Foundations of the Regulatory State
 Spring 2005, Section 3

Comments on memo assignment #2

(Posted 3/11/2005)

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For your reference, here is a link to the original assignment.

In retrospect, this assignment was somewhat more open-ended that would have been ideal, so the TA's and I gave a fair amount of leeway in your choice of material to cover. Still, we were looking for you to apply ideas from the course, so memos that spent excess space summarizing facts from the background news articles were less effective.

Not everyone was equally adept at the bullet-point format; the most common problem was writing in an overly abbreviated fashion. Many of you used sentence fragments or even single words or phrases as the individual elements of your memo, and this was not effective.  Remember that the function of a bullet-point memo is to provide information effectively and efficiently to a busy reader, and so it should be written to be readable, with transparent organization and complete [or almost-complete] sentences for each point. [Formatting is also important; for example, memos are much more readable if they use single spacing within each point, and extra spacing between points. And using consistent and simple symbols for the setoffs [e.g., round or square bullets] is much easier on the eyes than using a variety of non-standard typographical symbols [e.g., fancy arrows or dashes].

As with the first memo, many of you spread yourselves too thin by trying to cover too many points. The bullet-point format does allow you to be more concise, but it's still important to explain your points clearly and in depth. In fact, writing in the bullet-point format is good practice for writing short essays generally, since it forces you to pay attention to the internal structure of your paragraphs, and the relationship between major and minor points.

The next memo will also be in bullet-point format to give you extra practice in the format; here for your reference is ra sampling of student essays that I thought were among the most effective we received. 

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[1]

To: Head of Policy Analysis
From: Policy Analyst
Re: Regulatory Strategies for Cox-2 Inhibitors

Five possible regulatory strategies and their major considerations have been identified.

1. Continue the present approach of encouraging pharmaceutical companies to conduct their own trials.

• The lack of conclusive evidence about Cox-2 inhibitors makes a cost -benefit analysis of the drug difficult. Waiting on more evidence may allow the FDA to later adopt the best regulatory approach.
• This approach allows the market and judicial system to regulate availability, however problems of lack of information and proof requirements in lawsuits may make this an inefficient strategy.
• This approach does nothing to encourage drug manufacturers to conduct tests specific to heart disease risk.
• Continuing the status quo in the face of this scandal may further decrease public confidence in the FDA’s job performance.

2. Ban Cox-2 inhibitors.

• This strategy completely eliminates the heart disease risks of the drug class, but also negates any helpful effect of having pain relievers that do less damage to the stomach.
• A policy of hasty bans may discourage drug companies from investing in research on new drugs, may raise drug prices, and may hurt public health by discouraging drug development.

3. Encourage stricter warnings on labels and advertising.

• This approach allows the public to make their own decision about valuation of health risks and benefits.
• This places the responsibility for cost benefit analysis on the consumer who may not have the ability to accurately weigh the potential effects.
• There is also the possibility that people have biases that would result in over or underdeterrence.

4. File civil and/or criminal charges against the makers of Vioxx.

• This tactic would encourage drug manufacturers to take immediate action when they see a health risk related to one of their products.
• This might encourage risk-specific tests to be performed, enhancing the public knowledge about the risks of certain drugs.
• Depending on how strictly this punishment is enforced, drug producers could be frightened into removing helpful drugs from the market when there is a small indication of danger.
• This would likely increase operating costs, and therefore increase the retail price of drugs.

5. Create a policy where possible drug risks are immediately disclosed.

• This approach gives the public quicker access to information allowing them to make informed choices about the health risks they are willing to take.
• This strategy would likely lessen the anger people feel upon learning that the FDA knew of risks associated with certain drugs but took no action.
• The public may be scared easily by anecdotal evidence of risks, which might deter the use of beneficial products.
• If information from drug company tests is immediately used against their products, the drug companies may be less likely to test or more likely to slant the trials in their favor.

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[2]

TO: Mr. Smith, Counsel, FDA
RE: Cox-2 Inhibitor Regulation
DATE: February 25, 2005

An FDA-appointed panel of doctors has just found that cox-2 inhibitor pain medications markedly increase the risk of heart attack and strokes. In response, the FDA can:

Option 1 (preferred): Restrict direct-to-consumer advertising and require heightened scrutiny of prescriptions.

• Direct-to-consumer advertisements do not transmit complete information; their goal is to sell a product.
  • Due to high cardiac risk, direct advertising of cox-2s should be restricted to print advertisements that provide risk statistics and warnings in clearly readable and bold print.
  • Drug companies may protest this limit on their freedom to advertise, but risk to consumers and benefits accrued by improved information outweigh.
• Consumers may still fail to read or completely understand the ad information.
  • Therefore, FDA should institute a review process that requires physicians to provide a reasoned explanation for their cox-2 inhibitor prescriptions.
  • Doctors will protest the addition of paperwork, but this option burdens them less than a complete ban would.
• The cost of compliance with advertising requirements will be minimal. Compliance with the review process will cost little for doctors, but more for the FDA.
  • However, these measures cost less than the other options, while increased information and monitoring should yield substantial benefit.

Option 2: Ban sales of cox-2 inhibitors.

• A ban would remove a potentially dangerous medication at little cost and potentially great benefit in risk avoidance.
• However, a ban might do more harm than good and probably wouldn’t work anyway.
  • Doctors need to have these drugs available for patients who can’t tolerate other medications because of allergy or sensitivity.
    • A ban would deny palliative care to these patients.
  • History shows that if cox-2 medications are banned, consumers will acquire them through the black market or by going to Canada.
    • These consumers would get less information and fewer protections than they would get in the U.S. market.

Option 3: Maintain cox-2 regulation at its current level, relying on liability to police the medicine’s use.

• This approach would let the market solve the problem by forcing companies to compensate injured consumers directly.
  • Reliance on tort avoids the increased costs (ultimately, to taxpayers) of government involvement.
• However, the cost of settlements is passed on to consumers—especially inframarginal consumers who need these specific drugs and cannot substitute away when cost rises.
  • The outcome is unjust because it does not distribute the cost of safety over all those who benefit from it.
• Reliance on tort may also fail to curb use of unsafe drugs because the claims are extremely difficult to prove.
  • Adverse-reaction drug cases often fail because of information and causality problems.
  • If companies don’t have to settle or pay out, their incentive to stop or alter their marketing of unsafe drugs is greatly reduced.
• Costs stem from increased use of the courts, increased drug prices, and increased health problems resulting from continued use of unsafe drugs.

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[3]

To: Head of Department
Date: February 25, 2005
Re: Proposed Regulatory Policy of Already-Approved Drugs

• Give the FDA (or independent advisory panel) the power to mandate and regulate drug manufacturers' behavior with respect to approved drugs and the on-going use of approved drugs.
• Benefits:
• Dispensing with protracted negotiations allows information regarding risks to reach patients and doctors quicker.
• Prevents or minimizes drug manufacturers from using deceptive marketing and advertising without proper risk disclosure.
• Could require post-marketing or post-approval studies making it easier for the FDA to monitor ongoing risks and discover new ones.
• Obstacles:
• FDA would require additional funding to enforce these regulations.
• Funding would also be required to complete the additional studies.
• All randomized clinical trials should be registered, and their results should be made public in a timely fashion.
• Benefits:
• Transparency; allowing more informed decisions for physicians and patients.
• Timeliness; the possibility of serious risks requires that patients be advised sooner rather than later, even if these disclosures are based on studies not yet final.
• Restore credibility; failure to publish the findings of studies not only violates the trust of the volunteer participants as well as the public, but also misrepresents the evidence about risks and benefits for patients and physicians.
• Problems:
• Some information may be premature and not fully validated creating unnecessary worry.
• The public will not be able to understand the information and/or will not bother to read or apprise themselves of it.
• Requiring physicians to become aware of the information and explaining it to their patients may solve these problems.
• The independent advisory drug safety panel should have the authority and funding for monitoring on-going use of approved drugs.
• Benefits:
• The panel would have the authority and financial ability to mandate studies it deems necessary.
• Different situations and new available information will require different types of studies and an independent agency (without financial dependency on the results) will be able to best decide which studies to order.
• Could direct physicians as to the warnings necessary and limit use to selected patient groups.
• Negatives:
• Enforcement of widespread regulations of physicians in addition to drug manufacturers will be very expensive.
• The studies are also very expensive.
• Disclosure of risks associated with the drugs should be provided directly to the public through an independent agency.
• Benefits:
• The independent panel could take advantage of direct advertising to insure public gets the information.
• The public will be able to balance direct-to-consumer advertising with non-biased reports of potential risks.
• Negatives:
• Public may not avail themselves of the information and may not understand the information they do receive.
• However, having the information out there in the same format as drug advertising may encourage patients to ask their physicians about potential risks.

 

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[4]

I. The FDA could require all Cox-2 inhibitors to be withdrawn from the market.

• But categorical withdrawal would be a heavy burden on drug companies
• Withdrawal might impair drug companies' ability to function and provide needed drugs
• However, forced withdrawal might encourage companies to develop newer, safer drugs more quick ly
• Also, there is evidence that some patients respond better to Cox-2 inhibitors than to alternatives like naproxen (those prone to ulcers)
• Final ly , some patients claim taking Cox-2 inhibitors is the on ly way they can find relief (arthritis patients)

II. The FDA could allow all Cox-2 inhibitors to remain on market, under certain conditions:

• FDA could require stern warnings to be placed on each drug's label
• But warnings are often disregarded and thus rendered ineffective
• FDA could require datasheets detailing potential health risks to be developed for and distributed with each drug
• But many patients would not read these datasheets on their own initiative
• So, FDA could require pharmacists or prescribing doctors to review the datasheet with patient
• FDA could ban consumer advertising of drugs
• But patients are sometimes helped through consumer advertising, as they become aware of new remedies and are more like ly to consult a doctor
• So, FDA could regulate consumer advertising—allowing on ly FDA-approved, non-biased advertisements
• FDA could regulate prescriptions:
• Requiring that doctors first prescribe naproxen before resorting to Cox-2 inhibitors
• But Cox-2 inhibitors were created to counter health risks posed by naproxen (ulcers)
• So, FDA could take a patient-specific approach—if the patient is at low risk for ulcers, naproxen must first be prescribed
• Problem: patients at risk for ulcers are often the same people at risk for heart disease (the elder ly )
• Requiring that on ly the lowest effective dose of a Cox-2 inhibitor be prescribed

III. Under some or all of the conditions above, the FDA could allow on ly certain Cox-2 inhibitors to remain on the market.

• Drugs that have been shown to increase the risk of heart disease significant ly (Vioxx and possib ly Bextra) could be withdrawn, while “safer” drugs could remain on the market (Celebrex)
• But only a few studies have been done—it is not certain that Celebrex is safer than other Cox-2 inhibitors
• Allowing some companies to sell Cox-2 inhibitors and not others would upset the competition dynamic, potential ly harming companies to the detriment of consumers needing their products

IV. The FDA could allow Cox-2 inhibitors to remain on the market and re ly on private enforcement (tort lawsuits) to police the activities of drug companies.

• But this method on ly addresses the problem after patients have suffered harm
• Consumers and drug companies have unequal access to information—without regulation, consumers cannot make informed choices about taking drugs or initiating lawsuits
• Litigation would result in unequal enforcement of rulings on drug companies and unequal compensation to consumers
• Drug companies would expend more resources on specifical ly evading or winning lawsuits, rather than making safer drugs
• Drug companies would not be able to predict the extent of their liability and order their business according ly

 

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[5]

Major Regulatory Options for COX-2 Inhibitors

The FDA should introduce regulation to address health problems associated with COX-2 Inhibitors

•  The FDA's complete reliance on voluntary efforts by drug makers to evaluate and control their drug's safety has failed to address health problems for COX-2 users.

•  The market has not corrected the problem on its own

•  Businesses lack incentives to conduct adequate studies, and are motivated by financial gain (only indirectly by safety concerns)

•  Litigation often only affects one case at a time, and is a slow and expensive process.

•  The FDA has a credibility deficit that can be improved through effective regulation.

•  Counter: The FDA has had problems regulating in the past (ie. Vioxx), regulation could be costly

•  But: The correct regulation, regulation that was cost-effective and reached a large percentage of end users, could improve consumer's health without suffering from the problems associated with these and other counter arguments

 

Active regulatory options:

•  Warning Labels: Require that manufacturers of COX-2 Inhibitors include stricter, more detailed warning labels containing information about health risks and side effects.

•  This would be an inexpensive way to reach almost every consumer as they take COX-2 Inhibitors

•  It would demonstrate active FDA involvement in drug safety.

•  The cost would be relatively small, when compared with other regulations or litigation

•  Labels already exist and would only need to be altered.

•  Counter: Labels would lead to information overload, possibly causing consumers to disregard labels along with useful information they already receive

•  But: Warning labels could be made clear and easy to read.

 

•  Education: Require drug makers to provide educational materials to doctors before the prescribe, and patients before they take, COX-2 Inhibitors

•  Ex. Pamphlets / medical guides outlining: when to take COX-2 Inhibitors, when to take over the counter drugs, health risks associated with COX-2 Inhibitors, etc.

•  Increased education would result in informed consumers, more able to evaluate health risks, ask questions, and make better decisions.

•  Doctors, adequately informed and educated, could make better decisions as to when to subscribe COX-2, how the drugs would affect particular patients, and when alternative measures might be more effective.

•  This would also lead to greater disclosure by the companies producing COX-2 Inhibitors

•  Incentivize manufacturers to increase concern for the health of their consumers

•  Counter: This could require costly supervision by the FDA and may be hard to enforce in practice.

•  But: More needs to be done than better labeling alone, and this system is more cost effective than others.

 

•  Combining warning labels and education would be the best regulatory scheme.

•  The effectiveness of labeling would increase as consumers were educated, and education would be reinforced by labels containing information about risks.

•  The absence of regulation would perpetuate the problem.

•  Other regulatory plans, like consumer advertising, would be more costly, less effective, or both due to information distribution costs and the higher risk of information overload.

 

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Key to symbols used to mark essays:

On some essays we circled particular words or phrases that seemed found questionable or unclear, and attached these symbols to them.  

	good point or argument
!	excellent point or argument
~	fair point, or incompletely or unclearly expressed
–	weak point
…	point needs elaboration
"	point already made, repetitive
?	unclear
??	very unclear, confused, mixing together separate points
x	mistake of law, misstatement of fact, misuse of term
x?	point appears mistaken
#	irrelevant or tangential point
#?	point's relevance unclear
#cl	point irrelevant to interests of client or to your assigned role
abs	overly abstract
c-a	fails to discuss obvious counterargument
conc	conclusory; result of argument stated without reasoning
contra	contradiction
dir?	didn't follow directions
exag	otherwise good point is overstated or exaggerated
ff	fighting facts: contradicting stated facts or making assumptions inconsistent with them
jg	jargon: using technical language as substitute for analysis
lec	lecturing: abstract discussion unconnected to or unnecessary for the problem at hand
ll	laundry list: throwing in relevant and irrelevant arguments alike, without distinction
mix	mixing together issues that should be discussed separately
ns	non sequitur: conclusion does not follow
rew	reword phrasing or diction
rf	repeats facts unnecessarily
sa	straw argument: weak or caricatured argument set up merely for sake of rebuttal
ss	slow start:  too much space spent restating the issue or getting to the point
tc	throat-clearing; same as slow start
ua	unsupported assertion
vb	verbose; too much space devoted to the point or points in question
vg	discussion is overly vague