I remember the first time Congress set up user fees (1992) for the medical and pharmaceutical industry. I feared that companies like mine would wither and die, since we were small and would need to pay tithes to the FDA for the right to be regulated by them.
These user fees have been reauthorized time and time again. That is, until recently, due to the pandemic, when the user fee reauthorization has been delayed.
But, on the 8th of June, Congress passed the user fee reauthorization bill. Not by a close vote at all- but by a wide margin of 392 to 28.
There are many wrinkles that the House added to the bill- and now the bickering with the Senate begins. These wrinkles include measures to address the infant/baby formula shortage, augment the food safety center to hire more staff, bring generics to the market sooner, and to improve/accelerate the rapid approval process for various drugs and devices. (There also is a provision to ensure that drugs that are approved actually provide a clinical benefit! How refreshing!)
The provision that specifically intrigues me is the FDA’s drug accelerated approval pathway. (Note: [It is how several of our developments got the fast track.] This was the vehicle that afforded the debacle of Biogen’s Aduhelm (Alzheimer’s “non-treatment” drug) to be approved. The House passed version addresses this error by requiring regulators truly consider the benefits before approving such drugs. Believe it or not, post-approval studies will now be required- and if no clinical benefit is proved, or the studies are not complete, drug approval will be withdrawn.)
This rapid approval process lets the FDA approve drugs in the matter of weeks to a few months (once clinical trials are complete). This process, however, doesn’t demand the drug clearly manifest clinical benefits, because such proof may add years to the clinical trial process. [I will discuss two such efforts over the next two days.] However, there must be indications (i.e., arrested tumor growth) that the drug has merit, even if the clear clinical benefits cannot yet be shown.)
Not surprisingly, more drugs are approved via the accelerated approval program than the conventional process nowadays.
This may be a bit off topic but I am amazed, when listening to drug commercials, that some drugs for conditions that don’t seem life threatening seem to have possible life threatening side effects? I wonder, sometimes, how certain drugs get approved to begin with. Of course I also know we have to balance having drugs available quickly (COVID, just for one) with not having the years a full review would take.
I, too, wonder why I would take some drugs after that litany of potential side effects, Alana. However, the propensity to develop those side effects are rders of magnitude below the propensity for patient improvement.
The question arises when the drug treats a condition that is not life threatening- what is the tradeoff then?