Regulatory Focus™ > News Articles > Legislator: Expect FDA Regulation to Stay Under the Microscope in 2014

Legislator: Expect FDA Regulation to Stay Under the Microscope in 2014

Posted 06 January 2014 | By Alexander Gaffney, RAC

2013 was a momentous year for the US Food and Drug Administration (FDA) for many reasons, but perhaps no issue loomed as large as pharmaceutical compounding, the vestige of a 2012 outbreak of fungal meningitis that was traced back to a Massachusetts-based compounder.

While the issue may have appeared to have been settled near the end of 2013, one legislator now says that he plans to maintain his scrutiny of FDA in 2014 in the hopes of ensuring "proper implementation" of new safeguards.


In the wake of the outbreak, which left hundreds injured and dozens dead, legislators moved to evaluate whether changes to the US regulatory system were needed. At the time, FDA maintained that its authority to regulate compounding pharmacies was not on par with its authority to regulate traditional pharmaceutical manufacturers, leaving it unable to inspect facilities on a timely basis or even demand access to manufacturing and compliance records.

Congress would ultimately concede that FDA needed more authority and passed the Drug Quality and Security Act (DQSA) in November 2013, but the law was far from a complete overhaul of the way in which compounding pharmacies are regulated.

For example, the law creates a new category of compounding pharmacies known as "outsourcing pharmacies" subject to heightened levels of scrutiny by FDA. Smaller compounding pharmacies, however, would still be regulated by state-level boards of pharmacy. The hope of legislators is that purchasers of compounded drugs will flock to inspected facilities and eschew the less-regulated ones.

Scrutiny of FDA to Continue

But left unanswered for now is a critical question: Will the new authority succeed in preventing another outbreak of fungal meningitis?

The answer to that question may still be years away, but that doesn't mean Congress will be ignoring the issue until the next health crisis. This week at least one US legislator said he intends to "hold FDA accountable in 2014" to ensure that no future compounding problems emerge.

"We worked for a year to create legislation that would help prevent another meningitis outbreak like the one that killed 16 Tennesseans and made so many others sick," Lamar Alexander (R-TN) said in a statement. "Tennesseans deserve to know that the FDA and other regulators are properly implementing this new law, which makes clear who is on the flagpole to prevent another nightmare like the deadly meningitis outbreak of 2012."

Alexander, one of the DQSA's primary authors, said he will push for a legislative hearing on the law in the coming year, with a particular focus on FDA and its "proper implementation" of the law's provisions.

Alexander Statement

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