Pharmaceutical Labeling Challenges

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.

The Food and Drug Administration, also known as the FDA or USFDA, is responsible for protecting and advocating public health. They are the official government agency that ensures our drug supply is safe and effective. This is achieved through the regulation and supervision of food safety, dietary supplements, veterinary products, cosmetics, vaccines, biopharmaceuticals, medical devices, prescription and pharmaceutical drugs that can be purchased over- the- counter.

Pharmaceutical companies are provided with temporary monopoly rights on the production of new drugs which result in a higher cost on consumers. If competing companies were allowed to produce generic forms of those drugs, consumers will be able to afford those medications even in cases where those consumers have no insurance coverage. The company responsible for developing and inventing the original medication could be offered incentives to invent in the future by either obtaining tax breaks or NIH funding for future research. They could even be offered a percentage of the sales of the generic drugs. Economist Gary S. Becker advocates dropping many FDA requirements that, in his opinion, provide no additional safety measures but rather delay the development of new drugs.[12] Betamethasone, for example, has been part of the standard prenatal care in Europe since the late 1970’s while it got adopted in the U.S. after 1997. On many occasions, the FDA ignores all scientific evidence concerning certain drugs because the manufacturer did not follow their mandated bureaucratic standards.

Improvements in health care and life sciences are an important source of gains in health and longevity globally. The development of innovative pharmaceutical products plays a critical role in ensuring these continued gains. To encourage the continued development of new drugs, economic incentives are essential. These incentives are principally provided through direct and indirect government funding, intellectual property laws, and other policies that favor innovation. Without such incentives, private corporations, which bring to market the vast majority of new drugs, would be less able to assume the risks and costs necessary to continue their research and development (R&D). In the United States, government action has focused on creating the environment that would best encourage further innovation and yield a constant flow of new and innovative medicines to the market. The goal has been to ensure that consumers would benefit both from technological breakthroughs and the competition that further innovation generates. The United States also relies on a strong generic pharmaceutical industry to create added competitive pressure to lower drug prices. Recent action by the Administration and Congress has accelerated the flow of generic medicines to the market for precisely that reason. By contrast, in the Organization for Economic Cooperation and

U.S. based companies hold rights to most of the world’s rights on new medicines and holds thousands of new products currently being developed. As of 2012, the industry helps support almost 3.4 million jobs in the U.S. economy. It is also one of the most heavily R&D based industries in the world. In the United States, the environment for pharmaceuticals is much friendlier than other countries around the world in terms of pricing ability and regulations. Both the Pharmaceutical and Biotechnology industries have experienced significant growth in the past year with year-over-year increases of 13.02% and 34.69% respectively. It is an even more striking when looking at the past five years considering both have beat out the S&P 500 with pharmaceuticals increasing an additional 31.44% and the biotechnology sector besting an astonishing 269.3% more return than the

I have spent my time as a student pharmacist learning about opportunities within clinical pharmacy and making certain that I was equipped with the knowledge and skills necessary to succeed. In my pursuit, I became an active member of pharmaceutical organizations, held multiple leadership positions, attended clinical conferences, established research projects, participated in community service events, and other initiatives. I excelled academically, which was manifested in not just a high academic standard but also in tutoring fellow classmates and arranging sessions with other pharmacy students to help them improve time management and study skills. I shadowed pharmacists and residents before my advanced pharmacy practice experiences commenced to discover which areas of clinical pharmacy I found intriguing. I have obtained valuable pharmacy practice experiences in five specialties thus far including inpatient internal medicine, long term acute care, geriatrics and telehealth, and primary care. Through these rotations, I built upon the knowledge I acquired from my didactic courses but also developed patient-centered approaches and strengthened my clinical skills. I enjoyed many aspects of my rotations, including contributing pharmacotherapy recommendations, providing patient education, attending rounds and interdisciplinary team meetings – all of which have solidified my desire

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.

The demand for the medical services offered by pharmacists increases every year as the elderly population grows and the number of prescriptions increases to meet their needs. The United States Census Bureau recently found that 1 in 5 Americans will meet the age criteria necessary to be considered elderly. The National Association of Chain Drug Stores projects the growth of filled prescriptions in the United States from 4.1 billion in 2015 to 4.7 billion by 2021. Pharmacists perform a variety of tasks beyond just filling prescriptions, such as researching new drugs, working in hospitals, and writing patents. The high demand for pharmacists provides a wide array of career choices in both the private and public sectors.

The Food and Drug Administration is a regulation agency within the Department of Health and Human Services. It’s role in our nation is to be responsible for “protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation” ("What We Do."). One of the most important responsibilities and the topic I will be discussing throughout this paper is drug regulation. The Food and Drug Administration approves drugs that are intended for use in diagnosis, cure, relief, treatment, or prevention of disease, and is intended to affect the function of the body. In order to do so, The Food and Drug Administration reviews drug manufacturer’s via application to put drugs on the market; therefore, a drug may not be sold or marketed unless it has and remains approved by the FDA. Even though a drug has been approved does not mean it will remain on the market, drugs have the likelihood to be recalled. For example, when you see those late night personal injury lawyer commercials saying, “If you have been prescribed and taken said drug, and experienced any of these side effects such as blood clots, seizures, etc., you may be entitled to compensation.” those drugs have usually been recalled due to adverse effects

Bailey, Urimala, Schillinger & Wolff (2012) investigated the benefits of drug labels that are multilingual and informative. The researchers utilized ConcordantRx, which are instructions aimed at informing patients to take their medication at four specific times: morning, noon, evening, and night. CondordantRx also implemented simple terminology and used numbers rather than words in the appropriate contexts in order to clarify medication instructions. The researchers specifically analyzed limited English proficient (LEP) adults who spoke Chinese, Vietnamese, Russian, Korean or Spanish. Furthermore, investigators emphasized that the underlying cause of many adverse drug events is from poor comprehension of drug labels. To test whether or not

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.

Making medications safe, efficacious and affordable have been a long lime pursuit by the US government, pharmaceutical industries and advocacy groups and ordinary citizens of the US. This responsibility started with regulations of vaccines in early 19th century by the government. At the time infectious disease was a major killer in the whole world and vaccines have been proven to be effective in combating infectious. However, the techniques and standards available today were not available then but some sort of regulation still needed to be put in place to ensure safety.

Being competent these days requires more than the knowledge for graduation. One of the important goals of the academic curriculum is to encourage students to be lifelong learners. It requires getting continuous knowledge and education. Most of the employers have workshops or continue education credits for their employees to keep them competent to the changing environment. Changes that continuously ongoing in pharmacy practice and in the role of pharmacists will require that pharmacists have a different set of competencies to seize work

Therefore, protection of patents is one of the key conditions necessary for further development of the pharmaceutical industry. At the same time, non-efficient legislation that does not provide the necessary level of patent protection is one of the factors that hamper expansion of “Big Pharmaceutical” companies to the developing countries8.

The concept of product patent for pharmaceutical products is likely to make life saving medicine beyond the reach of the poor and deprived section of the society around the world.