We are trying something new this week in our Viewpoint, hoping to dispel the idea that you can’t teach an old dog new tricks. To learn about the impact of videos in recruiting, all you need to do is click on the link below…to a short video.  Even an old dog would have seen that coming!

Click here to view our video viewpoint.

Jeff Santosuosso

It was with sorrow we learned of the passing of Queen Elizabeth last week , a long and fruitful life in service to her country and countrymen. As an American, you grow up and are taught certain ideas about the British Monarchy and its role. But after living under the constitutional monarchy under the Queen, both in Australia and The United Kingdom, I gained a greater understanding and appreciation of the positive things they present.

And while I was in the UK, I quickly learned how adamant a supporter of Agriculture the Queen was. Of course well known for her love of horse racing, what was not well understood or appreciated was her steadfast support for farming and the ‘countryside’. She served on various Agricultural societies including the Young Farmers Clubs and The Great Yorkshire Show, a large agriculture event. UK farming will miss her steadfast loyalty and support.

Unlike Queen Elizabeth, many of our leaders across the world today do not really understand agriculture and its critical role in feeding the world and national security. They are too willing to trade off farming requirements for ‘green’ initiatives that many times inevitably damage or restrict farmer’s abilities to supply food to feed the world. For example, The Netherlands, a country that is twice the size of New Jersey, happens to be the 2^nd largest exporter of agricultural products in the world, behind the USA. Recent ‘green’ legislation passed by their government aims to reduce the number of farms by half, believing that this will benefit climate change. So now what? Where does the production go? And what about the loss of the farming industry? This could easily happen here; just look at California.

Recently the FDA announced its intent to open a dialogue on how to deal with ‘environmental claims’ on pharmaceutical products. We as an industry need to be very careful in how we address this issue as it may become a Pandora’s box. In principle, our products are developed to prevent or treat diseases. While some products may have collateral environmental benefits, if a pathway is developed to support such a claim, it may in fact be desirable. But it may end up being a future standard that does not fit all products, and even may be retroactively required of all. Be careful!

Paul Casady

For those who are Saturday Night Live fans from the late 70’s may recall Roseanne Rosannadanna’s famous line, “It’s always something.  If it’s not one thing it’s another”. Gas prices continue to decline.  Inflation rates are beginning to moderate.  It seems that the recent economic woes are stabilizing and even improving.

The cattle producing states are facing one of the worst droughts in recent history.  According to a new survey by the American Farm Bureau Federation, this year’s drought conditions are taking a harder toll than last year’s, as 37% of farmers said they are plowing through and killing existing crops that won’t reach maturity because of dry conditions. In addition, ranchers are being forced to sell off their cattle herds earlier than normal due to extreme drought, as water sources dry out and grass burns up. Ranchers in Texas reported the largest reduction in herd size, down 50%, followed by New Mexico and Oregon at 43% and 41% respectively.

In the short run, there should be reduction in beef prices as the additional supply works its way through the value chain, which is good.  However, in the medium/long term, prices should increase as supply moderates while ranchers rebuild their herds which can take years.  The animal health companies will likely be adversely impacted this year and into the future by losing potential doses of vaccines, antibiotics, parasiticides and hormonal implants as a result of early cattle harvesting and reduced herd sizes.

There are so many variables out of our control that impact key segments of the US economy.  Drought, floods, what’s next…pestilence?  Like Roseanne Roseannadanna said, “if it’s not one thing it’s another”.

Randy Freides

This week found me thinking more about innovation in the animal health industry, primarily driven by attending the 2022 Animal Health Corridor Summit on Monday and Tuesday.  KCAHC’s Kim Young and Emily McVey did a great job organizing a sold-out event that had a theme of brining innovation to our industry.

One half day of the Summit was dedicated to presentations from emerging companies, and I caught up with Tom Overbay of Expedite Animal Health, who led the coaching and selection teams for these start-ups, to find out more about them.  There were 32 emerging companies that applied to present at the Summit and of these, surprisingly, about 60% of them were focused on livestock and 40% on companion animals.  And of these 32, about 15% were product related, where an FDA/USDA approval would be needed and 85% were diagnostic or technology related.  Of the 12 finalist companies, 7 were diagnostic or technology related, and an emerging diagnostic company won the competition, Vidium Animal Health.

Fabian Kausche touched on this at the Summit in his presentation, titled “Transitions in Innovation in Animal Health” where he reminded us of the historical waves of innovation in animal health – we are in a technology-based wave of innovation.  But I cannot help but think expensive FDA user fees hamper drug innovation, a topic raised in a recent Viewpoint.

If you lead or know someone in an emerging company or would like to voice your opinion on FDA user fees and innovation, you have a chance to do so on September 6^th from 10-11 am.   Click here to join the meeting, where the FDA will be in “listening mode”. These sessions are generally very poorly attended.  Written comments may be also submitted to the docket at any time by clicking here and currently, there are very few comments posted.   Innovation in animal health is not easy, but perhaps if the FDA hears from you, they can help make new drug approvals easier.

Bob Jones

I was interested to read in this week’s news that VCA is launching an urgent care veterinary service. It marks VCA’s first effort to build rather than acquire veterinary hospitals. But more intriguing is the business model: they plan to offer only urgent care appointments for non-life-threatening conditions, with free teletriage to determine whether a pet needs urgent care, emergency care, or routine care from their regular veterinarian. They are also offering a ‘virtual waiting room’ so clients can wait at home until it’s time for their appointment. Given the widespread concerns about long waits to see both general practitioners and emergency-only practices, this seems to fill a need in the veterinary care space.  Urgent care facilities are well-established in human medicine; it will be interesting to follow this initiative to see if the urgent care concept takes off in the veterinary space.

Lynn Fondon

When our two daughters went to university, we encouraged them to participate in study abroad programs.  We also travelled internationally occasionally on family vacations because we felt it was important to gain on-the-ground understanding of other cultures and traditions.  This week’s newsletter really highlights the value of approaching life and work from a global perspective. Several items report on cross-border registrations, transactions and initiatives.  Today even small companies need executives familiar with the way pets and food animals are cared for in other parts of the world, and how business is conducted.  Given the investment required to develop and market innovative products, there’s no room for provincialism any more.  Success will go to those prepared to learn and adapt to more cultures.

John Volk 

We should not give up on developing a MLV vaccine for ASF.

In recent meetings with R&D leaders of domestic and international animal health companies in China, the topic of a modified live virus (MLV) vaccine for African Swine Fever (ASF) was often discussed. Most of these company leaders do not believe that an MLV vaccine will be approved by the Chinese regulatory agency anytime soon. The major concern is the safety of MLV vaccines.

The danger of an ASF MLV vaccine has been clearly demonstrated by the unauthorized introduction of various attenuated ASF viral strains as experimental vaccines in China in the last few years. These “less-virulent” MLV strains caused more damage than the wildtype ASFV because the disease became clinical when pigs grew older and were stressed.

However, we should not give up the hope that a safe and efficacious MLV vaccine for ASF is possible. Afterall, the safe and efficacious C-strain Classical Swine Fever (CSF) vaccine is an MLV vaccine and it has been successfully used to control CSF in many countries in the last few decades. Because MLV vaccines are often administered once and are more efficacious (quicker onset of immunity and longer protection) than subunit vaccines, they are usually a more cost-effective tool for infectious disease prevention and control compared to other types of vaccines. If an MLV ASF vaccine has a similar level of safety and efficacy profile as the C-strain CSF vaccine for CSF, it should be approved for use in ASF control and prevention.

Jishu Shi

In this space last week, Bob Jones published a thought-provoking Viewpoint on the topic of FDA Animal Drug User Fees. He asked if readers felt that the User Fee amounts are reasonable. Not surprisingly, 57% said the fees are too high.

I recently read “Flying Blind: The 737 MAX Tragedy and the Fall of Boeing” by Peter Robison. Robison outlined the issues regarding the 737 MAX and the accidents that resulted. A recurring theme is the policy of the Federal Aviation Administration (FAA) to “outsource” oversight of airplane development to the manufacturers themselves. Boeing made decisions about the development of this plane and the training for its pilots that would have been visible to a competent and independent regulator; unfortunately, the FAA lacked the understanding to challenge these decisions and 346 people died in 2 crashes, resulting in the grounding of the airplane and one of the costliest corporate scandals ever.

So…what does this have to do with Animal Health? The industry agreed to support CVM’s efforts through the User Fee system maintaining expertise and providing for certainty in the review process. Yes, it can take a lot of money to register a new compound or a new generic drug; however, the regulatory system continues to help our industry maintain a position in our society that we can be proud of. And that has a value that is certainly real.

Jim Kroman

Do high FDA Animal Drug Users Fees slow innovation in animal drugs?

Each year the FDA ADUFA/AGDUFA fees change due to inflation, workload, and prior year excesses or shortfalls in collections.  Starting in October, New Animal Drug Applications will require a $659,364 check and a supplemental application will need a $329,682 check, 13.5% more than last year.  A generic drug ANADA will need a $494,983 check in 2023, down from $548,628 in 2022 due primarily to excess collections in 2021.  That’s a lot of money and it must impact innovation.

Some interesting information on innovation comes from the workload calculation.  The average number of NADAs submitted over the last 5 years (ending May 2022) is 12.8, which is down 22% compared to the 5 years ending September 2018, which had an average of 16.4 applications.  The FDA expects 5.25 NADAs in 2023.  Comparing these same 5-year periods to each other, supplemental applications are down 22% also, investigational study submissions are down 7%, manufacturing supplements are up 4% and investigational protocol submissions are up 1%.  This all leads to an overall 4.5% reduction in workload, which doesn’t reflect well on innovation.

However, the workload for Generic Animal Drugs is booming – it’s up 77%. Over these same two 5-year periods, ANADAs are up 12.5% (27 vs 24), generic investigational study submissions are up 125%, generic investigational protocol submissions are 77% and manufacturing supplements are up 30%.  The FDA estimates that in 2023, there will be 11.6 full fee ANADAs filed, double the NADAs filed.

So, less risky, cheaper generic drug development has replaced more risky, expensive new drug development.  There are provisions for fees to be waived or reduced if the product is deemed to be innovative and that the fee would be a significant barrier to bringing the product to market.  The number of NADAs that were filed with the FDA and had the fees waived is not published by the FDA – we assume it is insignificant.

This is the last year of ADUFA IV and negotiations are underway now for ADUFA V, which would begin in FY2024.  Let’s hope its structured to drive more innovation.

Bob Jones

In recent weeks I have been visiting corporate offices and cannot help but notice how empty some of them are. As we recover from the pandemic and are now in the endemic part of the story, will there ever be a return to the days when people went to offices to work and did not operate in the virtual Zoom world. While many people I asked desired a return to that environment, they were also quick to point out the joys of flexible work arrangements – especially those with long commutes. And no doubt the cost of gasoline is now replacing Covid as a reason not to drive to the office every day. In the end, will companies and employees come to an appropriate compromise that encourages good work performance- while meeting the new expectations for the remote work opportunity?

Another observation is that the last couple of years has made many of you think differently what a ‘successful’ career would look like. Work/life balance was really brought back into perspective and many people have reengineered what they are defining as success. How about you? It’s perfectly natural to stop and see if you are headed where you want to be after what we’ve been through. If you haven’t done this in a while, it’s always good to stop and really look hard at your career/life balance and make sure you are headed where you want to go. And you may be surprised by the outcome!

Paul Casady