FDA goes after largest manufacturer of generic animal drugs

The federal government is suing Teva Animal Health, the largest manufacturer of generic animal drugs in the United States, after FDA inspections turned up adulterated animal drugs:

The lawsuit... charged that three inspections by the Food and Drug Administration between 2007 and 2009 “documented numerous” Good Manufacturing Practice violations at the facilities.



Denise Bradley, a spokeswoman for the company, said Teva "regretted the deficiencies in our manufacturing practices and we have already initiated corrective actions to ensure that we will swiftly meet all regulatory requirements."

Get the full story here.

Comments

[Anne T]

Thanks, CathyA. I will refrain from further comments other than the imaginary insertion of a head exploding emoticon.

[CathyA]

In case anyone wants to see their products:



http://www.tevaanimalhealth.com/Products/ProductSearch.aspx?searchTerm=&searchType=

[Steve]

Well well well who'd a thunk it! . . . Teva's Debra Barrett is lobbying hard to shorten the protection period for biotech drugs and get generic versions to market more quickly



With a master's degree in public policy from Harvard University, she worked as a health-care policy aide for Senators Patrick Leahy (D-Vt.), Charles Schumer (D-N.Y.), and Chris Dodd (D-Conn.). At age 29, she drafted a bill for Schumer to improve consumers' access to generic drugs. Some of her proposals were enacted as part of the Medicare Modernization Act of 2003. "It's crunch time," she says. "One out of every four new drugs is a biologic. We want to play in that market."



http://www.businessweek.com/magazine/content/09_32/b4142000023338.htm

[Steve]

Profits before safety. Whatever it takes to Win huh?

[Gina Spadafori]

I'm shocked ... shocked, I tell you! Gambling at Ricks! Who'd have thunk it?

[Lis]

At least they're not claiming that there's nothing that needs fixing. If only they'd realized that after the first failed inspection!

[The OTHER Pat]

Comment by Fred — August 2, 2009 @ 1:02 am



Teva Pharmaceuticals USA is initiating a voluntary recall of Propofol Injectable Emulsion 10 mg/mL 100 mL vials, lot numbers 31305429B and 31305430B. The product lots identified are being recalled due to the presence of elevated endotoxin levels in some vials within these lot numbers.



Interesting. Propofol is the name of the drug that keeps popping up in media reports about what might have contributed to the death of Michael Jackson . . . . . . . . . . . .



http://latimesblogs.latimes.com/lanow/2009/07/detectives-were-looking-for-powerful-drug-at-michael-jackson-doctors-home.html

[Barb]

"Regretted"... HA

They regret getting caught!

[Sandi K]

Hmmm, I dont think failing 3 inspections in a two year period of time is considered "swiftly" meeting anything. So where's the "3 strikes you're out" rule for companies like this?

[Fred]

Problems with human market drugs, too.



http://www.fda.gov/Safety/Recalls/ucm172474.htm

"FOR IMMEDIATE RELEASE - July 16, 2009 – Teva Pharmaceuticals USA is initiating a voluntary recall of Propofol Injectable Emulsion 10 mg/mL 100 mL vials, lot numbers 31305429B and 31305430B. The product lots identified are being recalled due to the presence of elevated endotoxin levels in some vials within these lot numbers.



Teva has been notified of 41 propofol-treated patients who experienced post-operative fever, chills and other flu-like symptoms. Based on available information it appears that all febrile or flu-like reactions were self-limiting with spontaneous resolution.



Adverse health effects, such as fever, chills, or rigors, are possible with exposure to product with elevated levels of endotoxins. Serious adverse effects, such as disseminated intravascular coagulopathy, acute respiratory distress syndrome, shock, and death, are possible with exposure to product with high endotoxin levels.



For use as an anesthetic agent, propofol should be used only by professionals trained in the administration of general anesthesia. For sedation of intubated, mechanically ventilated patients in the Intensive Care Unit, propofol should be administered only by persons skilled in the management of critically ill patients."

[The OTHER Pat]

I have often felt like generic pharmaceutical companies are just trying to ride the back of the "cash cow" of drugs that the original company has sometimes spent as long as 20 years to get from first inception to market - having to follow FDA guidelines every step of the way. Then - when the few remaining years of patent protection they have left runs out - in step the generic manufacturers to profit from all the work that went before. And I wonder to what extent they really *get* how pervasive the mindset has to be to work with and follow the GMP (Good Manufacturing Practices) guidelines mandated for all of those making drugs meant to go into living beings?



Then - on top of that - this is a company that was bought out by a non-US company (Isreali) in 2006, so that makes me wonder even MORE if they really, really understand how hard (and expensive!) it is to follow the US-mandated GMP's to the letter?



I don't like generics for a LOT of reasons. And this is a good example of why.

[Lis]

Many generic manufacturers also manufacture brand-name drugs, and they are as tightly regulated regardless. A generic is not always the right choice, but it often is, and there's no reason for the consumer not to get whatever benefit there is.



Also, while developing a new drug really is quite expensive, and the developing company has an exclusive market for it for only a few years usually, the cost isn't as high as the companies claim. They go to a fair amount of effort to fold marketing costs into "development" costs and claim they have to make back every penny of the combined costs in order to not go broke.



Meanwhile, in Europe, drug development has been going on quite effectively for several decades under tighter cost controls and the same "twenty years from filing" patent protection scheme that we only adopted in the late 1990s.



Don't cry for Johnson & Johnson.

[The OTHER Pat]

Lis, have you ever worked in a pharmaceutical drug development laboratory under GMP guidelines? (Just wondering - not sure if you've ever mentioned this).

[Lis]

Pat, I know not all pharmaceutical or R&D facilities have in-house staffed libraries, because of the reaction of newly-hired scientists when they discovered what I could do for them, so I'm sure you just honestly have no idea what librarians in pharmaceutical and R&D facilities do.



No, I didn't operate under the same kinds of constraints, but I was responsible for making sure that the labs, the animal facility, and the pilot plant all had the information they needed both to stay in compliance, and to actually do their jobs.



I was employee number 25, because the parent company valued libraries and librarians highly as a means to accomplish those ends, and we were much, much larger by the time I left. In part because I made sure they had what they needed while controlling costs in that area much better than in facilities that either didn't have a librarian, or didn't have one, pardon me for saying so, as good as I am.



Not all of the expenses are direct R&D and regulatory compliance. A lot is marketing, and it's a natural impulse of corporations to tuck as many of the expenses as possible into categories that are more beneficial to the bottom line and, at the size level of pharmaceutical companies, to the ability to cry poor-mouth to the government.

[Lis]

I wasn't in the lab; I was the librarian. For ten years.

[The OTHER Pat]

Where you were, could you be written up for things like using the wrong color of ballpoint pen, or not writing your dates in the proper format? And did you find it necessary to spend about the first two hours of each morning logging out the equipment before you could actually start working?



(I'm not asking these questions to be snitty - I just literally wonder if you were under the same degree of controls as exist in the laboratory and manufacturing settings.)

[Carol V]

Pain killers, antibiotics, heart meds, thryoid meds....the list goes on and on...absolutely disgusting is all I can say right now...Don't the people responsible for this have any kind of conscience? Is it really just about profit for them? And we can't just "blame this one on China" can we???

[Ally]

Teva's product site was up this morning but now, *poof* it's gone. I didn't realize how many products of theirs by DVM Pharmaceuticals I had in my house until I went looking. The 3VCaps are going in the trash. Then there's the Malaseb, ChlorhexiDerm shampoo & OxyDex gel to consider. Not making me feel real comfy right now...

[Original Lori]

Teva is also a sponsor of the Philadelphia Eagles. Strike two...unless they pull out as a sponsor.

[daenette]

I worked for Teva Animal health, this had nothing to do with them it was all about the original owners, Phoenix Scientific, the feds went back on their practices, that owner should be in jail!

[Paul]

This stuff still in the news in early 2010. Guess TEVA is still killing people's pets, putting profits ahead of safety, while still being evasive. Nice going TEVA. Greedy jerks.