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

US President Donald Trump signed four executive orders implementing policies on drug pricing on July 24. One of the orders directs the secretary of the US Department of Health and Human Services (HHS) to condition future grants under Section 330(e) of the Public Health Service Act on Federally Qualified Health Centers (FQHCs) establishing practices that ensure the 340B discount they receive on insulin and injectable epinephrine is passed through to low-income patients who lack insurance or have high co-pays or deductibles. The HHS secretary has discretion to set the standard for eligible patients.

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.

As summarized in a July 17 LawFlash, FDA has resumed inspections of regulated domestic facilities using a new risk assessment rating system that takes into account the reopening phase of the applicable state, and county level COVID-19 statistics. Based on the risk rating, in any particular US geographic area, FDA may decide to only conduct only mission-critical inspections, inspections with precautions to protect vulnerable staff, or all regulatory inspections. All inspections will be preannounced.

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.

Read the full LawFlash >>

Our FDA lawyers discuss provisions in the Coronavirus Aid, Relief, and Economic Security (CARES) Act that are of particular concern and interest for the pharmaceutical, medical device, animal drug, and food industries, as well the potential effects of the stimulus package, in this recent 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.

As we reported on Health Law Scan, the Centers for Medicare and Medicaid Services (CMS) issued an Open Payments COVID-19 Announcement on March 25, citing its plans to exercise enforcement discretion regarding the late or incomplete submission of Program Year 2019 data in some cases.

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.

Read the LawFlash.

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.