FDA Takes Additional Steps To Improve Drug Supply Monitoring

I’ve been posting irregularly about shortages in the production of drugs and other critical elements.  But I’ve barely scratched the surface of the drug shortages.  The Food and Drug Administration (FDA) is starting to take steps required by a recent federal law to try and get a better handling on drug shortages as they appear (H/T Scientific American).

In Monday’s Federal Register there is a notice of a proposed rulemaking and request for comments from the FDA on changes in reporting on drug shortages.  Prompted by the 2012 Food and Drug Administration Safety and Innovation Act, companies will now be required to report six months in advance of discontinuing production or a shortage of production of certain drugs.  The FDA will also maintain a list of drugs under shortage conditions.

Much of these actions are putting into law and regulation guidance advanced in a 2011 Executive Order.  The rule would require a minimum of 6 months notice, with rare exception.  Failure to provide notice would prompt a public noncompliance letter, and the rule would give specifics both to the letter and the notice that companies must provide to the FDA.

The agency is persuaded that better information exchange between manufacturers and the FDA could further mitigate shortages.  From the notice:

“Working closely with manufacturers and other stakeholders, FDA was able to help prevent just under 200 drug and biological product shortages in 2011 and more than 280 such shortages in 2012, using tools such as:

“Working with manufacturers to resolve manufacturing and quality issues contributing to short supply.

  • Expediting FDA inspections and reviews of submissions from manufacturers to prevent and/or alleviate shortages.
  • Identifying and working with manufacturers willing to initiate or increase production to cover expected gaps in supply.
  • Exercising enforcement discretion in appropriate circumstances, if this would not cause undue risk to patients.”

An important change is that the proposed rule would require notice for marketers of certain compounds regardless of whether they hold an approved application from the FDA.  IANAL, but I wonder if this might be a means of exerting a bit more control over compounding pharmacies, which are not presently under FDA regulatory control.  (It is arguably a big stretch to suggest it might allow control of these pharmacies over drugs made for execution purposes.)

Comments will be open for roughly 60 days, closing on January 4, 2014.