Prescription Drug User Act ( Pdufa )

The Food and Drug Administration (FDA) is best known for its role on protecting the health of the public by making sure that food, medications are safe and effective. Especially when it comes to the pharmaceutical industry, its mission is to regulate pharmaceutical manufacturers, as well as the drug approval process. However, in the recent years, many arguments and controversy regarding drug development and regulation have risen. Drug advertisements make false and misleading claims, products are being put out on the market without any proof of safety, causing many unwanted incidents such as the Avandia incident and Vioxx incident, which could have been prevented in the first place.

When a pharmaceutical company creates a new drug, it has to go through the FDA and is required to submit a New Drug Application (NDA) to the FDA. The FDA reviews the application to assure that there is an objective proof that the proposed drug is safe and effective. If the

Making the health information available, reducing duplication of tests, reducing delays in treatment, and patients well informed to take better decisions.

On June 17th 1971, President Richard Nixon stood in front of congress and announced his widely criticized War on Drugs. The President claimed that drugs were the “Public Enemy Number One” among Americans. Fast-forward to 1986, Congress passed the Anti-Drug Abuse Act of 1986. This act placed mandatory minimum sentences on minor drug infractions. The war on drugs not only incarcerated a very high number of Blacks, but also tore families apart in an effort to clean up neighborhoods which still affect many African American families almost a half-century later.

In 2010, the Obama Administration passed into law The Fair Sentencing Act, which directly targeted the harshly different punishments for people caught in possession of crack versus people caught in possession of cocaine and effectively overruled the punishments of each drug outlined in the Anti-Drug Abuse Act of 1986. Immediately, there was discussion regarding the purpose and effectiveness of this act versus the 1986 act. The Anti-Drug Abuse Act of 1986, although it was eagerly pursued and supported by black communities, has ultimately been accused of being indirectly, or purposefully, discriminatory towards African Americans. This law established shockingly different punishments for users of crack versus users of cocaine. As is commonly known and has been proven statistically, African Americans are more likely to consume crack than cocaine and are more likely to consume crack than any other race would.

The time frame and cost to release a drug for sale into the United States market is enormous. After nearly 20 years and about one billion dollars spent, a drug manufacture can begin to market its product to consumers (Philipson & Sun, 2008). The reason behind these huge numbers is the drug approval process mandated by the Food and Drug Administration. Understanding the testing process will explain the long time frame and huge costs associated with drug approval.

These new guidelines will allow for a 12-year period of data exclusivity for new branded biologics. During the 12- year period, rivals are not allowed to use any prior data to try to come up with their own product. Before, the passage of the ACA, the Federal Drug Administration (FDA), could not legally approve new biologic medicines because they had to have clinical trials. This law opened up the regulatory guidelines for the FDA to approve

1. The patients will see ease of dosing as well as improved results as compared to the market. They will identify for the drug to decrease disease complications and improved bone health. Give patients alternatives to treatment for their own disease.

In most cases, there is a committee that decides this. The committee typically includes both physicians and pharmacists. They meet periodically to update the drug list in order to keep it current and relevant.

Laws are created by parliament which is made up by the MP’S society votes for during the election process. The Misuse of Drugs Act (1971) was introduced to prevent the misuse of controlled drugs such as cannabis, amphetamine and other drugs stated in the Act. The Act attempts to prevent the misuse of drugs by making it a criminal offence to be in possession or supply, manufacture, import and export drugs (Drugscope, 2015). The Act also gives the Home secretary authority to ban new drugs and increase the penalties associated with them.

S.959—Pharmaceutical Compounding Quality, Security and Accountability Act, was introduced into the U.S Senate May 15, 2013 by Thomas Harkin, Democratic senator of Iowa, along with the support of five cosponsors. The bill, if it’d passed would have amended the Federal Food, Drug, and Cosmetic Act (FFDCA) to expand the regulation of compounded drugs. It would have allowed the Federal Government to oversee drug compounders’ operations to ensure drug quality and safety. Most recently, the bill was referred to the Senate Health, Education, Labor, and Pensions Committee but never made it to the floor for a vote. Supporters of S.959 were both Republicans and Democrats. This bill was a bipartisan effort. There was opposition to this bill from the

After all research has been conducted including the testing of all animal and human studies associated, the New Drug application is completed by the drug developer. The results provided are used by the FDA to determine whether the drug is approved or the recommendation of further testing. Finally phase four is based on the monitoring of the drug’s risks and benefits monitored by various sponsors hired by the FDA.

Although all the signals from the FDA were positive, there was also the risk that the FDA, which

One factor that must be considered is that the drug had not yet been approved by the FDA, but was in phase III trials. Historical data shows that 65% of drugs in this phase eventually get approved for sale to the market. It was felt that approval of the drug would occur late in 1998.

Phase III is the first large-scale trial of human testing. This phase can only begin if the new drug shows to be effective in the phase II. Phase III seeks to further determine the effectiveness of the drug. This is done by testing the drug on different populations, meaning that testing will be done on more people, testing will be done on different drug doses, and the drug will be tested on patients who are also taking other drugs. If Phases I through III show the investigational new drug to be safe and effective, then the pharmaceutical company will file a New Drug Application (NDA). The NDA includes both the results of the first three trial phases and data on how the drug is manufactured (Frank & Hargreaves, 2003; Lipsky & Sharp, 2001;