or detect common physiological parameters, are used to support patient monitoring, and may help eliminate unnecessary patient contact during the public health emergency. These devices may be connected to a wireless network to transmit a patient’s measurements directly to their health care provider. FDA does not intend to object to limited modifications to the indications, claims, functionality, hardware, or software of these devices without submission of a premarket notification as long as the modification does not create an undue risk. Examples of modifications that fall within the scope of this guidance include:

  • Monitoring statements related to patients with COVID-19 or co-existing conditions (such as hypertension or heart failure);

  • Changes to the indications or claims regarding home use for devices previously marketed only for use in hospitals or other health care facilities; and

  • Hardware or software changes to allow for increased remote monitoring capability.
    (Authored by Christine Zimmerman)

• While companies continue to focus on the safety and well-being of employees, customers, suppliers and other stakeholders during this time, the decisions to be made regarding how and when to re-open and bring employees back to work are complex and often involve balancing the needs of different stakeholders. In such times, the board of directors of a public company plays a critical role in overseeing management and guiding the company through the disruption and uncertainty. Many companies will face litigation related to COVID-19, whether merited or not. Therefore, ensuring that the board of directors has the necessary information to fulfill its fiduciary duties, including its oversight responsibilities, and properly documenting board actions are even more important in the current environment. This article briefly overviews directors’ fiduciary duties in the context of COVID-19 and outlines a number of practical tips and recommendations. (Authored by John B. Beckman)

• The European Medicines Agency (EMA) has announced that it now offers the possibility for simultaneous review of centralized marketing authorization applications (MAAs) and applications for a scientific opinion under Article 58 of Regulation (EC) 726/2004 on the authorization and supervision of medicinal products for human and veterinary use. Read more here. (Authored by Elisabethann Wright)

• On 29 May 2020, Belgium's Federal Agency for Medicines and Health Products (AFMPS) issued a new decision which further extends the measures initially provided in the Decision 1 April 2020 concerning supply of specific medicinal products by another month. These measures were previously extended until 1 June 2020. The new Decision also provides for the relaxation of some of the measures that were previously imposed. Read more on that here. Then, on 3 June 2020, the AFMPS issued the third version of the Agency’s alternative test protocol (ATP) for surgical face masks. The alternative test protocol was initially published on 14 April 2020, and allowed masks that had not undergone a conformity assessment procedure in accordance with applicable standards to be placed on the Belgian market. The purpose of this protocol is to facilitate the supply of face masks during the COVID-19 pandemic. The previous versions of the protocol permitted surgical face masks that did not comply with the alternative test protocol to be placed on the market as comfort masks. In light of the fact that Belgium no longer faces a shortage of comfort masks on the market, the latest version of the protocol no longer offers such a possibility. Read more on that here. (Authored by Elisabethann Wright)

• The Hogan Lovells Government Relations and Public Affairs group is tracking all of the latest developments in U.S. Congress and relevant news stories. A group of House Republicans sent a letter to leadership asking that unemployment benefits be excluded from the next coronavirus relief package. Despite Senate Majority Leader Mitch McConnell (R-KY) promising that the unemployment benefits would not be extended again some conservatives are growing worried that the Senate GOP will cut a deal with Democrats to boost unemployment insurance. President Donald Trump met with White House Economic advisors to discuss the next COVID-19 stimulus package and mentioned a list of priorities it wants in the next package, including infrastructure, liability protections, and several tax changes. On 5 June, the Labor Department unveiled the nation’s unemployment rate was at 13.3 percent and added 2.5 million jobs in May. There was some question of the true numbers due to a “misclassification error." In the U.S., coronavirus cases have been on a gradual rise since Memorial Day weekend, according to data from Johns Hopkins University. Read about these and other updates online here. (Authored by Ivan Zapien)

• The Hogan Lovells IP & Media Technology team is tracking the changes being made by intellectual property offices around the world in response to the coronavirus so we can keep you informed on the key developments. Our latest update for the US PTO is online here. (Authored by Imogen Fowler)