FDA LAW
RUGER
SPRING 2011
HISTORY AND STRUCTURE
· Early Regulation of Food and Drugs
o Purposes of regulation
§ Prevent fraud in the marketplace
§ Prevent sale of unsafe food
§ Protect the nutritional integrity of food/drug supply
o Ancient Times- ancient Greeks and Romans wrote treatises on plants, foods, and drugs and passed laws which recognized fraud in the sale of adulterated or wrongly marked products
o Regulation in England, 1200-1875- mostly regulated by local government, price controls were effective measure to regulate quality
o Development of Chemistry and the Accum Treatise
§ 19th century- chemistry was developed and used to evaluate and detect adulterants in food
§ Frederick Accum’s Treatise on Adulterations
· Identified common adulteration practices and ways to detect
· Increased awareness and effected legislation in U.K. and U.S.
· Statutory and Institutional History
o The FDA
§ 1830s- Patent Office began collecting information regarding safety of agricultural industry
§ 1846- Professor Lewis C. Beck published treatise on adulteration of food and drugs which moved Congress to fund more investigations on subject
§ 1862- USDA founded in basement of Patent Office
o The Evolution of Federal Food and Drug Legislation
§ State and Local Laws in the 19th Century
· Industrial revolution led to the rise of cities which in turn led to markets for food as people lived further from where food was from
· Local laws put in place as adulteration became a major health hazard
· T.F. De Voe studied expansion of food market and published a study on the expansive amount of adulteration in 1867
§ The Federal Food and Drugs Act of 1906
· Biologics Act of 1902- 1st national statute on food/drugs. 1st incarnation of the FDA which gave power to the group to prohibit interstate commerce in adulterated and misbranded foods and drugs
· The new authority controlled the food and drug market which was formerly uncontrolled, unpredictable, and unsafe
o Ex. Legislated after a tetanus-infected antitoxin was distributed in St. Louis and killed a number of children (note: there is a pattern b/w highly publicized incidents and growth in the power of the FDA)
· Poison Squad- group of USDA employees that volunteered to test the effects of preservatives and food coloring (1902-04)
· Upton Sinclair’s The Jungle- profiled the Chicago meat industry and was so disgusting that it got Congress to pass the Federal Food and Drugs Act of 1906 and the Meat Inspection Act of 1906
· 1906 Act applied quality standards to drug manufacturers and for food is simply barred the sale of spoiled food and food that had ingredients altered (unless marked as such)
§ Limitations of the 1906 Act
· Lacked legal standards for food
· Lacked the authority to inspect warehouses
· No restrictions on many more dangerous poisons b/c not classified as drugs (e.g. cosmetics, diet drugs at the time)
§ FD&C Act of 1938
· Increased regulatory power of FDA as a result of highly publicized health crises
oElixir Sulfanilamide- drug produced by a Tennessee manufacturer that did not go through toxicologic analysis (b/c FDA didn’t require it) à 107 people died from ingesting adulterated product
• Widens definition of products falling under FDA authority
• Catalogues definitions of “adulterated” and “misbranded”
• Increases FDA power by authorizing sanctions, criminal prosecution, injunctions, seizures of goods, and civil penalties
• Also endorses non-explicit remedies like publicity, recalls, and warning letters
§ Post-1938 Amendments
• 1962- switches drug regulation to pre-market approval instead of notification
oSpurred by thalidomide incident (drug was approved in Europe and led to death and defects of babies born to mothers who took the drug while pregnant)
oCreation of an effectiveness requirement for drugs
oDES (drug given to women to prevent miscarriage) was approved before the Act and so was not taken off the market for its lack of effectiveness (that had been found in large, randomized studies)
§Decades later its effects were devastating and might have been prevented if the effectiveness requirement had been in place at the time of approval
§ FDA’s increased standards led companies to better test their products which encouraged innovation and progress in pharma
• 1976- enlarged FDA authority to medical devices
• 1980s and 90s- continued to have amendments regarding both food and drugs
• FDA has inherited programs formerly under the authority of other agencies
o 1968- gained authority of seafood, milk, and food service sanitation from Public Health Service
o Late 60s and early 70s- National Center for Toxicological Research, Radiation Control for Health, and Safety, and Biologics absorbed into FDA
o 2007- FDA gets jurisdiction over Tobacco
o Lawsuits Threatening the FDA’s Authority
§ 1st Amendment Challenges to FDA
• Allergan v. US (D.D.C.)
o Drug company challenged FDA authority to require premarket review of “off-label” uses of drugs
o Companies want to be allowed to get drug approved for one use and then market it for anything else w/o FDA test for each use which would be confusing/dangerous
• Commonwealth Brands v. US (W.D.Ky.)
o Tobacco companies challenged FDA’s ability to prevent companies from marketing products with claims before they’ve been reviewed
o If tobacco wins, it would get rid of premarket approval
• Companies argue to switch burden of proof of ineffectiveness to FDA rather than effectiveness proof on them
o Option would be prohibitively costly for FDA
§ Power challenges to FDA would have effect of reversing power of FDA from pre-market to post-market
o Premarket Review versus Peer Review
§ Peer review- studies and articles in medical journals
§ Strong accompaniment to FDA tests and standards but not possible replacement as FDA tests are more broad
§ Other problem with a peer review system: positive studies are more likely to get published (biased results)
o Regulatory Science and Innovation
§ Future expectations of FDA
• More efficient evaluation of drugs w/o lowering standards
• Promote innovation and creativity throughout development
§ Ways to increase efficiency and efficacy
• Invest in regulatory science
• Evaluate the prospect of personalized medicine
• Consider t
DA’s statutory definitions do not have to match up precisely with medical definitions
§ However, this case took place before the Device Act of 1976, which made there difference in regulations more severe than would be today
o 201(g)(1)(A)-(D)- definitions of drugs (see below)
o 201(h)(1)-(3)- definitions of devices
§ The term “device” . . . means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is–
§ (1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
§ (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
§ (3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes
§ If intended use is for diagnosis, cure, mitigation, treatment, or prevention of disease or is intended to affect the structure or function of the body then it gets classified as a drug or a device
o National Nutritional Foods Association v. Mathews (2d Cir. 1977)
§ Court overturned an FDA regulation that reclassified vitamin A and D as drugs b/c they failed to present adequate information that the product was used as a drug
· “Device” Definition
o i. Cosmetic devices- regulated if they are intended to affect the structure of any function of the body
§ Example: Decorative Lenses issue
· At first went unregulated by the FDA but then was switched to be categorized as a device since it has potential side effects that make it more similar to a medical device
· Reclassified as cosmetic in 2003 based on the plain-language meaning of the product
o ii. Diagnostic Devices
§ US v. 25 Cases, More or Less, of an Article of Device … “Sensor Pad for Breast Self-Examination” (7th Cir. 1991)
· 321(h) defines medical device under FDA
· Court upholds FDA seizure of sensors even though the product aids in determining the nature and circumstances of a disease and not the disease itself
o Limits of the Device Definition
§ Products that have medical uses and fully non-medical uses
· VeriChip- regulated by the FDA when used for health applications but not when used for security, financial, and personal identification applications
