Session 3: Introduction to the Regulatory Process

Speaker 1: 

Okay. All right. With that we will wrap up lunch and start our third panel for the day. Want to say welcome to any new faces that have joined us during the lunch hour. Just a quick reminder, we will be recording the panelist presentations, but we will not be including the Q and A section in the recording that goes onto the website. Just so y’all feel comfortable asking any questions you want to ask. If you prefer to write your question down, there’s these green cards all on your table. Please write those down and just flag a member of the alliance staff and we’ll come and grab that and give it to our moderator. And with that, I am pleased to welcome our third panel introduction to the regulatory process. Our moderator is Mike Pak, Partner in the Healthcare Legislative and Policy Group of Alston & Bird and also a valued member of the Alliance Board. We are thrilled to have you join us, Mike and I will hand it over to you. 

Mike Pak: 

Okay. Hi there. So thanks again for inviting me and take part in this program. Just as a reminder, you spent the last session with Dr. Whitlock moderating a panel on how the law is made. In this session, we’re going to be talking about how the executive branch implements the law. So the topics we’ll be covering are who are the key players in the regulatory development and review process. We’ll also talk about what are the key steps during this process. And then finally we’re going to talk about in what ways or how the key players interact. We have three excellent speakers involved, three seasoned veterans when it comes to health policy and folks I’ve held in high regard over the years. First we have Dr. John O’Brien, he’s currently President and CEO of the National Pharmaceutical Council, which is a research organization dedicated to examining the clinical and economic value of pharmaceutical innovation. 

He also has a broad experience spanning the private sector, government and academia. For example, he was recently senior advisor to the US Secretary of Health and Human Services and also served as the Assistant Secretary for Planning and Evaluation. He’s also had senior policy positions in the life sciences and managed care industries, including CareFirst BlueCross BlueShield. He also was a career official at CMS during the Obama Administration and spent some time on the Hill as a Health Policy Fellow in the Senate. Next we have Sara Singleton, who’s a Principal at Leavitt Partners. She’s based in Washington DC and also is an advisor to the National Alliance to impact the social determinants of health. She advises her clients throughout the healthcare sector on federal healthcare policy issues ranging from research and development, public health and the Affordable Care Act. Sara comes to us with significant experience on Capitol Hill, most recently as a Senior Policy Advisor with the Senate Help Committee under the chairmanship of Senator Tom Harkin. 

She also served as a Legislative Assistant for Senator Dick Durbin and was a Health Policy Fellow on the Help Committee under the chairmanship of Senator Ted Kennedy. And then last but not least, we have Jeremy Sharp who’s Managing Director at Waxman Strategies. He has extensive experience as a senior official both on the Hill and in the Administration. Most recently as Deputy Commissioner for Policy, Planning, Legislation and Analysis at FDA. Before that, he was Counselor to the HHS Secretary for Science and Public Health and spent time on the Hill as a Legislative Director for Senator Chris Dodd from Connecticut. And as one of the senator’s professional staff members on a Senate Help Committee’s subcommittee on children and families. His portfolio on the Hill included the Affordable Care Act, the Family Smoking, Prevention and Tobacco Control Act and other healthcare legislation. So thank you all for joining us today. We’ll kick it off by turning it over to John. 

John O’Brian: 

Well, thanks Mike. And regardless of what Rodney and Mike just said, I believe that all of the action is in the regulatory process, which is why there is no reason or risk really of anybody falling asleep after lunch. Here’s why. Congratulations. You’ve done what very few people will ever have the opportunity to say that they’ve done and that is work with their boss on crafting a major piece of health policy, ultimately passing it through the House and the Senate and getting it signed by the President. But before you will see your work make a difference, you will need to see it go some not as famous, but still very important processes including being published in the Federal Register likely a few times. 

The road to the Federal Register is not on any of the maps in DC, but it is one of the most important roads in the policymaking process. I also have to give a shout-out to the even nerdier OMB OIRA regulatory dashboard, which will show you what they might have received for an agency from a regulatory perspective to review. And people in this town make small sums of money selling to clients things that they could get and do get solely off of these websites and making what they would consider to be an educated guess about the timing of when something is actually going to come out. 

When Congress passes a law, particularly in healthcare, it is typically giving the Department of Health and Human Services the authority to create a program, regulate a program or spend money to implement a program. And there are three, maybe four ways that that typically happens. The first are regulations, which we know are actually laws. They’re published in the Code of Federal Regulations. One of the first things I had to learn in town was the difference between the USC and the CFR and why the citations were different and why they sometimes said the same thing, but sometimes said different things. They typically contain more granular details than the statute. Now, some statutory language is copied verbatim into the regulations, other statutory text, maybe one sentence, giving the agency the authority to do something which they then have the responsibility to describe how they’re going to do it, maybe the way your boss thought it was meant to be done, maybe not. 

And then ultimately putting those regulations out through a variety of different opportunities to get public feedback. Some examples of regulations again that carry the force of law, the annual physician fee schedule. Every year in June, Medicare tells doctors how much they’re going to get paid and they propose the different payment rates that they’re going to pay across all of the different services that physicians can provide on the outpatient setting. And then they take comment, which will often include, “You can’t pay us as little, we’ll go out of business, we won’t see any more Medicare patients.” And then ultimately there is a final rule that is published and that dictates what the payment will be the following calendar year. There are calendar year rules, there are fiscal year rules. There’s a whole bunch of different rules, but if you care about changing the way that physicians get paid or you care about the benefits that people who receive insurance through the exchange receive, you don’t just need to know the statute of the Affordable Care Act. 

You need to actually know what the agency’s proposing via things like the Notice of Benefit and Payment Parameters. There’s also something that the agency publishes referred to as guidance. Now, guidance doesn’t have the force of law, hence the term Sub Regulatory Guidance, but it describes how the agency is thinking, either to implement the things that are contained in the regulations like many of you may have wondered when we said this, did we mean that? But sometimes some programs don’t have regulations at all and the whole program can be described or implemented via guidance. And because it doesn’t carry the force of law, some people will say, “Well, we appreciate your thinking on this topic, agency, but we think that we are going to do this instead.” And then sometimes one party will sue the other party and then it all ends up in court until someone decides whether or not the agency actually had the authority in the statute to require anybody to do the things that they ask them to do via guidance. 

Some examples of things that could be considered guidance, in addition to by and large the entire 340B Program, include the Medicare Claims Processing Manual and the Qualified Health Plan Frequently Asked Questions. Oftentimes Congress will give the agency some temporary authority and we tend to refer to those as waiver programs or demonstration projects. So they will say in regard to a specific piece of the statute, we know that this is what the statute says you must do, but we’re also going to give you some flexibility to test some different ways to do this. And sometimes it can even become permanent if this test goes the way you want it. For example, it saves money without hurting patient quality, we will let this program become permanent. And there are some examples of different waivers and demos there. 

The majority of the people who are implementing your law are not the political appointees of the Administration. They are the career staff that do a great job caring a lot about the programs to which they’ve been entrusted. But their marching orders come from the politicals who sit at the top of various boxes. The boxes often look the same, but being Washington, they have to have different names. So at the Department of Health and Human Services, the secretary has their immediate office, their secretary, their deputy, the chief of staff and key people that either serve as the person who’s going to manage a program for them or someone who may be an expert about a particular thing. And they’re typically referred to as counselors. So one job I had, I was the Counselor for CMS and HRSA, but I also had a different job, which was I was the Senior Advisor for Drug Pricing. 

So the secretary said, “You’re the drug pricing person, go handle all of that.” But the agency itself is broken out into what we refer to as OpDevs or operating divisions, which you typically know as agencies. And both of our next speakers have some great montages and collages of what that actually looks like. But you also have your staff divisions and your staff divisions, typically in HHS, they’re at the assistant secretary level, they’re the people that help you with some really key functions of implementing your policies and programs. So you may have your own lawyer, the general counsel, you may have an expert in financing like an assistant secretary for financial resources. You’ve got a press shop, you’ve got a legislative shop. All of those support functions help you do your job. And at HHS, they’re at the assistant secretary level. CMS has much of the same structure except they refer to their operating divisions as centers, the Center for Medicare, the Center for Medicaid and Survey and Certification Services. They tend to be your program boxes. 

And then you also have your actuary, your legislative shop, your press shop. I’ve had many jobs in the agency. The coolest one I ever had is in a department of CMS you’ve never heard of called the Office of Strategic Operations and Regulatory Affairs. And that meant that my job was to manage what we referred to as the agency clearance process. Now, an agency can draft a rule because Congress said, “Here’s a new statute, implement it.” It can also be because a political appointee or a new president comes in and says, “I think HHS or CMS has been using the authority in the Medicare program incorrectly, and I want to do something different with it.” These are shown as single boxes. They are often multiple boxes. I believe the Affordable Care Act when it arrived in the Humphrey Building in 2010 had about 1,315 different decision points, pieces of rule making or guidance or grants that had to be drafted, and as many deadlines. 

Clearing a rule means once we’ve drafted the rule, someone then has to ask the program, “Can we do this? Does the Medicare program have the capability to do what this law is asking us to do?” And then you’ve got to ask your general counsel, “Can we do this legally?” But other department or other programs within CMS are going to have an opinion about, “Is this going to spill over or duplicate other programs? If we pay doctors more, what’s that going to do to the Medicaid population? Is there going to be a return on investment?” Medicaid demonstrations to reduce smoking may be great, but if the actuary doesn’t think that you’re actually going to have the return on investment you describe, then you might not be able to get the rule through the actual process. 

And likewise, you ask your press shop and your partner shop or any of our allies outside the agency going to think that we did this the right or wrong way. And last and potentially not least is asking the Hill, are we doing this by and large in accordance with what you thought when you drafted the statute? Once those decisions are answered, then and only then can the agency take a rule to the administrator and actually approve it. But your work isn’t done. And with that, I’ll hand it over to Sara. 

Sara Singleton: 

Thanks. There we go. That was a great setup, John. So I’m going to take us through the next bit of the regulatory process. So John just walked us through the box on the left, the agency drafting the rule. I’m going to walk us through this next piece, which is how you get the rule through the department, how you get it through the White House clearance process, and then what are the next steps after that? So after, for example, CMS has gotten its rule, then it goes into an office that I definitely had never heard of when I was on the Hill. But it becomes very important when you’re in the department called the HHS Executive Secretary, and their job is really to manage a lot of processes of gathering opinions and moving things through the departmental process. Sometimes it’s internal things like a memo to the secretary that involves lots of different players, and sometimes it’s something like a rule or a major guidance document. 

So the HHS Exec Sec, as the short name is for it, we’ll send to all the offices within the Office of the Secretary and all the relevant HHS agencies and they’re going to receive back all the comments and work to resolve those. But let’s break that down a little bit. So this is my beautiful chart of all of the different HHS agencies. So any one of these probably could be the source of a rule originating. So as John said, CMS puts out a lot of rules every year, payment for hospitals, payment for doctors, et cetera. FDA has a lot of important rules on regulation of food and tobacco and drugs, et cetera. So all of those different agencies might be players in generating a rule. You also have the Office of the Secretary that John mentioned before. So within there you have the key players like the counselors to the secretary. 

That was something again when I was on the Hill, was not very aware of, but a really important person because the secretary has a ton of things coming across his or her desk and really relies on the counselors as a key advisor managing the process because obviously only a tiny fraction of what is happening in the department really warrants secretary level attention. So the counselor is doing a lot of air traffic control and making sure that by the time that something comes out, it’s in shape and advising the secretary of any liabilities that come with it, any concerns, any blowback, they might get applause, warning them of what’s coming. Then there’s another role, the Assistant Secretary for Legislation. And Mike, you didn’t say this in our intros, and I’m not usually one to want to talk about our bios, but the only reason I have any standing to be on this panel is because Jeremy and I both had the role as Deputy Assistant Secretary for Legislation. 

So the Assistant Secretary for Legislation is a senate confirmed position, and then there are Deputy Assistant Secretaries that handle different portfolio areas. So Jeremy held the job. And then after Jeremy, I held the job in the Obama Administration. So the Assistant Secretary for Legislation, I hope you guys have gotten to know that office because their whole job is to be sort of the link between the Hill and the Administration. And so they’re coming at it with the lens of how is the Hill going to react to this or what does the Hill want from this? There’s also a lot of technical assistance that the ASL provides on draft bill. So if you’ve written a bill and you’re hoping that the committee will pass it at some point along the way for it to get through, you’re going to likely going to ask for technical assistance, which is the way that you share how the agency would be able to implement a bill or if there’s big hiccups or things that can’t be done, the agency will suggest those improvements. 

So when it comes to regulation, the Assistant Secretary for Legislation is looking and advising the secretary on the political interest and what the Hill intended and who cares about what. And obviously it’s not always all the same. You might have members on both sides of an aisle. So the ASL is advising about that. The Assistant Secretary for Public Affairs is the press office for the secretary. So their job is to let the public know when a rule comes out. So the ASPA as they’re called, has a really critical function because their materials, press releases, press conferences is going to be how the public often learns about a rule because a big CMS rule can be thousands of pages. So what goes into the press release about what’s in the rule is really important. That’s the way that the average person can understand it. 

And sometimes you got to dig into all of it, but that’s the public message about what the Administration wants to convey. The Assistant Secretary for Planning and Evaluation, they’re advisors to the secretary on how programs are working and doing a lot of policy coordination. And so they’re going to be reviewers on every rule. The general counsel is going to be obviously checking and making sure that things can be done, that it’s legal, and sometimes the Administration will take calculated risks and say, “The statute is silent on this matter, and so we want to take it in this direction.” And the general counsel’s job is to advise and say either, “Okay, you might get sued, but we think you should do it”, or “You really, really can’t do that. We’re going to have to change it.” So they’re a really critical player, and I learned a lot when I was in the DAS job about words and phrases I had used when I was on the help committee on laws that became laws, sometimes came to the department and caused all kinds of confusion. 

For example, we would very often as part of the negotiation on the health committee, add something about the department should do something as necessary. And then it would come and the lawyers would go, “What does necessary mean? We have to think about what’s necessary.” And I had no idea that the as necessary, which was a compromise, was going to cause all kinds of problems when it came to regulating. And then the Assistant Secretary for Financial Resources manages the money. That’s the CFO of the department. So I name all of these because I don’t think that they’re super visible to the Hill, but these are all within the office of the Secretary. And so when a rule goes out, there’s a chance for other agencies to review it. So if you’re doing a rule about, there’s a lot of overlap between the Food and Drug Administration and the CDC and the Department of Agriculture on food safety issues. 

So if FDA is doing a rule that relates to food safety, CDC is going to want to review that and they may have some important comments because of the function they play and also all these offices are going to be a part of it. In really tiny print at the bottom, I have some of the other offices that may review. And the reason I put those separately is because they may not be involved in the review of every rule, and they also are uniquely, some of them also offices in the secretary’s office that might issue a rule. So for example, the Office for Civil Rights, they actually have some of the most significant rules. They oversee health information and privacy, HIPAA, and so their rules are a really big deal. And the office of the National Coordinator of Health IT, they put out rules relating to how technology is certified. 

So they may be generating rules, but for the most part, the office of the Secretary’s Office isn’t generating rules. So just going back here, a sec. So the HHS Exec SEC sends the rule that, for example, CMS has written around to the offices in the Office of Secretary and around to all the relevant agencies. That’s called the clearance process. And they receive back all the comments and then they’re going to work with the high up persons such as the counselor to negotiate any of the big disputes. So sometimes you’ll have one agency saying, “No way, they can’t do that.” And then it’s going to be up to the counselor and maybe the general counsel and some other key folks to resolve that dispute and find the peace or decide that one agency is just going to have to stand down and live with it. 

So after you’ve gone through that process, which is not always just one process, sometimes it takes a few different rounds, if one of those major objections is raised, sometimes they’ll say, “Go back and try again.” But once you get it through that process, then it’s in this next phase, which is the White House clearance process, and very similar to the HHS clearance process, they send out the rule for review to a whole bunch of offices within the White House. So that includes the Office of Information and Regulatory Affairs, OIRA, which does an economic calculation on the rule. The Domestic Policy Council, which are the President’s key advisors on domestic policy issues, the White House Council, which is the President’s lawyers. So if it’s a really contentious thing and one of those areas where the agency is going out in a limb, the White House Council may weigh in. 

If it’s a health rule, the Office of Science and Technology policy may weigh in. And then there’s a number of other offices. I didn’t put all of them, but those are some of the most relevant. And then again, they’ll get back all the comments, and then usually your counselor and your White House will adjudicate those disagreements that arise in review. And maybe Jeremy can comment on that in questions because he was right in the mix of that when he became a counselor to the secretary. So once you’ve gotten through all those processes, then it is time to issue the rule. So it’s published in the Federal Register, which John showed you a lovely picture of. Usually you’re going to start with a notice of proposed rule making where you put it all the policies, and then there’s a comment period, sometimes 30 days or 60 days or 90 days. 

But sometimes there are different reasons, for example, the need to move fast, that the agency might go directly to what’s called an interim final rule. And that means they’re going to skip the first step of the notice proposed rulemaking. They’re going to put out a rule, and when it’s out, there’s an effective date and it’s going to be implemented, but they’re also going to have a comment period. And so they may come back and change it. And sometimes this is for political reasons like the Affordable Care Act. A lot of the rules, because of the timing and ability to get them done came out as IFRs, but it also sometimes is in response to an emergency situation that for timeliness, it has to happen. When you’re looking at the rules, the preamble is the beginning part of the rule. It’s really important to read, to understand the intent and the additional detail, because even though the rule is giving you more detail than the statute did, sometimes the preamble tells you even more and gives you examples of how something might be applied. 

And then finally, the rules out, and there’s a public comment period. So I said it’s 30 to 60 days, sometimes as long as 180. Sometimes the agency may hold public hearings or meetings during the comment period, and they have to consider, but they don’t have to take all the comments that are submitted. So when you get to the final rule, which is going to loop you back into the process, they’re going to have to address the public comments that they got and talk about why they did or didn’t take them. And it’s not based on the volume of comments. So you see a lot of stakeholders writing in sometimes in the thousands, tens of thousands, but it’s really on the merit of the comments, not the volume of the comments. 

And so based on all the comments they receive, the agency can decide to open another comment period. They can decide to terminate the rule making because they realize there’s a fatal flaw. They can make changes to address the comments because they’ve heard really loudly that there’s an issue. And so they want to change it in the final rule, or they can say, we like what we had and we don’t really see an issue with the comments. And so the final rule might almost exactly resemble the proposed rule. So that’s your process, and I’m going to pass it to Jeremy now. 

Jeremy Sharp: 

Thanks, Sara. Thanks Mike and John. So my task, let’s see if I can technically do this right, is to talk to you a little bit, I called it the inter-agency process. We’re really talking about the agency process and how they interact with each other in the development stage of this, but also basically before we get to HHS, and I came up with a less comprehensive scatter map of the agency logos, which I was very proud of until I saw Sara’s slides and I realized I was dealing with the pro. Here would be what I would say is despite the fact that all three of us spent a lot of time at the secretary’s office and above, most of the action is in the agencies. The agencies have the expertise. They have the resources to really do the work, to think about policy, to think about how can it be implemented, what are the positive and negative consequences of it? 

What are the interactions of that policy with different policies that Lord knows I never was very good at keeping track of when I was on the Hill or even in some of my administration positions. And so for you all who were trying to figure out how to influence policy, you want to get to know the agencies that are involved in the policy you’re working on. If you’re working on food or drug policy, you really want to get to know FDA. If you care about how doctors operate and hospitals operates, you really want to get to know CMS. If you are worried about workforce issues, you’ve got to get to know the way HRSA is, the Health Resources Services Administration and understand their authorities and understand their personalities. Each agency has a very different role, has a very different dynamic inside of it that’s based on the human beings who have been working there for so long and on where their authorities come from. 

Grant making agencies that are used to giving out money, HRSA, NIH are two good examples, SAMHSA is another. They have one way of thinking about the role of government and what are the tools at their disposals, and it’s largely writing checks and putting conditions on those checks. Regulatory agencies like the Food and Drug Administration thinks of itself as an independent neutral arbitrator of evidence and evaluation. CMS thinks of itself as a payer and runs the system. And these are gross generalizations and these are huge agencies that have lots of different personalities within them, but broadly speaking, that’s the way they operate. And when you’re writing legislation, you want to be thinking about which agency is going to end up implementing this, what are the tools they actually have and how will they implement it? The other thing about their personalities is they are different levels of cooperative with each other and with the department as a general rule, and I hope John won’t take umbradge at this, CMS doesn’t really think of itself as part of the Department of Health and Human Services. 

It basically thinks it’s an independent agency, doesn’t like taking any input from higher up, usually tries to skip HHS to talk to the White House, and they’ve got a lot of grounds for that. They have a huge budget that is entirely their own that is mandatory. And so don’t not dependent on other parts of the government as much as others. FDA thinks similarly except that it’s more on a, “We are the scientists who really know how this works. And Jeremy, you’re a political appointee with a bachelor’s degree. You’re trying to tell me what FDA policy should be. No, we don’t like that at all.” On the other hand, FDA knows that it is always going to be the punching bag of political debates in this country. And so they know they have to have the department and the White House on their side to help shield them from political consequence. 

These are just two personalities. Each of the agencies have their own versions of this. And understanding that will help you figure out both how to interact with them and also how to get legislation drafted that they can implement correctly. And the legal authorities I talked about a little bit, but one, I want to just hit a point that Sara made well, which is and put in relationship to the general counsel is these are agencies that are used to bright line tests. They don’t want to be tasked with making a judgment. And I’ll give an example here. 

Congress may say, “Oh, let’s pass legislation to require FDA to set a standard for arsenic in rice.” Okay, great. Now, FDA’s job is to go set a standard for arsenic in rice. It’s going to go out, check the health literature, check the scientific literature, ask for data, and it’s going to have to then figure out, well, what is that standard? What is the safe and appropriate amount of arsenic in rice? Is there a safe and appropriate amount of arsenic in rice? Can we quantify that? And they want guidelines from Congress on how to consider it. They don’t need Congress to say it should be X parts per million, but what they need is standards on which they can say, “Okay, it will reduce developmental disabilities” or “It will ensure for a food supply that is enough for our population to have. So these are the things they want guidelines from Congress, from political leadership for how to make decisions and how to decide what data is useful. 

So thinking about those and thinking about these agencies, you want to do that. This has been pretty well covered so far, but I will just say, thinking about it from the agency’s perspective, they are often initiating their own policies. It’s program offices and agency leadership say, “Oh, we want to deal with”, I focus on FDA because that’s my most deep background, “So we want to work on tobacco. We want to reduce e-cigarette use”, or “We want to see fewer opioids”, or whatever. They’ll start to put together policy. They’ll start to run it through the traps that Sara described and John described. But they will do a lot of the work ahead of time to figure out what those policies are. 

They will sometimes, but not always, consult with the other agencies that have similar jurisdiction. One of the fun ones is the distinction between CDCs, Advisory Committee for Immunization Practices I think it’s called, ACIP, and FDA’s labeling authority on vaccines. You will sometimes find out that FDA and CDC don’t agree on what’s the right dose of a vaccine and how should it be administered and when it should be administered. And when I was a counselor at HHS, it was always fun to have to find out that you had two federal agencies that had already told the public two different things on a matter. And both of them are convinced they are right. And so that is something that comes up and something you want to take into your awareness. And sometimes if you’re a legislative person, you want to make something happen, you want to take advantage of those divisions sometimes. 

So the last thing I want to do is, this is my thumbnail version of the things I would think about in the outside world about how to engage with and influence the agencies. One is there is the informal process and there is the formal process. The charts we’ve seen today are all about the formal process. The informal process starts well before any of those charts start where program officers start to talk to their senior officials about an idea they’ve had, something they’d like to do. Sometimes the agency official will vet that idea with more senior leadership, sometimes with HHS and White House officials, sometimes they won’t. Sometimes they’ll try to float trial balloons out there before they’ve gotten someone above them saying no. And engaging with the agencies and the program offices before there’s regulation is a great opportunity to influence the way they’re thinking. 

And you can do that both in direct communications but also through outside forums and briefings and opportunities where you may get a more unprotected encounter with government officials. The informal process continues throughout the chart. Before an HHS sends over to OMB a draft regulation, you can be pretty sure that someone in one of our three positions has had a lot of phone calls with people at the White House about what it is we’re sending over. Because usually when it gets sent to OMB, that’s the first time the public becomes aware that there is a rule on the subject matter of that. And the White House tends to be pretty protective of when someone puts that out in the public. So there’s a big difference between agency driven policy where it’s like, hey, someone who’s really smart, who’s been say 30 years, running a program on something really wants to do something, versus someone like me who says, “Isn’t it a great idea if we decide we’re going to ban football?” 

And the agency’s like, “What are you talking about? That doesn’t fit into our legal authorities? There’s no evidence to support that. We wouldn’t know how to do that yet. What are you smoking, Jeremy?” And I’m exaggerating, obviously, because often there are great ideas that come from the political leadership and are necessary from the political leadership. Agencies can become stultified, can become caught up in their own history and their own experience. And it is important to have that dynamic between the political and the career staff. But those processes matter. What I will say is if it’s controversial policy and it isn’t a White House driven policy or an HHS driven policy, the agency is going to have a hard time making it happen, because usually HHS and the White House do not want to take on fights that will distract from their priorities. 

During the formal process there are very hard limits on how the agency can communicate with you all and with anyone in public and members of Congress and their staff are not exempt from those limits. The agency is required by the Administrative Procedures Act to communicate with the public at large. They cannot reveal details of draft proposals or things to one group or another ahead of time and give anyone any special treatment on this. So you’ll often be frustrated when the agent says, “We can’t tell you about that because it’s an APA violation. It’s under regulatory review or whatever.” There’s a variety of language. John probably has the language better down than I do, or actually Sara may too, because she probably had to say this to a million congressional offices. 

It’s aggravating. I was just talking to someone about the FDA approved, genetically engineered salmon when I was there, and a certain senator from Pacific Northwest was furious that they didn’t get a heads-up. Well, guess what? Nobody gets a heads-up when FDA’s about to prove a drug or a device, at least not under the legal system. So there are limits, and you have to be respectful of them even as you’re trying to find your ways around them. 

I would say in your capacity, you should definitely be engaging with the stakeholders who engage with the industry because they often have a better sense of the internal map of the agency and have better contact with the staff in the agency and can give you a little bit of good intel about what an agency is thinking about. You have to take it with a grain of salt because they obviously have an agenda, but it’s a good pathway to do. The last thing is everything else in all of our jobs, it’s about relationships. 

So I would encourage you to go to the briefings where agency officials are coming and talking to you about things. Even if it seems a little boring, go up to the agency people afterwards and introduce yourself. See if you can get cards from the officials. I would say, especially if they’re not the legislative affairs staff, a big chunk of Sara’s and my job was to prevent those kinds of people from talking to you all. A big part of your job should be trying to find your way to talking to those people and their engagement with you all will help you flesh out your policy ideas, help you flesh out your boss’s legislation. And they may or may not be willing to do it, but usually somewhere in these agencies, there are people who want to share off the record information with Congress, and that is part of the way the system works.