The FDA makes all drugs for non-billion dollar a year illnesses cost-prohibitive, and thousands of people die, and millions more suffer every year as a result.
That's hogwash. The pharma co decide which meds go through FDA approval. They also decide whether they can make money off the drugs to recoup the development cost.
My cousin has a chronic illness for which there is a safe and effective treatment, however my cousin is made to suffer because the cost of getting FDA approval for this drug, exceeds the market value of it.
The FDA makes all drugs for non-billion dollar a year illnesses cost-prohibitive, and thousands of people die, and millions more suffer every year as a result.
Surely if this safe and effective treatment already exists it is unethical for the doctors to withhold it? I am intrigued as to just what this drug is.
I'm aware in the UK a doctor can prescribe a drug on an off-licence basis, i.e. outside the scope of the approval by the manufacturer and medicine regulator. It does place extra liability upon the prescriber but if there's good evidence that: i) it is effective treatment and ii) the patient will suffer without it, the prescriber could be considered guilty of failing in their duty of care to the patient.
Preventing tragedies like Thalidomide is the reason why bodies such as the FDA exist. It's notable that the FDA didn't approve Thalidomide despite pressure from the manufacturer. Undoubtedly numerous Americans are in better health from that single decision alone.
There are hundreds of British people living with the consequence of the less rigorous approach to drug safety at the time. Medicine approval was improved in the UK as a direct consequence of the Thalidomide calamity.
There's an article which suggests the application fee for the FDA to assess a drug can be between one to two million dollars.
So if a drug company were to get a drug approved, they will recoup the application fee after around a year if they charged one dollar for something used once a year by one in 350 Americans.
Putting things in context and perspective, the cost of one cab and semi trailer used to deliver the drug is at least $100,000.
The issue of pricing is strictly the responsibility of the pharmaceutical companies, certainly not the FDA.
While I might welcome FDA around to make sure people don't get harmed -- they've become more and more a puppet of the medical for-profit industry. I'm sure their main function now would be to make sure nothing INEXPENSIVE gets out the door in diagnostic tools.
Don't want a room full of million dollar blinking lights to get replaced by a $99 iPhone attachment after all. I hate being cynical but I'd place money on this bet over "they'll approve things and we'll see inexpensive sensors and responsible apps."
Comments
Originally Posted by Jessi
This is why the FDA needs to be shut down.
Shut down… and replaced, or shut down and anyone can sell anything with anything in it regardless of the consequences?
That's hogwash. The pharma co decide which meds go through FDA approval. They also decide whether they can make money off the drugs to recoup the development cost.
Yea, please take your smartphone into the bathroom stall and pee on it, damn it I dropped it in the bowl.
Quote:
Originally Posted by Jessi
This is why the FDA needs to be shut down.
My cousin has a chronic illness for which there is a safe and effective treatment, however my cousin is made to suffer because the cost of getting FDA approval for this drug, exceeds the market value of it.
The FDA makes all drugs for non-billion dollar a year illnesses cost-prohibitive, and thousands of people die, and millions more suffer every year as a result.
Surely if this safe and effective treatment already exists it is unethical for the doctors to withhold it? I am intrigued as to just what this drug is.
I'm aware in the UK a doctor can prescribe a drug on an off-licence basis, i.e. outside the scope of the approval by the manufacturer and medicine regulator. It does place extra liability upon the prescriber but if there's good evidence that: i) it is effective treatment and ii) the patient will suffer without it, the prescriber could be considered guilty of failing in their duty of care to the patient.
Preventing tragedies like Thalidomide is the reason why bodies such as the FDA exist. It's notable that the FDA didn't approve Thalidomide despite pressure from the manufacturer. Undoubtedly numerous Americans are in better health from that single decision alone.
There are hundreds of British people living with the consequence of the less rigorous approach to drug safety at the time. Medicine approval was improved in the UK as a direct consequence of the Thalidomide calamity.
There's an article which suggests the application fee for the FDA to assess a drug can be between one to two million dollars.
So if a drug company were to get a drug approved, they will recoup the application fee after around a year if they charged one dollar for something used once a year by one in 350 Americans.
Putting things in context and perspective, the cost of one cab and semi trailer used to deliver the drug is at least $100,000.
The issue of pricing is strictly the responsibility of the pharmaceutical companies, certainly not the FDA.
Don't want a room full of million dollar blinking lights to get replaced by a $99 iPhone attachment after all. I hate being cynical but I'd place money on this bet over "they'll approve things and we'll see inexpensive sensors and responsible apps."