Ever wonder whether a new drug is as good as the one you’ve been prescribing for years? Alec B. O'Connor, MD, MPH, wonders all the time. In a commentary published in the March 1 issue of the Journal of the American Medical Association, Dr. O’Connor calls on the FDA to help physicians answer such questions.
Dr. O’Connor, associate medicine residency program director for inpatient services at the University of Rochester Medical Center in Rochester, N.Y., says that as part of the drug-approval process, the FDA should require pharmaceutical companies to submit data comparing the efficacy and safety of a new drug to an established first-line drug.
TH eWire recently asked Dr. O’Connor about his proposal.
Question: What propelled you to write this editorial?
Answer: I’ve observed that physician tendencies and patient tendencies are to try new drugs, regardless of what they were taking before the new drug came out. … When new drugs come to market, they are compared only against placebo and, in reality, that is not a comparison. What I need to see is how the new drug compares to what I’m already using to treat the patient for the same indication. … For all we know, if we stop using the old drug and prescribe the new drug, we may be harming the patient, in addition to increasing drug costs.
Q: Is it possible these requirements could increase drug development costs?
A: [The increase] will likely be quite small because there are so many drug development costs that happen before you get to the trial. I think the bigger risk would just be that they would get to the end of the drug development process and discover they have a drug that can’t be approved because it’s not as good as what we are currently using. … The flip side is that if that happens, then we prevent the drug from coming to market and replacing a current treatment with a drug that was shown to be inferior. I think companies would find that if they get to that point, they can find niches for the drug where it’s added to an existing treatment. They can also determine what patient population the drug makes the most sense for and do a trial that shows it does have a clinical effect that is just as good as what is already out there. So they’ll still have a drug they can sell.
Q: Will the policy incentivize pharmaceutical companies to develop orphan drugs or new classes of drugs?
A: It might. They would see it as a potentially less-risky development. Unfortunately, drug companies have to invest a lot of money in a potential new drug before they get to the Phase III trials where they are comparing them. It’s possible that drug companies might strategize about choosing more orphan indications, where all they would have to do is compare the drug to placebo, because there is no other treatment option.