1. Are there arguments for regulating speech about drugs more comprehensively than, for example, about dietary supplements? What must an administrative record contain to sustain such a position? In particular, could FDA sustain a position that certain promotional speech about drugs is inherently misleading, unless it complies with FDA requirements? Does anything turn on whether the speech is made to learned intermediaries or to consumers? What is the evidentiary basis of such a distinction?
UNIVERSITY OF CINCINNATI
COLLEGE OF LAW
P.O. BOX 210040
CINCINNATI OH 45221-0040
JAMES T. O'REILLY
Visiting Professor of Law
(513) 556-0062/fax 556-1236
July 7, 2002
Dockets Management Branch
Docket 02N-0209 via email e-comments
Dear Ms. Lorraine:
I wish to file individual comments on docket 02N-0209. Under University policy I must state these are my own views and not necessarily those of the University.
For background, I teach FDA law and have done so for twenty years. I authored West Publishing’s encyclopedic Food & Drug Administration (1979, 1993, supp. 2002) which the U.S. Supreme Court cited as “Experts have written…” in FDA v Brown & Williamson. I have authored 28 texts and 130 articles and have been active in the FDA field as a teacher and in practice since 1974. By way of background and not endorsement of the comments I served four years as chair of the American Bar Association’s FDA Committee and four years as chair of the FDLI program committee, and also served on the editorial board of the FD&C Law Journal. I have been a paid federal consultant on improvements in the drug approval process and have consulted widely with federal agencies, corporations and attorneys in the FDA field.
Thank you for your consideration.
James T. O’Reilly
Visiting Professor of Law
INDIVIDUAL COMMENTS OF
PROF. JAMES T. O’REILLY
RE FDA DOCKET 02N-0209
There’s a great benefit to writing these comments in a quiet garden on a warm summer morning, hundreds of miles from Washington, while classes are out and the season for relaxation is ripe. I have drafted these comments far from the Beltway, out where real consumers take real medications and real judges still respect the work of real federal inspectors. It’s right to start these comments with that visual perspective – because Washingtonians may have a location-derived cultural bias that results in too introspective and too esoteric a view on these issues. Please consider a distant perspective. I have chosen to answer out of sequence in the order that seems most significant to my perspective.
9 – “Practices FDA Should Change”
Judges are among FDA’s greatest supporters in 93 of the nation’s 94 federal districts, with the possible exception of Washington D.C. The 661 federal district judges see FDA with great respect in the many products liability cases that involve FDA regulated products, for which their deference to FDA drug decisions is strong. On few occasions they see FDA inspection results in an enforcement case. Talk to the judges, bring them to classes as I do, speak with them at moot court competitions as I do – they love FDA cases. They actually like to hammer the fraudulent sellers and to help field investigators nail defendants who cheat the public. The FDA’s problem is not in the federal judiciary (absent a few cynics on Judiciary Square); it is in FDA fearing the judiciary.
The only thing FDA has to fear in court is Headquarters’ apparent fear of the courts. Please respect the “practices” with which veterans in the FDA field force are comfortable, but which the Headquarters seems to be eschewing. Please take the frauds and fakes among NDA holders, DSHEA companies and food marketers to the federal courts in Shreveport and Pierre and Tucson and Wichita, make the U.S. Attorney your friend and the judge your pupil – teach more lessons to malefactors, speak through the disgorgements you gain, educate by injunctions, and spend less time introspectively alarmed about esoterica. Western States did not constrain FDA’s power to attack “unlawful” or “misleading” acts . Attacking the bad actors is what Sam Fine, Walter Campbell and other giants of FDA enforcement did. As the CEO of a very large FDA-regulated corporation said, when first told of the Park decision: “The day before I go to jail, there’ll be a lot of people on the street.” This was the deterrence that FDA used to seek. Why not exhibit FDA’s historic willingness to test the boundaries of fraudulent conduct in front of today’s federal district judges outside of Washington?
Remember that if the Abbott Labs and Toilet Goods Assn. cases had never been published, the legal standing to preemptively sue FDA would not exist, and only the defense of FDA-selected enforcement cases would be available to your critics. The cheaters of consumers and the deceivers of patients, hopefully a small minority, would not be able to throttle regulatory zeal with their abstract challenges to what the rules might mean – and the incentive to challenge cheaters should remain with FDA.
So please awaken to your historic role as consumer protectors. Please attack if there’s a case to be made, and bring justice to drug or food consumers by using 301, 303, and 304 aggressively to make precedents that are on issues FDA selects where FDA chooses to sue. You may be surprised how receptive U.S. District Judges are out here in the hinterlands, where opinions don’t read like law review articles and real criminals serve real jail time while their peers take real notice of FDA’s message.
5 & 4 – “Warnings and Disclaimers”
The success of standardized disclosure label panels is already evident from NLEA disclosures, and it will be even more evident when OTC drug labels have been standardized and the comparisons of risks, across competing product labels, have become routinely useful for consumers. The key to consumer awareness of a risk related message is the clarity and commonality of presentation. I firmly believe that the consumer receives the greatest benefits from a visible bordered-box warning with clear phrasing that is kept simple and impactful. I urge that model be replicated much more broadly in consumer- and practitioner-visible materials and containers.
W.K. Viscusi of Harvard and other scholars of label warnings have been very adept at studying consumer responses to label warnings. The Viscusi and Magat treatise on warning comprehension (Informational Approaches to Regulation, MIT Press 1992) and his later book Product Risk Labeling (AEI, 1993) remain the best available research. The FDA can learn from the chemical warnings studies that are part of the administrative record of the OSHA Hazard Communication rules in the 1980s, when many thousands of pages of research were presented to the Labor Department about label perception and label understanding. These experiences were useful when I wrote my text, Product Warnings, Defects & Hazards (2d Ed., Aspen 1999). In very brief summary, OSHA’s record demonstrated that clarity and consistent presentation mattered most in achieving compliance. FDA staff should look at the product of that label research, among others, on OSHA’s website at http://www.osha.gov/SLTC/hazardcommunications/hc2inf2.html
The NLEA model and the OTC warnings box models will be relevant in the decision of how to present warnings. The failure of a federal system is illustrated by EPA’s 1976 decision to impose one rigid wording and presentation standard regardless of risk, which produces ludicrous results and makes low risk consumer pesticide labels sound like Agent Orange so that consumers turn off. What FDA can and should do is to have Box format warnings with a “performance standard” approach to clarity of the content warnings, using perception studies.
The performance standard should be meaningfully implemented. FDA is already familiar with the duty of the manufacturer of a prescription drug to have Poison Prevention Packaging Act test panels of children and seniors evaluate the use of the secure closure; the drug would be misbranded under 502(p) if the test were not performed. FDA knows that manufacturers must perform the 16 C.F.R. 1700.20 standard evaluation on packages by 100 senior adults. That is a useful template. FDA should require that “consumer confusion or inattention” be measured by such a test panel of consumers, and the results submitted along with the initial submission for final NDA approval and, where changes occur, in the subsequent annual report of the NDA holder.
It is not very expensive or time consuming to suggest that the marketer’s warnings Box and its content of words should be tested as part of the final NDA approval and thereafter when changes are made to the warning. FDA authority for the suggested label perception study requirement is the duty for labels to not mislead the user, under 502(a). The brilliant strategy that FDA created in support of the consumer confusion-avoidance rationale for cosmetic ingredient labeling has been long accepted: consumers who do not get actionable information about avoidable risk cannot make a sound purchase decision under the FPLA. Here the drug is subject to both 502(a) and the FPLA, 15 U.S.C. 1459(a), so the regulation would have a valid and substantial basis. Note that Western States expressly reserved FDA power to control labeling where it “would be misleading”.
The disclaimer support data is in the same sources and should be tested by the same methods. Disclaimers carry a role that Western States’ majority would recognize, the avoidance of “misleading”. Section 201(n) has survived legal challenges and remains the guidepost for claims drafters. Marketers whose affirmative statements fail the 201(n) test should be expressly required to undergo a similar panel screening of the combined effect of their claim and its limiting disclaimer. This is not an invitation to stack the deck with false research, but an effort to discern how the disclaimer will be understood by a 100-consumer sampling as in the senior examination of package opening steps in 16 C.F.R. 1700.20.
7 – “Off-Label Promotion”
The very basic point made by Sen. Estes Kefauver, father of the 1962 amendments to section 505 that first required drug marketers to demonstrate a rigorous proof of efficacy, is that effectiveness of a drug must be verified by the gatekeeper (FDA) before the claim is presented to the drug consumer directly or via the prescriber.
Kefauver was correct. There is no way for the individual consumer to experiment with efficacy of a calcium channel blocker, for example. Gatekeeper physicians at CDER with no financial stake and a health service career orientation will serve a valuable role, a role justifying the marginal addition of a constraint on commercial speech. Kefauver’s legacy lives on, and the consumer expects that the gatekeeper role is being taken seriously. Generations of CDER Directors who have endured oversight hearings have shown that Congress placed a high value on the gatekeeper role.
So gatekeeping is an essential screening function, like a functioning liver in the human body, screening out the ineffective drug products through an objective and rigorous risk-benefit assessment in the NDA review process. The off-label promotion is like a cancer of indeterminate outcome that negates the ability of the organ to do its function; the claim reaches the user without benefit of screening. The recipients of off label information no longer benefit from the qualitative role of the gatekeeper. The result is a mistaken perception by the protected persons that the gatekeeper is protecting them, when in fact novel and dubious claimed benefits are being touted across a gaping hole just south of the statutory “gate”.
The Western States majority does not un-do the gatekeeper’s role in preventing a misleading statement to prescribers about the unapproved uses. The spread of an exception can swallow the rule; the spread of the off-label promotional permission can ruin the gatekeeper role. If the gatekeeper CDER consciously allows the unproven claim of effectiveness to be made, in order to expand the sales market for a drug, what value does the gatekeeper role carry? Why should taxpayers pay CDER staff for their 1938-2002 function if their gatekeeper role is to be consciously undercut by abandonment of the function?
The economics of new unproven claims do not override the public health imperative: the children who died terrible deaths from elixir sulfanilamide would have been protected by a gatekeeper, and in 1938 Congress created the gatekeeper role and later enhanced it. Certainly the money to be made from off-label claims is a profit center for the drug developer. But society loses if the gatekeeper is evaded. Western States permits control on statements that would be unlawful or misleading. Without an attestation of effectiveness on the data, the manufacturer is not entitled by statute, and should not be entitled by quasi-constitutional obfuscation, to sell an attribute of its product into interstate commerce.
6 – “Labels & Advertisements”
Yes, label regulation is and should be more stringently supervised by regulators than the more ephemeral expressions in advertising. Labels were not at issue in Western States. Advertisements swim in the broad stream of broadcast ideas, and enjoy greater free speech protection than do the tangible products they discuss. Misleading statements on the product confront the purchaser at the decision point, quite focused on that product, and are historically and logically to be assailed, as they have been since Hammurabi punished those who marked Mesopotamian bread with false weight statements. To mislead on a label (or by 201(n) silence on the label) is worse than to launch a flawed idea into the stream of broadcast ideas.
A useful illustration of how courts treat label and advertisement differently comes from California. Take for example the choice between printing a drug label warning on labels, or offering an advertisement posted in the store offering the consumer an 800 number to call to receive any warnings. This was not an experiment; it was an actual effort to deal with a state warnings requirement. After a three week bench trial with expert witnesses on warning labels, including the undersigned, the judge concluded that only label warnings would be effective in communicating to consumers, and that the relatively infrequent consumer use of the advertised 800-line supported a finding that only label warnings would suffice. The court’s decision was upheld on appeal . Rarely is the relative value of the label so exhaustively compared against the advertising media as a means to reach the consumer with a caution message.
Labels physically touch the product and deliver facts at the essence of interstate commerce: the consumer purchase decision. One of the statutes FDA has administered for 34 years, the Fair Packaging & Labeling Act, is expressly premised on the finding that “Packages and their labels should enable consumers to obtain accurate information as to the quantity of the contents and should facilitate value comparisons.” FPLA was created expressly on the congressional belief that labels mattered to the consumer decisional process much more than advertisements. They do so matter.
Similarly, when Senator Royal Copeland agreed to break off the Wheeler-Lea amendments from what became the 1938 Food Drug & Cosmetic Act, he was acknowledging the FDA role over labels was more integral to FDA’s mission than was the advertising function which the FTC could retain. So there is ample history for the distinction. If there is continued doubt, FDA should assert the distinction in a court far distant from the Beltway.
On a more practical note, FDA enjoys what might be called the “Kordel heritage” of long standing judicial support for FDA policing of label statements with health-justified federal controls on claims. Technical distinctions of label and advertising were rejected by the Supreme Court in the Kordel decision with the words: “The high purpose of the (FD&C) Act to protect consumers who under present conditions are largely unable to protect themselves in this field would then be easily defeated.” FDA should not abandon the advantage that heritage offers, and should not assume that the First Amendment arguments would prevent FDA from being an aggressive consumer protection agency. If a claim is misleading as the claim appears on a label, Western States does not protect the marketer from punishment.
8 – “Speech Restrictions”
Yes, FDA label regulations do advance the public’s desire to have accurate product effectiveness information in a convenient format at the point of sale. FDA was given the gatekeeper role over drug safety in 1938, and over drug efficacy in 1962, because the public cannot protect itself from misconduct. Physician-Senator Royal Copeland, father of the 1938 Act, created the NDA system expressly to shield the consumer from errors of those like Massengill, and Senator Kefauver created the efficacy screening role expressly because the market was full of products which lacked efficacy.
Alternatives exist that would be more costly. The prime alternative approach is to reconvene panels like DESI of the 1960s and force the NDA holders in each therapeutic category to explain what actual marketplace claims are being made, with the penalty that any indication or condition not substantially supported within the NDA must be withdrawn and/or disclaimed by “Dear Doctor” letter within 30 days. The result would be voluntary abandonment of many unjustifiable claims.
Subsequent to the “Son of DESI” screening panel project, future NDA drug claim presentations in sales rep materials, print ads, PDAC and the like, should be submitted electronically to DDMAC at least 10 days before use. Those found to have violated the terms of the NDA can be subjected to a forfeitures system like that of the Federal Communications Commission , in which the licensee pays the equivalent of a penalty or surrenders the license if the penalty is not paid. I would proposed that the DDMAC review of claims should go from the NDA drug’s pre-approvable letter stage to the 5th year anniversary after NDA approval. The forfeiture could also be tied to a disgorgement remedy which FDA has used with court approval in a number of recent settlements.
3 – “The Ill Effects of the DSHEA Compromise”
I have already expressed my strong concerns about the holes that DSHEA left in the regulatory safety net of consumer protection, in my comments to the DSHEA Commission created by the statute. I supported a stronger view of the problems than did virtually any member other than perhaps Prof. Gilhooley. In retrospect our critiques were correct: DSHEA was the nadir of 90 years of FDA’s existence, the low point of dis-investment in the FDA public health gatekeeping function.
Yes, strengthening of the disclaimer provisions of NLEA is a problem of misleading consumers, a problem staring out at us from our Cheerios boxes and our Lean Cuisine cartons. Yes, consumers cannot see the DSHEA product effects and thereby the DSHEA products should be held to a higher standard of accuracy and non-misleading content, even if it takes reform of DSHEA to do so. Yes, the vulnerability of persons regarding benefits does increase exponentially when the attribute claimed as a benefit cannot be empirically measured by the putative recipient. What you see is what you get, but what you can’t see might or might not be what you get.
I read question 3 several times over and perhaps I see too much weakness in its tone. There may be non-industry research that answers the last subquestion, but why isn’t FDA assuming the mantle of protector of the consumer as it should? The FDA by asking this question in this way seems to yield the power of implication of claim meanings, yielding the historical trend of court deference toward FDA and FTC that has prevailed for decades. The Federal Trade Commission has shown no comparable reluctance to have judges entrust decisions to accumulated expertise. The body of experience supporting FTC prosecutions is just as intangible as is CFSAN’s. The FTC has no greater potency to its opinions that somehow FDA lacks. The Western States majority did not disdain FDA’s ability to challenge the “unlawful” or “misleading” claim. You are the delegate of congressional policy choices about misleading claims, choices from 1906, 1912 and 1938 that predate the desperate rush at the end of the 1994 congressional session that hatched the DSHEA.
Thank you for the opportunity to offer these individual comments.
Prof. James T. O’Reilly
July 12, 2002