FDA’s mission is “at risk” because of inadequate funding. So says Alliance for a Stronger FDA President Diane Dorman, testifying before the FDA Science Board. Her remarks come 5 years after the Science Board made a similar declaration, concluding that decades of underfunding had left FDA without the resources to fulfill its mandate and make science-based decisions. Congress responded with more monies for the agency, but since then the FDA’s workload has increased even faster. The current threat to FDA comes from two sources: four major new laws to implement since 2009; and changes in the environment in which FDA operates, notably acceleration of globalization and increasing scientific complexity. Ms. Dorman’s remarks are reprinted below. If you care about FDA, FDA Matters urges you to read her testimony, go to the Alliance’s site (www.StrengthenFDA.org) and join.

At a time when FDA’s responsibilities continue to grow rapidly, the agency has been caught in an across-the-board reduction (sequester) in federal discretionary spending, effective March 2, 2013. Although Congress may yet reverse course and restore money to affected federal agencies, this is not considered a high probability. Altogether, FDA will lose about $209 million between now and September 30, 2013. This will reduce inspections, slow drug and device approvals, and restrict implementation of the Food Safety Modernization Act and other recent legislation. Because of the many questions about the process and outcome, this is FDA Matters’ primer on the sequester of FDA funds.

Chicken was once an expensive delicacy. In 1928, America’s quest for a better diet and a better standard of living was summarized by the campaign promise of “a chicken in every pot.” Today, chicken is a ubiquitous, low-cost source of protein, which we largely take for granted. Despite depletion of ocean-based stocks, fish hold similar potential. To begin this transformation, FDA must approve a scientifically-based innovative product—a faster growing genetically-engineered (GE) Atlantic salmon. When FDA Matters wrote about this subject 18 months ago, I believed the agency was near to approval of this first-ever food product from a GE animal. It is still not resolved and there are implications for all innovations that require FDA approval.

The FDA doesn’t care about the First Amendment rights of the companies it regulates. It cares even less about the “free speech” rights of those companies’ sales and marketing representatives. And why should the agency care? One of FDA’s primary missions is to protect the public health and safety of the American people from illegal, adulterated and misbranded products. Doing so involves restraining food, drug, device and cosmetics companies from committing fraudulent and deceptive acts that are not protected by companies’ commercial free speech rights. Nonetheless, FDA Matters envisions opportunities for FDA and industry to broaden permissible product communications. The key is understanding history, not constitutional law.

FDA Matters appreciates your patience. New columns will be coming in June, with fresh insights into FDA and the FDA-regulated world.  Meantime, I write a weekly column in the Friday Update, published by the Alliance for a Stronger FDA. If you want to receive the Friday Update when it's published each week, you can sign […]

“The Hill” newspaper recently reported that: “a survey of federal budgets devoted to developing and enforcing regulations found that many agencies will spend more in 2013 and 2014 than in previous years, indicating that the writing and enforcing of new regulations is largely unimpeded by the massive cuts, known as sequestration.” That certainly sounds authoritative…until you look at the analysis. In fact, the report’s authors appear to know nothing about the federal budget and have used inherently unreliable data in calculating FY 13 and FY 14 spending levels. One can only hope that the authors—allegedly academic experts--know more about regulatory policy than they do about federal budgets.

<p>On 19&nbsp;September 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP)&nbsp;adopted a positive opinion,&nbsp;recommending the granting of marketing authorization&nbsp;for&nbsp;two aflibercept biosimilars:&nbsp;&nbsp;Sandoz’s Afqlir and Samsung Bioepis’s Opuviz.&nbsp;These products are biosimilars of the reference product Eylea, developed by Regeneron and Bayer.</p>

<p>On 3^&nbsp;June 2024,&nbsp;Resolution&nbsp;RDC No. 876 was published in Brazil in the Official Journal of the Union (DOU)[1],&nbsp;modifying the current regulations regarding the post-registration of biological products (RDC 413/2020).</p>

<p>The global biologicals market surged to an impressive US$419.07 billion in 2023. Blood and blood products led the market, commanding a dominant 66% share. Oncology stood out as the leading application segment, accounting for 36% of the market. North America held the largest revenue share, at 46%, while the Asia-Pacific region emerged as a rising star, poised to be the fastest-growing region over the next decade.</p>

<p>The US Food and Drug Administration (FDA) granted approval for two&nbsp;biosimilars, Formycon’s FYB202/Otulfi (ustekinumab-aauz) and Samsung Bioepis’ Soliris biosimilar, Epysqli (eculizumab-aagh), on 27 September and 22 July 2024, respectively. FYB202/Otulfi, a biosimilar referencing&nbsp;Johnson &amp; Johnson’s Stelara, while Epysqli is a biosimilar referencing Alexion’s Soliris.</p>

<p> <b>BIOSIMILAR RED TAPE ELIMINATION ACT (S2305):</b><br /> <b><i>Weakening FDA Regulatory Standards for Biosimilars, Undermining Physician Confidence and Jeopardizing Patient Health</i></b><br /><b>31 October 2024&nbsp;|&nbsp;</b><b><a href="https://youtu.be/X6-dYZ7fjhM" target="_blank">WATCH REPLAY</a></b></p>

<p> <b>23rd Regulatory Affairs Conference 202</b><b>5</b><br /> <b>27</b><b>‒</b><b>28 February 2025</b><br /> Hilton Amsterdam Airport Schiphol<br />Amsterdam, The Netherlands</p>

<p>In May 2024, Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) announced that it will trial new timelines for variation applications&nbsp;of registered pharmaceutical products and natural health supplements (TMHS).</p>

<p>In October 2024, China based Bio-Thera Solutions&nbsp;(Bio-Thera)&nbsp;and Hungary’s Gedeon Richter announced they have reached an exclusive commercialization and license agreement for BAT2206, a biosimilar candidate to&nbsp;Johnson &amp; Johnson’s Stelara (ustekinumab).</p>

<p>The European Commission (EC) granted marketing authorization for<b>&nbsp;</b>three ustekinumab biosimilars<b>:&nbsp;</b>Samsung Bioepis’ Eksunbi on 12 September 2024; Formycon’s Fymskina, and Fresenius Kabi’s&nbsp;Otulfi on 25 September 2024.</p>

<p> <b>Abstract</b><br />CinnaGen, the largest biopharmaceutical company in the MENA region, is a leader in developing follow-on biologicals/biosimilars. Dr&nbsp;Haleh Hamedifar, Chairperson of CinnaGen, spoke to GaBI<i>&nbsp;</i>(Generics and Biosimilars Initiative) about the company’s strategic focus, which includes expanding its product portfolio, entering highly regulated global markets, and advancing affordable treatments for conditions such as multiple sclerosis and&nbsp;immunological diseases—transforming healthcare in underserved regions.</p><p><b>Keywords</b>: Biosimilars, clinical development, commercialization, MENA</p>

The UK body that oversees health research is writing a new strategy on clinical trial transparency and it wants to hear opinions on it. The Health Research Authority (HRA) says its strategy aims to “make transparency easy, make compliance clear and make information public.” It has opened a public consultation on the strategy and some […]

An AllTrials report for the House of Commons Science and Technology Select Committee this week has found that 33 NHS trust sponsors and six UK universities are reporting none of their clinical trial results, while others have gone from 0% to 100% following an announcement from the Select Committee in January that universities and NHS […]

When university and hospital trusts were called to the UK parliament last year to answer questions on why they were not following the rules on reporting results, we saw how effective the questioning from politicians was. Those of you who watched the parliamentary session saw the pressure the university representatives were put under. Because the politicians asked […]

New research has shown that the majority of clinical trials which should be following the US law on reporting results aren’t. Less than half (41%) of clinical trial results were reported on time and 1 in 3 trials (36%) remain unreported. The research also found that clinical trials sponsored by companies are the most likely […]

A judge in New York has ruled that hundreds of clinical trials registered on ClinicalTrials.gov are breaking the law by not reporting results. The ruling came in a court case launched against the US Department of Health and Human Services by two plaintiffs, a family doctor and a professor of journalism. The case focused on […]

Learn how to take simple x/y coordinates, and create map polygons shaped like holiday images, that can be plotted using SAS/Graph's PROC GMAP.

Act now for the best deal on SAS Global Forum 2016 registration. You already know that SAS Global Forum will pay for itself in learning opportunities.

Currently, more than 20 SAS products, solutions, and technology packages interact with Hadoop. Read this book to understand how to maximize your big data assets.

Watch the video and learn basic principles of modeling panel data using SAS/ETS.

SAS admins need to know about these menu options that may not be available in SAS Visual Analytics Viewer.

This new program offers two immersive program levels, industry-recognized credentials, classroom instruction, around-the-clock access to SAS software and course materials, and more.

This paper highlights the many enhancements to SAS/ETS software and demonstrates how these features can help your organization increase revenue and enhance productivity.

 We introduced a Topics tab in the online documentation a few releases ago, and there are corresponding pages in our focus area that briefly describe the topic areas and the procedures that perform analyses for those areas.

This paper begins with a look at both optimization modeling and discrete-event simulation modeling, and explores how they can most effectively work together to create additional analytic value. It then considers two examples of a combined optimization and simulation approach and discusses the resulting benefits.

This paper provides recommendations for circumventing memory problems and reducing execution times for your mixed-modeling analyses, as well as showing the new HPMIXED procedure can be beneficial for certain situations, as with large sparse mixed models.

This paper provides a high-level tour of five modern approaches to model building that are available in recent releases of SAS/STAT.

 This paper presents the essential information that you need to get started with ODS Graphics in SAS 9.4.

This SAS Usage Note illustrates fitting a model containing a spline effect in PROC GLIMMIX. It discusses the spline basis output, the interpretation of the output, how to use the spline model to make predictions, and how to use the LSMEANS and ESTIMATE statements to compute quantities of interest.

You have just a few more days to submit your paper proposal for the 2017 SAS® Global Forum in Orlando on April 2–5. The call for papers ends and registration begins October 3.

This paper provides an example that shows you how to use multiple RANDOM statements in PROC NLMIXED to fit nested nonlinear mixed models, and it provides details about the computation that is involved in fitting these models.

I have had a long-standing interest in South Africa, and in 1995 briefly contemplated moving there to work. The country had just had its first multi-racial election, and the great Nelson Mandela had been elected President. I was deeply curious to see, at first-hand, what the land and its people would make of their hard [...]

In one of the first books I read, the writer had posed the question: ‘Who was the greatest all-rounder in the history of cricket?’, before providing this answer: ‘He was a left-arm bowler and a right-hand batsman, who was born in the village of Kirkheaton’. I now forget the title of the book, but remember [...]

I saw Christopher Nolan’s Oppenheimer earlier this week. The main character in the film, J. Robert Oppenheimer, was a physicist whose family was Jewish, and who worked for many years at the Institute of Advanced Studies in Princeton. In these respects he was akin to Albert Einstein, who makes several appearances in the movie itself. [...]

My first editor, Rukun Advani, once described himself as ‘a composite hybrid of the Indian and the Anglo-European’, who sought to reconcile ‘within himself those varying cultural influences which chauvinistic nationalists could only see as contradictions.’ This self-characterization I might avow as my own. One mark of the Anglo-European in me is that, unlike members [...]

The climate crisis has brought human ill-treatment of nature forcibly to our attention, though of course India’s environmental problems are by no means the product of global warming alone. The staggeringly high rates of air pollution in the cities of Northern India, the ongoing devastation of the Himalaya by carelessly planned roads and dams, the [...]

In recent years, a stream of books and articles have appeared seeking to analyse the theory and practice of Hindutva. They have sought to alternatively explain, critique, or justify the rising influence of the BJP and the RSS. Some have focused on organizational questions, on the building of social networks on the ground and how [...]

The Indian socialist tradition is now moribund, but there was a time when it had a profound and mostly salutary influence on politics and society. Yet few people now know of its past vigour and dynamism. The Congress, the Communists, the regional parties, the Ambedkarites, and (especially in recent years) the Jana Sangh and the [...]

An Indian I greatly admire is the social worker and pioneer of the Chipko movement, Chandi Prasad Bhatt. My first meeting with him, when I was in my early twenties, had an transformative impact on my life. I have met him many times since; each encounter providing fresh insights into the moral, political and environmental [...]

Last month I spent several stimulating days in Mizoram. I had some knowledge of the state’s political history, met numerous Mizos in the course of my life, but never visited the state before. I flew first to Guwahati, where I caught up with some old friends, gloried in my sightings of the Brahmaputra, and spoke [...]

In about a week’s time we shall mark the sixtieth anniversary of the death of India’s first Prime Minister, Jawaharlal Nehru. This column focuses on one key aspect of Nehru’s political career, his collaboration with Vallabhbhai Patel. These two men worked shoulder-to-shoulder during the freedom struggle and in the early years of Independence. They had [...]

Members, bestow yourselves with back pats of honor, for everything is going exactly as planned!

The Alloy Origins Core is a tenkeyless mechanical keyboard made of airplane-grade aluminum, which prompts the question: Why don't they make the whole plane out of keyboard?

Knifedads and youtube celebrities Karate Johnathan and Steeliest Daniel train the Appleton County High Security Elementary School on resisting drugs and witchcraft.

Jurassic Park was based on actual events. Specifically, the time that Steven Spielberg stumbled and yelped in surprise at the sight of a small lizard on top of a fence.