Foundations of the Regulatory State
 Spring 2005, Section 3

Memo Assignment #2

(Posted 2/18/2005)



This memo assignment is designed to reinforce material discussed in class and to help you exercise writing skills in the area of regulatory policy. You must complete at least 3 of the 4 memos assigned during the term. These assignments will not be graded, but will be marked "check," "check-plus," or "check-minus," generally with brief comments. Superior or delinquent performance on the memos will count toward your grade in the same way as contributions to class discussion, but the main way in which the memos influence grades is by providing practice in writing short essays of the same format that will be used on the final exam.

Please submit your memo via e-mail if at all possible; this will enable us to keep better track of the memos and to provide more timely feedback.  So that files are not overwritten, please give your memo a filename that includes your last name. E.g., if I were submitting a memo in Word format, it would be called katz.memo1.doc.  Please also be sure to include your name in the memo text as well, so that it will show when we print out hard copies. You should send copies of your memo both to me and to the TA responsible for your panel. For this second memo, the TA assignments are as follows:

Panel 1: Eric Haskell
Panel 2: Karla Valenti
Panel 3: Dominique Alepin
Panel 4: Spencer Barrowes

As before, I will presume, unless you tell me otherwise in your cover message, that if we find your essay to be among the best we receive, I have your permission to post it [with your name removed] as part of my feedback to the class, as with last year's memos. If you do not wish to grant such permission, please let me know expressly.  Your decision whether to grant or reserve such permission will not affect your memo score or class standing in any way.

This assignment is due on or before Friday, February 25 at 5 pm.  Extensions will not be granted absent compelling circumstances.  You should not do any additional research in preparing your analysis, and you should limit the time you spend on this assignment to not more than four hours.


On February 15, 2004, the New York Times reported: "Responding to widespread criticism of the government's handling of drug safety problems, the Food and Drug Administration announced Tuesday that it was creating a board to advise it on drug complications and to warn patients about unsafe drugs. Dr. Lester M. Crawford, the acting commissioner of the drug agency, said the board would be made up of scientists drawn from throughout the federal government. The board, which is to make its conclusions public on a Web page, will not have independent power to force the withdrawal of drugs but will simply advise the F.D.A. . . .The announcement comes as Congressional committees are investigating the agency's ability to discover drug dangers. It also comes on the eve of a landmark three-day advisory panel hearing into the safety of the pain pills Celebrex, Bextra and Vioxx, a hearing that could prove embarrassing to the agency."

You are a policy analyst for the F.D.A. You have been asked to draft a short internal policy memo, addressed to the head of your the department and focusing in particular on the specific issue of COX-2 Inhibitors -- the category of pain pills that includes Celebrex, Bextra and Vioxx. The memo is intended to frame for senior policymakers in your department the major regulatory options to be presented to the new advisory board, and the main policy considerations associated with those options. Your memo might be shared with the members of the advisory board after it is appointed, but it will not be made available to the general public or the media (unless, of course, it is leaked).

Because your boss and the other officials who may read your memo have limited time and patience for reading policy papers, you should limit it to no more than 500 words and no more than two pages, and should write it in "bullet-point" format;  i.e., with individual points explained in one or two sentences at most, and with minor points indented and set off by bullet-points or similar markings in order to distinguish them from major points.  [You are strongly encouraged to look at the feedback memo from last year's second assignment for further illustration of this format, as well as successful memos making use of it.]

Please note three additional issues in regard to your memo: first, remember that when writing in bullet-point format, you still need to explain your reasoning and logic.  Full sentences are usually best in this regard, though if you are clear enough you may possibly be able to get away with less.  Second, although you have been asked to advocate a policy position, you should make sure to identify and respond to possible counter-arguments to your position.  Third, please leave enough space between lines and at the margins for the TA's and me to write comments.

For additional factual background, you may wish to consult the following sources:

One last warning: beware of taking all the claims that are made in the background articles at face value. One of the goals of the course is to teach you to take a critical perspective on arguments that you may hear coming from lawyers, lobbyists, journalists, and even scientific experts.