Controlling Costs and Increasing Access to Prescription Drugs: State and Federal Solutions

Spending on health care in the United States continues to increase rapidly, consuming a greater share of the total economy each year. Over the past decade, prescription drug spending has been the fastest growing component of health care expenditures both nationwide and in Washington state. The federal government, state governments, individuals and employers all pay for prescription drugs, and everyone is affected by rising costs. While it is true that overall drug prices have gone up, and in many cases at more than triple the rate of inflation, price increases alone do not account for the drastic increase in spending on pharmaceuticals. The three biggest cost drivers, in order, are:1) the average person fills more prescriptions than ever before (increased utilization),2) new classes of drugs arrive on the market in high demand and at high prices, and3) pharmaceutical companies hike prices on existing drugs. Double-digit increases in total prescription drug costs create two interrelated problems. First, higher prices mean less access for uninsured individuals, and often a difficult choice for the poor: to treat or eat? Second, increased drug spending forces state governments to face a similar choice: to continue funding drug coverage for seniors, the disabled and others at escalating prices and pay for it by cutting teacher salaries, raising taxes, and underfunding firehouses, or to roll back drug benefits and eligibility for already vulnerable groups? While Congress has thus far failed to pass Medicare prescription drug or generic drug legislation, and the executive branch has taken a hands-off approach, the states have taken the lead in designing innovative policies to reduce manufacturer prices and expand access to necessary drugs. Legislation in Washington state, debated in 2002 and expected to be reintroduced in 2003, would allow the state to evaluate the benefits and costs of various and competing prescription drugs, negotiate price discounts for the best-value drugs, and pass the savings on to those who lack prescription drug coverage. Allowing the state to shop smarter is a sensible, near-term way for Washington to address the related problems of access and cost. Furthermore, an emerging consensus among states may drive more fundamental policy changes at the federal level

Challenges and Opportunities to Updating Prescribing Information for Longstanding Oncology Drugs.

A number of important drugs used to treat cancer-many of which serve as the backbone of modern chemotherapy regimens-have outdated prescribing information in their drug labeling. The Food and Drug Administration is undertaking a pilot project to develop a process and criteria for updating prescribing information for longstanding oncology drugs, based on the breadth of knowledge the cancer community has accumulated with the use of these drugs over time. This article highlights a number of considerations for labeling updates, including selecting priorities for updating; data sources and evidentiary criteria; as well as the risks, challenges, and opportunities for iterative review to ensure prescribing information for oncology drugs remains relevant to current clinical practice

Transparency and Innuendo: An Alternative to Reactive Over-Disclosure

Lassman examines the tension between transparency and other public health interests in the context of the FDA\u27s proposed Drug Watch web site. He argues that although the FDA proposal seeks to achieve a laudable goal--the prompt communication of important useful safety information about drug products to physicians and patients-- it fails to properly balance transparency and other legitimate public health interests

Ethical Issues in the Drug Approval Process

The Food and Drug Administration’s (FDA) drug approval process carries great significance for both pharmaceutical companies and for patients. In recent decades, there has been a shift towards expedited approval so that drugs, especially those for terminally ill patients, can be brought to market faster. However, the FDA still has the responsibility of protecting patients from harm. The case studies of two drugs, Vioxx and Avastin, highlight several of the ethical and practical issues of the drug approval process, including the nature of clinical trial research, the risk-benefit analysis of new treatments, the growth of Contract Research Organizations (CROs) and the ethics of post-marketing research. In today’s rapidly advancing global society, there is grey area in terms of how to act ethically in performing research on human subjects, yet provide the drugs that patients want in a timely manner. I advocate that the FDA should take a patient centered approach to the drug approval process. First, the FDA should continue to use accelerated approval and work to streamline the approval process further, since it has been shown to benefit patients greatly. Second, the agency should continue to utilize the comprehensive informed consent process. If in the future they can eliminate the theoretical misconception about research, by better educating patients about the difference between research and treatment, only then would I advocate for streamlining or removing the informed consent process. Until then, patients need to be made fully aware of their role as a research subject

The Future of Generic Biologics: Should the United States “Follow-On” the European Pathway?

The United States is embarking on a biotechnology drug revolution. In the last few decades, biotech drugs have saved millions of lives, and the market for these miracle cures continues to grow at an astronomical rate. Unfortunately, as the market for biotech drugs is skyrocketing, drug prices are following suit. As Congress strives to make these new drugs more affordable, it must not ignore significant safety concerns unique to these revolutionary therapies. Congress should follow the lead of the European Union to create an accessible pathway for generic forms of biotech drugs that includes strict regulatory measures to ensure drug safety and efficacy

The Future of Generic Biologics: Should the United States “Follow-On” the European Pathway?

The United States is embarking on a biotechnology drug revolution. In the last few decades, biotech drugs have saved millions of lives, and the market for these miracle cures continues to grow at an astronomical rate. Unfortunately, as the market for biotech drugs is skyrocketing, drug prices are following suit. As Congress strives to make these new drugs more affordable, it must not ignore significant safety concerns unique to these revolutionary therapies. Congress should follow the lead of the European Union to create an accessible pathway for generic forms of biotech drugs that includes strict regulatory measures to ensure drug safety and efficacy

After Heparin: Protecting Consumers From the Risks of Substandard and Counterfeit Drugs

Based on case studies, examines globalization and quality management trends in pharmaceutical manufacturing, barriers to Federal Drug Administration oversight, and the security of pharmaceutical distribution. Makes policy recommendations to ensure safety