Regulatory Guidance / Compliance Management

Sound Advice

This year, pharma regulators faced their own music

By Karen Langhauser, Chief Content Director

Anyone who grew up in the ‘80s or ‘90s understands the lost art of the mixtape. Mixtapes served many purposes. Going on a road trip? Make a mixtape! Need a birthday gift? Mixtape. Want to tell someone you love them? Mixtape. But perhaps the most important of all mixtapes were the ones you made yourself when you were going through a tough time. Some had creative titles (“My Heart BEATS On”) while others stuck to more literal titles (“Do Not Call Him, He is the Worst”). And yes, these are both mixtapes in my possession.

What is funny about these mixtapes is that despite the insane amount of time and effort I put into creating them (recall that these pre-dated online music sharing), rarely did I follow the advice I had painstakingly embedded behind each heart-wrenching song. So basically, a lot of preaching, zero practicing on my part.

If you follow FDA press statements, you will know that the agency’s favorite lyrics are “encourage innovation” — and rightfully so given the ongoing demand for solutions that address pressing healthcare needs. And yet, the more the FDA sings the praises of innovation, the more ironic it becomes that the agency itself has a historic reputation for being woefully outdated. 

But in the words of mixtape staple Bob Dylan: the times they are a-changin.’ As you’ll read in this month’s cover story, the FDA has been busy. The agency has broken some prior benchmarks for both new drug and generic drugs approvals. The FDA’s push for harmonized global standards, support of electronic submissions, and added clarity through guidances are all helping to speed products to market.

This year, acknowledging the current crisis, the FDA released must-needed new standards in guidance documents that address various parts of opioid manufacturing and consumption. In acknowledgement of the future direction of the industry, the agency released six new guidance documents aimed at providing more clarity at gene therapy development and manufacturing. 

In November, the agency announced it would be modernizing its facility inspections program with a new way of assessing, recording and reporting inspection data. This new protocol will allow the FDA to more efficiently collect and analyze information to give better and timelier insight on the state of quality in drug facilities. The protocol is being applied first to sterile injectables — an area with a lot of quality issues — and then will be rolled out to other pharma facilities.  

I know what you’re thinking — another journalist singing the praises of the FDA (and using as many music puns as possible in the process). But given the FDA’s size and the fact that it’s a government entity, it’s impressive to see it working towards improving practices in much the same way it demands from those it regulates.

Truth is, you can’t encourage innovation without being willing to innovate yourself. It doesn’t matter how many “breakup recovery” mixes you make, nothing changes if you don’t heed your own advice. This year has been a step in the right direction for regulators, and for companies pushing themselves to innovate, this should be music to their ears.

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