President-elect Donald Trump has made no secret of his interest in eliminating regulations that burden businesses unnecessarily. And he may take a particular interest in those that were newly imposed under President Obama. He has vowed to use his first 100 days to repeal “Obamacare”, the Affordable Care Act (ACA) and his plans include “… cutting 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.” Could the Drug Supply Chain Security Act (DSCSA) get caught up in that vow and also be repealed? There are three obvious possibilities.
The DSCSA does impose a large burden on companies within the pharma supply chain, and it was enacted in 2013 under President Obama, so on first look, it seems to have some of the major ingredients that could bring it under consideration by the new Administration. But a full repeal of the DSCSA is very unlikely.
A full repeal would eliminate the preemption clause that blocks states from imposing regulations that are more restrictive than the DSCSA. You can bet that Florida and California and others would respond with new laws that would put us right back where we started. For that reason, the industry will not support a total repeal, and if the industry doesn’t support it, Congress is not likely to spend any time on it. Remember, Congress only got involved in drawing up the original DSCSA when the industry approached it to solve the 50-state different pedigree law problem. It was the industry that asked for a single, nationwide regulation that would preempt all state laws (especially the one in California).
LEAVE IT AS-IS
It’s hard to judge how strong Trump’s campaign vow to repeal the ACA is when a full repeal would end the availability of health insurance to millions of Americans, and would bring back things like pre-existing conditions riders that nobody likes. More than likely, Congress will pass legislation that significantly changes the ACA, but still keeps some of the things that are viewed positively by people in both parties. But that would take a lot of time and an intensive effort, much like the effort that led to the passage of the ACA in the first place. In that case, Congress may have little time to deal with a “niche” regulation like the DSCSA. It could remain untouched for years while Congress is preoccupied by bigger issues.
And it is entirely possible that the Trump administration will view the DSCSA as the “good” kind of regulation. Obviously, in that case, it will remain untouched.
LEAVE THE GUN, TAKE THE CANNOLI
Another possibility is for the industry to bring a new proposal to Congress, now that a new wind is blowing in Washington. Attitudes about regulations have changed. They could propose a new law that would eliminate parts of the DSCSA and keep the preemption clause.
For example, they could eliminate the need for serialization and aggregation, but keep the exchange of lot-based transaction information. That is, cut the regulation to what is already being done today throughout the supply chain. That way the language of the preemption clause still makes sense (see “The New Draft Guidance On The Effect of Section 585 of the FD&C Imposed By The DSCSA”).
If this happens, it will likely start with a new proposed bill from the Prescription Drug Security Alliance (PDSA) which would likely be introduced into the Senate by newly reelected Senator Richard Burr (R-NC). The PDSA is the lobbying organization that represents its members—companies in the U.S. pharma supply chain—and promoted the DQSA. Senator Burr was instrumental in developing and passing the Drug Quality and Security Act (DQSA), of which the DSCSA was a part.
If changes are going to be made to the DSCSA as the result of this historic election, I don’t think it will take long to see evidence of the effort that will lead to it. The new Congress will be sworn in on January 3, 2017 and the backers of any bill aimed at repeal or trimming of the DSCSA should probably be in a hurry to wrap it up well before November next year. Most of the time would be consumed by work within Congressional committees. Just like there was no surprise that President Obama signed the original DQSA, President Trump would certainly sign any bill that reduces the regulatory burden on members of the pharma supply chain.
Which of these three possibilities do you think will happen?