FDA Regulatory

On Monday, April 27, Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) announced the next steps for 21st Century Cures 2.0 (Cures 2.0), legislation that will build on the original 21st Century Cures Act enacted in December 2016 (Cures 1.0). While Cures 1.0 aimed to speed up the process of bringing new treatments to market, Cures 2.0 is generally envisioned to emphasize public health and streamlined care delivery, particularly in light of the COVID-19 pandemic. Elements envisioned to be in Cures 2.0 were outlined in a recently published concept paper that we discuss in this post.

Citing poor quality, the U.S. Food and Drug Administration (FDA) has barred the importation of certain KN95 filtering facepiece respirators manufactured in China. On May 7, 2020, FDA revised and reissued the Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China Emergency Use Authorization (EUA) that provided eligibility criteria authorizing the importation of respirators from China that are not approved by the National Institute for Occupational Safety and Health (NIOSH) (i.e., not certified as meeting the N95 standard).

The Food and Drug Administration (FDA) continues to churn out policy statements, guidance documents, and emergency use authorizations (EUAs) to address the COVID-19 public health emergency. At the outset of the pandemic in early 2020, the agency concentrated its efforts on measures relating to devices that may help directly diagnose, treat, or prevent COVID-19, such as facemasks, ventilators, and diagnostic test kits. Recently, however, FDA appears to have shifted its focus to devices that may assist in the defense against the spread of COVID-19. For example, FDA issued enforcement policies and EUAs that help to expand the availability and capability of various remote monitoring devices and systems that can be used to diagnose and monitor medical conditions while mitigating circumstances that could lead to patient and health care workers’ exposure to SARS-CoV-2 (the virus that causes COVID-19) for the duration of the public health emergency.

In response to the COVID-19 pandemic, the Coronavirus Aid, Relief, and Economic Security (CARES) Act was signed into law on March 25, 2020. In addition to the $2 trillion made available for medical countermeasure development, business relief, and other measures, the CARES Act amends the drug shortage reporting requirements and creates new requirements related to medical device shortages. With increased demand for products used to diagnose and treat COVID-19 patients and the stress placed on the manufacturing and delivery of vital products, having more information about drug, drug ingredient, and device shortages is becoming more critical.

The food industry has been upended by the recent COVID-19 pandemic – restaurants and bars are scrambling to adjust to a new way of life after governors across America issued statewide “stay at home” orders in response to the coronavirus pandemic. Restaurants are now only permitted to serve take-out or drive-thru orders, and some restaurants have transformed themselves into neighborhood markets, or bodegas, selling food items not labeled for retail.

On April 2, 2020, the Food and Drug Administration (FDA) issued a revised temporary enforcement policy regarding the manufacture and distribution of face masks and filtering facepiece respirators during the COVID-19 public health emergency. The revisions address two key omissions from the initial policy, which was released on March 25, 2020 and which we summarized in a prior blog post. Specifically, the agency has now provided guidance on: (1) the importation of respirators not approved by the National Institute for Occupational Safety and Health (NIOSH) and (2) the manufacture and distribution of face shields. FDA also added a question and answer about respirators manufactured in China to the KN95 air filtering standard (the Chinese equivalent of the U.S. government’s N95 standard) to its FAQ page on the personal protective equipment shortage and issued an emergency use authorization for non-NIOSH-approved respirators made in China.

On March 25, 2020, the Food and Drug Administration (FDA) issued a temporary policy relating to enforcement of regulatory requirements for face masks and respirators during the COVID-19 crisis. Since the public health emergency began, the United States has experienced a shortage of masks, respirators, and other personal protective equipment (PPE) which are critically needed for health care workers caring for COVID-19 patients in all states. FDA previously created emergency use authorizations (EUAs) for NIOSH-approved disposable respirators for use in health care settings and imported non-NIOSH-approved disposable respirators, but the temporary enforcement policy represents an attempt to open the manufacturing, importation, and distribution flood gates to make more masks and respirators available as quickly as possible.

In recognition of the widespread disruptions the COVID-19 crisis is posing to planned and ongoing clinical trials at sites throughout the United States (and global clinical sites), the Food and Drug Administration (FDA) issued on Wednesday, March 18 a guidance describing potential considerations for adjusting trial processes and, potentially, protocols and statistical analysis plans to mitigate any difficulties meeting trial objectives due to interference from the virus and related social and governmental restrictions. The document, titled FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic, describes various potential complications, such as subjects being unable to travel to the trial site, loss of access to investigational product, or the need to screen subjects for COVID-19, as well as general recommendations for addressing them.

We have previously blogged about the regulation of cannabidiol (CBD) products by the Food and Drug Administration (FDA) and the government’s actions to create a comprehensive regulatory framework for CBD, which includes introducing the Cannabidiol and Marijuana Research Expansion Act and hosting an FDA Public Hearing in May 2019 to obtain scientific data and safety information regarding cannabis-derived compounds. Most recently, on March 5, 2020, Commissioner Stephen Hahn provided an update to FDA’s efforts to increase education, research, and enforcement in this area. While the update alerted consumers, health professionals, and industry of FDA’s ongoing efforts to regulate CBD products, the efforts themselves are not dramatically new.

ML Strategies’ Aaron Josephson explains why FDA is looking to Collaborative Communities to help solve challenges in 2020 and the potential benefit to companies who participate in the development of public policy.

On Tuesday, February 11, 2020, Senators Bill Cassidy (R-LA), Jeanne Shaheen (D-NH), and Tammy Baldwin (D-WI) introduced legislation to eliminate the “orphan drug loophole.” Current law allows the Food and Drug Administration (FDA) to grant seven years of market exclusivity to a drug manufacturer if the drug is intended to treat a disease or condition affecting fewer than 200,000 patients in the U.S., or less commonly, if the manufacturer cannot expect to recover the costs of developing and marketing a drug. In some cases, even if the drug developer meets the orphan drug criterion of having no hope of recovering the costs, the drug does actually become profitable—some significantly so—but competitors are still barred from entering the market with a lower-cost alternative during the 7-year exclusivity period that exists by operation of law. To combat this issue, the recently introduced Senate bill (as well as a nearly-identical House bill introduced in October 2019) targets a loophole that allows market exclusivity under the Orphan Drug Act to be extended for future versions of the same drug without the drug's manufacturer having to show that the drug remains unprofitable.