FDA Regulations Kill
Paul Howard and Yevgeniy Feyman in Health Affairs:
Meningitis is a terrible disease that can kill its victims in a single day. About 4,100 new cases are diagnosed annually in the U.S., with a mortality rate of more than 10 percent. Even with treatment, survivors are often left with serious side effects that can include brain damage and limb loss…
Swiss drug manufacturer Novartis has developed a vaccine — Bexsero — that specifically targets this strain of meningitis; the drug has already been approved for use by the European Medicines Agency (EMA), the European Union’s equivalent of the Food and Drug Administration (FDA). And within about nine months the FDA allowed Princeton University to offer the vaccine on campus to its students.
But the drug is not available elsewhere in the U.S. And it won’t be until Novartis completes a costly phase III trial. The authors ask:
The natural question to ask is why the FDA shouldn’t just approve a product already approved for the European Union, Canada, and Australia, while monitoring the vaccine (as all vaccines are already monitored — Bexsero is being actively monitored in the E.U.) through postmarket surveillance records? (Indeed, the more than 5,000 patients vaccinated at Princeton are close to the total number of patients tested in the EMA required trials.)
The article notes that some drugs don’t have to go through Phase III – what determines that?
“Meningitis is a terrible disease that can kill its victims in a single day. About 4,100 new cases are diagnosed annually in the U.S., with a mortality rate of more than 10 percent. Even with treatment, survivors are often left with serious side effects that can include brain damage and limb loss”
Meningitis is a horrible disease and it’s a fantastic idea that government forced colleges to make students have the shots.
A member of my fraternity died and was the inspiration of the bill and was thus the bill was named after him. Thousands will now continue life. Phi Alpha.
That’s an amazing story. It just goes to show how the government should be more worried about diseases than the economy.
“The natural question to ask is why the FDA shouldn’t just approve a product already approved for the European Union, Canada, and Australia, while monitoring the vaccine (as all vaccines are already monitored — Bexsero is being actively monitored in the E.U.) through postmarket surveillance records?”
An international agreement between countries for safety could prove essential to a growing world.
That would be landmark. Imagine if Canadian scientists could push through drugs and then make them immediately available in the US?
Many more would have access to drugs
Care and price of drugs could go down
And there you’ve hit the FDA’s true nail head. If FDA was really there to protect consumers they wouldn’t have top FDA officials with close ties to US drug manufacturers. FDA’s TRUE purpose of being is to protect the US Pharmaceutical manufacturer’s and make sure their profits can stay high because the drugs manufactured and sold in other countries normally aren’t made available for use in the USA.
If I’m wrong on that, then why does the FDA have top officials who went to work with FDA directly out of, and in a few cases even while the person was still working at a US drug manufacturer instead of being FULLY staffed by INDEPENDENT people with absolutely NO direct ties to ANY US drug or medical device manufacturers???
Especially while maintaining intellectual property rights for the pharmaceutical companies. There would not be issues in getting drugs throughout other countries like India, that do not respect IP rights like other countries do.
Ahhh the real reasons!
Right?? I saw the amount of money the FDA makes, that is truly insane.
“The AIDS precedent. Lastly, we’ve already seen what loosening the FDA’s reins can mean for deadly diseases. Perhaps the best lesson is the war on AIDS in the 1990s, chronicled in films like the Dallas Buyers Club.”
An amazing film that really does look at the problems associated with tight government regulation
Yes the FDA was an absolute power hungry authority in that movie
Well, it was an accurate representation
That’s for sure
“In the long run, reciprocity would encourage beneficial regulatory and scientific competition between advanced regulatory agencies, forcing the FDA and its sister agencies in advanced economies to compete on the efficiency and rationality of their regulations.”
At the very lease drugs approved in one or more advanced countries should be eligible for a experimental track drug approval process.