Now You See It, Now You Don’t: Vanishing Drug Approval Information and Other FDA Actions Making Drug Approvals Opaque

December 22, 2016By Kurt R. Karst

Change is inevitable (cue David Bowie’s “Changes”). Sometimes change occurs slowly and goes (largely) unnoticed, and sometimes it comes fast and unexpected.  Sometimes change is good, and sometimes it’s not.  Change should not be confused with progress, growth or retreat, which are not inevitable, but rather optional and potential reactions to change.

We were reminded about change and the reactions to change the other day when listening to a piece on National Public Radio about how some scientists are racing to preserve climate data before January 2017 when a new administration takes the helm in the United States. That got this blogger thinking about change in FDA-world . . .  but not fast and unexpected change caused by a world-altering event.  Instead, we were reminded of change of the slow and largely unnoticed variety.   And change at FDA that isn’t particularly good for the regulated industry, and that seems to be counter to FDA’s commitment to transparency.  In fact, you might say that recent changes are part of an effort by FDA to be opaque.

The change we’re talking about concerns drug approval information. Over the past several years, we’ve noticed the slow pull-back and disappearance of drug approval information that has historically been very valuable to the regulated industry for purposes of making drug development and business decisions.

We’ll start in 2009, when FDA implemented a new information technology platform called DARRTS (Document Archiving, Reporting and Regulatory Tracking System). As we reported back then, DARRTS implementation meant the creation of a new application numbering system (i.e., the new 200,000 series application numbers).  Under that system, all NDA and ANDA submissions are numbered sequentially regardless of application type.  With that new numbering system, as well as the ability to reserve an application number well before submission, the generic drug industry lost some transparency with respect to the ability to track when an ANDA is submitted to FDA.

Despite the loss of some transparency with DARRTS implementation, folks swallowed the change. After all, when (and if) FDA posts a tentative or final ANDA approval letter, the date of application submission is provided and companies can use that information to make some initial determination on 180-day exclusivity eligibility . . . right?  Not so fast!

That was the case . . . until recently. As our friend Bob Pollock over at Lachman Consultants reported earlier this year, FDA’s Office of Generic Drugs decided (for unknown reasons) to no longer identify the date of ANDA submission in approval letters.  So instead of the first line of an approval letter stating “This is in reference to your abbreviated new drug application (ANDA) dated [DATE], submitted pursuant to section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), for [DRUG],” approval letters now state: “This is in reference to your abbreviated new drug application (ANDA), submitted pursuant to section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), for [DRUG].”

Well, at least companies can still refer back to a tentative approval letter once an ANDA is approved to help inform business decisions or to inform an analysis of 180-day exclusivity . . . right? Wrong again!

The recent transition of FDA’s Drugs@FDA database to a new platform and address brought with it some other changes. Historically, the Drugs@FDA database identified and included links to approval and tentative approval information and letters.  Now the tentative approval history of an application is erased.  If you don’t believe us, then go to the Drugs@FDA webpage and select “Drug Approval Reports by Month.” From there, select a month and “Tentative Approvals by Month.” Note the message at the top of the page: “This report lists Tentative Approvals for the selected month.  This page shows current information for the products listed.  If a submission was approved after its tentative approval, it no longer appears in this report” (emphasis in original).  In fact, not only does the tentative approval information not appear in the Drugs@FDA report, but other than a possible mention in a final approval letter, it’s gone entirely . . . . no link to the tentative approval letter or any mention of tentative approval in the database.  (One real-world example is ANDA 202653.  The final approval letter references a July 1, 2013 tentative approval letter that is neither available nor identified in the Drugs@FDA database.)  Of course, the letter is still available, but someone would have to submit a FOIA request to obtain it.

The disappearance of drug approval information is not limited to ANDA approval information. We’ve also seen information on NDA drug approval packages disappear from FDA’s website.  Take, for example, NDA 022051.  FDA initially approved NDA 022051 on April 27, 2007 for the prescription drug VERAMYST (fluticasone furoate) Nasal Spray.  On August 2, 2016, FDA approved a supplemental NDA for a prescription-to-OTC switch of the drug product (now known as FLONASE SENSIMIST).  With that change, information on FDA’s drug approval package (also known as a Summary Basis of Approval) stemming from the initial 2007 approval of NDA 022051 was removed from the Drugs@FDA website.  That’s too bad, because not only is easy access to FDA’s review documents now gone, but also FDA’s Exclusivity Determination.  (Fortunately, however, the old link still works . . .  but for how long?)

In any case, we hope this short post will cause some change of its own. Unless the regulated industry speaks up, who knows what other drug information will disappear from FDA’s website in the months and years to come.