Preemption and Pharmaceuticals

Preemption in Drug Cases

To understand why certain causes of action are and are not viable in pharmaceutical mass torts, and the preemption decisions that are ever-present in pharmaceutical litigation, it is necessary first to understand the regulatory environment for drugs in the United States.

Drug Regulation Under FDCA

The Food, Drug, and Cosmetic Act defines drugs as:

(A) articles recognized in the official United States Pharmacopœia, official Homœopathic Pharmacopœia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C).[1]

Approval of new drugs can be broken down into three separate phases. First, the drug company, research institution, or other organization (known as a sponsor[2]) engages in basic background research and preclinical development [define], which culminates in an investigational new drug application (“IND”). Second, the drug company engages in three phases of clinical development, leading to a new drug application (“NDA”). Finally, the FDA reviews the NDA and either approves it, denies it, or approves it contingent on minor changes being made.

Investigational New Drug Application

There are three types of IND. First, an Investigator IND may be submitted by a doctor, who both oversees the investigation and directs the administration of the investigated drug. Second, a Treatment IND is used so that experimental drugs with promising clinical results can be used while the final clinical work and FDA review is conducted. Third is the Emergency Use IND, which has two purposes. It allows FDA authorization of an experimental drug when an emergency prevents FDA approval under the normal process, and also allows administration to patients who do not fit the investigation protocol’s criteria.

INDs include animal studies, information about the drug’s manufacture, and information about the proposed study and investigator.

An IND will bear the disclaimer “Caution: New Drug—Limited by Federal (or United States) law to investigational use,” unless the sponsor receives an exemption to this requirement.[3]

New Drug Application

A New Drug Application must contain:

  1. full reports of investigations into the drug’s safety and effectiveness;
  2. a list of the drug’s components;
  3. a full statement of the drug’s composition;
  4. a description of the manufacturing methods, processing, and packing; and
  5. “specimens of the labeling proposed to be used for such drug.”[4]

Labeling Requirements in the New Drug Application

Labeling must “contain a summary of the essential scientific information needed for the safe and effective use of the drug” that is neither “promotional in tone nor false or misleading.”[5]

For prescription drugs, labeling must also include details on administration, dosage, and any contraindications, warnings, or adverse reactions.[6]

Changes to an Approved New Drug Application

Once a New Drug Application has been approved, “the applicant must notify FDA about each change in each condition established in an approved NDA.”[7]

Among other things, changes to labeling of an approved New Drug Application “to reflect newly acquired information” may be made “[t]o add or strengthen a contraindication, warning, precaution, or adverse reaction” or “[t]o delete false, misleading, or unsupported indications for use or claims for effectiveness.”[8] Such changes may be made 30 days after submitting a supplement submission to the FDA, but the applicant need not await approval of the FDA in order to make such a label change, a momentous detail in drug litigation.

Generic Drugs

Similar to medical devices, a manufacturer can obtain FDA approval to sell a generic drug if it shows the drug is equivalent to a previously approved brand-name (reference listed) drug.[9] In the application for approval, the manufacturer must “show that the labeling proposed . . . is the same as the labeling approved for the [brand-name] drug.”[10]

Orphan Drugs

Sometimes, a sponsor may wish to develop a drug to treat a rare disease (one affecting fewer than 200,000 people in the United States[11]).

Over-the-Counter Drugs

The Coronavirus Aid, Relief, and Economic Security (“CARES”) Act[12] included provisions that drastically changes the so-called OTC Monograph System—the process for regulating over-the-counter drugs are regulated.


[1]           21 U.S.C. § 321(g)(1).

[2]           21 C.F.R. § 312.3. Note that the Code of Federal Regulations distinguishes between a sponsor, which “takes responsibility for and initiates a clinical investigation . . . [but] does not actually conduct the investigation unless the sponsor is a sponsor-investigator,” and a sponsor-investigator—“an individual who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. The term does not include any person other than an individual.” Id. Note too that “[a] person other than an individual that uses one or more of its own employees to conduct an investigation that it has initiated is a sponsor, not a sponsor-investigator, and the employees are investigators.” Id.

[3]           21 C.F.R. § 312.6.

[4]           21 U.S.C. § 355(b)(1).

[5]           21 C.F.R. § 201.56(a).

[6]           21 C.F.R. § 201.56(d)–(e).

[7]           21 C.F.R. § 314.70(a)(1)(i).

[8]           21 C.F.R. § 314.70(c)(6)(iii)(A), (D).

[9]         21 U.S.C. § 355(j)(2)(A).

[10]         21 U.S.C. § 355(j)(2)(A)(v).

[11]         21 U.S.C. § 360bb(a)(2).

[12]         Pub. L. No. 116-136, 134 Stat. 281 (2020).