FDA Law Blog: Has FDA Already Resolved One Critical Issue Concerning Forced Rx-to-OTC Switches?


Have you ever wondered what the FDA’s authority is to force a change from prescription medication to over-the-counter?  The following blog by the firm of Hyman, Phelps & McNamara just came across on my Tweetdeck – FDA Law Blog: Has FDA Already Resolved One Critical Issue Concerning Forced Rx-to-OTC Switches?.

Kudos to this firm for a well-written piece on the rule-making authority of the FDA.  It is an instructive piece on the concepts of ‘adjudication’ and ‘rule making’ and how those potential avenues of ‘forced change’ have played out over the decades since the 1951 Durham-Humphrey Amendments to the FDC Act gave FDA the authority to require that drugs be limited to Rx status when they cannot be used safely for OTC use.  “Thus, the underlying presumption (then and now) is that Rx restrictions are the exception, and that if a drug can be used safely and effectively OTC it should be.”

After presenting a detailed history of the amendments to the Act creating the FDA and the various attempts to effect a ‘forced switch,’ the authors conclude:

FDA in its petition decision appears to have determined that informal notice-and-comment rulemaking is the appropriate route to effect a forced switch over an NDA sponsor’s objections, and that administrative adjudication is not necessary.

While FDA rule-making and policies are certainly not one of my areas of expertise, it does make me wonder if all of this talk about health care reform being contingent – at least in part by some – on tort reform is a bit myopic.  Ever wonder about the cost of prescription medications, the Medicare donut (okay – doughnut by some) hole and drug lobbyists on our health care crisis?  Maybe the FDA can start taking charge with the power it has been given to consider a list of drugs that just might make sense to ‘force a switch’ to OTC at a much lesser cost to the consumer.

Tags: , ,

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

%d bloggers like this: