In this episode of the Diagnosing Health Care Podcast: On April 21, 2023, the U.S. Supreme Court ruled to preserve access to the prescription abortion drug mifepristone.
However, while the case continues in the U.S. Court of Appeals for the Fifth Circuit, the future of mifepristone—and the U.S. Food and Drug Administration’s authority to approve new drugs—will continue to be debated on appeal.
Continue Reading Podcast: The Legal Battle Over Mifepristone – Diagnosing Health Care
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
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?
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
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
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
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
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.”
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.
Continue Reading Unpacking Averages: Creating an Industry-Specific Index to Track the FDA Regulatory Environment
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.
Continue Reading Unpacking Averages: The Difference Between Data and the Truth: Comparing FDA’s UDI Database with FDA’s 510(k) Database