Pharmacy Law--Acts and Amendments

Question 1

Pure Food and Drug Act of 1906

Answer 1

• Concern for risks to public health and safety associated with unsanitary and poorly labeled foods and drugs (Upton Sinclair’s The Jungle)
• Law prohibited the adulteration and misbranding of food and drugs in interstate commerce
• In 1912, it was amended to prohibit false and fraudulent efficacy claims…failed to achieve its purpose…difficult to enforce because it required the government to prove fraudulent intent on the part of the one who made false statements on the label
• Sulfanilamide elixir tragedy of 1937…1906 law did not grant FDA authority to ban unsafe drugs…FDA removed Sulfanilamide on a technicality

Question 2

Food, Drug, and Cosmetic Act of 1938

Answer 2

• No new drug can be marketed until proven safe for use under the conditions described on the label and approved by the FDA
• Expanded definitions of misbranding and adulteration, requiring that labels must contain adequate directions for use and warning about the habit-forming properties of certain drugs
• Applies to cosmetics and devices
• Drugs marketed before 1938 were exempted
• 1941 amendment to allow FDA to require batch certification of the safety and efficacy of insulin to ensure uniform potency
• 1945 amendment to allow FDA to require batch certification of the safety and efficacy of penicillin then for other antibiotic drugs

Question 3

Durham-Humphrey Amendment of 1951

Answer 3

• 1938 FDCA required drugs to be labeled with “adequate directions for use” but many drugs were not safe except under medical supervision, thus did not meet requirement
• Two classes of drugs were established: prescription and OTC, provided that the labels of prescription drugs need not contain “adequate directions for use” as long as they contain the legend “Caution: Federal law prohibits dispensing without a prescription” – pharmacist label when dispensing satisfies requirement
• Authorization for oral prescriptions and refills of Rx drugs

Question 4

Food Additives Amendment of 1958

Answer 4

• Amendment to FDCA to require that components added to food products must receive premarket approval for safety
• Delaney Clause prohibits the approval of any food additive that might cause cancer

Question 5

Color Additive Amendments of 1960

Answer 5

• Amendment to FDCA to require manufacturers to establish the safety of color additives in foods, drugs, and cosmetics…may approve a color for one use, but not others
• Also contains Delaney Clause

Question 6

Kefauver-Harris Amendment of (Drug Efficacy Amendment)

Answer 6

• Thalidomide tragedies of late 1950s
• strengthened the new drug approval process by requiring that drugs be proved not only safe, but also effective…retroactive to all drugs marketed between 1938 and 1962
• Transferred jurisdiction of Rx drug advertising from the Federal Trade Commission (FTC) to the FDA
• Established the Good Manufacturing Practices (GMP) requirements
• Added more extensive controls for clinical investigations by requiring the informed consent of research subjects and reporting of adverse drug reactions

Question 7

Medical Device Amendments of 1976

Answer 7

• 1938 Act did not give FDA authority to review medical devices for safety and efficacy prior to marketing…devices were classified as drugs when deemed appropriate and necessary…concerns about devices such as IUD
• Classification of devices according to their function
• Premarket approval
• Establishment of performance standards
• Conformance with GMP regulations
• Adherence to record and reporting requirements

Question 8

Orphan Drug Act of 1983

Answer 8

• Manufacturers argued that NDA process was too expensive to warrant the development and marketing of drugs for rare diseases
• Tax and exclusive licensing incentives for manufacturers to develop and market drugs or biologicals for the tx of “rare diseases or conditions”

Question 9

Drug Price Competition and Patent Term Restoration Act of 1984 (Waxman-Hatch Amendment)

Answer 9

• Streamline the generic drug approval process while giving patent extensions, in certain cases, to innovator drugs
• Intent was to make generic drugs more readily available to the public and provide incentives for manufacturers to develop new drugs

Question 10

Prescription Drug Marketing Act of 1987

Answer 10

• Due to growing alarm that a secondary distribution system for prescription drugs was threatening the public health and safety and creating an unfair form of competition
• Establishes sales restrictions and recordkeeping requirements for Rx drug samples
  Prohibits hospitals and other health care entities from reselling their pharmaceutical purchases to other businesses and requires the state licensing of drug wholesalers

Question 11

Safe Medical Devices Act of 1990

Answer 11

• Strengthened the Medical Devices Amendment Act of 1976, giving the FDA additional authority especially related to postmarketing requirements and premarket notification and approval, while expediting the premarket device approval process

Question 12

The Generic Drug Enforcement Act of 1992

Answer 12

• Due to FDA staff accepting bribes from generic drug industry personnel to facilitate the approval process of certain generic drug products
• Bans individuals or firms from participating in the drug approval process if convicted of related felonies
• Imposes penalties for any false statements, bribes, failures, to disclose material facts, and other related offenses

Question 13

Prescription Drug User Fee Act of 1992 (PDUFA)

Answer 13

• Private industry should shoulder part of the costs of new drug approval rather than the taxpayers
• Requires manufacturers seeking NDAs to pay fees for applications and supplements when the FDA must review clinical studies…fees provide the FDA with resources to hire more reviewers to assess these studies and (hopefully) speed up the NDA reviews
• PDUFA must be reauthorized every 5 years

Question 14

Nutrition Labeling and Education Act of 1994 (NLEA)

Answer 14

• Mandates nutrition labeling on food products and authorizes health claims on product labeling, as long as they are made in compliance with FDA regulations

Question 15

Dietary Supplement Health and Education Act of 1994 (DSHEA)

Answer 15

• Dietary supplement manufacturers felt that NLEA left too much authority with the FDA and thus restricted promotion of dietary supplements
• Defines dietary supplements and permit manufacturers to make certain claims that otherwise would have been illegal under the FDCA
• Forced FDA to regulate dietary supplements more as food than as drugs

Question 16

Food and Drug Administration Modernization Act of 1997 (FDAMA)

Answer 16

• Critics felt FDA was not efficiently administering its statutory responsibilities and FDCA was too burdensome for drug approval
• FDAMA passed to streamline regulatory procedures to ensure the expedited availability of safe and effective drugs and devices
• Intent to eliminate backlogs in the approval process and ensure timely review of applications
• Creates fast track approval process for drugs intended for serious or life threatening diseases, establishes a database of info on clinical trials, authorizes scientific panels to review clinical investigations and expands the rights of manufacturers to disseminate unlabeled use info
• Expands the FDA’s authority over OTC drugs and establishes ingredient labeling requirements for inactive ingredients

Question 17

Food and Drug Administration Amendments Act of 2007 (FDAAA)

Answer 17

• FDA broader use of the fees generated from PDUFA, substantially increasing fees
• In response to postmarket problems with certain drug products (i.e. Vioxx), the law provides FDA with increased responsibilities and authority to regulate drug safety, label changes related to safety, clinical trial data reporting and registries, requiring postmarket clinical studies to assess risk and requires companies to implement risk evaluation and mitiation strategies (REMS)

Question 18

FDA Safety and Innovation Act of 2012 (FDAISA)

Answer 18

• Reauthorize PDUFA
• Allows FDA to continue to collect user fees from manufacturers seeking NDAs or medical device approvals, but also adds new user fees for generic drugs and biosimilars
• Provisions to reduce drug counterfeiting, blocking the import of adulterated products, detecting and reducing drug shortages, and enhancing the exchange of prescription drug diversion info across state lines
• Enables FDA to inspect foreign drug manufacturers more regularly and requires the agency to target problematic manufacturing sites