Biosimilar Drug Case Study

Another issue involving the Orphan Drug Act that has caused great conflict and controversy is the market exclusivity it provides as an incentive. In 1989 Amgen’s drug erythropoietin was approved by the FDA to treat anemia. Amgen was given exclusive marketing rights for seven years and erythropoietin became one of the most successful drugs in history. In these types of instances, the issue is that these companies have essentially created a monopoly where they have complete control. [6][7] Since there is no competition, companies have the opportunity to drive up the prices forcing people to be left with the ultimatum of either paying high out of pocket prices or leaving their condition untreated. The reduction in competition also severely limits the access to treatments for patients with rare diseases. [6]

Shortages of prescription drugs in the United States are a serious threat to our nation’s health and safety. At first blush, this problem appears fairly simple and straight forward to solve. In reality, there is a complex web of causation with a number of root causes contributing to drug shortages. The aim of this paper is to answer the question: How do we mitigate prescription drug shortages? This discussion is written from the standpoint of advising the current presidential administration how to address this crisis. This essay begins with a discussion regarding the background of the issue. Next, the landscape, including stakeholders in this matter is identified. Following, political, social, economic, and practical factors surrounding

The Medicare beneficiaries’ contribution to the coverage gap decreases each year, with the majority of cost absorbed by the government and the drug manufacturers. Drug manufacturers also agreed to pay a fee to the federal government health care programs on branded prescription drugs (BPD), based on its sales of BPD’s. There was an expansion of the Public Health Service Act (PHSA), that required drug manufactures to provide eligible entities with significantly reduced drug price. The PHSA, also expanded those entities such as free-standing cancer centers and critical access hospitals (CAH), that were eligible to participate in the 340B program In, addition they also agreed to increase rebates on sales of prescription drugs to the Medicaid program (Spats, 2010). The rebate was increased from 15.1 percent to 23.1 percent. In addition, drugs, such as those used for pediatric care and clotting factor drugs there was a 17.1% rebate. Perhaps, most importantly, the firms extended the rebates to Medicaid patients enrolled in Managed Care Organizations (MCO). This new agreement allows plans to negotiate rebates in addition to the new ones

Morgan, S. G., & Daw, J. R. (2012, August). Canadian pharmacare: Looking back, looking forward. Healthcare Policy, 8(1), 14–16. Retrieved from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3430151/

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.

This bill will force physicians and pharmacists alike to become more vigilant in prescribing and dispensing controlled substances to not only the correct patients but those who actually need the medication. Although some of the changes are abrupt and somewhat swift in their calls to action, policy makers believe these changes are necessary in order to shift the trend facing Florida regarding prescription drug abuse.

The bill was introduced by Senator Kohl (WI) due to the practice in which drug companies provide money to makers of generic medications to delay the introduction of certain generic medications (Policy and Medicine, 2011). The reason that the original maker of the drug would want to delay the production of a generic is that they make more money of they maintain exclusive rights to sell a certain medication. Unfortunately, the public ostensibly loses in this transaction because the drug company is not forced to reduce the price at which they sell the drug (Open Congress, 2012). This makes healthcare costs increase overall. The bill would save these costs to consumers as it would ensure that generic

The court found in favor of the manufacturer stating “federal law still preempted injured patients from bringing lawsuits in state courts, because the state laws in question require a safer label, not communicating with the FDA about the possibility of creating a safer label,” (Glantz & Annas, 2011, p. 682). Despite this regulatory standing, a controversial issue may entail for the FDA in the allowance of medications to be “interchanged” to promote an additional avenue for savings in prescription medications. Much foresight needs to be included to protect the safety and well-being of patients.

Recently I identified an area of our medication policy that required some improvement due to the way that the list of medications were deemed as “controlled medications” and was such a comprehensive list that included medications that we do not use at our service along with medications that are deemed controlled by our own policies but not by government which then became restrictive to what time a service user could take their medication.

Conclusion: Ultimately, a pharmacist’s role would greatly expand with the Provider Status law. In the future, all states should adapt a form of the Provider Status law. Pharmacists should be utilized to their utmost capabilities, they endured four years of education studying medications, their uses and the effects. A pharmacist’s expertise is very vital to a patient’s treatment. Eventually, pharmacists should be granted the right to prescribe

The rise in costs of prescription medicines affects all sectors of the health care industry, including private insurers, public programs, and patients. Spending on prescription drugs continues to be an important health care concern, particularly in light of rising pharmaceutical costs, the aging population, and increased use of costly specialty drugs. In recent history, increases in prescription drug costs have outpaced other categories of health care spending, rising rapidly throughout the latter half of the 1990s and early 2000s. (Kaiseredu.org, 2012).

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.

In an effort to make the most expensive and life saving biological drugs, more affordable and accessible to large population, under the act of “Affordable care Act” the U.S. Food and Drug Administration have approved Zarxio, the first biosimilar product in the United States.

The necessity of having generics to biologics. I can say about this based on patient's economic ability. Taking biologic treatment is not a matter to wealthy person. but it matters for poor people. Biologics is not affordable by all classes in the society, where as biosimilars is affordable. Majorly biosimilars are similar to their reference products in terms of safety, efficacy, route of administration and patient compliance etc. So in my view, it is better to have biosimilars in the market in order to provide better health care to the society when compared to conventional drugs.

A recent decision by the California Supreme Court is a big win for consumers. In In Re Cipro Cases I & II, the state’s highest court made it more difficult for manufacturers of brand name drugs to enter into so-called “pay-for-delay” agreements, which keep lower-priced generic medications out of reach for patients.