Federal Preemption and States' Rights

US Pharm. 2006;31(9):74-84.

Practicing pharmacists should know that on June 30, 2006, new regulations went into effect that substantially change the content and format of the labeling requirements for human prescription drugs and biologic products manufactured and distributed in the United States. In terms of pharmacy practice, the appearance of the manufacturer's package insert will be the most visual change in the regulations. This is the first time since 1981 that the FDA has addressed comprehensive standards for drug labeling.¹ The original idea was to make drug labeling more uniform and therefore easier to understand as a method to reduce medication errors. It does so by providing health care practitioners and patients with current medical information in a concise format. Laudable goal, yes! But there are other intertwining issues getting substantial notice that direct attention away from the primary purposes of the reform measures. The controversial aspect of the rule lies in a small, almost unnoticeable section of the regulation's preamble to the substantive content.

While somewhat complex, boiled down to the lowest common denominator is a provision that exempts FDA-approved drugs from state-based product liability lawsuits involving allegations that a manufacturer failed to warn of known risks in its FDA-approved labeling. In "legalspeak," the federal regulation preempts all state laws dealing with litigation over drug-product liability and consumer protection. Put another way, it gives drug manufacturers and distributors blanket immunity from lawsuits filed by individuals who claim they were injured after taking a particular drug. As might be imagined, there are arguments on both sides about the merit of this regulation. Before this divisive section of the rules is discussed, some of the changes in the regulations are indicated so that pharmacists know what to look for in providing pharmaceutical care services. After that discussion, a little bit about the history of how and why this provision ended up in a law that was supposed to be all about drug labeling will be offered, along with implications that pharmacists need to be aware of.

Labeling Changes

Pharmacists who have been in practice for 25 years or so may recall FDA attempts to revise drug labeling laws in 1981. The Reagan administration canceled a proposed regulation requiring FDA-approved leaflets to be dispensed with prescriptions just before the rule was to go into effect. A watchdog organization, Public Citizen, opined, "The abrupt reversal came at the behest of drug companies, pharmacy organizations, and some physician groups. Private sector–designed leaflets not approved by the FDA thereby continued to be the norm."²

One of the more important revisions to the mandatory drug labeling information is the inclusion of a "Highlights" section in the package insert and publications where this information is printed, such as the Physicians Desk Reference. This section must present a concise summary of the most important prescribing information about a drug, including Boxed Warning, Indications and Usage, Dosage and Administration, and Warnings and Precautions. This section will also provide a list of recent changes made to these categories within the past year. Also, this part of the labeling must indicate the FDA's initial approval date of the original drug product and how and where health care practitioners may report adverse reactions, including a toll-free number and Internet address. In most cases, the Highlights section is expected to be approximately one half of a page in length.³

The label must also include a new section delineated as the "Patient Counseling Information." This is in addition to the requirement that all FDA-approved patient information must be reprinted in, or accompany, the drug's package insert. The purpose of this section is to enhance the prominence of patient information, with the goal of increasing communication between health care practitioners and patients.

This new rule will be implemented in several phases. Initially, it will be applied to newly and recently approved drugs, i.e., under the new drug approval process, and to drugs that receive approval for new indications under the supplemental new drug approval process. The FDA did produce labeling guidelines to help manufacturers understand what information is required in the Highlights, Adverse Reaction, Clinical Studies, Warnings and Precautions, Contraindications, and Boxed Warning sections of the package insert.

FDA stated that it intends to integrate this new prescription drug information format in other e-Health initiatives. For example, the National Institutes of Health will add this updated drug information to the DailyMed Web site, a new interagency online health information database designed to provide the most current medication information free to patients and health care practitioners.⁴

While these changes are widely recognized as necessary and timely, as more potent and potentially dangerous drugs are approved and more adverse drug events are reported and made public, they are not without criticism. Some suggest that the new rule "continues to ignore the fact that its rule will not guarantee patients the most accurate, up-to-date information about their medications."⁵ Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, stated that the rule "will simplify and prioritize the labeling information that doctors receive. But the vast majority of patients will not get that information unless they specifically request it. Instead, they commonly receive patient information leaflets (PILs) that are commercially produced but whose content is not scrutinized by the FDA."⁶ Dr. Wolfe noted that a study initiated by the FDA found that only 50% of the privately prepared information sheets actually result in conveying the most important information to patients. Dr. Wolfe observed, "The notion that consumer drug information can be 50% useful is unfathomable. Drug information that communicates only half of what it should is misleading, and misleading drug information is potentially dangerous."

He also pointed out that the FDA has the authority to require agency-approved medication guides for each medication dispensed by pharmacists but has done so for only about 75 drugs. He goes on to say, "It is time to end the double standard where doctors and other health professionals are informed by FDA-approved labeling, but patients are treated like second-class citizens, receiving whatever the out-of-control purveyors of patient information leaflets choose to dispense. This is a dangerous situation, made worse by the FDA's poor record of approving harmful drugs based on limited, and even fraudulent, clinical trials performed by the drug companies."⁷

The important lesson for pharmacists to understand is that manufacturer labeling under the new rules will reorder and emphasize information for health care providers and patients in a manner that permits easier access to critical information. The rule should be considered only a minimal legal requirement. Pharmacists should always supplement information found on a package insert with other information that may be present due to unique individual needs of patients.

Federal Preemption

Recall that the new rule also contains a very controversial provision that would preempt state tort lawsuits for recovery of damages by a patient who has allegedly been harmed by the use of a drug product. A capsule summary of these issues is presented here.

The term preemption is used to determine which law will be given final authority when there is a conflict between two or more rules or regulations. Federal preemption involves the "supremacy clause" of the Constitution, which provides that federal laws take precedence over conflicting state laws. As used in the context of this discussion, if a state permits a product liability lawsuit to be brought against the manufacturer of an alleged defective drug product, the provision in the federal drug labeling law would preempt any contrary state law and provide complete immunity to the drug manufacturer. While it is easy to articulate the concept, it is far more difficult to grasp the depth and width of the preemption doctrine. It is certainly not without any boundaries, and there are mounds of questions as to how and why this provision ended up in an administrative rule. More important will be whether this regulation will survive judicial scrutiny. There are certainly enough policy and procedural debates that will have to be addressed before the law will be given legal effect.

In the normal or typical world of procedures, preemption is available when the federal government (meaning the Senate and House of Representatives) votes to approve a bill that contains specific language to the effect that Congress fully intends that law to preempt any inconsistent state laws. As an example, pharmacists ought to recall that federal consumer safety laws requiring child-resistant packaging on "household" goods, including both prescription-only and over-the-counter drugs, preempts any state laws that might address the same topic.

That begs the question: How is one to know whether Congress intended a federal law to preempt a state law? In the best of situations, Congress states, in the language of the statutes themselves, that state law will be preempted by federal laws. That seems easy and straightforward enough to end the discussion right here. Alas, though, if it were that easy, there would be huge legions of lawyers who would not have enough to do. And so, there are all kinds of legalistic rumblings that can be made about congressional intent when the statutes are silent on the preemption issue.

Once in a while, statutes include statements to the effect that Congress does not intend its laws to be preemptive over state laws. Another example familiar to pharmacists is found in the federal Controlled Substances Act. That law contains a specific provision that it is not intended to preempt state laws dealing with controlled substances. In this regard, states are permitted to adopt provisions that are stricter than those found in the federal laws. However, if a state has a law less strict, the federal law would be applied. Put another way, if a "concurrent" jurisdictional situation is encountered, the stricter law is to be followed. More often than not, federal statutes do not address the issue of congressional intent to dominate a subject matter to the extent that state laws are invalidated. That is where the fun starts, because there are several rules of jurisprudence that can be applied to determine whether federal statutes should take precedence over those from a state legislature. This gets pretty complicated and is beyond the scope of the issues under discussion. There is one point, though, that merits further attention. All of the above description of the preemption doctrine hinges on the acts of Congress and not on the administrative agencies established by Congress to implement the legislative policies.

In the introductory discussion about the controversial provision on federal preemption of state-based drug liability laws, it is noteworthy that it was the FDA, not Congress, that promulgated the drug manufacturer immunity provision. Perhaps as interesting, the preemption discussion is found in the preamble to the rules, not in the rules themselves. This then begs the next question: Can a rule promulgated by an administrative agency be enforced if doing so will violate an inconsistent state law? This is the fodder of political pundits and legal scholars.

The supporters and critics tend to follow political party divisions. On the conservative side, the argument goes that if the FDA has done all of its prolonged and costly review of a drug, finds it to be safe and effective using scientific criteria, and delineates exactly what information can and cannot be in the drug's labeling, there is no reason to let a judge or jury in a state-based lawsuit second-guess the wisdom of the FDA. Awarding the manufacturer a license to market a drug after the company jumps through the hoops and fire of the new drug approval process should, in the eyes of the FDA, prevent claims being entertained in courts by those who claim they were damaged by a foreseeable, and therefore preventable, risk.

On the other side, one might identify with the critics who claim the FDA rule is a lame-duck payback by the President as his legacy to the member corporations of Pharmaceutical Research and Manufacturers of America that provided major campaign contributions for his election and reelection.⁸ While this may be "fringe group" thinking, even for those who dismiss the potential motivations for how or why this rule came to be, there are people who question the infallibility of the FDA, pointing out the agency's failure to act sooner when it learned of problems associated with Vioxx and other Cox-2 inhibitors.⁹ Several Democratic congressmen filed a prolonged objection stating that Congress never gave the FDA authority to preempt state-based drug product liability laws. ¹⁰

Not all questions or comments originate from political sources. The National Conference of State Legislators (NCSL) describes itself as a bipartisan organization that serves the legislators and staff of the nation's 50 states, whose purpose it is to provide research, technical assistance, and opportunities for policymakers to exchange ideas on the most pressing state issues.¹¹ It is concerned with the broader implications of federal versus state rights in making and enforcing laws. The organization, in its "Preemption Monitor" of August 2006, takes note of the fact that "The volume of federal legislation that preempts state authority has increased. Pressure is mounting for Congress and the White House to support federal usurpation of state authority in a variety of areas such as immigration reform, criminal law, tort reform, driver's license security, and the environment."¹² One example it cites in support of this concern is the recent FDA prescription drug labeling rule and its far-reaching consequences.¹³

This organization noted that when the FDA promulgated the proposed rule in December 2000, there was nothing in it to indicate that the FDA believed it has authority to usurp state law; in fact, the proposed rule contained verbiage indicating that the FDA did not believe the rules would have any effect on state laws.¹⁴ However, between early 2001 and the publication of the final rule, the FDA changed courses. It filed amicus briefs in state lawsuits seeking to hold manufacturers liable for failing to warn consumers and prescribers about known adverse problems with drugs. The FDA took the position that the state product liability laws were preempted by the Food, Drug and Cosmetic Act and the FDA labeling regulations. The NCSL noted that courts have uniformly rejected the FDA assertion. One judge went so far as to state that FDA's preemption argument "contravenes common sense and vitiates rather than advances the Food, Drug and Cosmetic Act's purpose of protecting the
public."¹⁵

Despite these adverse holdings, the FDA notified the NCSL in January 2006 that the preemption language mirroring the position taken in the FDA amicus briefs would now be included in the preamble to the final rule on prescription drug labeling.¹⁶ Within days, NCSL notified the FDA that it objected to the new preamble language and asked the agency to reopen the final rule to permit interested parties to submit comments regarding this new provision. The FDA refused. The primary objection asserted by the NCSL is that the "FDA has usurped the authority of Congress, state legislatures and state courts." It then went on to note that "there is no statutory authority in the FDCA for FDA to preempt state product liability laws as they relate to prescription drugs." It went on to claim that "instead of seeking valid congressional authority, unelected agency officials are seeking to preempt state product liability laws by writing this preemption into a final rule, thereby undermining state policy and judicial decision made in this area."¹⁷

Analysis
The events leading to this sea change of philosophy are not unique to the pharmacy or pharmaceutical industries and are not even a reflection of only the current administration. Observers have noted that the Office of the Comptroller of the Currency has issued a variety of rules over the past few years that are intended to preempt state consumer protection laws with respect to banking. In more recent months, the National Highway Traffic Safety Administration proposed safety standards for cars accompanied by notice that the new standards would preempt state product liability law as they pertain to vehicle safety.¹⁸ Drug law preemption seems to fit the same pattern.

Despite what one thinks about the values of a litigious society, it should be remembered that product liability laws do protect individuals by giving manufacturers incentive to avoid claims of injuries suffered after being exposed to an unsafe product. Is not accountability a legitimate approach to justice against errant producers of poor-quality goods?

Whatever one thinks about the wisdom of the federal preemption of state drug product liability laws, as a pharmacist, be aware of the consequences if this regulation is upheld in the courts. This means that patients allegedly harmed after taking an FDA-approved drug can no longer seek reimbursement for damages from the manufacturer of the drug. So where do you think the plaintiffs' and their legal counsel will turn their attention to? The pharmacists and the prescribers will likely be the next target. And if the pharmacist is found liable, even though the pharmacist may not have done anything "wrong," it would also be likely that the pharmacist could not seek reimbursement or "indemnity" from the drug manufacturer. 

It is way too early to predict how or to what extent these rules will alter the liability landscape. Irrespective of that outcome, pharmacists should review drug labeling information to make sure it addresses the information covered by the rule and how pharmacists should use that information to interact and communicate with patients and prescribers.

References

1. FDA Unveils Major Changes to Prescription Drug Information Format. Available at: arentfox.com/LEGAL_UPDATES/CONTENT1202.HTML. Accessed August 14, 2006.

2. FDA's Drug Label Rule Fails to Guarantee Access to Vital Information and Includes "Sneak Attack" on Patients' Legal Rights: Bush Administration Abuses Executive Powers in Attempt to Override State Liability Laws. Available at: www.citizen.org/pressroom/release.cfm?ID=2114. Accessed August 14, 2006.

3. See Note 1, supra.

4. Id.

5. See Note 2.

6. Id.

7. Id.

8. See, e.g., GDO Report: President Bush Uses FDA to Shield Big PhRMA From Lawsuits. Gwinnett Daily Online Edition. Available at: gwinnettdailyonline.com/search/archiveSearch.
htm. Accessed June 12, 2006.

9. See Note 2.

10. Letter from Democratic leaders of Congress to the Secretary of Health and Human Services, dated February 23, 2006. Available at: www.democrats.reform.house.gov/
Documents/20060223172644-18096.pdf. Accessed August 12, 2006.

11. Governing NCSL. National Conference of State Legislatures. Available at: www.ncsl.org/
public/govern.htm. Accessed August 12, 2006.

12. Preemption Monitor. National Conference of State Legislatures. Available at: www.ncsl.org/standcomm/sclaw/PreemptionMonitor_Index.htm. Accessed August 12, 2006.

13. Id.

14. FDA Final Rule on Prescription Drug Labeling. National Conference of State Legislatures. Available at: www.ncsl.org/statefed/health/FDArule.htm?CFID=
2387171&CFTKEN=28264072. Accessed August 12, 2006 (archived).

15. In re PAXIL Litigation, Civ. No. 01-7937 (C.D. Cal. 2002).

16. See Note 2, supra.

17. Id.

18. Zieve AM, Wolfman B. The FDA's argument for eradicating state tort law: why it is wrong and warrants no deference. Toxics Law Reporter 21(21), May 25, 2006, pp. 516-525. Copyright 2006 by The Bureau of National Affairs, Inc. Available at:www.bna.com and www.citizen.org/documents/PDFArtic.pdf. Accessed August 30, 2006.

19. Menges v Blagojevich, Slip Op No 05-3307 (June 8, 2006), USDC Illinois, 2006 US Dist Lexis 37770.

20. Chase J. "Pharmacies Told to Post Contraceptive Signs." Chicago Tribune. Available at: www.chicagotribune.com/services/site/premium/access-registered.intercept. Accessed August 9, 2006.

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