FDA Matters subscribers often start their week with my Q&A Monday column. To join them, you can subscribe (free) at www.fdamatters.com. A substantial amount of new information surfaced during the often quiet Thanksgiving week, so I wanted to share an edited and updated version of yesterday’s (December 1) Q&A column. This column addresses four issues: Commissioner Makary’s standing with the White House and HHS and what would likely happen if he quit or was pushed out, food policy…
This week, many of us will be sitting down to a Thanksgiving dinner and talking about the parts of our lives for which we are grateful. Consider adding thanks to FDA and its more than 15,000 diligent and dedicated staff. And a special thanks to the inspectors and compliance staff who never get sufficient credit for their difficult, invisible, and potentially dangerous work overseeing nearly 300,000 FDA-regulated facilities, including farms, food and medical ingredient processing plants, and…
Dr. Pazdur’s appointment to lead FDA’s Center for Drug Evaluation and Research (CDER) has been widely acclaimed….and rightly so. It is particularly pertinent to last week’s FDA Matters column about the direction of employee morale at FDA (here). If the situation improves, Dr. Pazdur’s appointment might be the turning point. In response to media inquiries, I made four statements that I am reiterating here with additional commentary: No one has a longer history of public decisions…
Over the past two weeks, several news stories have reported low morale at FDA. Although they all reached the same conclusion, each story focused on a different driver. One was about how the shutdown was exacerbating low morale; another focused on the cumulative impact of ten months under the new administration; and another examined leadership instability, as illustrated by the peculiar case of Dr. Tidmarsh’s ouster as head of CDER. The agency has endured a lot, starting with the DOGE cuts…
This week’s questions: Any initial thoughts on CDER Director George Tidmarsh’s response to being accused of abusing his office? Your column on national uniformity and federal preemption (here) was critical of both industry and consumer advocates who are involved in the fight over food ingredient safety. Did you wind up in hot water? The FDA’s newly-announced reforms of the approval process for biosimilars are being greeted with both plaudits and yawns. Which is the correct response?…
This week’s questions: What do you think about this past week’s stories on increased lobbying by pharma (and others) this year? Why was your analysis (here) of the nine vouchers awarded under the National Priority Review Voucher Initiative more positive than most? Q: What do you think about this past week’s stories on increased lobbying by pharma (and others) this year? A: The pharma companies have been more active in DC this year, with much higher-level executives than in the past (i.e., the…
To keep our country safe, counterterrorism efforts must be operational and effective 24/7/365. It only takes one terrorist at one specific moment to create a catastrophe. When it comes to food and medical products, FDA is our nation’s Department of Homeland Security. FDA needs to be funded and staffed at a level that reflects our vulnerability and the potential consequences. The threat is both domestic and foreign; we need support for systems that are effective in protecting us from both…
This week’s questions: It appears that no progress has been made to end the federal government shutdown. What happens next? There have been recent headlines that FDA’s FY 26 funding might be appropriated, separate from resolution of the shutdown. Is this true and how likely is it? FDA has announced the first nine companies to be granted vouchers under the Commissioner’s National Priority Review Voucher Initiative. What do you think? Q: It appears that no progress has been made to end the…
Since the founding of our republic, there has been debate about states’ rights vs federal rights. And in times of stress, the discussion gets more heated and gains more traction. Once again, FDA is moving into the center of such debates. Federalism is at the Heart of FDA’s Responsibilities National uniformity is central to FDA’s mission and responsibilities. In general, food and drug regulation is based on the need for–and value of–comprehensive nationwide coverage of regulated…
The announcement that former CBER Director, Dr. Peter Marks, was joining Lilly as SVP for molecule discovery and head of infectious diseases….set the internet ablaze with unjustified outrage about his transition from a government career to industry. My multiple comments and responses on LinkedIn (e.g. here) received nearly 20,000 impressions in total: “There are numerous crazy posts on LinkedIn about the revolving door. Where is Dr. Marks supposed to take his education and…
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Steven A. Grossman, JD, is the founder and author of FDA Matters. Read more about Steven here.