FDA Warning Letters – Their Relationship to Drug Shortages — An Interesting Counterpoint

Recently (June 12, 2014) I authored a Blog re: “FDA Warning Letters – Their Relationship to Drug Shortages”.  This Blog elicited several very interesting comments.  Within this Blog, I noted that Douglas C. Throckmorton, MD, Deputy Director for Regulatory Affairs, CDER, FDA recently presented at the ISPE meeting on June 4, 2014 where he discussed this topic and illustrated the “FDA Response to Drug Shortages”.

A private communication that subsequently arrived looked at this issue from a different vantage point.  This vantage point discusses how many drugs that have had import alerts, seizures, consent decrees and other judicial actions have required the drugs to be removed from the market without any apparent regard for medical necessity.  In all fairness to the FDA, the Agency does attempt to have replacements available.  However, when they are not available, perhaps the FDA needs to consider what will happen when that patient, often cancer related, cannot receive a medication for several months.  I am not advocating non-sterile products be introduced into the product stream, but, as noted below, will a few particulates harm anyone who may otherwise be critically harmed before the medication is again available?

Please read the note below.  As always, your comments are appreciated.

“WOW! This discussion has hit so many points it could easily be broken down into a dozen different threads. However, the major concern I have with these types of discussion is that there really is no completely right or wrong answers given as people focus on answering a part and don’t address the whole issue. It is also interesting to see how “data” can be manipulated, i.e., FDA working with early notification has prevented some 200+ shortages. How about the other side of the coin where the remaining large number of shortages not prevented by the FDA was being created due to over interpretation of regulations by any investigator who happens to “believe” that something is wrong – even if there is no data to prove it.  How many hundreds of lots and tens of thousands of dosages with absolute MINIMUM potential for medical harm (virtually non-existent) have been “lost” to patients?  In these non-critical medical recalls, why hasn’t the FDA gotten “with it” and worked out these issues with risk analyses regulatory discretion resolutions as well?  Sorry – but I do not see the needs of patients being helped more by holding back or withdrawing these products from the marketplace. In a personal discussion with a cancer patient well respected in our industry and known to most – when I asked if it was a question of “possibly getting a particle injected OR not getting the drug at all – the reply was “not even a decision to be given a second thought – GIVE ME THE DRUG!!!” Stopping the problems in the industry – particularly with some notorious firms – is absolutely needed – but we can’t do it while causing more harm than good.”

About Barry A. Friedman, PhD LLC

Regulatory Compliance, Expert Witness, Pharmaceuticals, Biotechnology, Aseptic Processing, GMP, GLP, Quality Control, Positron Emission Tomography (PET), Microbiology, Process Validation, Validation of Analytical and Microbiological Methods
This entry was posted in FDA Compliance, Import Ban, Recall, Regulatory Compliance, Seizure and tagged , , , , , , , . Bookmark the permalink.

One Response to FDA Warning Letters – Their Relationship to Drug Shortages — An Interesting Counterpoint

  1. And having been involved with clients who have had these issues, there are many times the FDA does in fact weigh the question posed and through risk management makes these decisions. An its not the FDA only, I have personally been involved with Health Canada, MHRA just to mention two where the issue of whether to supply the market or not has been deliberated upon, especially with the company as well..

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