Prescription Drug Marketing Act Of 1987 Essay

The principle reason for the Act is to keep the abuse of controlled medications and attains to this by forcing a complete boycott on the ownership, supply, make, import and fare of controlled medications with the exception of as permitted by regulations or by permit from the Secretary o

In 1906, the Pure Food and Drug Act, that was years in the making was finally passed under President Roosevelt. This law reflected a sea change in medicine-- an unprecedented wave of regulations. No longer could drug companies have a secret formula and hide potentially toxic substances such as heroin under their patent. The law required drug companies to specify the ingredients of medications on the label. It also regulated the purity and dosage of substances. Not by mere coincidence was the law passed only about five years after Bayer, a German based drug company began selling the morphine derivative, heroin. Thought to be a safe, non-habit forming alternative to morphine, heroin quickly became the “cure-all drug” that was used to treat

This act, under the direct administration of the Bureau of Chemistry, forbade the interstate transport of illegal food and drugs, and exposed any responsible parties, that dare to violate the law, to penalty of seizure of the questionable products and/or prosecution. In fact, the foundation of the law relies on the regulation of product labeling rather than pre-market approval. The selling of Drugs, which are defined according to the standards of strength, quality, and purity in the United States Pharmacopoeia and the National Formulary, is denied under any other condition except that the specific variations from the applicable standards were clearly stated on the label. However, there were different standards that defined foods, but the law outlawed the addition of any ingredients that would alternate for the food, hide damage, generate a health danger, or constitute a filthy or decomposed substance. The controversial interpretations of the food provisions in the law engendered many, sometimes prolonged, court battles. In case the manufacturer decided to list the weight or measure of a food, this had to be done accurately. Also, the food or drug label could not be false or misleading in any particular, and the presence and amount of eleven dangerous ingredients, including alcohol, heroin, and cocaine, had to be listed (Nash 276-77).

The history of drug use dates back for thousands of years with diverse purposes throughout humanity. According to Levinthal (2012), the drug-taking behavior gained federal awareness in the early 1900s, due to the lack of drug control regulations. Moreover, Levinthal (2012) mentions four major drug control laws which were established, including: (1) The Harrison Narcotic Act 1914, (2) The Marijuana Tax Act 1937, (3) The Boggs Act 1951, and (4) The Controlled Substance Act 1970. The drug control laws formed help regulate importation, manufacture, selling, or distribution of drugs within the United States (Levinthal, 2012).

Before 1906, the working conditions and practices of the meatpacking industry were horrendous and caused lots of health issues for many Americans. A book published by Upton Sinclair called “The Jungle” called attention to these issues to the White House when President Teddy Roosevelt read it (Oakes, McGerr and Lewis). Thus, the Pure Food and Drug Act of 1906 and the Federal Meat Inspection Act of 1906 was created (Oakes, McGerr and Lewis). This expanded the mission of the Bureau of Chemistry which was now responsible for regulation of these new acts (FDA's Origin & Functions - FDA History). The Bureau of Chemistry was later changed to the Food, Drug and Insecticide Administration

House Bill 7095, relating to Prescription Drugs or more commonly known as the “Pill Mill Bill” was passed by the Florida Legislature on May 6, 2011, and signed by Governor Rick Scott on June 3, 2011. In essence, H.B. 7095 regulates all facets of the prescribing and dispensing of pain killers and controlled substances, from distributors all the way to pharmacists and doctors. One of the main aspects of the bill is its enforcement of s. 456.44 F.S.; which deals with the dispensing of prescription drugs such as pain killers and controlled

There are many direct to consumer advertising for prescription drugs. On television, magazines, radio etc, you see the most recent advertisements for prescription drugs. After some people see the advertisements they soon rush over to their doctor and their illness and life would be perfectly pain and stress free. Making the public conscious of options for treatment is not a bad thing. But these false advertisements are misleading consumers onto unnecessary treatment.

Frequently, consumers like you and I buy items everyday not knowing chemicals or harsh byproducts that they are made with. We trust that cosmetic products we buy everyday will be safe, but there are ingredients in our daily products that could or has caused some health or skin conditions. In 1820, the U.S gathered physicians to create, The FDA and regulations on drugs in the United States. The general purpose of The Food and Drug Act was to have a standard on the specific food and drugs that were being imported into the United States. It was not until 1848 the Drug Importation Act was passed by Congress. It required U.S. Customs Service Inspection to stop entry of adulterated drugs from outside our border. In the middle of 1906, fifty-eight years later the food and drugs act was passed. The original Food and Drugs Act was passed by Congress on the 30th of June and signed by President Theodore Roosevelt. The Food and Drug Act prohibits interstate commerce in misbranded and adulterated foods, drinks and drugs (FDA). The Food and Drug establishes standards and regulations ensuring that general public is safe from harmful domestically and internationally produced products.

In the United States, a drug can only be advertised legally after being approved by the Food and Drug Administration (FDA). Once attaining at least one FDA-approved use, physicians can prescribe a drug for other unapproved uses, based on their clinical judgment; this is referred to as “off-label use” (McCambridge, 2008). In general, marketing drugs for off-label uses is illegal; however, pharmaceutical companies have gone to various lengths within their legal rights to accomplish exactly that.

Pharmaceutical companies are receiving negative allegations due to the “off-label” advertising of drugs. The Federal and Drug Administration require strict regulations for the use of “off-label” drugs in the pharmaceutical industry. “Off-label” practice of drugs are not prohibited, however, promoting the drugs are illegal. The concern of effective treatment is weighing the benefits and risks of “off-label” drugs for the best interest of the patient. In addition, companies who fail to comply with the FDA regulations, face consequences such as costly fines as well as criminal issues. Pharmaceutical companies often settle with the government, due to lack of proper procedures, complying with public health agencies. Modifying the policies of pharmaceutical companies with a different approach will limit the misuse of “off-label” drugs (Ghillyer, 2014).

actually illegal for pharmaceutical companies to promote off label use and there was a lot of

This issue started many years ago and will keep on going for several more to go. It started in the U.S. about 100 years ago. “The “grandfather” of American drug law is the Harrison Narcotics Act, passed in 1914” (Eldredge 99). The law “was meant by the U.S. Congress essentially to ensure safe record keeping” (Eldredge 99). Before that act was introduced there was very little being done about the national drug

Dead rats, infection diseases, and poison. These are only a few of the absolutely horrid things that would carelessly be thrown in by factory workers during the making and packaging process in the 1900s. People of that time period were completely unaware of how uncared for the meat that they were eating every day really was. Their food wasn’t cared for the way ours is today and it definitely wasn't inspected, therefore ending up with that unwanted rat chunk in your meat. The Food and Drug Act and the Meat Inspection Act of 1906 really shaped the cycle our food before it hits stores today compared to the 1900s, by making it a law to have all equipment cleaned correctly, including the food, and making sure all food gets inspected before it goes to the mouths of buyers like you and me.

Prescription drug prices are on the rise in the United States. Currently, the United States does not implement a price control on prescription drugs. Every day the supply and demand for prescription drugs fluctuates. Pharmaceutical companies produce drugs that are necessary for survival. Therefore, it is necessary for research and development to continue in the United States. Those suffering the effects of exorbitant prices must do so until a generic form of a prescription drug is produced. Once approved by the FDA, new drugs will make their appearance on the market and patients will no longer suffer financially. Until then, it is necessary for pharmaceutical companies to price their drugs based on the idea of supply and demand. This produces the profit used to fund research. Price controls discourage innovation. If a price control were set in place, of course the price of prescription drugs would decrease. However, the development of new drugs decreases with it. Today’s generation would benefit from lower prices, while future generations would suffer from the loss of drug innovation.

Medicines in the Public Interest predicts that counterfeit drug sales will reach US$75 billion globally by