Distilling this week’s 13,706 alerts into the 19 alerts that you care about
Mary Kopczynski, CEO of RegAlytics, breaks down this week’s hot regulatory topics, exclusively for Exiger.
- Happy National Manufacturing Month
- Medicare Pharma Direct Negotiations
- Regulator of the Week: Customs and Border Protection
- Regulator of the Week: U.S. DOT
- Topic of the Week: Partnerships
- Egypt, Hungary, Albania: Subsea Cable
- Sweden, Canada: Small Modular Reactors
- Treasury, Homeland, Customs: Fentanyl Supply Chain
- DoD, GSA, NASA: Whistleblower Protections
- DoD, GSA, NASA: Cyber Incident Reporting
- CISA, NSA: Cyber Misconfigurations
- CT, MA, RI: Offshore Wind
- BIS: ‘Lengthening’ Supply Chains
- Other Interesting Alerts
Happy National Manufacturing Month!
And I begin with a Happy National Manufacturing Day, Week and Month! President Biden gave a speech on the day saying that, and it just so happens that the jobs report came out announcing the economy had created 336,000 jobs in September, which is pretty good.
Medicare Pharma Direct Negotiations
The Biden-Harris Administration also announced that official negotiations started between Medicare and the manufacturers of 10 specific drugs directly. This is a practice that has formerly been barred, typically lobbied against heavily by Big Pharma, but the Inflation Reduction Act allowed it. So we’ll see how this shapes the costs of healthcare for both the patients on them and also the manufacturers of them.
Boy oh boy, did I have a tough time deciding on the regulator the week. Again, these choices are simply what I see as interesting and keep in mind, I monitor about 8,000 regulators globally for the past three years, so they have to do something pretty interesting during the week to catch my eye. So, drumroll, I give you a tie. It’s between the U.S. Customs and Border Protection and the U.S. Department of Transportation.
Regulator of the Week: Customs & Border Protection
So, the U.S. Customs and Border Protection (CBP) did what appeared to be a routine extra check of a driver enrolled in the Trusted Trader Program run by CBP. On this random search on the Mexican border, the dogs found eight packages within the tractor containing 19 pounds of cocaine with a street value of $253,000.
Regulator of the Week: U.S. DOT
And then, the U.S. Department of Transportation put out a request asking if there are any companies out there who would make available a commercial grade eLoran system to the general public in the United States. They could charge a fee-for-service basis but would not get any federal investment, subsidy, procurement or commitment. So that got me, of course, trying to understand what is an e-Loran system and apparently, it’s a type of GPS system, or better said, a complement to GPS systems with a terrestrial backup to allow for precision navigation and timing. And the idea in the request for information is that — in response to a 2020 Executive Order under Trump having to do with Position, Navigation and Timing security and Resilience — it was determined that we needed a good back up if the U.S. GPS system goes down. So they’re looking for information from the players in this space. It’s not a request for vendors. It’s just information to help them decide what to do. eLoran system designers, I hear that as an opportunity.
Topic of the Week: Partnerships
Okay, so more reasons why it was hard to choose a regulator of the week is because the topic of the week is intergovernmental partnerships, starting with Egypt, Albania and Hungary.
Egypt, Hungary, Albania: Subsea Cable
A Memorandum of Understanding has been signed between the parties to build a new subsea cable between Egypt and Albania to improve connectivity.
Sweden, Canada: Small Modular Reactors
Other interesting bedfellows this week included Sweden and Canada, who wrote a joint statement on critical raw materials and clean technology, which includes Small Modular Reactors (SMRs) and their supply chains. They are focused on increased business collaboration and opportunities to foster the development of strong ecosystems with innovative companies from their two countries.
Treasury, Homeland, Customs: Fentanyl Supply Chain
Treasury along with Homeland Security and Customs and Border Protection are on a serious tear to cut down on the importation of fentanyl. So Treasury sanctioned 28 Chinese and Mexican individuals and entities that have been involved in manufacturing precursors to drugs like fentanyl.
DoD, GSA, NASA: Whistleblower Protections
The other regulators are the federal acquisition team, which in this case is DoD, GSA and NASA. So this week, two rules really came out that are worth noting. One, whistleblower protections on your employment contracts. You can’t have a nondisclosure agreement with an employee that doesn’t have a carve out that they will not be penalized for making a whistleblower claim. This is part of an effort by the U.S. federal government to make sure employees are aware of their rights to report bad acts on the part of their employers. This is a final rule, so get it done.
DoD, GSA, NASA: Cyber Incident Reporting
The second from the same federal acquisition team is the official implementation of cyber incident reporting and information sharing for federal contractors. Comments are due by December 4, so speak now or forever hold your peace.
CISA, NSA: Cyber Misconfigurations
CISA and the NSA have worked together for the past several years doing Red and Blue Team operations, where basically, the red team is made up of offensive cybersecurity experts who try to attack an organization’s cyber defenses (the blue team). This week they issued a joint report on their findings of these exercises called “NSA and CISA Red and Blue Teams Share Top 10 Cybersecurity Misconfigurations.” The report provides clear guidance to drive down these misconfigurations. So go read it.
CT, MA, RI: Offshore Wind
And in our final example of regulatory partnerships this week, the partnership winds are blowing strong in New England, with Connecticut, Massachusetts and Rhode Island signing an MOU to coordinate first multistate offshore wind energy procurement process.
BIS: ‘Lengthening’ Supply Chains
Finally, the Bank of International Settlements is still focusing on supply chain risk and putting out a ton of really interesting studies, some of which I mentioned in earlier episodes; but this week was about the lengthening of global value chains. They found that the direct supplier to end user relationships are become less common, and a trend is growing in having additional firms interposing in between the initial sellers and the final buyer. This is particularly noticeable between China and the U.S. And, as you know, Exiger allows you to really have a solid command on your 2nd and 3rd level suppliers, which is not only helpful for the U.S. government, but many national and international agencies that are following this carefully.
And that’s it this week for Exiger’s Regulatory update. Join me every week no matter where I am for your dose of regulatory news.