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

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.

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.

Read the full LawFlash.

With the increasing numbers of coronavirus (COVID-19) cases and the declaration of a global pandemic by the World Health Organization, the pharmaceutical and biotech industries are assessing how this situation may impact business operations.

Some areas that companies should consider include the following:

  • Supply chain disruption, including active pharmaceutical ingredient (API) and excipient shortages
  • Drug shortages and related FDA notices
  • FDA inspection priority shifts
  • Potential impacts on import surveillance
  • Delays in FDA’s review of pending drug applications
  • Possible impacts on clinical trials and necessary changes to relevant trial documents
  • The impact on drug promotion and new risks created by the changing landscape

For further analysis, please see our March 13 LawFlash, Potential Impact of Coronavirus (COVID-19) on the Pharmaceutical and Biotech Industries.

FDA issued a draft guidance, Demonstrating Substantial Evidence of Effectiveness for Human Drugs and Biological Products (Draft Guidance), on December 19, 2019, as an expansion of its 1998 guidance, Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products (1998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.

As part of the US Food and Drug Administration’s (FDA’s) overall reorganization of the Office of New Drugs, the former Office of Hematology and Oncology Products (OHOP), the FDA office responsible for approving cancer therapies, was recently restructured and renamed the Office of Oncologic Diseases (OOD).

Per Dr. Richard Pazdur, the acting OOD director, the reorganization will allow for greater stakeholder engagement and streamline the drug review process. OOD is now composed of six divisions, including three divisions of oncology.

The US Food and Drug Administration (FDA) issued an updated draft guidance on March 7 on the nonproprietary naming of biologics, titled Nonproprietary Naming of Biological Products: Update. This update is FDA’s second attempt at guidance concerning nonproprietary name suffixes for biologic products. It also highlights the perceived tension between FDA’s pharmacovigilance role and goal of increasing the availability of biosimilars. At least for this round, FDA’s interest in tracking pharmacovigilance data seems to have received priority.

Read the full LawFlash.

In FDA’s latest Director’s Corner podcast, Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER or Center), reflects on the Center’s accomplishments of the past year and priorities for 2019. As expected, parts of CDER were affected by the government shutdown, which has caused a delay in the development of some of the Center’s policy activities and accomplishments to start the year. However, despite the delay, Dr. Woodcock provided updates on several initiatives coming up in 2019. Below is a summary of the major initiatives to expect in 2019. Overall, it looks like CDER is gearing up for a busy and productive year. Industry stakeholders should be on the lookout for many new developments coming out of the Center.

Law360 published an article on August 18, 2018, by Morgan Lewis life sciences lawyers that discusses the FDA’s plans to advance biosimilar products. In an effort to reduce the cost of prescription drugs, the Biosimilars Action Plan (BAP) focuses on four key strategies:  (1) improving the efficiency of the biosimilar and interchangeable product development and approval process; (2) maximizing scientific and regulatory clarity for the biosimilar product development community; (3) developing effective communications to improve understanding of biosimilars among patients, providers, and payors; and (4) supporting market competition by reducing gaming of FDA requirements or other attempts to unfairly delay market competition to follow-on products. As discussed in the article, the BAP outlines several priority deliverables to achieve each strategy. Time will tell, however, if the BAP is able to achieve its goal of facilitating biosimilar development and promoting biosimilar use.

Read the full Law360 Article.

In an attempt to minimize perceived obstacles to generic drug market entry, the FDA issued two draft guidance documents on May 31, 2018, related to shared system risk evaluation and mitigation strategies (REMS), providing the industry with insight into a previously underdefined area of FDA regulation. A shared REMS is one that encompasses multiple prescription drug products and is implemented jointly by two or more applicants. One of the new draft guidance documents sets forth the circumstances when a shared REMS program is required. The other draft guidance explains how to request a waiver from a shared REMS, signaling FDA’s willingness to grant such waivers.

Unfortunately, FDA did not provide any concrete steps to assist drug manufacturers with the challenging task of working cooperatively with market competitors on these drug safety programs. Nevertheless, the two guidance documents are a must-read for both brand and generic drug applicants.

Read the full LawFlash.