Please describe your work with the FDA.
For the last 25 years, I have been involved in assessment of phase I trials, phase II and phase III study design and conduct, as well as regulatory assessment and oversight thereof through the FDA. I have kept up with a lot of the recent changes and evolving treatment concepts, especially around benign functional urology, which has to do with symptomatic conditions and how best to measure outcomes from the objective and the patient-reported outcome (PRO) standpoint. I’m happy to say that I was involved in the recent development of a drug, desmopressin nasal spray (Noctiva), where the development process included the use of a novel PRO instrument.
Forty percent of all over-the-counter drugs in the U.S. today were once prescription drugs. Most OTC products are not covered by insurance, resulting in higher out-of-pocket costs. Some of this cost increase is balanced by reduced medical service use and less time away from work. What are your thoughts on this conundrum?
There is relative value to some products being OTC. Certainly, given the current constraints in development and what is asked of a switch from prescription to OTC status, I find the controls to be very interesting, specifically because they are so patient-centric. One of the concerns when anything goes OTC is how it is really going to be used if it’s put into the public domain. Patient safety is critical, as is the importance of patient literacy concerning the condition being treated and also the formulation being taken.
Increases in medical service use following prescription-to-OTC switches may reflect product substitution. The absence of insurance coverage for OTC products may induce some individuals to seek covered prescription substitutes, resulting in more physician visits to obtain new prescriptions or failure to take any medicine at all. What are your thoughts on this?
I think that is a valid concern. One of the things that OTC medications allow is essentially a presumptive trial for management of a person’s condition. As an example, I started using, unfortunately, quite a bit of OTC anti-reflux treatments just because I didn’t want to have an esophagogastroduodenoscopy. I believe the potential for inappropriate use of OTC agents exists and their use potentially could increase costs. But I also think from the standpoint of patient-centric decision-making and patient involvement in care, the OTC availability of some drugs is a very reasonable option.