What are those requirements? Is it six month notice?

Dr. Rhea:  From my understanding there is now a six month notice period where the FDA requires manufacturers if they’re going to permanently discontinue marketing a product, if there is any type of planned interruption, or even unplanned interruption. As soon as they know there’s a chance there could be a supply disruption they’re legally required to contact the FDA and let them know, mainly so the FDA can work with them and other manufacturers to make sure they can mitigate these other problems from coming to the market in the first place.

The notification, is that something that the FDA is going to share with pharmacists and physicians?

Dr. Rhea: I believe so, yes. I think they’re probably going to work a lot behind the scenes because this is a large complex process that involves companies around the globe and making sure they can bring materials to the manufacturers. Sometimes it’s something as simple as not having a foil overwrap to go over a bag and because the suppliers are overseas and/or they don’t have a secondary backup supplier for the manufacturer, then the product can’t come to the market. So I think these things the FDA can really help with and they’re really going to now have the authority to do that. I think that’s a really good thing and hopefully it prevents some of the problems that we’ve been seeing.

It’s not just generic injectables because I talked to a doctor and he said he had patients that needed oxycodone and he can’t find it anywhere. So it’s not just for people who go to the hospital, it’s for people who have back problems down the street who need pain medications and can’t get it.

Dr. Rhea: Yes, absolutely. The vast majority of the problem has been sterile injections, but we’ve seen it across all different dosage forms and types. The problem has extended to brain drugs, engineered drugs. One thing that we’ve seen, you mentioned oxycodone, is problems where at certain points in  the year manufacturers are held up by DEA limits on the amount of controlled substances they can produce. There are reasons for that, but when there are shortages in the market one of the things the User Fee Act does is it allows the FDA to work closely with the DEA on making sure that if there’s a quota issue that’s keeping product from the market, they can raise those limits and allow patients the needed treatment that they deserve.

Are patients helpless in this situation or is there anything they can do?

Dr. Rhea: Like in every situation asking questions is a good thing. Whenever you see your healthcare practitioner ask them about your medications and ask them if they’ve heard of any supply interruptions. If they’re in a situation where they’re having difficulty obtaining a drug their physicians can hopefully work with local pharmacists or groups or organizations that might be able to help them. So I think keeping abreast of the situation and asking lots of questions when you go in to all of your healthcare practitioners can really help to keep them informed.

I was reading on line if a patient does find a drug overseas or another country that is legitimate their doctor can actually get a prescription for them but only up to ninety days. Is that correct?

Dr. Rhea: I don’t know the details on that, but I think if patients are in situations where they’re not able to find a product that they need they really need to contact their physician and make sure that they have a long conversation about the different options that they have because most of the time there are different options available. Sometime physicians just don’t know that they’re in that position in the first place.




Sarah Clark-Lynn

FDA Office of Public Affairs
Drug Shortages Notification and Updates: