Most RxTrace subscribers are aware that the FDA is way overdue to publish four guidance documents mandated by the Drug Supply Chain Security Act (DSCSA) (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?” and “Is The FDA Intentionally Delaying Publication Of The Overdue DSCSA Guidance?” for a list of the missing documents). Two of those four documents could impact how some drug manufacturers deal with the November 27, 2017 deadline for full serialization of prescription drug products, depending on what the FDA says in them.
Every day since the original due date of those documents (November 27, 2015) I have monitored the list of Public Inspection Documents scheduled to be released so I can write an RxTrace essay about them as soon as they are available. That means I have been monitoring every document that the FDA is about to publish on a daily basis for the last 67 weeks without seeing any of those four documents. Over that time I have become familiar with the flow of documents streaming out the giant agency. And that’s how I recognized a significant change that occurred around the middle of January. The flow stopped completely for an unprecedented five business days, and then continued as a trickle after that.
I wanted to see what it looked like over time so I constructed a graph that shows the number of Public Inspection Documents published by the FDA per week over the time I have been monitoring it. The change was very abrupt, beginning on January 20, which just happens to be the day President Trump was inaugurated. I don’t have comparable numbers around the inauguration day of any previous Presidents so I don’t know if perhaps this is a normal thing that always happens. Keep in mind that it typically takes a new President several weeks to get their nomination for Health and Human Services (HHS) Secretary and then the FDA Commissioner approved and in place. President Trump took an unusually long time to get a Director of the Office of Management and Budget in place. The combination of these might explain a temporary lull in publications coming from the FDA.
But it may also have something to do with some of the Executive Orders that President Trump has signed since taking office, including the federal hiring freeze, appointment of a regulatory reform watchdog in each agency, the need for agencies to eliminate two regulations for every new one they impose, and severe cost controls on any new regulation. According to USA Today, on the day President Trump took office, his Chief of Staff, Reince Priebus ordered a 60-day freeze on all new regulations in all agencies. In fact, I understand that every new President does something comparable to that freeze so they can ensure that any new regulations reflect their priorities from day one, especially when the Presidency changes parties.
Back in 2011 President Obama initiated a program to find and eliminate obsolete regulations, known as Executive Order 13563. I never heard much about the outcome of that order. Some of you may recall that the FDA looked at the elimination of the linear barcode rule as part of their search for obsolete regulations under that Obama order (see “Will the FDA Accept RFID for Drug Identification?”) but that effort was quickly forgotten as other priorities loomed.
Maybe the document output of the FDA will return to its typical flow after an adjustment period. On the other hand, President Trump’s Executive Order 13771, “Reducing Regulation and Controlling Regulatory Costs” might cause the flow of documents coming from the FDA to remain lower than recent history. That’s the one that requires the elimination of two regulations for every new one. Here is the definition of “regulation” or “rule” contained within the Order:
“Sec. 4. Definition. For purposes of this order the term “regulation” or “rule” means an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy or to describe the procedure or practice requirements of an agency, but does not include:
(a) regulations issued with respect to a military, national security, or foreign affairs function of the United States;
(b) regulations related to agency organization, management, or personnel; or
(c) any other category of regulations exempted by the Director [of the Office of Management and Budget].
Is seems to me that the DSCSA guidance documents we are waiting for might fall under this definition of “regulation” or “rule” because they would be “…an agency statement of general or particular applicability and future effect designed to implement, [or] interpret … law … or to describe the procedure or practice requirements of [the FDA]…”. In that case, before they can publish these four missing guidance documents, they would have to find eight old guidance documents to repeal. Good luck with that, considering the public announcements, analysis and reviews necessary to eliminate existing regulation.
I stand by my opinion that President Trump alone cannot block the implementation of the DSCSA because it is a law enacted by Congress and signed by the President at the time (see “Will President Trump Eliminate The DSCSA?”). But he probably can block the FDA from doing anything to assist the industry in implementing it, and perhaps even block them from doing anything to enforce it—at least until the next big discovery of counterfeit drugs in the U.S. supply chain or other supply chain malfunction (see “How Counterfeit Avastin Penetrated the U.S. Supply Chain“, “Lessons from “Drug Theft Goes Big”” and “Pew Prescription Project: After Heparin“, etc.).