Weekend Talk: Accelerated approval and slow withdrawal

An example of a corporate drilling FDA accelerated approval loophole is accelerated approval with conditional approval, not full approval.
condition of the agreement is that the company completes the agreed clinically confirmed trial within the agreed time, as agreed with the FDA.
is that if the expected clinical benefit-risk ratio is achieved, the FDA will upgrade the accelerated approval to full approval, or it will "accelerate" the withdrawal of the accelerated approval.
this was highlighted in the first paragraph of the 69-page ruling in 2011, when the FDA revoked Avetin's accelerated approval.
month, the FDA offered to revoke the accelerated approval of AMAG's prematric progesterone drug Makena because a corrogical trial failed.
As not as grand as the above ruling, but the plan to withdraw the notice to the enterprise also has a 10-page length, showing the FDA's scientific rigour and strict discipline of the consistent style, and give companies the opportunity to appeal, hold hearings."
seems to be all right.
, however, the author notes that although Makena has not yet been fully approved as a new drug, the FDA has approved five generics as a comparation agent.
, the FDA's plan to revoke the notice was sent to five generic drug companies at the same time.
out of curiosity, the author looked up the relevant historical data, found that the FDA's approach, there is also questionable.
fda approved Makena's first generic drug in June 2018, and four others in the following year.
, Makena's sales began to plummet.
from $390 million in 2017 to $120 million in 2019.
that the "effective sales cycle" of makena, a drug, has largely ended since accelerated approval, and that commercial purposes have been achieved.
fact, Makena has always been controversial.
before Makena went on sale, the hospital had been supplying pregnant women with Makena's progesterone, known as 17P, at a low price of $10 a shot.
but as soon as Makena went public, it came out at a high price of $1,500 a shot.
forced to cut prices to $690 a shot, but still 69 times the price of the drug, under intense pressure from a social uproar.
the entire course of treatment required 20 injections, the total price was $13,800, a far from the $200 price of the drug.
more importantly, Makena is not safe and effective.
note that two weeks ago the FDA notified companies to withdraw the accelerated approval, but that it was only a planned withdrawal and was still a long way from a final withdrawal.
because, by law, the FDA must give companies the opportunity to appeal the FDA's decision to withdraw by holding hearings.
hearings, which could take months or more.
, AMAG, the company that owns Makena, filed a revocation request against the FDA's withdrawal on Wednesday, calling for a hearing to appeal.
approval was intended to encourage product innovation, but in the case of Makena, it appears to have been drilled by companies.
policy, no matter how well thought out in advance, will inevitably lead to extra-intentional consequences.
the FDA's approach - giving companies seven-and-a-half years to make up the data - has it laid the ground down from the start? At the very least, the FDA has failed to speed up the withdrawal of accelerated approvals.
if the accelerated approval cannot be accelerated , what is the difference between such accelerated approval and full approval ? Birch