@Stray wrote:
@pitdakota wrote:
@Stray wrote:
a shortage of the much needed vaccine in our Country. So it's a double edged sword...we want safe drugs, pure drugs and I don't know the standards elsewhere but I also think that part of the FDA role should be assuring access to people who need important drugs and that there is more than one company providing them allowing for competition and preventing monopolies which in turn causes price gauging and greed. I am sure many people who need these drugs are not purchasing them or using expired drugs which is dangerous.....so is the FDA keeping Americans safe?
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@Stray, I think you make some good points. However, from a health policy perspective I think the situation is really far more complex. Drug companies will file for patents on new medications or medication delivery systems which will prevent any other company from being able to replicate the medication for a number of years. That leads to a monopoly on the market during that period of time and has nothing to do with the FDA. The FDA cannot do anything under those circumstances to allow more than one company to make the pharmaceutical because the developing company has a patent.
From an economic perspective, many experts believe it is essential to allow companies to patent their medications for a variety of reasons.
But if companies are not bound by patents or trying to get their product approved the FDA is a laborious project in order for them to follow their rules and regulations to try and ensure public safety as best they can.
In fact, the FDA has come under some critism because they relaxed some of the rules for their approvals so that some medications were being released to the public sooner only to have problems turn up with those medications when large numbers of patients started taking them.
So, in many ways they are between a rock and a hard place.
I was trying to find something other than my pdf files that discusses the complex situations and just happened on this article that specifically discusses the EpiPen. I guess since that situation is front and center in the news people are writing about the situation.
Here is the link to that article. It does a good job of discussing some of the various aspects involved and gives specifics about problems that other companies had in bringing their product similar to the EpiPen to the market:
http://theconversation.com/the-real-reason-the-epipen-and-other-off-patents-are-so-expensive-64346
@pitdakota- I agree with you and the article and the position of the FDA with patents. But, the FDA has approved agencies from abroad or within the Country for other meds. that may have the same ingredient but a different delivery system or some minor difference. But, the FDA is above all responsible for safety and I for one, as a nurse, as a patient would not order from Canada or any other Country. But, I do think the FDA bears responsibility when they know a monopoly exists and should research other sources. It's wonderful to have safe drugs but access should have no barriers. A communication from the FDA to a drug company warning of price gauging with a fine attached could stop the practice. I know with new cancer therapies a few were released too early but people who are desparate for a cure don't necessarily care about safety or FDA guidelines. The agency has a tough job and it's easy to sit here, for me, to quarterback but the Epi pen issue should not have happened as the drug itself is quite safe and been in use forever. This clearly was the delivery system and price gauging by both companies. I don't know who manufactures the pen itself but I am sure they increased their prices and Mylan passed that cost on to the customer.
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Hi @Stray. Sorry I have not been on the board lately and just now saw your post.
As a nurse I know you are aware that epinephrine is the same thing as adrenaline (made by our bodies). So there is no patent on epinephrine. Every pharmaceutical company I know has their own version of epinephrine or adrenaline. In fact, it is more commonly referred to as adrenaline in European countries.
The patent is on the delivery system and Mylan is the one that acquired the patent for that delivery system. The Adrenaclick is epinephrine with a different delivery system which is just a smidge difference. Enough that it doesn't violate the patent. Other companies have tried to develop their system, but as you know they had to pull one delivery system because it did not consistently deliver the correct dosage.
I appreciate your comments about the FDA notifying companies of a monopoly on the market, but FDA simply does not have the authority to do that. Furthermore, it is not within the law for the FDA to get involved with companies and their pricing of medications.
There would have to be a law passed by Congress to set parameters of what price gouging was in the pharmaceutical arena and empower the FDA to oversee & regulate pricing for meds.
And I think we all know that isn't going to happen anytime soon. It is a shame because it would certainly help people with the costs of meds. When Medicare Part D was passed, as terrier 3 identified....they were not able to get agreement to allow Medicare to negotiate for better prices in companies. Too many in Congress felt it was not in keeping with capitalism, ie, the companies would not be able to charge more than the market could bear.
At any rate, the FDA has no legal power to determine what constitutes price gouging or warn any company about pricing at this time.
I do think things are changing though. For so long companies could charge exorbitant amounts and individuals really didn't realize it because insurance was picking up the majority of the costs. Now with co pays and insurance companies not covering many meds, people out there are getting a real look at what the costs of these medicines are in this country and the practices of raising costs significantly over the years. This is not a new practice by any means. It is just now that people are seeing it as it has existed and still exists today. So maybe with public pressure there might be some hope of getting some type of legislation passed to change things in terms of pricing for pharmaceuticals.
I remember early in the 1980s when TPA first came into the market. The cost was over $6,000 for a single dose. That was very expensive back in the early 80s. But few people knew it since insurance covered the cost. So maybe things will change with public knowledge and public pressure. One can hope.
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