As one of the strangest and most ferocious election cycles in the U.S. has come to an end, and Donald Trump was named President-elect,industry experts are unboxing their crystal balls to try and predict what the future holds for the fate of existing regulation red tapes and one of its parts, the Drug Supply Chain Security Act (DSCSA). Even though we have yet to see the new administration in action, there is some evidence we can analyze to answer the question that keeps the industry tense – will Donald Trump eliminate the DSCSA?
Enacted in 2013, DSCSA is considered a heavy burden by many companies in the pharma supply chain. So some might think that there is a possibility the new administration would scrutinize it since Trump promised to “cut the red tape at the FDA: there are over 4,000 drugs awaiting approval, and we especially want to speed the approval of life-saving medications.”
Again, just as a full repeal of the ACA is unlikely, we assume the same could be true for the DSCSA mainly because of the preemption clause. Eliminating the DSCSA in its entirety would also remove the preemption clause, which prevents states from passing more restrictive regulations than the ones in the DSCSA, such as the one in California. Elimination of the preemptive clause is very likely to cause much distress to the industry and be counter to Trump’s advocating of “cutting the red tape.” So, with the industry in opposition to the full DSCSA repeal, the Congress might not want to tread in those waters.
Let’s really think about this… A repeal of the DSCSA and removing a standardized federal law applied nationwide would allow States like Florida and California to once again enact their own laws. This takes us back to a fragmented track and trace disaster that the industry begged Congress to change in 2013, hence why the DSCSA was created.
So, if there is a change for the DSCSA on the table, it will most likely keep the preemption clause. Could some parts be eliminated? Some say yes, the ones that have not been applied by the companies in the supply chain by now – serialization and aggregation.
There is, of course, a chance for the DSCSA to fall under the category of the regulations that both parties “like” alongside coverage for patients with pre-existing conditions and plans that allow children to remain on their parents’ plans for extended time. We might assume, with the workload that the ACA repeal and replacement will be, the Congress might leave the smaller regulations like the DSCSA untouched.
In any case, the odds are in favor of President Trump signing the bills that would ease the regulatory pressure on businesses, but all direction points that with regards to the DSCSA, it will probably be an exception.
-Chris
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