RULEMAKING ADVOCACY AND PLAN B©Dave Owen

University of California, Hastings College of the Law

This case study asks you to consider how you, as an attorney representing parties outside an agency, might affect the progress of an agency rulemaking. Attorneys routinely face this challenge, and it raises a host of subsidiary questions. What formal legal mechanisms, like petitions and court filings, would you use? What informal mechanisms, like meetings with agency officials, would you try to use, and are you allowed to use? What kind of information would you try to provide to the agency, and how? And to what extent would you try to work with entities outside the agency—Congress or the media, for example—to advance your client’s cause?

As you read the materials below, please think about what you would do if you represented the following three groups:

Planned Parenthood is a national organization devoted to promoting reproductive health. Since its creation, a core part of Planned Parenthood’s mission has been promoting women’s access to birth control, which it views as centrally important to family planning and to women’s health.

Pharma, Inc. is a (fictional) drug company. The company has developed an emergency contraceptive pill that it hopes

to sell to American consumers.

The Family Research Council is a religious advocacy organization. It promotes what it describes as traditional family values, and it is particularly focused on promoting sexual abstinence among teens and on limiting or eliminating abortions.

As you might guess from those teams, this exercise will address some loaded issues. When we cover those issues in class, and you are assigned to a group, some of you probably will find yourself thinking through an advocacy strategy to advance a policy positon that you find distasteful. As you take on that uncomfortable task, please keep in mind that it is an essential part of lawyering. Even if you succeed in obtaining a job with a firm or organization that represents only clients you believe in, you’re unlikely to believe in all of those clients’ positions. And sometimes the best

way to help a client you deeply believe in is to try to anticipate the thinking of an organization you oppose.1

Of course, please also keep in mind that your classmates are going to be advocating for clients’ positions, not necessarily stating their own beliefs.

INTRODUCTION

The Food and Drug Administration, a federal agency, regulates the safety of medical drugs in the United States. Pursuant to the Federal Food, Drug, and Cosmetic Act, the FDA divides drugs into three general categories:

Prescription drugs can only be purchased by patients with a current prescription;

Behind the counter drugs can be purchased without a prescription, but only from a licensed pharmacist. Those sales are often subject to strict recordkeeping requirements, and regulations may limit the quantity of drugs that pharmacists can sell to individual consumers. This category includes drugs like ephedrine and pseudoephedrine, which have important medical uses but also have significant potential for abuse;

Over the counter drugs can be purchased without a prescription, from any checkout worker, and without any regulatory constraint.

This question addresses efforts to move emergency contraceptives—commonly known as “morning after pills”—from the first or second category to the third.2 More specifically, it addresses what you would do if you were an attorney trying to convince the FDA to make that switch, or if you were trying to convince it not to do so.

APPROVING (OR NOT APPROVING) EMERGENCY CONTRACEPTIVES: A VERY BRIEF OVERVIEW

Not long after contraceptives pills emerged, physicians discovered that they could be taken, in heightened doses, to avoid pregnancy during the period shortly after intercourse. For years, this potential use was neither widely publicized nor well known. But in the 1990s, medical and public health advocacy groups began asking the FDA to include the possibility of emergency contraceptive use in the labeling requirements for contraceptive pills. Initially, those advocacy efforts did not produce relabeling or new drug approvals, but they did lead to studies. The FDA convened an advisory panel, which concluded that oral contraceptives could be safely and

1 To provide one example of that need: diligent lawyers typically practice oral arguments before appearing in court. And in the practice argument, someone from the firm or organization will typically play the role of opposing counsel. Playing that role well has obvious benefits; a tough practice argument can be the best possible preparation for the real thing.2 This fact pattern is based, loosely, on real events, as recounted in Lisa Heinzerling, The FDA’s Plan B Fiasco: Lessons for Administrative Law, 102 Georgetown L.J. 927 (2014).

effectively used as emergency contraception, and it invited applications from drug companies for relabeling of such drugs.

The FDA instead received applications for approvals of new drugs as emergency contraceptives, and here is where the plot thickens (this is also the point at which I’ve begun to exercise some poetic license, for the sake of creating a problem that isn’t too complicated). Two years passed without action or any form of public statement. But rumors swirled. According to fairly credible sources, the FDA was likely to approve the petitions, but would only allow non-prescription use by women who were seventeen or older. Girls under aged sixteen or younger would be able to purchase the drugs, but only if they first obtained a prescription. The FDA, according to the (fairly credible) rumors, would create this distinction because it lacked information about whether the drugs could be taken safely by girls under the age of sixteen. But that explanation seemed to run counter to past practices; the FDA had often extrapolated from studies of older patients to assess whether other drugs were safe for adolescents. And there were further rumors that top agency decision-makers were worried about encouraging adolescent sexual activity—and about limiting what some advocacy groups considered to be a form of abortion.

THE FDAA key decision-maker (but not the only one) on this issue is the FDA, and some description of the FDA’s role and responsibilities therefore will inform your advocacy strategy. The FDA is a federal agency within the Department of Health and Human Services. One recent law review article provided the following brief summary of the agency’s position:

The FDA is an agency within the Department of Health and Human Services (HHS). Its Commissioner is nominated by the President and confirmed by the Senate. Id. § 393(d)(1). For a deprecating take on the place of the FDA Commissioner in the hierarchy of executive-branch political appointees, see In re Kessler, 100 F.3d 1015, 1017 (D.C. Cir. 1996) (FDA Commissioner's rank is “the journeyman level of those appointed by the President and confirmed by the Senate,” “at least three levels down from the Secretary of HHS”). Specific provisions of the FDCA suggest that the Secretary is to make certain regulatory decisions, but a cross-cutting provision states that the Secretary of HHS, “through the Commissioner,” will implement the Act. 21 U.S.C. § 393(d)(2) (2012). A delegation of authority between HHS and the FDA provides that the Secretary of HHS has delegated to the FDA Commissioner “all authority as follows,” which includes “[f]unctions vested in the Secretary under” the FDCA. [citation omitted] Outside of the FDA Commissioner's office, there are few political appointees within the agency.

Heinzerling, 102 Georgetown L.J. at 937 n.57 (internal citations omitted). This passage contains two key points. One is that the FDA itself does not hold final authority over decisions within its jurisdiction. Instead, the Secretary of Health and Human Services is the ultimate decision-maker. Second—and this is shown in more detail in the charts below (which you may also find, in more legible form, on the agency’s website)—the agency has very few political appointees. Most of its staff are career staff with technical training.

THE FFDCA: SOME KEY PROVISIONS

The FDA implements the Federal Food, Drug, and Cosmetic Act, a statute designed to allow drugs and other products to come to market but also to ensure that those drugs are reasonably safe. Several key provisions of the statute would apply to the FDA’s potential approval and reclassification of emergency contraceptives. I have pasted excerpts of the key sections below. As you review those excerpts, keep in mind your task: you’re looking for language that helps explain what the agency is supposed to do, what information it can and can’t use, and when it is supposed to act.

First, 21 U.S.C. section 353 allows the FDA to limit the circumstances under which consumers can obtain some drugs. This section authorizes the FDA to put drugs into the prescription and behind-the-counter classifications.

21 U.S.C. § 353. Exemptions and consideration for certain drugs, devices, and biological products

…(b) Prescription by physician; exemption from labeling and prescription requirements; misbranded drugs; compliance with narcotic and marihuana laws(1) A drug intended for use by man which--(A) because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug; or(B) is limited by an approved application under section 355 of this title to use under the professional supervision of a practitioner licensed by law to administer such drug;

shall be dispensed only (i) upon a written prescription of a practitioner licensed by law to administer such drug, or (ii) upon an oral prescription of such practitioner which is reduced promptly to writing and filed by the pharmacist, or (iii) by refilling any such written or oral prescription if such refilling is authorized by the prescriber either in the original prescription or by oral order which is reduced promptly to writing and filed by the pharmacist. The act of dispensing a drug contrary to the provisions of this paragraph shall be deemed to be an act which results in the drug being misbranded while held for sale.

Next, 21 U.S.C. section 355 provides procedures and deadlines for listing new drugs. The provisions for reclassifying drugs are much more limited. However, the FDA and courts have interpreted the first sentence of subsection 355(b)(1) to authorize petitions for reclassification.

21 U.S.C. § 355. New Drugs

(a) Necessity of effective approval of applicationNo person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) of this section is effective with respect to such drug.

(b) Filing application; contents(1) Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a) of this section. Such person shall submit to the Secretary as a part of the application (A) full reports of investigations which have been made to show whether or not such drug is safe for use and whether such drug is effective in use; (B) a full list of the articles used as components of such drug; (C) a full statement of the composition of such drug; (D) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug; (E) such samples of such drug and of the articles used as components thereof as the Secretary may require; (F) specimens of the labeling proposed to be used for such drug….

…(c) Period for approval of application; period for, notice, and expedition of hearing; period for issuance of order

(1) Within one hundred and eighty days after the filing of an application under subsection (b) of this section, or such additional period as may be agreed upon by the Secretary and the applicant, the Secretary shall either--(A) approve the application if he then finds that none of the grounds for denying approval specified in subsection (d) of this section applies, or(B) give the applicant notice of an opportunity for a hearing before the Secretary under subsection (d) of this section on the question whether such application is approvable. If the applicant elects to accept the opportunity for hearing by written request within thirty days after such notice, such hearing shall commence not more than ninety days after the expiration of such thirty days unless the Secretary and the applicant otherwise agree. Any such hearing shall thereafter be conducted on an expedited basis and the Secretary's order thereon shall be issued within ninety days after the date fixed by the Secretary for filing final briefs.

…(d) Grounds for refusing application; approval of application; “substantial evidence” defined

If the Secretary finds, after due notice to the applicant in accordance with subsection (c) of this section and giving him an opportunity for a hearing, in accordance with said subsection, that (1) the investigations, reports of which are required to be submitted to the Secretary pursuant to subsection (b) of this section, do not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof; (2) the results of such tests show that such drug is unsafe for use under such conditions or do not show that such drug is safe for use under such conditions; (3) the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug are inadequate to preserve its identity, strength, quality, and purity; (4) upon the basis of the information submitted to him as part of the application, or upon the basis of any other information before him with respect to such drug, he has insufficient information to determine whether such drug is safe for use under such conditions; or (5) evaluated on the basis of the information submitted to him as part of the application and any other information before him with respect to such drug, there is a lack of substantial evidence that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof; or (6) the application failed to contain the patent information prescribed by subsection (b) of this section; or (7) based on a fair evaluation of all material facts, such labeling is false or misleading in any particular; he shall issue an order refusing to approve the application. If, after such notice and opportunity for hearing, the Secretary finds that clauses (1) through (6) do not apply, he shall issue an order approving the application. As used in this subsection and subsection (e) of this section, the term “substantial evidence” means evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof. If the Secretary determines, based on relevant science, that data from one adequate and well-controlled clinical investigation and confirmatory evidence (obtained prior to or after such investigation) are sufficient to establish effectiveness, the Secretary may consider such data and evidence to constitute

substantial evidence for purposes of the preceding sentence. The Secretary shall implement a structured risk-benefit assessment framework in the new drug approval process to facilitate the balanced consideration of benefits and risks, a consistent and systematic approach to the discussion and regulatory decisionmaking, and the communication of the benefits and risks of new drugs. Nothing in the preceding sentence shall alter the criteria for evaluating an application for premarket approval of a drug.

The FDA also has promulgated regulations setting procedures for reclassifications. A key excerpt appears below. Pay particular attention to the last sentence.

21 C.F.R. § 310.200 Prescription-exemption procedure.

(a) Duration of prescription requirement. Any drug limited to prescription use under section 503(b)(1)(B) of the act remains so limited until it is exempted as provided in paragraph (b) or (e) of this section.

(b) Prescription-exemption procedure for drugs limited by a new drug application. Any drug limited to prescription use under section 503(b)(1)(B) of the act shall be exempted from prescription-dispensing requirements when the Commissioner finds such requirements are not necessary for the protection of the public health by reason of the drug's toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, and he finds that the drug is safe and effective for use in self-medication as directed in proposed labeling. A proposal to exempt a drug from the prescription-dispensing requirements of section 503(b)(1)(B) of the act may be initiated by the Commissioner or by any interested person. Any interested person may file a petition seeking such exemption, which petition may be pursuant to part 10 of this chapter, or in the form of a supplement to an approved new drug application.

SOME GENERAL GUIDANCE ON INFLUENCING AGENCY ACTIONS

Figuring out how to influence agency decision-making is often difficult, and the techniques that work are likely to vary from agency to agency and from controversy to controversy. Nevertheless, the excerpts below—both of which are transcripts of oral presentations at a law school conference—do provide some good general advice. As you read, bear in mind that these statements were made twenty-five years ago, before the advent of the

internet and modern social media. So you might consider whether some of the advice still holds or whether it seems anachronistic today.

You might also keep in mind that in a realm as complex as this, even the best advice isn’t likely to be right all the time.

Initiating Agency Action: Comments of Patricia Bailey, 5 ADMIN. L. J. 24-30 (1991)

…The questions posed in the program seem to me, at least at the beginning of them, to carry an assumption that an agency has already taken an action which you are seeking to change. Thus, my message would be: Don't wait for that to happen if you can avoid it. Get in on the ground floor. Try to become a part of the process before decisions are made. I understand that sometimes it is difficult to represent clients who don't come to you until the house is burning down and the city's run out of water and you don't have anything to do but to try to clean up after the problem. But still, the sooner you can get there, the easier it will be for you all the way around.

Some of these suggestions that I have for dealing with agencies will apply, I think, at whatever stage you're into the picture. My recommendations are based on a number of years in the government in law enforcement policy…. And, as I say, I don't think anything I'm going to say is particularly remarkable. A number of others have made these observations.

The first thing to do is to think about what you're trying to do. Agency actions are taken pursuant to statutes and regulations [and] congressional oversight [committees]. And in that respect, they are making legal decisions. But that is the only respect in which you can call a lot of these decisions legal, while regulations and statutes are at the foundation of agency action, decisions that are being made are what government should do, not really so much what the government is compelled to do by the statute. And so you have to remember, I think, when you go forward to do battle with the government agency, that an agency is not a courtroom….

So these people are making policy decisions…. Getting the agency to act in a certain way requires certain policy advocacy skills. And in no particular order, I would say that those skills are an ability to understand the agency's problem, to have a fairly firm grip on the legislative process, the ability to deal with the political environment that the agency finds itself in, and an understanding of basic policy analysis tools that most all agencies use. The final skill would be, of course, to know when none of these other skills would work, and to know what to do then.

Let me elaborate a little bit. Let's say that you are dealing with an agency where a decision is going to be made and a proposal has already been made about it. I think that there is no need to come whining to the agency that

some policy or decision that they make is going to harm your client or harm consumers or do harm to someone. Because almost any decision that an agency makes is going to harm someone. Allegation without more does not surprise them and does not cause them to change course.

You have to know what the agency's mission is, what its purpose is, what its causes are. And that may enable you to argue that whatever action it is that they are proposing to take will damage their own interests. This is often a good tactic to take, because, hopefully, you can get them to see that whatever it is you want them to do is in their own best interests, based on your understanding of what they have been told to do and what they are trying to do. And at the same time, don't ever try to conceal your own self-interest, because your reasons from the outside are inherently suspect.

If you understand an agency's position, you may discover that what is primary for the agency is really secondary or even unimportant to you. But what may be crucial to you is only secondary for the agency. If you can look at it that way, you may be able to get something that is very important to you eliminated or added, whatever your interest is, in a way that will enable the agency to deal with the problem without compromising its own cause. A 100% win is not attainable. It is probably a waste of money to pursue, and unwise in the end.

Now, understanding the [] process is important because it is very easy to stumble in at the wrong place and to make the wrong arguments to the wrong people, and to get sort of hopelessly bogged down. The government decisionmaking process sometimes seems vulnerable, whereas it's only fragmented. So, if you get an organization chart, that is the beginning of wisdom. It doesn't help a lot, but it gives you at least some idea. Wherever you go there are going to be technical experts and economists and lawyers and planners and program generalists and a whole category of other people. As the input of people in these divisions begins to rise up the decision ladder, the proposed action will receive less and less in-depth review.

Now, regardless of how serious and significant the issue may be, the decision reached will be based largely on the material generated at the staff level by the staff. To be most effective, input of data and arguments from outsiders must be made at that level. It will make less and less of an impact as a matter for decision moves up the chain.

I cannot tell you the number of people I know who want to come in and talk to the Secretary of Commerce about a matter that somebody has said in the regulatory agenda he's going to make a decision on this week. The problem, however, is that it is too late, it is just too late to do that, unless you have certain kinds of issues which I will mention in a minute. You need to sort out who you're talking to. I watch with amazement as lawyers make

insistent legal arguments to economists. There are economists everywhere in the government. They are prominent, even in law enforcement agencies. They know the law, generally, but our keen legal arguments do not interest them. Have you ever watched an American in a foreign country asking a question in English and ask it louder and louder to someone as though if they could get the decibel level right, this Greek would be able to understand him? Well, that's what I always think of when I see lawyers getting more and more upset and testy with the technical experts or economists they're speaking to because they're not responding right. Well, they can't. And the reverse is also true. So you have to be careful. When you take economists to talk to lawyers, there is enough [cross]-pollenization now so that everybody knows in general the other's field. But for an economist to argue earnestly to a lawyer that a party should not be sued, not because they didn't break the law, but because what they did was economically rational, is not going to make a big impression for the lawyer.

You have to educate yourselves about the agency's normal procedures. And all government agencies have the same kind of modus operandi. They have these lengthy in-depth analyses by the stack, but somewhere-and you should find out where-somebody is responsible for making an overall synthesis of these arguments so that it tells a story that makes sense to somebody. And then there's going to be a summary at the top for the people at the highest levels of the decision chain. So you should prepare your papers in the same format.

Understand that once the papers leave the staff unit, the decisions made in that unit will not be reversed. The lawyers are not going to reverse anything that the economists have written. And that's true all across this spectrum. In the end, the arguments of the unit may be rejected, but they're not going to be reversed by anyone. So you have to get in on the ground floor. You cannot risk missing out at that level….

Lawyers in agencies, lawyers and planners, in general, I think, have the same problem internally. It really is a credibility problem. They are always accused of not being in touch with the real world, whatever that is. So one of the things that people on the outside can often do to enhance their ability if they think that the economists or planners are with them is to put some money into outside research that can buttress these internal arguments. I think it is a very useful thing to do. I would say that you have to be prepared wherever in the process you are able to make an oral presentation. But oral presentations have a short life and you don't need to go in and make one without leaving behind a piece of paper on which there are listed the points that you made or intended to make while you were there.

…I would say, partly because of the foregoing, do not gratuitously insult the staff of an agency. What will happen is that most likely the agency will close

ranks against you, freeze you out. That is going to be true even if you have a pretty good case or an argument. I have seen it happen a lot. I call it the "New York lawyers' syndrome." It is sort of, you know, "These people are really not very bright. They're not very something." They have an animosity toward my client, born surely of their ignorance. And it could as well be called "the Chicago's economist syndrome" or "the cumulus single-minded public advocate approach." There is a way not to deal with these things. In court you can go in and make light of somebody else's argument. But to try that in an agency; you're on your way out.

Now I would say, try to understand the political environment that the agency is involved in. Don't talk about unelected bureaucrats with arbitrary unchecked power; that is not how it seems to them. With OMB (the Office of Management and Budget) on one shoulder and the White House on another and congressional oversight investigative appropriations committees, agency constituents-whomever they may be-labor, agriculture, business, and the media. The media's agencies make public decisions and the media is always there, disclosing things, commenting on things, criticizing them and subjecting them to ridicule. It doesn't seem to them like they have unchecked power. So you should keep in mind when you're urging an agency to take a certain kind of action how it is going to appear to the significant others that surround that agency. Because that is the way that agency will be looking at it.

I would also say that if your views are an anathema to some of those people that you are trying to persuade, if you represent Exxon and you're trying to deal with the EPA on oil spill regulation or something, what you might try to do is to form a coalition and get someone else to make your argument. I think that would be the best thing. Agencies like to reach consensus decisions so that everyone gets something and nobody with a really legitimate concern is left somewhere out in the streets screaming as loud as they can on the way to Capitol Hill or to the Washington Post.

…[T]ry to find out as you look around, who are the people you'll have to deal with, who have discretion to act and who are really in a non-discretionary position where they have to do certain things. Don't waste your time trying to push someone around who really doesn't have a lot of discretion, because it would be wasting both your time and theirs.

It is helpful if you know the rudiments of policy analysis-cost/benefit analysis, risk assessment, knowledge of market forces and all that stuff. All agencies talk a lot about that now. And actually these are useful tools. But, don't try to play games. Don't come in and say, "Well, you know, this is cost/benefit and we're going to pay all of the costs so we want all of the benefits to go here." If you do that without any sort of analysis, you're not

going to help yourselves, because agencies increasingly have more sophisticated means of doing these things.

And that is what you are up against.

So whether you are seeking to obtain relief from an agency through rulemaking petitions or exemptions or waivers or otherwise, will often depend on where you come into the process. And your success, I think, is going to depend on how well you understand and appreciate the process and the agency's mandate and its problems. If all else fails, you can, of course, turn to outside pressure.

I only offer one caution about the Congress that became very obvious in the last few years. One thing the Congress can do is to get an agency not to do something, because they can always threaten to shut off the money. For a particular project, we had to stop working on a few over at the FTC three times because the money was cut off. So you can stop an agency from doing something but you can't do what Congress has already learned-to its absolute fury-that you can't make an agency do something that it doesn't want to do… So the limits of congressional pressure really come from that side. In sum, it is much easier to stop something than to start it.

Influencing Agency Action: Comments of Cornish Hitchcock, 5 ADMIN. L. J. U. 53-62 (1991).

So having given you a very quick look at almost ten years of rulemaking [involving an aviation safety issue]… what lessons can one draw? The first one is, knock on every door. What that means is look for various supporters when people might be interested in whatever form. People in Congress might be interested to the extent that they are willing to introduce legislation. People at the agencies may be interested in the subject matter. People in the news media may be interested if it is a good story. Whatever door maybe open, try it.

The second rule of thumb is look for allies. That is important for several reasons. One is political. The more friends you have, the more people you have saying, "This is a good idea," the more likely you are to achieve the goals. The second reason that this rule is important, particularly if you represent groups like ours, is that it provides a way to get empirical data to bolster your case. We used that with the doctors' letters. We were able to find stories where real people had died on a flight or been seriously afflicted. The media wanted stories also to be able to get the story in a way to dramatize it more than dry statistics. Interestingly enough, we also got a communication from the medical director at Air Canada, who had previously worked for a U.S. airline for a number of years, who was frustrated by the reluctance of the U.S. carriers to move forward on this and who was able to

put such a regime in effect once he moved to Air Canada. He sent me the types of equipment that they had on their aircraft.

The third rule of thumb is read the newspapers. Now why do you do that? The reason is because it is important in terms of learning what signals the administration, the agency, and political higher-ups are sending. What are they looking for? What is the policy? How does your particular proposal comport with the overall regulatory policy? How does it fit in? What are the signals that are being sent? What are the things that the agency, the staff is going to be asked when they come forward with the recommendations?

The fourth rule of thumb (which is sort of related to the last rule of thumb) is know your audience. This operates at several levels…. It also deals with something that lawyers seem to have trouble getting the knack of, and I think it reflects on legal training, which tries to teach you how to be a litigator but not necessarily how to influence agencies or Congress. One thing you have to know is that in the agencies, the Bureau of Economics gets the economic issue, the General Counsel's office looks at the legal issue, things get farmed out, and you have to make sure that the comments are structured so that they will be considered by professionals with different backgrounds, not all of whom respond to legal points. In this case we were dealing with medical evidence, so we had to make sure that we could address medical points, that the Office of Aviation and Medicine would care about, while separately handling the legal issues that would be addressed by the Chief Counsel's office. We had to make sure that we could respond to those. The other principle in terms of knowing your audience involves comments in rulemakings, that is, sounding the themes that the Secretary or the Administrator or the administration generally is interested in sounding. As your policy proposal works its way into the system, you can put in arguments that this will achieve the following three goals in the state of the union message or whatever else you want to use as your jumping off point. And that needs to be reflected in your writing. You also need to keep in mind a broader audience: Congress, the press, the public at large. You get calls from the Hill or from the news media. What are you people doing? What are you saying? If you have a ten or twenty page statement with all of the material in there, readily understandable, you are going to accomplish a lot. The point I made a moment ago about lawyer-training is that a lot of time lawyers think of doing comments pretty much as if they were writing a brief to a court. However, it is a different exercise. Agency practice is much more like congressional practice. Your focus really has to be to persuade the agency, whoever may be reading it, why the world would be a better place if your proposal is enacted. And that is a different exercise than trying to persuade an appellate court that case A is really distinguishable from case B, or that the court is compelled to rule in your favor on the basis of case C. That is what litigation is about.

Point number five is read the rules. You need to know to what extent you can talk to the staff. When do the ex parte rules drop like an iron curtain across your ability to communicate and provide additional information? What are the chances for expediting it? What are the chances for, as in the medical kit case, a notice in the Federal Register that can be used to trigger letters from doctors? Knowing the rules makes a big difference.

And finally a point on style in terms of writing comments. I have expressed it in the outline this way: If you can't think of something nice to say, say it anyway. What that means is there will be times when there is a proposal that comes from an agency that you think is truly dreadful; there is the temptation to say it is truly dreadful. And that may be good if you're talking to the news media who want to understand whether something is good or bad-nuanced distinctions don't always get into the coverage. What I have found to be fairly successful is trying to find something good to say about a proposal. On one instance, I had to comment on a proposed rule that I thought was truly dreadful. I managed to say something nice like, we appreciate the fact that you're looking at this issue so quickly. We started out, at least, on a high note, and then purported to offer a critique of some of the proposals and how they could be made to work better, even though sometimes we were saying send this back to the shop and hopefully it will not return. To some extent that is an accommodation to the staff, who may have been told by the higher-ups, "This is the way it's going to be. We don't care if it doesn't make sense or if the court of appeals has ruled against us or whatever the case may be, this is the way it is going to be." And the staff may have an impossible position in light of the statute or the scientific evidence or something else, and they do not necessarily need to be reminded of the fact.

I want to conclude by offering one general comment. In talking with people about this morning's program, there probably is some overlap in terms of what I have said about initiating agency action in terms of what you are going to hear about later on in terms of what Congress does and what role Congress plays. I don't think that you can really separate out each issue into discrete topics. I think ultimately what I have found is that you have to consider the other players as well as the agency itself. Congress has a particularly important role. If the substance of agency action gets too far out in front of what is politically acceptable, you end up with things like the great Jihad which the business community waged against the Federal Trade Commission ten years ago. So in that sense dealing not only with the agency, but also with the Hill and the news media and with whatever other entities out there may be interested in your issue is critically important. Because it is all tied up as part of the same process. Thank you very much.