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In prior posts here and here, I analyzed new data obtained from FDA through the Freedom of Information Act about FOIA requests.  I looked at response times and then started to dive into the topics that requesters were asking about.  This is the third and final post on this data set, and it builds on the last post by taking the topics identified there to explore success rates by topic.  From there, I look at who is asking about those topics and how successful those individual companies are in their requests.…

Continue Reading Unpacking Averages: Success Rates for FDA FOIAs by Topic and Requester

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In this episode of the Diagnosing Health Care Podcast:  A complex landscape of state laws overlays the direct access testing model, ranging from physician order requirements, such as telemedicine standards and the corporate practice of medicine doctrine, to specimen collection considerations, including how the varying options for collection could impact a model.

How do these factors combine to create a roadmap for companies navigating the direct access testing industry?…

Continue Reading Podcast: Direct Access Laboratory Testing – Physician Orders and Specimen Collection – Diagnosing Health Care

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In this episode of the Diagnosing Health Care Podcast:  Renewed interest in the potential benefits of psychedelic treatments has led to an upsurge in research. Is the first FDA approval of a psychedelic for therapeutic use on the horizon?…

Continue Reading Podcast: Legal and Regulatory Landscape for Psychedelics as Therapies – Diagnosing Health Care

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Continuing my three-part series on FOIA requests using a database of over 120,000 requests filed with FDA over 10 years (2013-22), this month’s post focuses on sorting the requests by topic and then using those topics to dive deeper into FDA response times.  In the post last month, I looked at response times in general.  This post uses topic modeling, a natural language processing algorithm I’ve used in previous blog posts, including here[1] and here[2], to discern the major topics of these requests.…

Continue Reading Unpacking Averages: FDA FOIA Response Times by Topic of Request

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In a March 6, 2023 constituent update, the U.S. Food and Drug Administration (“FDA”) announced the launch of its new Dietary Supplement Ingredient Directory (the “Directory”), which the agency describes as “a one stop shop of ingredient information that was previously found on different FDA webpages.”  According to the FDA, the Directory is “intended to help manufacturers, retailers, and consumers stay informed about ingredients that may be found in products marketed as dietary supplements and quickly locate information about such ingredients on the FDA’s website.”  With the release of the Directory, the FDA is now retiring the “FDA Dietary Supplement Advisory Ingredient List.” …

Continue Reading FDA Introduces Dietary Supplement Ingredient Directory

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On February 22, 2023, the U.S. Food and Drug Administration (“FDA”) announced a much-anticipated draft guidance regarding the naming and labeling of plant-based milk alternatives.[1] Significantly, under the draft guidance, FDA will not prohibit the use of the identifier “milk” in plant-based milk alternatives but does recommend the product be labeled with “voluntary nutrient statements” to help consumers understand the nutritional differences in the products.

Over the past decade, plant-based milk alternatives have dramatically increased in both availability and consumption. During this time, industry stakeholders have disagreed over the use of the term “milk” for plant-based alternatives that do not contain milk from cows. The dairy industry has lobbied both federal and state governments to restrict the use of “milk” to only fluid “obtained by the complete milking of one or more healthy cows.”[2] To address this debate and to acknowledge the exponential increase in the sale of plant-based milk products, FDA issued a notice for public comment in September 2018 on the “Use of Name of Dairy Foods in the Labeling of Plant-Based Products” that amassed over 13,000 comments. The recently issued draft guidance indicates that the agency did in fact rely on the findings from this notice in developing its recommendations.…

Continue Reading FDA Issues Draft Guidance on Labeling of Plant-Based Milk Alternatives

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Federal agencies in health care publish large amounts of data, and my posts typically analyze that data.  To provide more value to readers, I’ve started submitting FOIA requests for unpublished data to produce additional insights into how FDA works.  And what better first topic than data on FDA responses to FOIA requests.

Information is important, and thus so is access to it.  Our democracy needs to know what’s going on in our government, and businesses trying to navigate the FDA regulatory process likewise need to understand the regulatory process.  For both purposes, the FOIA process should be fair and efficient.

FDA has been releasing data on its FOIA process, specifically its FOIA logs, for a few years.  For data analysis purposes, those data are missing some important fields such as the date of the final decision.  Further, when it comes to looking at the data on the closed cases, the data only go back four years.  In my experience, the pandemic years were anomalous in so many ways that we can’t treat any data from the last three years as typical.  As a result, I wanted to go back 10 years.…

Continue Reading Unpacking Averages: Exploring New Data on FDA Responses to FOIA Requests

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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?
Continue Reading Unpacking Averages: Using NLP to Assess FDA’s Compliance with Notice and Comment in Guidance Development

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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.…

Continue Reading FDA Issues Final and Draft Guidance Documents Regarding Food Allergen Labeling

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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 11th 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.”…

Continue Reading FDA Issues Orphan Drug Exclusivity Policy That Could Be a Catalyst for Future Litigation