Alexander Gaffney, RAC, Manager, Regulatory Intelligence at the Regulatory Affairs Professionals Society (RAPS) is right on top of any new proposed legislation related to FDA and other health-related federal government agencies. Last week he reported on the contents of a discussion draft of the “21st Century Cures” Act that was made public by the House of Representatives Energy and Commerce Committee (see Gaffney’s “Regulatory Explainer: The 21st Century Cures Act”).
At 393 pages, the draft bill, if enacted in its current form, would implement a very wide range of changes in the way the Food and Drug Administration (FDA) regulates drugs and devices—some subtle, and some major. The draft also includes potential changes in the management of the National Institutes of Health (NIH), Centers for Disease Control (CDC) and Centers for Medicare and Medicaid Services (CMS).
The draft includes a section called “Supply Chain Security for Devices”, which is an extract of some of the parts of the Drug Supply Chain Security Act (DSCSA), which were then modified for medical devices. These have the effect of locking down the distribution of medical devices to only pass through companies that are properly licensed—something that is not a requirement today. In its current form, those provisions would take effect on January 1, 2016.
The draft also includes the same kind of “uniform national policy” section as the DSCSA. It would prevent States and other local governments from establishing or continuing any standards, requirements or restrictions with respect to device distribution or third-party logistics provider licensure that are inconsistent with, different than, or in addition to the standards and requirements contained within this draft.
Gaffney followed up his excellent original article with a more concise overview called “10 Proposals Worth Paying Attention to in the 21st Century Cures Act”. Draft bills are made public before they are introduced for lots of reasons, but one reason is to attract comments about what is right and what is wrong with them so the bad ideas can be corrected more easily.
Remember these gems from the long, winding and sometimes bumpy path toward enactment of the DSCSA?
- What If RxTEC Isn’t Adopted?
- Congressional Legislation Development: Mad Libs Edition!
- The Congressional Draft Proposal to Improve Drug Distribution Security
- More Thoughts On The Congressional Discussion Draft
- The New Pharma Track & Trace Discussion Draft In The Senate
- California Responds To The Senate Pharma Track & Trace Discussion Draft
- House Subcommittee To Markup Track & Trace Draft Today And Tomorrow
- An Industry Protection Bill Concealed Under The Veil Of Patient Protection
- InBrief: Important New Bicameral Draft Of A Pharma Supply Chain Security Bill
Gaffney does a great job of shining a light on ideas that people should take a close look at so they can support those that are good, and help correct those that are not so good.
At least one of the things we learned from the passage and implementation of the DSCSA is that absolute dates (like “January 1, 2016”) are a bad idea in bills like this because you cannot predict how long it will take to pass through the House and the Senate. Most of the dates in the DSCSA are relative to the effective date of the law (the date the President signed it). For the DSCSA, the problematic date was “January 1, 2015” because it came only a little more than one month after a key relative date (see “The Flaw That Must Be Addressed in H.R. 3204, The Drug Quality and Security Act” for the details).
Note to the authors of the new discussion draft: Please change the “January 1, 2016” date references to “one year after enactment”, or even “18 months after enactment” to give the industry time to prepare properly.
What are the odds this proposal will be formally introduced into the legislative process, and then make it through enactment? Gaffney does not tell us his opinion, and I’m not equipped to make that kind of judgment. So what do you think? Do you see any other flaws in this draft? Leave a reply below.