Despite FDA and Industry’s Efforts, Drug Shortages Continue

Over the last few days, FDA has posted information on new and updated drug shortages (here) with 6 new shortages listed over the last week.  (We do not know why Surmontil capsules were listed twice but surmise that the three firms reporting a shortage of the product did so on different days.)  Below is a list of the new postings for the week of August 12-19.

New Postings

August 19, 2014

Phenylephrine Hydrochloride Ophthalmic Solution (Currently in Shortage)

Trimipramine Maleate (SURMONTIL) Capsules (Currently in Shortage)

August 18, 2014

Trimipramine Maleate (SURMONTIL) Capsules (Currently in Shortage)

August 15, 2014

Famotidine Injection (Currently in Shortage)

August 14, 2014

Cefotetan Disodium Injection (Currently in Shortage)

August 12, 2014

Dihydroergotamine Mesylate Injection (Currently in Shortage)

We have noted the problems that drug shortages create in previous posts (here and here) and we have all followed the media accounts of the problem; however, it still seems that, while many of the causes of drug shortages have been identified, stopping them from happening in the first place appears to be more elusive than any regulation, required notification or interaction with regulatory bodies can resolve.

I don’t want to get into all of the factors that cause drug shortages, but simply wanted to point out that no matter what the industry and regulatory bodies are doing to help reduce the problem, apparently its elimination is far from within our grasp.  As the supply chain becomes more complex, small ripples can cause big waves and resolving shortage issues can become more difficult, as each component of the supply chain becomes dependent on one another-when one component fails, the interruption on the flow of necessary materials can be devastating.  This is especially true where there is no redundancy in suppliers, manufacturing sites, contractors or other co-dependent pieces of the drug manufacturing puzzle.  We will continue to follow the drug shortage issue and hope that with all the good news about averted shortages, the number of actual shortages continues to decline as the industry and the regulatory bodies learn to work together to solve this crucial and continuing problem.