INAUGURAL POST: INSIDE PHARMA - JANUARY, 2022

Nonpartisan pharma news and views from the horse’s mouth, not the jockey’s

It was the truth then, as it is now:

WE NEED TO KNOW THIS WILL GET PROPER REGULATORY SCRUTINY

Hot on the heels of the Pfizer/BioNTech SARS-CoV-2 injection comes the next candidates for mRNA treatment – Shingles.

In an article published in PHARMACEUTICAL TECHNOLOGY, titled Pfizer and BioNTech enter deal to develop first mRNA vaccine for shingles, January 6, 2022, the deal was described by Pfizer Worldwide Research, Development & Medical chief scientific officer and president Mikael Dolsten as so: “With this agreement, we continue on our journey of discovery together, by advancing mRNA technology to tackle another health challenge ripe for scientific innovation, supported by our world-class manufacturing network.”

Inside Pharma says:

Given there is no rationale for an emergency approval, this MUST go through the normal channels before being approved for use in humans.

Regulations (laws) on licensing new drugs have been harmonised globally in recent years under the auspices of The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

For simplicity, we will refer to the laws as applied by US FDA, remembering that all countries must abide by the principles and practices agreed with ICH.

Firstly, satisfy yourself here that these are laws not nice to have’s. You should see Food and Drugs (FDA) listed in the US Code of Federal Regulations, Title 21.

Then, click on CFR Title 21, then Subchapter F, Biologics.

Now click on Part 600, Biological Products General.

To say the requirements and regulatory expectations are onerous is like saying rocket science is complicated.

Remember also that none of the companies developing mRNA injections have ever developed or manufactured a Biologic in their lives, let alone an mRNA based product—it is all done by contract development and manufacturing organisations (CDMOs) and contract research organisations (CROs).

The final layer of complexity is this. mRNA drugs are classed as advanced therapy medicinal products (ATMPs), as they are gene therapy. See FDAs account of them under Cellular & Gene Therapy Products.

That’s it for now…

Not to overload you, let’s leave it there for now.

The main takeaway from the above is that there is no SAFE shortcut to developing any drug—it goes inside your body for heaven’s sake.

Average time to get regulatory approval is 12 years. It could and should be quicker, but nothing has changed to speed up a system designed to keep patients safe as the main priority. Be back soon.

Cheers,

Hedley