Posted on 08/18/2011 3:41:05 AM PDT by EBH
According to last Tuesday’s Wall Street Journal, pets who rely on drugs approved for people are likely to suffer now that nearly 200 of these are in short supply, according to the American Society of Health-System Pharmacists.
So you understand, only a fraction of the drugs veterinarians use on animals are actually approved for use in veterinary settings. That’s mostly because it’s expensive to get drugs approved for specific uses in specific species (as the FDA requires for each individual drug). Luckily, the federal government makes exceptions for what’s called "extra-label" drug use.
This means that when a critical mass of veterinarians have deemed a certain drug for a certain species, at a certain dosage, useful in the treatment of a certain disease, then this drug is legally acceptable to implement, despite the fact that it’s not gone through the onerous approval process. This kind of drug use is referred to as "off-label" pharmaceutical therapy.
This is also how veterinarians have come to rely on human preparations of so many drugs in our daily lives. So it is that when humans suffer drug shortages, we experience them even more acutely. After all, people come first when it comes to distributing drugs.
But lately, there have also been shortages of some animal-specific drugs.
According to the article,
The only FDA-approved drug to kill adult heartworms in dogs, Immiticide, is currently unavailable for weeks or months due to a manufacturing issue.
So, okay, it’s not enough that upwards of 200 human drugs are largely unavailable to us, now our own dedicated animal drug manufacturers are leaving us in the lurch. Still, it’s the human drugs we mostly rely on. And –– predictably, perhaps –– we’re last in line to gain access to these drugs. Which only makes sense.
But here’s the big question: Why has this been happening?
According to the Institute for Safe Medication Practices, which last year called the shortages of key human drugs "unprecedented," drugs become scarce for a variety of reasons, including the unavailability of raw ingredients, FDA-enforcement actions that halt production, voluntary recalls, poor inventory ordering, a change in product formulation and even rumors of an impending shortage, which can cause hoarding.
Ah, hoarding ... it happens in all circles. But should you be worried for your pets?
Mostly? ... Not so much. After all, more than 99 percent of the drugs we lack are those not approved in vet medicine because they’re not terribly common. The downside is that these drugs we lack are those veterinarians use in times of serious crisis. Consider:
Vets reported shortages of doxorubicin, a chemo drug used to treat different cancers in humans and pets, and of another oncology drug, mechlorethamine hydrochloride (brand name Mustargen). The latter is a "rescue" therapy for lymphoma used when other drugs don't work in people and pets. "When it's not available, that limits the little bag of tricks" to reach into, says Kristine Burgess, a veterinary oncologist at the Foster Hospital for Small Animals at Tufts University's Cummings School of Veterinary Medicine. Not offering it "is denying your pet a really good drug.
So sad that so many pets are going without. And yet, it’s even MORE sad to hear that all of us are missing out.
Given the table I’ve set, here’s the inevitable question: What is it about modern manufacturing processes that these behemothic pharmaceutical companies haven’t yet come to understand about producing chemicals and biologicals on a global scale? How can it be that they’ve gone so inept at keeping pace with basic supply and demand?
Call me cynical, but somehow it seems to me as if there are certain industries who’ve recently proved they’re not best built for globalization and oligopoly — especially when they’ve obviously not lived up to their blustery promises of greater efficiency and seamless supply. If anything, our reliance on their ginormity and outsized global reach has proven overblown and altogether unfounded.
So it is that we sit and wait for our drugs. While our patients die ... and big pharma plays its ticker-tape game of thrones.
Dr. Patty Khuly
What amazes me...is that we have this huge significant number of garage drug-makers...working to make mostly illegal drugs. If these guys simply sat down and grasped the market to make cheap copies of the real drugs or get the ingredients for drugs already approved in Europe...they could make an entire new industry in the United States (illegal of course).
It’s not the drug companies so much as excessive regulations.
I’m all for the FDA drug approval and safety monitoring programs; one could argue that those programs fall right in line with the constitutional duty to promote the common welfare.
But when raw ingredients are so controlled that companies must jump through hoops and do months of paperwork in order to get approval to buy those ingredients, that is the result of heavy-handed regulations going too far. Companies dealing with such regulations cannot easily ramp up or down production to keep up with market demands.
I wonder how much of the heavy-handed regulation is related to Obamacare? I don’t recall hearing of drug shortages like this before Obama.
Does the author seriously believe we would face these shortages if the FDA simply focused on drug safety and didn’t insist on lengthy, extremely expensive clinical trials to prove efficacy?
And the shortages we’re observing aren’t a chronic feature of the U.S. drug market. On the contrary, Americans have access to a far greater array of pharmaceuticals than citizens stuck in national health systems that don’t provide access to products deemed “too expensive.” Thus, to infer from a temporary shortage that private drug manufacturers simply are inept at matching supply to demand is inappropriate. Sadly, it is rants such as these that impel public policymakers to find government “solutions” to badly misdiagnosed problems, thereby making things even worse.
If private drug manufacturers were inept at keeping up with demand, one would expect to see shortages that were both pervasive across the industry and persistent over time. In fact, the shortages we’ve seen haven’t been around that long and more importantly, are restricted to prescription drugs (i.e., those most heavily regulated by the FDA), not over-the-counter drugs (much more lightly regulated).
Part of the problem is that a lot of the generic drugs were licensed for x amount of years and the licenses expired. So the companies that were manufacturing them can’t legally do so anymore. That leaves or forces the consumer to use brand name drugs. The problem there is that many insurance companies won’t pay for the more expensive ‘brand’ name drug.
Another problem is that some drugs are so expensive because they are derived from plant sources that we haven’t yet fully mastered in the lab. (My son was working on research of this type during the summer in a Fellowship program for the American Society of Plant biologists) Over harvesting can make the costs rise, so they are trying to create synthetic drugs in the lab. It’s just that they don’t always fully understand how plants do certain things at various phases.
The question I guess is whether or not the manufacturers of the brand name drugs will allow their products to be re-licensed again for generics.
...when you see that in order to produce, you need to obtain permission from men who produce nothing—
—you may know that your society is doomed.
~~The Money Speech, Ayn Rand
I thought that was the other way around? Drug prices expected to tumble as patents expire
That doesn’t make sense. Generics are cheaper. So if the generics are no longer made, guess what you’re back to the more expensive brand name.
Ah I see your confusion. You mistook generic licenses for the brand name patents. Two different things.
Yes when the patent expires it allows for generics to be made so ‘those’ drugs would be cheaper.
I was talking about the generics that can no longer be made because the license to make them expired. When the patent expires this allows for generics to be made.
Brand/patent (expensive) ——> licensed generics (cheaper) ———> (cheaper) expired licensed generics -——> back to expensive brand names again.
Does that help?
The patents expired on the name brand drugs...
no more need to license the generic.
It is the other way around.
You have it backwards. When a manufacturer has a patent, they are the only source for the drug if they don't license it, which can create manufacturing bottlenecks if there is an issue with that production line. Once a drug is off-patent, anyone can manufacture it, so if there is a shortage and the price goes up, there is an incentive for another company to start making the generic.
Not that I have an issue with drug patents - to the contrary, I think patents should not take effect until the drug is approved by the FDA.
Maybe this will help.
A company (company A) has a patent on a drug/brand name. Another company (company B) petitions them to get a license to create a generic cheaper version for the usual 20 years. When that 20 year license expires they can’t make it anymore without getting a new license.
Over time and 20 years is a long time in drug manufacturing, improvements come along. Company A can make an improvement to their product and repatent it.
I’m not sure if a company is obligate to allow for generics before their patent wears off. Researach and development isn’t cheap.
We may be seeing a lull in between ‘versions’ of generics.
see 12
FDA, industry reach generic drug fee agreement
U.S. regulators and generic drugmakers have reached a compromise agreement for a user-fee program that would require the companies to pay some $299 million in the first year to accelerate drug approvals.
The Food and Drug Administration has been in negotiations with the generic drug industry since February to establish a user-fee program similar to one in place for brand-name drugs and medical devices.
Through the program, companies would pay fees to give the FDA extra money to hire more staff and improve support systems in its drug review process. Some of the fees would pay for bulking up FDA inspection of U.S. and foreign manufacturing facilities.
The FDA is holding a public meeting on the issue on August 25. The notes from the July meetings between the FDA and are at: http://r.reuters.com/muz23s .
Anyone been to the vets with a dog or cat lately? Ya cant getta out of there for less than $175-$200 any more.
Im gonna put my cattle dog on obummer care.
Then again if obummer care takes hold i might try and work a deal with my vet to treat me along with the pets , maybe get group rate.
A rather interesting supposition, given a patent is only good for 17 years.
A rather interesting supposition, given a patent is only good for 17 years.
From the link in post 7
This is because the standard 20-year patents on an unprecedented number of widely prescribed brand-name drugs, such as Lipitor, Plavix and Singulair, are set to expire in a very short time.
And that means ... drum roll ... THAT THEY NO LONGER NEED A LICENSE TO MANUFACTURE THEM!
You don't even perceive your own contradictions here.
If the company makes a change they can RE-PATENT it!
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.