In August, the FDA calculated the 2014 Facility Fees for the Generic Drug User Fee Amendments (www.fda.gov/gdufa); domestic Final Dosage Form (FDF) facilities saw their fees jump $45,000 to $220,152, while fees for domestic API supply facilities rose $8,000 to $34,515. Non-U.S. facilities in both categories faced the same increases, along with a $15,000 charge for not being American: foreign FDF facilities were billed $235,152 and foreign API facilities were billed $49,515.

The big increase was due — as I noted in our March issue — mainly to the one-time $50 million backlog fee in the 2013 budget. In its absence, the 748 FDF and Primary Packaging facilities on FDA’s Self-Identified Generic Drug Facilities, Sites and Organizations List are on the hook for an additional $28 million in 2014, in addition to covering $3.7 million in inflation costs (darn that cost of living!). The good news is that there are no major jumps for the final three years of GDUFA’s first term, just inflation increases based on FDA’s Personnel Compensation and Benefits calculation.

So what’s it mean? One CMO has told me that it has already exited generic manufacturing due to the fees. Another has told me that it has left contract manufacturing completely, for the same reason. Several more have told me that they’re in a “holding pattern” and will have to evaluate whether it’s worth manufacturing these drugs.

In addition, two CMOs have told me that they’ve been charged GDUFA Facility Fees for facilities that do not manufacture generics; in both cases, they contended that their sites ended up on the Self-Identified List because a third party listed them as a potential alternate manufacturer for a generic product, without their knowledge. Kafkaesquely (?), these companies had no idea why their sites were being charged GDUFA fees and, to date, have no idea how to get de-listed from the Self-Identified List.

I’m beginning to think that FDA’s notion of “self” is very different from mine. . .

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Trade Show Shuffle
The autumn trade show season is upon us! I feel as though I’m barely recovered from the spring season, splitting time between BIO and INTERPHEX, covering PDA, DCAT, CPhI China and various and sundry smaller meetings and visits. Now it’s on to Frankfurt, San Antonio and Washington, D.C. for CPhI/ICSE, AAPS and ISPE (and various and sundry meetings and visits). My suits are aired out, my shirts are pressed, my shoes are nice and shiny, and I’m ready to defend my “no checked luggage” vow with my trusty Delsey carry-on bag.

Before I pack on more frequent flyer miles, I get to help host a show in my own backyard: Contract Pharma’s 12th annual Contracting & Outsourcing Conference and Tabletop Exhibition on Sept. 19-20 in New Brunswick, NJ!

At the risk of violating the “no shameless self-promotion” warning I give all my editorial contributors (along with “Thou shalt not use ‘communication is key’ or ‘win-win relationship’”), I’m pretty excited about this year’s event. There’s a strong lineup of speakers, our FDA presenter is going to talk about a important subject for clients and providers (the agency’s Draft Guidance on Quality Agreements with CMOs), the tabletop exhibition sold out quicker than it ever has, and the amenities (including the catering menu) are All That.

Our big Conference Preview begins on page 121 of this issue and you can visit conference.contractpharma.com for more info about the event. See you there! (Or Frankfurt, or San Antonio, etc. . . )

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What I’m Reading
Pharma
Druggability: A Philosophical Investigation
Derek Lowe, In the Pipeline • bit.ly/142q96k
Comment: Our Lowe Down columnist takes on the meta-question of whether it’s possible for us to “run out” of new drugs, or if drug discovery is an essentially infinite field. I love theoretical/philosophical questions like this, but your mileage may vary.

Non-Pharma
Bug Music: How Insects Gave us Rhythm and Noise
David Rothenberg • amzn.to/15CMtku
Comment: A musicologist-philosopher-jazz-clarinetist takes the occasion of the emergence of 17-year cicadas to explore the ways in which insect sounds may have influenced human concepts of rhythm and dance. It’s a really charming book, without too heavy of a music-theory focus, about the relationship mankind has with the natural world. You’ll never hear katydids the same way again.

Why don’t you tell us what you’re reading? Write us at groth@rodmanmedia.com, www.goodreads.com/groth, www.linkedin.com/groups?gid=1775433 or www.facebook.com/contractpharma — and the first respondent wins a prize!