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YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS

Morgan Lewis FDA, litigation, and healthcare lawyers authored a LawFlash outlining key issues that companies marketing products and services for coronavirus (COVID-19) should be aware of, including healthcare, FDA, clinical laboratory, product liability, and digital and telehealth laws and regulations. Many companies working on COVID-19 products, services, and treatments are not traditional healthcare or life sciences companies. This, however, is a highly regulated space, and regulators are continually issuing new policies and regulations. As companies lend their expertise to the battle against the pandemic, they should be aware of the relevant regulatory and legal requirements to avoid enforcement and liability risks.

Morgan Lewis FDA lawyers authored a LawFlash on June 29 summarizing FDA’s drug and biologic coronavirus (COVID-19) guidances to date. As noted by the authors, entities within the drug and biologic industries should continue to track FDA’s COVID-19-related actions, as additional guidance and modifications to existing guidances are likely. In fact, just days following the LawFlash, FDA updated its guidance on the Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency to further clarify procedures for informed consent and the use of remote video conference participant visits and published a new guidance on Development and Licensure of Vaccines to Prevent COVID-19. With the continuation of the pandemic and the recent surge in cases, we should expect FDA to continue to quickly push out guidances that have an immediate effect. These guidances not only provide direction on how industry can address immediate challenges and questions, but how FDA may make more enduring regulatory changes.

The need for alternative sources of alcohol for hand sanitizer products continues to grow in response to the coronavirus (COVID-19) pandemic. Following its March 20 guidance, which allowed companies not previously registered to produce over-the-counter hand sanitizer to do so, the FDA released additional guidance on what conditions should be met for the manufacture of alcohol for hand sanitizer products. Kathleen Sanzo, Jacqueline Berman, and Alexandre Gapihan itemize those conditions in their recently authored LawFlash.

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In its March 20 guidance, FDA addresses postmarket adverse event reporting for drugs, biologics, medical devices, combination products, and dietary supplements during a pandemic. Kathleen Sanzo, Jacqueline Berman, Michele Buenafe, and Dennis Gucciardo explain the guidance in this LawFlash.

Through FDA’s Policy for Certain REMS Requirements During COVID-19 Public Health Emergency, FDA provides temporary relief from laboratory testing and imaging requirements for certain drugs and biologics subject to REMS with those specific prerequisites. These relaxed requirements will allow patients continued access to their medications during social distancing. Rebecca Dandeker and Jacqueline Berman dissect the new policy in their recently authored LawFlash.

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In light of the growing coronavirus (COVID-19) public health challenge, the FDA issued guidance on March 18 on general considerations for conducting clinical trials of medical products during the COVID-19 pandemic.

The guidance aims to “assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity.”

Partners Kathleen Sanzo and Jacqueline Berman provide key takeaways from the guidance in this LawFlash.

The FDA issued guidance on March 20 for the manufacture of hand sanitizers by companies not previously registered to make OTC drugs. The guidance comes in response to hand sanitizer shortages during the coronavirus (COVID-19) emergency, particularly among employers in the healthcare and essential services sectors where employees are still present or interacting with consumers. Morgan Lewis lawyers Kathleen Sanzo and Jacqueline Berman authored a lawflash detailing issues for manufacturers and purchasers under the new policy.

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The FDA announced on March 18 that it is suspending onsite routine domestic inspections in an effort to slow the spread of the coronavirus (COVID-19) and help flatten the pandemic curve. This announcement follows a March 10 guidance that routine foreign inspections were suspended. For-cause inspections will proceed if deemed “mission-critical.” Dennis Gucciardo, Michele Buenafe, and Jaqueline Berman address the tools that FDA will use to oversee the safety and quality of FDA-regulated products during this emergency in their recently authored LawFlash.

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FDA issued a draft guidance, Demonstrating Substantial Evidence of Effectiveness for Human Drugs and Biological Products (Draft Guidance), on December 19, 2019, as an expansion of its 1998 guidance, Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products (1998 Guidance). The 1998 Guidance provided examples of evidence that FDA could consider to be confirmatory evidence to potentially support FDA approval of a marketing application based on one adequate and well-controlled clinical trial. The new Draft Guidance provides further detail on clinical trial design considerations, as well as forms of confirmatory evidence that sponsors may consider when proposing to rely on a single adequate and well-controlled clinical trial.

The US Food and Drug Administration (FDA or Agency) on January 30 signaled what could be an about-face with regard to its role administering the List of Approved Drug Products with Therapeutic Equivalence Evaluation (referred to as the Orange Book). Historically, FDA’s Orange Book role has been solely ministerial. However, over the next year, FDA may begin taking a more active approach to the Orange Book.