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	==Kefauver-Harris Amendment of 1962==		==Kefauver-Harris Amendment of 1962==
		+
		+	The Kefauver-Harris Amendment (also known as the ''Efficacy Amendment'') was the first major update to the FDCA since the Durham-Humphrey Ammendment 11 years earlier.
		+
		+	From 1956 to 1962, approximately 10,000 children were born with severe malformities, including phocomelia, because their mothers had taken thalidomide during pregnancy. In 1962, in reaction to the tragedy, the United States Congress enacted the Kefauver-Harris Amendment.
		+
		+	Among other things, the amendment requires drug manufacturers to show the effectiveness of their products as well as their safety, to report adverse events to the FDA, and to ensure that their advertisements to physicians disclose the risks as well as the benefits of their products. Informed consent was required from participants in clinical studies. The FDA also was given jurisdiction over prescription drug advertising. In addition, the agency was required to approve a regulatory submission known as a new drug application before a company could market a new drug and be allowed to issue good manufacturing practice guidelines governing how drugs were to be manufactured. Inspection of drug manufacturers was mandated every 2 years.
		+
		+	The Kefauver-Harris Amendment provided this scenario for approving new drugs.
		+	Preclinical (animal) testing.
		+	*An investigational new drug application (IND) outlines what the sponsor of a new drug proposes for human testing in clinical trials.
		+	*Phase 1 studies (typically involve 20 to 80 healthy people).
		+	*Phase 2 studies (typically involve a few dozen to about 300 people with the ailment that the new drug is intended to treat).
		+	*Phase 3 studies (typically involve several hundred to about 3,000 people with the ailment that the new drug is intended to treat).
		+	*The pre-NDA period, just before a new drug application (NDA) is submitted. A common time for the FDA and drug sponsors to meet.
		+	*Submission of an NDA is the formal step asking the FDA to consider a drug for marketing approval.
		+	*After an NDA is received, the FDA has 60 days to decide whether to file it so it can be reviewed.
		+	*If the FDA files the NDA, an FDA review team is assigned to evaluate the sponsor's research on the drug's safety and effectiveness.
		+	*The FDA reviews information that goes on a drug's professional labeling (information on how to use the drug).
		+	*The FDA inspects the facilities where the drug will be manufactured as part of the approval process.
		+	*FDA reviewers will approve the application or find it either "approvable" or "not approvable."
		+	*Post marketing study commitments, also called Phase 4 commitments.
	==Comprehensive Drug Abuse Prevention and Control Act of 1970==		==Comprehensive Drug Abuse Prevention and Control Act of 1970==

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Revision as of 17:31, 4 April 2011

For over a century, federal legislation has been impacting the practice of pharmacy. In almost every case, the purpose of this legislation has been to protect the health, safety, and welfare of the patient from the potential risks of drug use or misuse.

Most of this federal legislation has been initiated in response to issues and concerns at a certain point in time. For example, the Federal Food, Drug, and Cosmetic (FDC) Act passed by Congress was done as a safety concern because of the deaths of over 100 individuals who consumed a drug product containing antifreeze. Other acts that followed also were the result of significant issues with national implications.

While defining pharmacy practice and regulating the profession has primarily been left to the individual states based on the Tenth Amendment to the Constitution, the federal government regulates drug distribution through the Interstate Commerce Clause. This regulation of drug distribution often results, either directly or indirectly, in the regulation of the profession of pharmacy as well. The federal government also has implemented legislation affecting pharmacy practice based on participation in such programs as Medicaid. The counseling provisions of the Omnibus Budget Reconciliation Act, while not directly requiring pharmacist actions, did require the individual state governments to establish expanded standards of practice or risk losing federal funding of their programs. In effect, a back door approach to regulating the profession was utilized.

Over the years, much of the federal legislation that has been passed by Congress has proven itself useful by providing the safety and security that our society has come to expect. Pharmacists have embraced this legislation, albeit sometimes reluctantly, as most legislation has imposed new requirements in such areas as record keeping, counseling, and packaging of pharmaceuticals.

Creating a federal law

This is the legislative process as established by President Franklin D. Roosevelt's New Deal administration in 1935.

Under our current systems we have two major routes in which federal legislation may become law:

1. The U.S. Congress (House of Representatives and the Senate) passes a law stating objectives to met, or
2. a federal agency decides to create or modify a regulation to meet a new situation.

Advanced notice of proposed rule making and/or the proposed rule is published in the Federal Register (FR). The Federal Register is the official journal of the federal government of the United States that contains most routine publications and public notices of government agencies. It is a daily publication excluding holidays.

After public viewing and discussion, any modifications to the rules are also published in the FR, and eventually the final rule will be published in the FR. Once a rule is made official it gets codified into the next edition of the Code of Federal Regulations (CFR). While new regulations are continually becoming effective, the printed volumes of the CFR are only issued annually.

Pure Food and Drug Act of 1906

The original Pure Food and Drug Act (also known as the Wiley Act) was passed by Congress on June 30, 1906 and signed by President Theodore Roosevelt. It prohibited interstate commerce in misbranded and adulterated foods, drinks and drugs under penalty of seizure of the questionable products and/or prosecution of the responsible parties.

To define a couple of terms, to misbrand something means to brand or label misleadingly or fraudulently; while, adulterated means to make impure by adding improper or inferior ingredients.

The Meat Inspection Act was also passed the same day.

Shocking disclosures of insanitary conditions in meat-packing plants, the use of poisonous preservatives and dyes in foods, and cure-all claims for worthless and dangerous patent medicines were the major problems (brought to the public's attention via journalists known as muckrakers) leading to the enactment of these laws. Two of the most famous muckrakers were a journalist named Samuel Hopkins Adams (whom wrote a series of eleven articles for Collier's Weekly, called “The Great American Fraud”) and an author and social activist named Upton Sinclair (whom wrote “The Jungle”)

The following are some important court cases involving the Pure Food and Drug Act:

• In 1911, the U.S. v. Johnson, the Supreme Court ruled that the 1906 Food and Drugs Act does not prohibit false therapeutic claims but only false and misleading statements about the ingredients or identity of a drug.
  • In 1912, in reaction to the U.S. v. Johnson verdict, Congress enacted the Shirley Amendment to over come the ruling in U.S. v. Johnson. It prohibited labeling medicines with false therapeutic claims intended to defraud the purchaser, a standard difficult to prove.
• In 1924 in U.S. v. 95 Barrels Alleged Apple Cider Vinegar, the Supreme Court ruled that the Food and Drugs Act condemns every statement, design, or device on a product's label that may mislead or deceive, even if technically true. This case helped to verify the Pure Food and Drug Act's enforceability for dealing with misbranded and adulterated products.

This Act is often considered the beginning of the FDA.

Harrison Narcotics Tax Act of 1914

The Harrison Narcotics Tax Act was a United States federal law that regulated and taxed the production, importation, distribution and use of opiates. The act was proposed by Representative Francis Burton Harrison of New York and was approved on December 17, 1914.

"An Act To provide for the registration of, with collectors of internal revenue, and to impose a special tax on all persons who produce, import, manufacture, compound, deal in, dispense, sell, distribute, or give away opium or coca leaves, their salts, derivatives, or preparations, and for other purposes."

This Act was intended to curve the growing number of opium addictions within the U.S. As well as to deal with concerns over our new territory in the Philippines.

Following the Spanish-American War the U.S. took over government of the Philippines. Confronted with a licensing system for opium addicts, a Commission of Inquiry was appointed to examine alternatives to this system. The Brent Commission recommended that narcotics should be subject to international control.

This proposal was supported by the United States Department of State and in 1906 President Theodore Roosevelt called for an international opium conference, which was held in Shanghai in 1909. A second conference was held at the Hague in 1911, and out of it came the first international drug control treaty, the International Opium Convention of 1912, aimed primarily at solving the British-caused opium problems of China.

In 1914, the Senate considered the Harrison bill. The act was supported by the Secretary of State William Jennings Bryan who urged that the law be passed to fulfill the obligation of the new international treaty. The debate was about international obligations rather than morality.

The act appears to be concerned about the marketing of opiates. However a clause applying to doctors allowed distribution "in the course of his professional practice only." This clause was interpreted after 1917 to mean that a doctor could not prescribe opiates to an addict, since addiction was not considered a disease. A number of doctors were arrested and some were imprisoned. The medical profession quickly learned not to supply opiates to addicts.

The impact of diminished supply was obvious by mid-1915. A 1918 commission called for sterner law enforcement. Congress responded by tightening up the Harrison Act — the importation of heroin for any purpose was banned in 1924.

This act fell under the regulation of the IRS for tax collection and was enforced by the U.S. Department of Justice.

Food, Drug, and Cosmetic Act of 1938

The Food, Drug, and Cosmetic Act (FDCA) served as a replacement to the Pure Food and Drug Act of 1906. This earlier act prohibited interstate commerce in misbranded and adulterated foods, drinks, and drugs and was most concerned with purity, not safety, issues. In addition, the 1906 act did not prohibit false therapeutic claims and, in some cases, even protected those claims. Furthermore, the 1906 law did little to inform patients as it did not require the label to list ingredients, include directions for use, or provide warnings regarding the product.

Because of the shortcomings of the 1906 Act, the FDA petitioned Congress for a new act. Between 1933 and 1937, a legislative battle ensued to replace the 1906 law. On one side of the battle were capitalists calling for laissez faire, on the other were social reformers fighting for government intervention due to concerns over public safety. Ultimately, it was a therapeutic disaster in 1937 that motivated Congress to act. A Tennessee company marketed a sulfa drug in an untested solvent (diethylene glycol) that resulted in the death of 107 people, many of whom were children. The public outcry not only reshaped the drug provisions of the new law to prevent such an event from happening again, but it propelled the bill through Congress.

After being passed by both houses of Congress it was signed into law by President Franklin D. Roosevelt on June 25, 1938

The Federal Food, Drug, and Cosmetic Act contains the following new provisions:

• Extending control to cosmetics and therapeutic devices.
• Requiring new drugs to be shown safe before marketing-starting a new system of drug regulation.
• Eliminating the Shirley Amendment requirement to prove intent to defraud in drug misbranding cases.
• Providing that safe tolerances be set for unavoidable poisonous substances.
• Authorizing standards of identity, quality, and fill-of-container for foods.
• Authorizing factory inspections.
• Adding the remedy of court injunctions to the previous penalties of seizures and prosecutions.

This particular Act is still the basis of the Food and Drug Administration's authority although it has received various amendments in the past 75 years. The major amendments include:

• Durham-Humphrey Amendment
• Kefauver Harris Amendment
• Medical Device Amendment
• Orphan Drug Act
• Drug Price Competition and Patent Term Restoration Act
• Prescription Drug Marketing Act
• Dietary Supplements and Health Education Act
• Food and Drug Administration Modernization Act
• Best Pharmaceuticals for Children Act

Durham-Humphrey Amendment of 1951

This amendment to the Food, Drug, and Cosmetic Act, also known as the Prescription Drug Amendment, was signed into law by President Harry S. Truman on October 26, 1951. This amendment was co-sponsored by former vice president and senator Hubert H. Humphrey Jr., who was a pharmacist in South Dakota before beginning his political career. The other sponsor of this amendment was Carl Durham, a pharmacist representing North Carolina in the House of Representatives.

The Durham-Humphrey Amendment, enacted in 1951, resolved the issues left open by the 1938 Act. It established two classes of drugs: Rx legend (prescription) and OTC (over the counter). Prior to the passage of this amendment, drug manufacturers were generally free to determine in which category their drug belonged. A subsection of this amendment granted the FDA the authority to categorize prescription drugs as those that are habit-forming, unsafe for use except under the supervision of a health care practitioner, and/or subject to the new drug application approval process.

Additionally, under this amendment, a drug manufacturer can switch their product from Rx to OTC status by doing any one of the following:

1. The drug manufacturer can request the switch by submitting a supplemental application.
2. The drug manufacturer can petition the FDA for the switch
3. And the primary mechanism for switching drugs to OTC is for the drug manufacturer to go through the OTC process, and a review board which the FDA would have to agree to.

If the FDA agrees, a final report switching from a prescription drug to OTC drug takes place.

The amendment also gave guidance as to what minimal information must be included on the prescription label:

• name and address of the pharmacy,
• serial number of the prescription,
• date of its filling,
• the name of the prescriber,
• the name of the patient,
• the directions for use, and
• any applicable warning labels.

Kefauver-Harris Amendment of 1962

The Kefauver-Harris Amendment (also known as the Efficacy Amendment) was the first major update to the FDCA since the Durham-Humphrey Ammendment 11 years earlier.

From 1956 to 1962, approximately 10,000 children were born with severe malformities, including phocomelia, because their mothers had taken thalidomide during pregnancy. In 1962, in reaction to the tragedy, the United States Congress enacted the Kefauver-Harris Amendment.

Among other things, the amendment requires drug manufacturers to show the effectiveness of their products as well as their safety, to report adverse events to the FDA, and to ensure that their advertisements to physicians disclose the risks as well as the benefits of their products. Informed consent was required from participants in clinical studies. The FDA also was given jurisdiction over prescription drug advertising. In addition, the agency was required to approve a regulatory submission known as a new drug application before a company could market a new drug and be allowed to issue good manufacturing practice guidelines governing how drugs were to be manufactured. Inspection of drug manufacturers was mandated every 2 years.

The Kefauver-Harris Amendment provided this scenario for approving new drugs. Preclinical (animal) testing.

• An investigational new drug application (IND) outlines what the sponsor of a new drug proposes for human testing in clinical trials.
• Phase 1 studies (typically involve 20 to 80 healthy people).
• Phase 2 studies (typically involve a few dozen to about 300 people with the ailment that the new drug is intended to treat).
• Phase 3 studies (typically involve several hundred to about 3,000 people with the ailment that the new drug is intended to treat).
• The pre-NDA period, just before a new drug application (NDA) is submitted. A common time for the FDA and drug sponsors to meet.
• Submission of an NDA is the formal step asking the FDA to consider a drug for marketing approval.
• After an NDA is received, the FDA has 60 days to decide whether to file it so it can be reviewed.
• If the FDA files the NDA, an FDA review team is assigned to evaluate the sponsor's research on the drug's safety and effectiveness.
• The FDA reviews information that goes on a drug's professional labeling (information on how to use the drug).
• The FDA inspects the facilities where the drug will be manufactured as part of the approval process.
• FDA reviewers will approve the application or find it either "approvable" or "not approvable."
• Post marketing study commitments, also called Phase 4 commitments.

Comprehensive Drug Abuse Prevention and Control Act of 1970

Occupational Safety and Health Act of 1970

Poison Prevention Packaging Act of 1970

Medical Device Amendments of 1976

Federal Antitampering Act of 1983

Orphan Drug Act of 1983

Drug Price Competition and Patent-Term Restoration Act of 1984

Prescription Drug Marketing Act of 1987

Omnibus Budget Reconciliation Act of 1987

Anabolic Steroids Control Act of 1990

Omnibus Budget Reconciliation Act of 1990

Dietary Supplement Health and Education Act of 1994

Uruguay Round Agreements Act of 1994

Health Insurance Portability and Accountability Act of 1996

Food and Drug Administration Modernization Act of 1997

2002 Best Pharmaceuticals for Children Act

Medicare Modernization Act of 2003

Combat Methamphetamine Epidemic Act of 2005

Medicaid Tamper-Resistant Prescription Law of 2007

Patient Protection and Affordable Care Act of 2010

See also

References

1. Pharmacy Times, A Review of Federal Legislation Affecting Pharmacy Practice, Virgil Van Dusen , RPh, JD and Alan R. Spies , RPh, MBA, JD, PhD, https://secure.pharmacytimes.com/lessons/200612-01.asp
2. Strauss's Federal Drug Laws and Examination Review, Fifth Edition (revised), Steven Strauss, CRC Press, 2000
3. Food and Drug Administration, Legislation, http://www.fda.gov/RegulatoryInformation/Legislation/default.htm
4. Food and Drug Administration, History, http://www.fda.gov/AboutFDA/WhatWeDo/History/default.htm
5. Wikipedia, Durham-Humphrey Amendment, http://en.wikipedia.org/wiki/Durham-Humphrey_Amendment
6. Wikipedia, Kefauver-Harris Amendment, http://en.wikipedia.org/wiki/Kefauver_Harris_Amendment