Introduction

Let’s say FDA proposed a guidance document that would change the definition of “low cholesterol” for health claims.  Now let’s say that when FDA finalized the guidance, instead of addressing that topic, FDA banned Beluga caviar.  If you are interested in Beluga caviar, would you think you had adequate opportunity to comment?  Would you care if FDA argued that Beluga caviar was high in cholesterol so the two documents were related?

The Food and Drug Administration (FDA) recently issued both draft and final guidance regarding food allergen labeling requirements.  The draft guidance document, Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5), updates the previous (fourth) edition with new and revised guidance concerning food allergen labeling. FDA also issued a final guidance document with the same title in order to preserve questions and answers that were unchanged from the previous (fourth) edition, which was published in 2004 and last updated in 2006.

On January 24, 2023, FDA published a notice in the Federal Register entitled, “Clarification of Orphan-Drug Exclusivity Following Catalyst Pharms., Inc. v. Becerra.”[1]  In brief, the Catalyst decision by the 11^th Circuit Court of Appeals[2] concerned FDA’s application of the Orphan Drug Act (21 USC 360cc(a)), and in particular the extent of the 7-year orphan drug market exclusivity (ODE) provided with an orphan drug’s approval. The ODE, per the Orphan Drug Act prevents FDA from approving another applicant’s same drug for “the same disease or condition.”

On November 18, 2022, the Alliance Defending Freedom (“ADF”), a conservative legal group, filed a motion with the federal district court in the Northern District of Texas against the U.S. Food and Drug Administration (“FDA”) to withdraw approval of Mifepristone, an FDA-approved drug used to end pregnancies in the first trimester.[1]  While this case addresses access to a single product and was prompted by abortion opponents’ efforts to eliminate access to medication abortion, a loss for FDA in this case could have far broader implications.

In this episode of the Diagnosing Health Care Podcast:   The Dobbs v. Jackson Women’s Health Organization decision, which effectively removed the federal constitutional protections for abortion, triggered a series of changes for health care providers and patients alike across the nation with respect to abortion services.

What additional implications are there for certain aspects of clinical trials and research?

On this episode, Epstein Becker Green attorneys Kate Heffernan, Marylana Helou, and Megan Robertson discuss how the changing state laws and regulations post-Dobbs may impact clinical research in different ways for different stakeholders.

The Joint Commission, one of the leading accrediting organizations of health care entities, recently announced significant updates to require that health care organizations invest in their health equity promotion infrastructure and The Joint Commission’s intention to acknowledge those organizations with more robust health equity initiatives and programs.

Effective January 1, 2023, The Joint Commission implemented new and revised standards for hospitals, ambulatory health care organizations, and behavioral health care organizations aimed at reducing health care disparities.

Most significantly, The Joint Commission added a new standard, LD.04.03.08, to the Leadership (LD) chapter. This standard provides: “Reducing health care disparities for the [organization’s] [patients] is a quality and safety priority.”[1] The new standard, which applies to all hospitals and certain ambulatory health care organizations and behavioral health care organizations, has the following six elements of performance:

In this episode of the Diagnosing Health Care Podcast:   With the recent midterm elections changing the composition of Congress, and the Biden administration’s first opportunities to advance its policy priorities from the very beginning of the rulemaking process, what are the key health care developments to watch out for in 2023?

Epstein Becker Green attorneys Ted Kennedy, Jr.; Alexis Boaz; and Philo Hall discuss the current landscape of health care policy from both the legislative and regulatory perspectives and analyze which key health care issues may arise.

More than just New Year’s resolutions went into effect when the clock struck midnight on January 1, 2023. The California Privacy Rights Act (“CPRA”) and the Virginia Consumer Data Protection Act (“VCPDA”) are now effective in California and Virginia, respectively. These comprehensive data privacy laws, along with three other state laws going into effect this year, establish new and complex obligations for businesses. If your business has not taken steps to prepare for these privacy laws, it is high time to start that process to avoid violations and enforcement likely to follow later in the year. See below for a timeline of key dates.

The regulatory environment at the US Food and Drug Administration (“FDA”) has a tremendous impact on how companies operate, and consequently data on that environment can be quite useful in business planning.  In keeping with the theme of these posts of unpacking averages, it’s important to drill down sufficiently to get a sense of the regulatory environment in which a particular company operates rather than rely on more global averages for the entire medical device industry.  On the other hand, getting too specific in the data and focusing on one particular product category can prevent a company from seeing the forest for the trees.

Recently, I was asked by companies interested in the field of digital medical devices used in the care of people with diabetes to help them assess trends in the regulatory environment.  To do that, I decided to create an index that would capture the regulatory environment for medium risk digital diabetes devices, trying to avoid getting too specific but also avoiding global data on all medical devices.  In this sense, the index is like any other index, such as the Standard & Poor 500, which is used to assess the economic performance of the largest companies in terms of capitalization.  My plan was to first define an index of product codes for these medium risk digital diabetes products, then use that index to assess the regulatory environment in both premarket and postmarket regulatory requirements.

It is certainly easy, when writing code to accomplish some data science task, to start taking the data on face value.  In my mind, the data can simply become what they claim to be.  But it’s good to step back and remember the real world in which these data are collected, and how skeptical we need to be regarding their meaning.  I thought this month might be an opportunity to show how two different FDA databases produce quite different results when they should be the same.