> “It isn’t that we changed our policies and are saying we are going to approve drugs faster,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, who joined the agency under President Ronald Reagan. “The difference now is we are going to see more of those because of the science. If there are people out there with no options and they have terrible diseases, we are going to get those drugs to them as fast as feasible.”
> But even as drugmakers, investors and patients cheer on the agency’s pace, patient-safety advocates argue that speed comes at a price. Studies show medicines approved on a faster time line are more likely to have safety problems emerge after they become broadly available, while other treatments offer fewer benefits than anticipated.
Not sure I understand the concern:
- "studies show medicines approved on a faster time line ...": which study(ies)? And that was the case for previous track records, which says nothing if the FDA is making the same mistakes that they may have done 20 years ago.
- "more likely to have more safety concerns once they are broadly available while other treatments offer fewer benefits than anticipated", wait, do such studies actually have drugs that are virtually identical in all properties and where the only factor that changed is the approval timing? Because if that's not the case, you are just comparing drugs with different profiles, different indications, and different targets, which is pretty much apples and oranges. Good luck making conclusions based on that.
I am not aware of the FDA or any other regulatory body at this time starting to remove regulatory requirements to speed up approvals. The typical things we see nowadays is an exception for "orphan indications" where there is no good treatment available and people are dying without anything to try. It seems fair that they take in account patients' needs when it comes to expediting the last bureaucratic mile to ensure new drugs can save more patients. At the end of the day, patients are also free to refuse newer drugs (and doctors usually tell them when a drug has just been approved and when there is lack of much safety experience beyond clinical trials) so I don't see how you can frame this whole story in a negative light.
_"It’s not just speed. The FDA also is approving more drugs, hitting a record 59 new therapies in 2018. Almost three-fourths received a priority review. That, combined with more efficient data collection, is responsible for the faster FDA action, said Aaron Kesselheim, a professor at Harvard Medical School. Companies are also communicating earlier and more often with the agency, which can head off issues at preliminary stages and help them get products through on the first attempt, he said."_
So as in any field, better communication with stakeholders improved the process and eliminated some issues earlier.
Then, better data collection helps them evaluate studies better. I bet it also reduces the back and forth and the "what does this mean" aspect of the studies after.
And then companies can pay for expedited evaluation.. which if they've been communicating clearly all along and have better data, doesn't seem far fetched.
The next thing you know, someone will suggest clear planning with stakeholders, code reviews, and unit tests will improve code quality and even ship dates! But that may be crazy talk.
> But even as drugmakers, investors and patients cheer on the agency’s pace, patient-safety advocates argue that speed comes at a price. Studies show medicines approved on a faster time line are more likely to have safety problems emerge after they become broadly available, while other treatments offer fewer benefits than anticipated.
Not sure I understand the concern:
- "studies show medicines approved on a faster time line ...": which study(ies)? And that was the case for previous track records, which says nothing if the FDA is making the same mistakes that they may have done 20 years ago.
- "more likely to have more safety concerns once they are broadly available while other treatments offer fewer benefits than anticipated", wait, do such studies actually have drugs that are virtually identical in all properties and where the only factor that changed is the approval timing? Because if that's not the case, you are just comparing drugs with different profiles, different indications, and different targets, which is pretty much apples and oranges. Good luck making conclusions based on that.
I am not aware of the FDA or any other regulatory body at this time starting to remove regulatory requirements to speed up approvals. The typical things we see nowadays is an exception for "orphan indications" where there is no good treatment available and people are dying without anything to try. It seems fair that they take in account patients' needs when it comes to expediting the last bureaucratic mile to ensure new drugs can save more patients. At the end of the day, patients are also free to refuse newer drugs (and doctors usually tell them when a drug has just been approved and when there is lack of much safety experience beyond clinical trials) so I don't see how you can frame this whole story in a negative light.