The Food & Drug Administration is perhaps the most important, ubiquitous agency in the daily lives of modern American consumers. Consumers rely on the FDA to verify the safety and effectiveness of $2.6 trillion in food, medication and tobacco every year. However, the luxury of such a regulatory system is not something consumers have always enjoyed.
Over the course of the 20th century, the federal legislation and regulations that now provide the framework for the FDA developed slowly, most often because Congress was compelled to legislate in a reactionary response to public outrage following a deadly disaster. As summarized below, through much trial and error, Congress and regulators have gradually been able to shift the FDA’s role to disaster prevention.
1906: The Jungle & The Food and Drugs Act
Until 1906, Americans had no effective government protection from mislabeled or dangerous consumable products, and “warnings against misuse were unheard of.”[1] Although widely included in over-the-counter “medications,” no labeling warned consumers about the presence of heroin, cocaine, morphine, or opium.[2] Suppliers were free to make baseless claims about the healing effects of their products, and caveat emptor prevailed. Industrialization led to increasing urban populations and demands on the supply chain, which exacerbated existing dangers related to unregulated food and drugs.[3]
Faced with these increasing problems, Upton Sinclair and President Theodore Roosevelt, an unlikely team, spearheaded efforts to pass the initial food and drug safety legislation, which would lay the foundation of the FDA.[4] Sinclair’s book The Jungle, which brutally portrayed practices of the meatpacking industry, arrived on Roosevelt’s desk in 1906, and the President jumped at the opportunity to curb the power of the Beef Trust.[5] Roosevelt had a bone to pick with the Beef Trust because of price hikes in 1902 and a revolting personal experience during his time in the armed forces when he was reportedly unable to keep down “embalmed” beef.[6] Although Roosevelt described Sinclair as “hysterical, unbalanced and untruthful,” he recognized the inflammatory power of The Jungle and used public outcry to push through the first modern meat inspection bill and the 1906 Food and Drugs Act.[7]
The 1906 Food and Drugs Act, primarily a criminal statute, prohibited interstate commerce of misbranded and adulterated foods, drinks and drugs.[8] The legislation, which was only six pages long, focused narrowly on preventing “misleading” claims about the ingredients and quantities of consumable products.[9] There was widespread debate about its applicability to false claims about the remedial effects of medications.[10]
In 1911, the Supreme Court dealt a significant blow to the 1906 Act, when it resolved the debate in favor of limited application of the statute. In United States v. Johnson, the defendant was indicted after marketing and selling a useless “medication” as a cure for cancer.[11] The Supreme Court affirmed the dismissal of the indictment, ruling that the 1906 Act did not extend to claims about effectiveness, which meant suppliers could continue to make baseless claims about the effects of their products with no threat of prosecution.[12] In 1912, Congress attempted to overcome Johnson by enacting the Sherley Amendment, which prohibited sellers from making intentionally misleading claims about a drug’s effectiveness. Because of the intentionality requirement, defendants could escape prosecution simply by feigning belief in any false claim about a product.[13] This loophole allowed ineffective, deadly products to stay on the market for decades. One such example, Mrs. Winslow’s Soothing Syrup, a medication containing mostly morphine and alcohol, killed thousands of children before it was removed from the market in 1930, even though it had been denounced by the American Medical Association in 1911.[14]
1937–1938: Sulfanilamide Disaster & The Food, Drug, and Cosmetic Act
In 1937, a drug disaster captured national attention and prompted Congress to pass the Food, Drug, and Cosmetic Act. More than 100 people, mostly children, died after ingesting Elixir Sulfanilamide, a strep throat “elixir” containing antifreeze.[15] The product had not been tested on humans or animals before it was marketed to the general public. The manufacturer’s recall efforts failed after it was discovered that physicians and pharmacists had neglected to keep adequate records. Luckily, the FDA had the authority to intervene because the deadly medicine was misbranded: the term “elixir” implied the product contained alcohol when it did not.[16] Had the product been labeled correctly, the FDA would not have been able to intervene because of the limited scope of the 1906 Act.[17]
The sulfanilamide disaster highlighted the need for an overhaul of food and drug regulation and a more expansive role for the FDA. In 1938, under public pressure, Congress passed the Food, Drug, and Cosmetic Act, designed to shift the FDA’s focus from disaster reaction to prevention.[18] Among other updates, the legislation:
- Extended the FDA’s regulation to cosmetics and therapeutic devices,
- Required new drugs to be “approved” prior to marketing,
- Eliminated the intent requirement of the Sherley Amendment,
- Required safe tolerance limits be established for unavoidable poisonous substances,
- Authorized factory inspections, and
- Permitted the FDA to pursue injunctions, in addition to prosecutions and seizures.[19]
Sponsors of new drugs were now required to submit a New Drug Application (NDA) with proof that the sponsor performed “adequate tests by all methods reasonably applicable to show whether or not the drug [was] safe.”[20] Notably, the NDA provision did not apply to manufacturers of medical devices.[21]
While the 1938 legislation marked a considerable improvement, major flaws limited its effectiveness.[22] Generally, the NDA “application” process did not actually require the FDA’s active approval of new drugs because sponsors were permitted to start selling their new drug if no regulatory response was received after 60 days.[23] The 1938 Act also lacked specificity regarding testing and methodologies and did not allow the FDA to determine the text or layout of labels.[24] Perhaps most significantly, Congress failed to include a mandate that drug suppliers prove the efficacy of their products to obtain approval.[25]
1949: FDA Publishes the First “Black Book”
In 1949, the FDA published its first guidance to industry, which came to be known as the “black book.”[26]
1962: Thalidomide Disaster & The Kefauver-Harris Amendments
In 1962, another drug disaster once again aroused public support for more stringent drug regulations.[27] Thalidomide was marketed and distributed to pregnant women in the 1950s and early 1960s as a treatment for morning sickness.[28] Before its international withdrawal from the market in 1962, thousands of women gave birth to infants with severe birth defects after their mothers ingested thalidomide.[29] Although thalidomide was never authorized for sale in the United States, several dozen American women also gave birth to deformed infants after ingesting samples of the drug provided by their doctors illegally.[30]
Following widely publicized hearings, Congress passed the Kefauver-Harris Amendments, which, for the first time, mandated that a supplier establish efficacy as well as safety before marketing a drug. The legislation also “required FDA to assess the efficacy of all drugs introduced since 1938, instituted stricter agency control over drug trials (including a requirement that patients involved must give informed consent), transferred regulation of prescription drug advertising from the FTC to the FDA, established good manufacturing practices by the drug industry, and granted the FDA greater powers to access company production and control records to verify those practices.”[31] Drug advertisements were henceforth required to include a balanced discussion of the risks and benefits of a treatment.[32] The 60-day default approval provision of the 1938 Food, Drug, and Cosmetic Act was also removed.[33]
1970: FDA Requires First Package Insert for Oral Contraceptives
1976: Dalkon Shield Intrauterine Device Litigation & The Medical Device Amendments
Prior to 1976, medical devices were exempt from the NDA application process, until Congress expanded the FDA’s authority following the Dalkon Shield intrauterine device disaster. The now-infamous Dalkon Shield intrauterine device was implanted into millions of women in the early 1970s to prevent pregnancy. The device caused serious injuries, including death, to hundreds of thousands of women around the world, resulting in massive litigation and public outcry. In response to Dalkon Shield, Congress enacted the 1976 Medical Device Amendments to ensure the safety and effectiveness of medical devices.[34] Because Congress recognized there can be significant variation with respect to the complexity and potential for harm of medical devices, the legislation and regulations incorporate a risk-based classification system. The classification of a device determines the requirements for approval. The 1976 Medical Amendments expressly preempts conflicting state requirements “different from, or in addition to, any requirement applicable . . . to the device.”[35]
1983: Anti-Tampering Act and Orphan Drug Act
Following public panic over the Chicago Tylenol murders of 1982, Congress enacted the Federal Anti-Tampering Act in 1983. Congress also enacted the Orphan Drug Act, which provides patent protection and tax incentives to encourage industry to develop drugs for rare diseases.[36]
1990: Safe Medical Devices Act
In 1990, Congress passed the Safe Medical Devices Act (MDA), which mandates that healthcare facilities report device-related deaths and serious injuries to the device manufacturer and the FDA. The MDA also imposes reporting requirements on manufacturers and distributers.[37]
1997: Food and Drug Administration Modernization Act
The Modernization Act of 1997 directed wide-ranging reforms of agency practices to facilitate technological advancements and the needs of modern industry players. Among other provisions, the legislation included measures to accelerate the review of devices and drugs as well as update regulations on off-label information.[38]
2004: Project BioShield Act
The BioShield Act authorized the FDA to accelerate research and review of medical countermeasures to chemical, biological and nuclear agents that may be used in terrorist attacks against the United States.[39]
2013: Drug Quality and Security Act (DQSA)
In response to a deadly outbreak of fungal meningitis linked to a compounded steroid, Congress enacted the DQSA, which expanded the FDA’s authority to regulate and trace prescription drugs.
2020 and Beyond
Although consumer products regulation has come a long way
since the FDA’s inception, the regulatory framework will undoubtedly continue
to change as institutions are forced to confront rapid technological
advancements, industry developments and an increasingly interconnected global
economy. The FDA is also utilizing technology to avoid known potential threats,
such as widespread vaccination shortages and contaminated products. For
example, the FDA recently completed the piloting stage of the New Inspection
Protocol Project (NIPP), which was developed to identify and avoid sterility
problems during the manufacturing stage of production. In theory, the protocol
will reduce risk to patients by aggregating data that allows investigators to
easily identify anomalies in manufacturing processes that could lead to
sterility problems in the future.[40] During
the pilot stage, the FDA focused on manufacturers of vaccines, but it is now
expanding the project to include manufacturers of other sterile products.
Hopefully, programs like NIPP will allow the FDA to continue its progression
away from its initial role as a disaster mitigator toward complete disaster
prevention.
[1] Wallace F. Janssen, The Story Behind the Laws Behind the Labels, FDA Consumer Magazine (1981).
[2] Id.
[3] Bee Wilson, Swindled: The Dark History of Food Fraud, from Poisoned Candy to Counterfeit Coffee 153 (2008).
[4] Id. at 200.
[5] Id. at 190.
[6] Id. at 196. During the Spanish-American war, the War Department sent soldiers canned beef, which was described as “embalmed” because it smelled like an embalmed human body and tasted like boric acid. See id. at 181. Roosevelt caught one of his soldiers gagging on the meat and ordered the soldier to “eat it and be a man.” Id. at 195. The soldier began vomiting, and to prove his point, Roosevelt himself attempted to eat the meat and could not stomach it. See id.
[7] Id. at 199.
[8] Milestones in U.S. Food and Drug Law History, U.S. Food & Drug Administration, https://www.fda.gov/about-fda/fdas-evolving-regulatory-powers/milestones-us-food-and-drug-law-history. The Bureau of Chemistry, a division of the U.S. Department of Agriculture, was assigned to administer and enforce the 1906 legislation until 1927, when its enforcement functions were separated into the newly-created Food, Drug, and Insecticide Administration, known since 1931 as the Food and Drug Administration. In 1953, FDA was transferred from the Department of Agriculture to the Department of Health, Education, and Welfare, known today as the Department of Health and Human Services. See Janssen, supra note 1.
[9] Part I: The 1906 Food and Drugs Act and Its Enforcement, U.S. Food & Drug Administration, https://www.fda.gov/about-fda/fdas-evolving-regulatory-powers/part-i-1906-food-and-drugs-act-and-its-enforcement.
[10] Id.
[11] U.S. v. Johnson, 221 U.S. 488, 499 (1911).
[12] Id.
[13] See Janssen, supra note 1.
[14] Id.
[15] Suzanne White Junod, FDA and Clinical Drug Trials: A Short History, U.S. Food & Drug Administration (2014), https://www.fda.gov/media/110437/download.
[16] Id.
[17] Id.
[18] Id.
[19] Milestones, supra note 8.
[20] Junod, supra note 15.
[21] Part IV: Regulating Cosmetics, Devices, and Veterinary Medicine After 1938, U.S. Food & Drug Administration, https://www.fda.gov/about-fda/fdas-evolving-regulatory-powers/part-iv-regulating-cosmetics-devices-and-veterinary-medicine-after-1938.
[22] Junod, supra note 15.
[23] Id.
[24] Id.
[25] Id.
[26] Milestones, supra note 8.
[27] Id.
[28] Neil Vargesson, Thalidomide-induced teratogenesis: History and mechanisms, Birth Defects Res C Embryo Today 140-156 (2015).
[29] Id.
[30] Junod, supra note 15.
[31] James Harvey Young, The Long Struggle for the Law, U.S. Food & Drug Administration, https://www.fda.gov/about-fda/fdas-evolving-regulatory-powers/long-struggle-law.
[32] See Janssen, supra note 1.
[33] Junod, supra note 15.
[34] See 21 U.S.C. §§ et seq.
[35] See Riegel v. Medtronic, 552 U.S. 312, 321 (2008); 21 U.S.C. § 360(k)(a).
[36] Milestones, supra note 8.
[37] Id.
[38] Id.
[39] Id.
[40] Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen and modernize agency’s oversight and reporting of inspections for sterile injectable drugs, U.S. Food & Drug Administration, https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-new-steps-strengthen-and-modernize-agencys-oversight.
Finis
