They have found a way to "lift this ban". The company simply has to conduct a well run trial, submit the trial data to the FDA, and ask for an emergency use authorization. Once they do that, it takes two or three weeks for the FDA to processes it. That two or three weeks is not red tape--it is the FDA having their own scientists and independent scientists go over all the data and do the safety and efficacy calculations themselves.
This worked fine for Pfizer, Moderna, and Johnson & Johnson.
Where is the FDA on this one? The problem should be solvable by bans. FDA does random sampling, if your product is found to be adulterated, then you are banned from importing into the US for 5 years.
Is there anyone else that sees this as a positive thing for the company? They've lived under the cloud of potential FDA regulation for a while, and I'm a bit surprised that it took this long for the FDA to step in.
Obviously, it would have been preferable to have the company and FDA work together to announce how FDA regulations apply before an enforcement action. But, now that it has happened, the process has started. If the company can come out of this with some kind of FDA approval, then that cloud will be lifted and they can keep on working. And then the company will know exactly what rules they'll have to play by. So, depending on how things work out, it could end up being a positive for the company.
Now that the FDA has played their hand, I'm very curious to know how the company will respond.
I'm not saying the FDA does a good job of catching this activity early. The only way they find out is either through inspections (they are horribly understaffed) or through product complaints.
When do they find out they drop the hammer. Most (all?) Ranbaxy plants are banned from importing product into the US and many products were recalled.
Where is the FDA in all of this? I would hope that after the widespread issues with the product, they would have stepped in and blocked shipment until safety studies have been done that comply with regulations.
Congress passed a law that made them do this - in 2017! The FDA has been going slow on implementation till the Biden admin gave them another kick in the pants.
There are lots of proposals to simplify FDA's approval process, for example, automatically approve it if it's already approved in a number of Western countries whose approval standards are high on average.
But in this specific case, seems FDA isn't being totally unreasonable. For example, from the letter
"Thus, months after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the PGS"
seems like a good idea to require companies to do this
the company simply shrugging their shoulders and saying there's no way you can prove that it's from this vs something else
That's not how it works. It doesn't matter if the company "shrugs their shoulders", if the FDA wants to pull the drug, it gets pulled.
The FDA has a requirement that all adverse events reported to a company must be reported to the FDA (massive fines if you don't). The FDA will then take that data and do their own analysis. Yes, they will work with the company to discuss the data and it's implications, but have zero qualms with yanking a drug if the company thinks it's still safe.
When we were negotiating our label with the FDA, we asked for a wording change because we thought the current wording was confusing. FDA came back with "we don't agree". So we added more explanation and they came back with "we're not changing it". We just accepted it as it was just delaying launch and it was clear we werne't going to get our way.
That's impressive as hell. The FDA is, by nature, a very conservative and slow-moving organization. They set a very high standard of evidence for anything that's actually called "medicine". (As opposed to supplements and devices that pretend not to make medical claims, in which they are largely hamstrung.)
It takes a ton of effort to get FDA approval. Navigating the process is expensive and aggravating.
This worked fine for Pfizer, Moderna, and Johnson & Johnson.
reply