The purpose of the Unapproved Drug Initiative is to take drugs that have been in use for a very long time (the colchincine mentioned above has been in use for literal centuries) and have them tested for safety, efficacy, and drug interactions. That would be a good thing. The idea was to give the drug companies an incentive to do this by letting them have a monopoly. KV Pharma just happens to be an unethical company on the brink of failure who thought they found a no risk way to make a lot of money.
Dammit. Didn’t mean to link to a signin link.
The good news here seems to be that the FDA told them they weren’t getting an exclusive patent on shit. So, the compounding pharmacies should now be back in the clear. Not sure what the true story will shake out to be, but if true I don’t understand how much value KVP will get out of their patent.
So, in other words, we shouldn’t be so pissed about this one particular case because the entire industry is fucked up and this happens every day.
I guess being involved in the pharmaceutical industry for so long has jaded me to the absolutely ridiculous shitty stuff they do. Yes, it happens every day, and no, I don’t think it’s a good thing. I agree that they are acting in a way which is beneficial to their bottom line while being detrimental to the affordability of a needed drug, but we basically have an FDA and lobbyists and politicians that are willing to bend over backwards to allow them to keep doing what they’re doing.
What I mainly came here to do was dispel a lot of the blatant ignorance about how the drug patenting process works, like “OMG, since when does the FDA grant patents? Who gave them the right to do this?!” Well, pretty much since forever. And they pretty much have to allow drug companies to have exclusive rights over those drugs for a certain period of time or nobody would be in the drug business.
Well, it’s both, really. The FDA has to allow financial incentives to continue research on the efficacy of drugs. Are they required to come up with all their own research? No, they’re not. So a lot of the time they rely on preliminary research that has been done by other organizations, such as the NIH. Or previous research that they have done for another drug in process that didn’t pan out. Every once in a while they get to rely entirely on research that somebody else did, or in this case, that was taxpayer subsidized.
Okay, I’m getting annoyed by the fact that the first two pages of this thread largely consisted of claims that the GOP had absolutely nothing – nothing – to do with this policy, because Democrats were in power when it was enacted, and then when I pointed out that this is factually untrue, it’s been ignored.
Do right wingers get a special dispensation to post things that are completely without factual basis here? Or is that privilege extended to everyone?
Look, i’m a left-liberal, like plenty of people on this Board, and i can’t stand Bush and don’t have much time for the GOP. But i still don’t think that this incident can be placed at the door of the Republicans, even if they were the ones in power when the Unapproved Drugs Initiative was put in place.
The UDI is, in many ways, a perfectly reasonable measure. It was instituted, as the name suggests, in order to comply with the broader mandate of the FDA, which is to ensure that the drugs available in the United States meet FDA standards of quality and consistency. The UDI was designed to clear out old (pre-1962) drugs that were still in use because they had been introduced before the requirement to submit drugs for FDA approval.
Also, as far as i’ve been able to tell, the Unapproved Drugs Initiative was not some party-political scheme by the Republicans. In fact, a Lexis/Nexis news search for 2006 reveals little except FDA announcements that it was stepping up its attempts to remove unapproved drugs from the market, beginning with those that posed the most risk to patient health (as per its mandate).
There was, as far as i can tell, no Presidential decree, no congressional legislation, and no edict issued by the Director of HHS, that led the FDA to focus increased attention on unapproved drugs. It was an internal decision made by the professionals who carry out the day-to-day work of policy implementation and observance in the FDA. This was, in short, a professional bureaucratic and medical decision made by the FDA.
If you have any evidence that this case, or even the UDI, was a result of a specific policy put in place by a Republican administration, i would be happy to stand corrected.
As this article notes:
Many people, on both sides of the political fence, agree that the sort of situation that arose with Makeda needs to be fixed. Personally, i think that if the FDA is going to have the authority to hand out exclusive rights to drug companies, especially for drugs that the companies did not really develop themselves, then the FDA should also be allowed to oversee pricing levels, especially in cases like this where the unapproved drug has been working without problems for years or decades.
The thing is, all of this reflects some fundamental paradoxes in the American pharmaceutical industry and its relationship with government.
On the one hand, despite criticisms of the FDA, very few people want a truly unregulated free market in pharmaceuticals. Allowing drug companies to just sell whatever they wanted whenever they wanted, without FDA-mandated testing and oversight, we’d probably end up with a bunch of disasters that would make the whole Thalidomide thing look like a tea party by comparison. The rush to get drugs to market quickly would lead to short cuts, insufficient testing, and the covering up of side effects and dangers.
I’m not arguing that drug companies actually want to kill or injure their patients. And a drug scandal that had adverse health consequences for a large section of the population could well sink a drug company. But we’re talking about health and money here, and the fear of financial collapse isn’t quite enough to deter bad behavior by the corporations when there are such high stakes in being the first to market with a new drug. Also, the consequences of bad drugs can be dead patients, and no amount of stock market correction or even post-incident fines can bring the victims back.
So we have the FDA. We interfere in the free market because safety in this particular industry in incredibly important. And the presence of the FDA undoubtedly helps to ensure that a much higher proportion of drugs come to market as safe products, and that side effects, even when serious, are known and can be taken into account when evaluating the cost-benefit analysis of using the drug.
But while the FDA probably gives us better drugs in many ways, its regulatory layer, which is very large and complicated, adds hundreds of millions to the cost of bringing a drug to market. Because the companies that produce the drugs are the ones that bear this cost, approval of a new drug (or a new use for a drug) brings with it a limited-time monopoly, allowing the company to recoup its investment. If the formula for the new drug could simply be grabbed by anyone as soon as it is approved, and marketed by any company that wanted to make the drug, then R&D would dry up. Why spend billions developing a new drug when your competition can grab your formula as soon as it’s approved and sell it themselves?
To be honest, i’m not quite sure of the best way to fix the problem. One might be to completely regulate drugs, to put new drug development in the hands of an expanded FDA/NIH, and to set prices that allow recouping of research costs without bankrupting patients. This, of course, is never going to happen in the United States, and some would argue that the lack of profit motive would retard the innovation necessary for the development of new drugs.
I think, at the very least, there needs to be a mechanism in places for cases like the one in this thread, where the drug company clearly has not made the sort of investment commonly associated with bringing a new drug to market, and where it has largely capitalized on the work of others (including taxpayer-funded laboratories). In such cases, either the monopoly should be rescinded, or the FDA should be allowed to set a price for the drug.
The FDA, in this case, has effectively rescinded the monopoly by making clear that it won’t seek to punish compounding pharmacies that continue to make the progesterone drug. What is not clear to me is whether this decision is something that is actually allowed for in the regulations, or whether the FDA is just saying, in effect, “We’re going to turn a blind eye to the rule-breaking.” I don’t know enough about the process, and the newspaper articles i’ve read haven’t made clear exactly where the authority for this decision comes from.
What i think we need is actual legislation or a change to FDA rules, something that puts in place a formal mechanism for preventing cases like this.
The problem with the FDA is that it doesn’t have objective standards. And that’s always and everywhere a problem in any kind of bureaucracy. It’s not a huge issue in a task-oriented government agency.
Think forest rangers versus office clerks. A ranger knows his land. His mission is to have people come see it. He has the expertise and the motivation to do a good job.
The FDA, well, doesn’t. Sometimes it may have the expertise, but given the complexity of what it tries to regulate and the generall crappiness of government work (and don’t get me started on how the application process favors nepotism and plodding idiocy over competence). Worse yet, it definitely does not have the motivation to do so. It will never be criticized for denying drugs. Even here, people don’t much criticize the agency, despite the fact that it excercised little thought in the decision and seems to have collected little or no data about problems itself. So it was regulating something sight unseen just because.
So the result is an agency which plays everything safe. Its being asked to make judgement calls which it shouldn’t be making, ever, period. I have no problem with the agency requiring data colelction on side effects. I do have a problem with things coming down to a flat “Yes/No” decision in most cases. Yes, sometimes it will grudgingly allow drugs to be used in marginal cases, but that’s like pulling teeth. Sick people really ought not need to go begging to bureaucrats for medicine. And that does happen, because the arcane councils who decide these matters make an arbitrary* decision on whether or not a drug is “safe” enough - an arbitrary standard, assigning a generic “value” to the interests of patients.
*Technically, the decision is full compliant with the rules. But those rules are arbitrary and designed as much to protect the FDA’s interests, not those of Americans.
Is asprin really particularly dangerous? Not really. It’s a useful drug. But any substance strong enough to affect your bodily processes will have some kind of side effects or interactions. Yet today’s FDA probably wouldn’t have approved asprin. Too dangerous. Too politically dangerous.
That is a real problem, and one that ought to be fixed. Do the thing right. Do the thing as it ought to be done. Americans don’t need to be babied by paternal bureaucrats. They can make their own choices, for better or worse, if they know the risks. And those who choose foolishly? Well, part of me says “Too bad,” and the other part says, “Who are you to decide what risks they ought to run?” Heck, I don’t even trust my own doctors - I know they’re half-educated screwups who can’t be trusted not to rip me off and say blindly stupid things. And I still trust them more than I trust the FDA.
Okay, let me just be totally clear in the fact that I think the Unapproved Drugs Initiative is essentially a good idea – from what I understand, it’s due to the Initiative that an important drug interaction with colchicine was discovered – and also I don’t think it’s a GOP effort – I’m assuming it was the result of largely non-partisan government-hired scientists who were doing their best to deal with the fact that a lot of drugs are not approved and have never been subject to the studies new drugs are put through. (In fact, I’ve read more than once from experts in the field that aspirin, if it were up for new drug approval, wouldn’t possibly make it through the approval process given the general approach these days to drug safety.)
I’m just irritated as fuck that this thread has gone on this long with people apologizing for (or, mostly, inarticulately defending) Dem involvement in something that was purported to be a Dem-sponsored initiative, when it was in fact started when the GOP was in charge.
As the leftardediest of leftards, I still believe that Vioxx should be available for the (small) segment of the market that could benefit from it. While I see the value in FDA approval, I have a strong distaste for the results of the current drug approval process and the attitude that results in useful drugs like Vioxx being pulled from the market.
The FDA is a joke, especially given their essential nonexistent ability to regulate the safety of the food supply. They have a little more power when it comes to drugs, and that power, they use badly.
P.S.: I came to this thread having read the Slate article SmilingBandit linked and I want to clarify something – despite the errors in the article, I’m pretty sure the brand name of the synthetic progesterone that the company is selling is called “Makena”. It is not called “Makeda”. “Makeda” is the name attributed to the Queen of Sheba (mentioned in the Bible, although not by name) among Ethiopian Christians, who have a traditional (extra-Biblical) story about her seduction by Solomon. According to their stories she was a woman of irresistible beauty; such a thing should be distinguished from an overpriced drug.
Yeah, I’m with Bricker on this one. The GOP is unlikely to get my vote for anything ever, but Barry Obama can’t use the excuse that he’s new anymore. The first year, the Obama admin pretended that they were just following on things that were in the works, or finishing things that were in the works. (Funny how people voted for them to stop that, but they didn’t.) It’s now clear that Obama’s people govern the way Democratic Party campaigns accuse the GOP of acting.
I’m done. I would say, “No more black caucus conservatives winning votes on white liberal guilt,” but it’s pretty clear the so-called “left” in this country is a false friend.
I’m starting a new party, I guess.
He doesn’t need such an excuse. He was in no way responsible for this situation, as virtually everyone in the thread has conceded. Hell, Bricker himself made clear that he was not actually attaching blame for this to the Democrats, but was essentially responding to unjustified attacks on Republicans.
Did you jump straight from Bricker’s post to this one without even reading the rest of the thread? Or did you read it, and are just too fucking stupid to understand it?
I did not read the thread.
Sorry.
That said, HHS & FDA can expect some phone calls, & if this isn’t fixed really fast, I expect to start the mudslinging in earnest.
This makes sense.
This makes little sense.
This wins the thread.
. . .
Well, no, it isn’t really a Dem vs. Pubbie issue, its very much a right vs left issue. You really have to drop this fanciful notion that the Dems are lefty, they are not. Some are, of course, but the status of the Democratic Party as representing the left in American politics was hollowed out by the menshevik, “centrist”, “business friendly”, Blue Dead Three-legged Dog Clintonista “leadership”.
Feh!
Admirably fair-minded and nonpartisan of you. If I were as fair as you I would have resisted the temptation to point out that this was the result of things done under a GOP administration. Lamentably, however, I am not.
There’s certainly a benefit to the citizens of countries with a single-payer health system and government-imposed price controls on drugs.
The thing is, though, that one of the reasons that countries like Canada and the UK and Australia can impose price controls is because the money earned from drugs in those countries is pretty much gravy for the pharmaceutical companies, because those companies are able to make a shit-load of money on the same drugs in the United States.
What effectively happens in the worldwide pharmaceutical market is that American consumers end up subsidizing patients in countries with universal health care. When the drug companies can get $150 for Nasonex from an American patient, they’re willing to take just £7.40 for it from a British patient, because the cost of actually producing the drug and putting in a little bottle is negligible and £7.40 is better than no revenue at all because it’s almost all profit.
I’d actually be interested to see what would happen to the global pharma industry if the US put price controls on drugs similar to those in Canada and the UK. Currently, the US accounts for almost 50% of all pharmaceutical revenue, but has much, much less than 50% of the total drug-using population. The pharmaceutical industry itself is one of the most profitable in the world, averaging profit margins of about 17% of income; that’s a level that would lead to rioting in the streets if it applied to the oil industry, which generally records somewhere around 7%.
If the US started imposing price controls, there could be a bunch of different effects. Most obviously, pharma profit levels could drop. Other possible consequences might be that R&D on more marginal products and new chemical entities would be reduced, and companies would focus even more on “me-too” drugs. Companies might refuse to sell their product at all to places where the government-imposed price controls fall below the level required to generate a profit. I’m not an expert on the economics of pharmaceuticals, so i’m sure there are possible consequences that i’ve missed.
Yep. United Statesians are subsidizing drug development for the entire world.
The difference is even more stark when you compare the prices charged by pharma in the Global South, where prices are even lower, because incomes there are lower. It’s a classic example of price discrimination.