Saturday, March 29, 2014

Friday, March 28, 2014

MUST READ The Law of Veterinary Medicine: Jockey Club Statement: Enough is Enough --Urges ...

The Law of Veterinary Medicine: Jockey Club Statement: Enough is Enough --Urges ...: Friday, March 28, 2014 Contact: Bob Curran Jr. (212) 521-5326 Statement of Ogden Mills Phipps, Chairman of The Jockey Club and Thoroughb...

Jockey Club Statement: Enough is Enough --Urges Racing Commissions to Take Action

Friday, March 28, 2014Contact: Bob Curran Jr. (212) 521-5326
Statement of Ogden Mills Phipps, Chairman of The Jockey Club and Thoroughbred Owner/Breeder

Following the allegations raised by People for the Ethical Treatment of Animals (PETA) and reported on March 20, 2014, by The New York Times, many of us in the Thoroughbred industry are eagerly awaiting the final determination of these issues by the New York State Gaming Commission and the Kentucky Horse Racing Commission.
It is my hope that these state bodies use all the prosecutorial powers available to determine if there is evidence of animal cruelty, medication violations — and cheating.
Like so many others, I was upset by what I read in the Times and disgusted by what I saw and what was alleged in that PETA video. Any person abusing a horse or caught with an electronic stimulation device like the one described in the video should be banned from the sport for life.
And as much as it pains me to see our industry being denigrated in the media, there is another part of me that feels that we, as an industry, deserve every bit of that criticism because the sport’s rules and our penalties have not been effective deterrents.
To be sure, we have seen some encouraging actions from racing commissions.
In 2011 in New York, the regulators handed trainer Richard Dutrow Jr. a 10-year suspension on the basis that Dutrow’s conduct at racetracks in New York State and elsewhere had been “improper, obnoxious, unbecoming, and detrimental to the best interests of racing.”
And last year, authorities from Louisiana, Oklahoma and New Mexico collectively issued fines and suspensions to 14 licensees totaling nearly $253,000 and carrying 213 years of suspensions for those held to have had a role in the administration of illegal drugs, such as Dermorphin, to racehorses.
Those are steps in the right direction.
Owners, trainers, veterinarians — and really anyone who makes a living in the Thoroughbred industry — need to speak up any time they witness improper and dangerous treatment of horses or dishonest activity.
We certainly shouldn’t need an animal rights organization or a major publication to identify bad actors or their bad deeds.
All of us should feel a personal and professional duty to police this sport and immediately report any wrongdoing, either directly to the appropriate authority or through a national hotline, such as the one maintained by the Thoroughbred Racing Protective Bureau (866-TIP-TRPB).
As recommended by the American Association of Equine Practitioners, owners, trainers and veterinarians should share and adopt a policy that any therapeutic treatment or veterinary procedure for a horse involved in racing or race training be based upon a specific diagnosis and communicated among each party.
And, above all, there must be respect for the horse.
The Jockey Club, in addition to our industry service and marketing of the sport, has devoted immense resources over a long period of time to ensure the health of our athletes, resolve medication and safety issues in our sport and bring much needed transparency to the regulation of our horse racing.
We continue to believe that horses should compete only when they are free from the influence of medication, and we have supported the reforms that make up the national uniform medication program that was first proposed in 2011 (horseracingreform.org) and encompasses controlled therapeutic medications, prohibited substances, accredited labs and penalty guidelines for multiple medication violations.
By our count, however, only four of the 38 states with racing have fully implemented the national uniform medication program thus far (namely: Delaware, Maryland, Massachusetts and Virginia) — and those states deserve our highest praise and appreciation. A dozen others are in various stages of “adoption” but have yet to commit to a definitive implementation date — often because of the simple fact the bureaucratic process can be painstakingly slow. In other cases special interest groups, intent on maintaining the status quo, have stalled action.
While there is no doubt that some of those shown in the March 20 video deserve condemnation for their actions and their attitudes, representatives of states that have not adopted the national uniform medication program should also shoulder blame for the current state of affairs. Their inaction feeds the negative perceptions of our sport and lends credence to the charge that we are incapable of broad-based reform.
For every small step forward — whether it’s a televised racing series, a marketing tour, or new owner and new fan initiatives — we take two giants steps backward when prospective fans, owners, television networks, sponsors, elected officials or animal rights advocates read and see media reports that convey inhumane treatment of our athletes and a lack of integrity in our sport.
Enough is enough.
The horses deserve better.
Owners and trainers deserve better.
And in a sport based on the integrity of competition, certainly fans who wager their hard earned money deserve better.
At the Round Table Conference last August, I said that The Jockey Club supported these reforms on a state-by-state basis, but the clock was ticking. I emphasized that if the state-by-state approach failed to produce the needed changes, we would look to alternative means to implement these reforms.
One alternative avenue is federal legislation.
The draft legislation proposed by some federal lawmakers involving the United States Anti-Doping Agency (USADA) is a highly attractive model. USADA has the experience, the knowledge and the credibility to bring much-needed integrity to our sport.
The time to draw that proverbial line in the sand is rapidly approaching and The Jockey Club’s Board of Stewards plans to do that no later than the 62nd annual Round Table Conference on August 10, 2014.
Over the coming weeks and months, we will carefully assess the progress and the status of the national medication reform campaign.
If the major racing states have not implemented these reforms, The Jockey Club will reach out to federal lawmakers who have previously proposed federal legislation for our industry and to other supporters of this approach. We will aggressively seek rapid implementation, including steps leading toward the elimination of all race-day medications.
With the safety of our horses, the integrity of competition and the general perception of the sport all at risk, we cannot afford to wait any longer.
Enough is enough.
quoted from here

‘Enough is enough’: Jockey Club urges medication reforms in wake of PETA scandal

‘Enough is enough’: Jockey Club urges medication reforms in wake of PETA scandal

Optimizing the Care and Management of Your Equine Athlete

Optimizing the Care and Management of Your Equine Athlete
Food Safety Modernization Act and Animal Feed - FDA Announces Availability of Draft Guidance on Prior Notice of Imported Foods – http://www.fda.gov/AnimalVeterinary/Products/AnimalFoodFeeds/ucm347941.htm
 
Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 3) – http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/FoodDefense/ucm078911.htm

Tuesday, March 25, 2014

The Law of Compounding Medications And Drugs: Tom Noonan--Yet Another Wake Up Call for Horse Rac...

The Law of Compounding Medications And Drugs: Tom Noonan--Yet Another Wake Up Call for Horse Rac...: Posted in: Horse Racing , Political/Social commentary , Politics . Tagged: Lasix , New York Gaming Commission , New York Times , NY...

Thought, feelings, observations on Asumussen video scandal

Thought, feelings, observations on Asumussen video scandal

Warning Letters Diamond B Dairy 3/6/14

Warning Letters Diamond B Dairy 3/6/14

Warning Letters Martin, Marlin 3/7/14

Warning Letters Martin, Marlin 3/7/14

Make Sure You Check Out the March 2014 Notices Relating to Animal Drugs and Foods from the FDA

2014 Notices




Friday, March 21, 2014

HEARTBREAKING: Horses Drugged for Racing!

HEARTBREAKING: Horses Drugged for Racing!

The Law of Compounding Medications And Drugs: States investigate racehorse abuse allegations-AP ...

The Law of Compounding Medications And Drugs: States investigate racehorse abuse allegations-AP ...: read here

The Law of Compounding Medications And Drugs: Blood-Horse Report: PETA Probe Alleges Cruelty to ...

The Law of Compounding Medications And Drugs: Blood-Horse Report: PETA Probe Alleges Cruelty to ...: A major Thoroughbred racing stable was the subject of a 2013 undercover investigation by People for the Ethical Treatment of Animals, whic...

The Law of Compounding Medications And Drugs: PETA Videos Prompt New York and Kentucky to Invest...

The Law of Compounding Medications And Drugs: PETA Videos Prompt New York and Kentucky to Invest...: The horse racing authorities in New York and Kentucky opened investigations on Thursday into allegations of mistreatment of thoroughbred r...

NY Times: PETA Files Complaint After Undercover Investigation of Asmussen Stable | Paulick Report – Thoroughbred Horse Racing News

NY Times: PETA Files Complaint After Undercover Investigation of Asmussen Stable | Paulick Report – Thoroughbred Horse Racing News

NY Times: PETA Files Complaint After Undercover Investigation of Asmussen Stable | Paulick Report – Thoroughbred Horse Racing News

NY Times: PETA Files Complaint After Undercover Investigation of Asmussen Stable | Paulick Report – Thoroughbred Horse Racing News

Tuesday, March 18, 2014

Product Safety Information VETORYL (trilostane) Capsules - Veterinarians

Product Safety Information VETORYL (trilostane) Capsules - Veterinarians

CFR - Code of Federal Regulations Title 21-Regarding Extralabel use and compounding for animals

CFR - Code of Federal Regulations Title 21

CFR - Code of Federal Regulations Title 21 on Extralabel use in animals and compounding for animals

CFR - Code of Federal Regulations Title 21

Product Safety Information GONAbreed - Veterinarians

Product Safety Information GONAbreed - Veterinarians

Product Safety Information EQUIDONE (domperidone) Gel - Veterinarians

Product Safety Information EQUIDONE (domperidone) Gel - Veterinarians

Product Safety Information Steroid Hormone Implants Used for Growth in Food-Producing Animals

Product Safety Information Steroid Hormone Implants Used for Growth in Food-Producing Animals

Warning Letters Canadian Feedyard, LLLP 2/25/14

Warning Letters Canadian Feedyard, LLLP 2/25/14

The Law of Compounding Medications And Drugs: Must Read From the Horse: Careful Compounding By ...

The Law of Compounding Medications And Drugs: Must Read From the Horse: Careful Compounding By ...: Compounding, the practice of changing the preparation, strength, or even flavor of a drug to meet a particular therapeutic requirement for...

Warning Letters Lowlite Investments, Inc. D/B/A Olympia Pharmacy 2/18/14

Warning Letters Lowlite Investments, Inc. D/B/A Olympia Pharmacy 2/18/14

Guidance, Compliance & Enforcement Federal Register Notices

Guidance, Compliance & Enforcement Federal Register Notices

Tuesday, March 11, 2014

Warning Letters Erickson Dairy LLC 3/3/14

Warning Letters Erickson Dairy LLC 3/3/14

FDA Draft Guidance: Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices

A new draft guidance document released by the U.S. Food and Drug Administration (FDA) aims to clarify the ways in which a pharmaceutical or medical device manufacturer may use scientific and medical literature to promote its products, even if the literature doesn't conform to the product's FDA-approved uses. FDA's guidance forms a checklist of sorts that companies will need to check against each instance of literature they wish to promote.
FDA's new draft guidance document, Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices, is meant to provide life science companies with a checklist for making sure they stay within the acceptable limits of promotion of scientific and medical publications. The guidance is a revision of a 2009 draft guidance, Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices. As noted by Regulatory Focus, that guidance came under fire from life science companies, which argued that it restricted their ability to "promote the public health" by distributing scientific information informing the safe and effective use of their products.
In an accompanying statement, the FDA stated that it's currently working on additional guidance on scientific exchange, responding to unsolicited requests for off label information, and interactions with formulary committees. 
- See more at: http://www.policymed.com/#sthash.M1j45cu5.dpuf

Pharmaceutical Companies Drastically Cut Speaker Payments for Doctors

A number of large pharmaceutical companies have greatly reduced payments to healthcare professionals for promotional speeches. ProPublica reports that GlaxoSmithKline and Pfizer have dropped their speaking payments by over 60% from 2011 to 2012. Eli Lilly reduced their spending by 55%, from $47.9 million in 2011 to $21.6 million in 2012. During the same period, Novartis reduced their spending from $24.8 million to $14.8 million. ProPublica states that the sharp drop in payments coincides with the large settlement figures pharmaceutical companies have forked over to the government for their marketing practices, including off-label promotion and allegations of kickbacks to doctors. The website also notes that the mandatory disclosures of the Physician Payments Sunshine Act are likely spurring the change. Members of industry argue that the numbers reflect their marketing needs, not the disclosure laws. Several companies are losing valuable patent protection for their products. "Eli Lilly began facing generic competition to its blockbuster antipsychotic Zyprexa in late 2011," ProPublica states. "Its antidepressant Cymbalta lost its patent at the end of 2013." Pfizer's patent on Lipitor, its top-selling cholesterol drug, expired in 2011. - See more at: http://www.policymed.com/#sthash.M1j45cu5.dpuf

Endo Health Solutions Lidoderm Settlement and Corporate Integrity Agreement, CME Obligations

Endo Health Solutions, Inc. and its subsidiary Endo Pharmaceuticals Inc. (Endo) have agreed to pay $171.9 million to resolve civil allegations of marketing their adhesive pain patch Lidoderm for off-label uses. As part of the settlement, Endo will enter into a Corporate Integrity Agreement (CIA) with the Department of Health and Human Services Office of Inspector General. 
The Department of Justice (DOJ) announcement states: "[F]rom March 1999 through December 2007, Endo caused false claims to be submitted to federal health care programs…by promoting Lidoderm for unapproved uses, some of which were not medically accepted indications and, therefore, were not covered by the federal health care programs." Endo has also agreed to pay $20.8 million to resolve criminal liability. In a deferred prosecution agreement to resolve the charge, Endo admitted to promoting Lidoderm to healthcare providers for unapproved indications.
Interestingly, the government press release failed to mention any allegations of kickbacks or false statements at all. These "plus factors" have become staples of off-label settlement announcements. The DOJ announcement focused purely on the fact that Endo promoted its drug for uses not yet approved by the Food and Drug Administration (FDA).
Lidoderm was FDA-approved for relief of pain associated with post-herpetic neuralgia ("PHA"), a condition that can affect individuals with a history of shingles. Endo admitted to promoting Lidoderm for lower back pain and chronic pain. This alone sufficed for criminal and civil liability. "Pharmaceutical companies have a legal obligation to promote their drugs for only FDA-approved uses," the release stated, quoting U.S. Attorney for the E.D. of Pennsylvania, Zane D. Memeger.
Endo is the latest company to settle with the government over False Claims Act (FCA) allegations. Since January 2009, the Justice Department has used the FCA to recover more than $19 billion from pharmaceutical companies. Most FCA action stems from qui tam relators—whistleblowers who can earn up to one-third of the settlement figure.
Corporate Integrity Agreement
The Inspector General of the U.S. Department of Health and Human Services, Daniel R. Levinson, stated: "Under our CIA, Endo agrees to promote its products legally, while board members and top executives are specifically held accountable for compliance."
Endo's CIA requires that the Board of Directors of the company be "responsible for the review and oversight of matters related to compliance." Furthermore, "Certifying Employees," including the CEO, Chief Operating Officer, and Senior Vice President, are "specifically expected to monitor and oversee activities within their areas of authority." The Certifying Employees "shall annually certify...that [Endo] is compliant with applicable Federal health care program and FDA requirements and with the obligations of this CIA."
Third Party Educational Activity
The CIA requires Endo to implement written policies and procedures for its compliance program, which must adhere to requirements of the CIA, the Federal healthcare program, and FDA. The CIA lists Endo's minimum responsibilities, and notably among the items are requirements for Third Party Educational Activity:
- See more at: http://www.policymed.com/#sthash.M1j45cu5.dpuf

Sanctions on trainer delayed

By
PUBLISHED: Tuesday, March 11, 2014 at 12:05 am
The 16-year suspension and $40,000 fine the New Mexico Racing Commission imposed on a horse trainer whose horses tested positive for the active ingredient in Viagra cannot be implemented until the appeals process is completed, 2nd Judicial District Judge Alan Malott ruled Friday.
Malott approved a preliminary injunction sought by renowned quarter horse trainer John Stinebaugh of El Paso that effectively prevents implementation of the stiff sanctions. At the request of Tania Maestas, an assistant state attorney general representing the Racing Commission, Malott required Stinebaugh to post a $20,000 surety bond and, should another infraction of state racing regulations occur before the case is adjudicated, the injunction will terminate. The sanctions, handed down Feb. 10, stem from four horses testing positive for Sildenafil during July 5-6 trials for the $1 million Rainbow Futurity and $1.05 million Rainbow Derby at Ruidoso Downs. Stinebaugh has appealed the ruling to the Racing Commission, which denied his request to stay the sanctions until the appeal is adjudicated – a process that typically takes months. Racing Commission executive director Vince Mares said Monday that Stinebaugh’s appeal hearing has not been scheduled but is likely two to three months away. Sildenafil citrate, the active ingredient in the human erectile dysfunction drug Viagra, is illegal in horse racing because it increases cardiac output and can boost a race horse’s on-track performance. Stinebaugh blames the positive Sildenafil tests on contaminated cinnamon ginseng powder that originated in China, made its way to Attix Pharmaceuticals in Toronto, and then to Weatherford Compounding Pharmacy in Texas. The Sildenafil wound up in an oral paste sold under the name Tourniquet, which is used to treat exercise-induced pulmonary hemorrhage. “I’ll accept a trainer’s responsibility all day long, 100 percent … for anything I can control,” Stinebaugh said by phone on Friday. “… But things I have no control of, that happened 10,000 miles away, that absolutely nobody could know, that’s a little hard to be responsible for.” Attorney William C. Marchiondo, who represented Stinebaugh and the horses’ owners at Friday’s injunction hearing, said he has letters from Attix Pharmaceuticals and Weatherford Compounding Pharmacy supporting Stinebaugh’s claims. Regardless of how a drug gets into a horse, Maestas noted at the hearing, state racing regulations hold trainers responsible for horses under their care. The affected horses had been placed on the state veterinarian’s list for 90 days, meaning they could not race during that time period. While the injunction is in place, the horses can continue to race, according to Mares. The Racing Commission also ordered the horses’ owners to forfeit $8,000 in purses from those races. The $23,737 PJ Chick in Black earned in the Rainbow Derby finals was also forfeited, Mares said. Marchiondo said Weatherford Compounding Pharmacy has accepted responsibility for the errant Sildenafil, and has reimbursed the owners for the lost purses. Stinebaugh said the pharmacy has also agreed to pay his legal fees.
quoted from here

Friday, March 7, 2014

AVMA Seeks Volunteers for these Positions

AVMA Volunteer Opportunities - Vacancies

Thank you for your interest in volunteer opportunities with AVMA!
Interested candidates should submit nomination materials via email to OfficeEVP@avma.org, via fax to 847-925-0944, or via mail to AVMA Office of the Executive Vice President, 1931 N. Meacham Rd, Suite 100, Schaumburg, IL, 60173.

If you're not quite ready to get involved in AVMA governance but would like to get more involved with the association, we'd love to have your help.
Please contact OfficeEVP@avma.org with any questions.

Thursday, March 6, 2014

The Law of Compounding Medications And Drugs: Must Read! Hawaii Board of Veterinary Examiners I...

The Law of Compounding Medications And Drugs: Must Read! Hawaii Board of Veterinary Examiners I...: BOARD OF VETERINARY EXAMINERS STATE OF HAWAII PROFESSIONAL AND VOCATIONAL LICENSING DIVISION DEPARTMENT OF COMMERCE AND CONSUMER...

The Law of Compounding Medications And Drugs: MUST READ: January 2014 Letter from Hawaii Board ...

The Law of Compounding Medications And Drugs: MUST READ: January 2014 Letter from Hawaii Board ...: VETERINARY PRESCRIPTIONS Dear Hawaii Pharmacists: At its January 2014 meeting, the Board of Pharmacy ("Board") unani...

The Law of Compounding Medications And Drugs: FDA Referral Letter dated 2/25/2014 to Oklahoma S...

The Law of Compounding Medications And Drugs: FDA Referral Letter dated 2/25/2014 to Oklahoma S...: Lowlyn Pharmacies, Inc. (dba Red Cross Drug ), Blanchard, OK Referral Letter to Oklahoma State Board of Pharmacy Issued 2/25/2014 6...

The Law of Compounding Medications And Drugs: MUST READ!! Safely Save Money on Horse Drugs Not a...

The Law of Compounding Medications And Drugs: MUST READ!! Safely Save Money on Horse Drugs Not a...: When your horse becomes sick, the bills begin to pile up. The veterinary fees are bad enough, but you understand that there’s equipment to ...