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“Developments in the Prescription Drug Market” February 4, 2016

ASHP (American Society of Health-System Pharmacists) respectfully submits the following statement for the record to the House Committee on Oversight and Government Reform hearing on "Developments in the Prescription Drug Market: Oversight."

ASHP represents pharmacists who serve as patient care providers in acute and ambulatory settings. The organization’s more than 43,000 members include pharmacists, student pharmacists, and pharmacy technicians. For over 70 years, ASHP has been at the forefront of efforts to improve medication use and enhance patient safety. For more information about the wide array of ASHP activities and the many ways in which pharmacists advance healthcare, visit ASHP’s website, www.ashp.org, or its consumer website, www.safemedication.com.

ASHP’s vision is that medication use will be optimal, safe, and effective for people, all of the time. A primary tenet of that vision includes access to affordable medications needed to save or sustain lives. Over the past several months, many ASHP members have brought to our attention an alarming trend in the generic drug market. Products that have been on the market for years and are considered essential to patient care have undergone dramatic price increases. ASHP is concerned that this trend may make some medications inaccessible to patients, and could have serious public health consequences. Furthermore, these price increases have placed enormous budgetary pressure on healthcare organizations, and long-term absorption of these rapid and unpredictable price increases is unsustainable.

ASHP does not collect, store, or report drug pricing information. However, we continually hear from our members that sudden, inexplicable price increases in connection with some of the most commonly used, longstanding generic medications are becoming more prevalent, and are occurring on a nationwide basis. ASHP is pleased that the House Committee on Oversight and Government Reform is holding this hearing, and we are eager to learn more about why these price spikes are occurring and to explore potential policy options and market-based solutions that may exist to prevent or minimize the likelihood of this occurring in the future.

In particular, ASHP would like to learn more about the marketplace dynamics that could contribute to this problem. We have long been interested in these market forces as we have worked diligently on the issue of drug shortages for well over a decade. While drug shortages are caused by a number of factors, we have observed that drugs in short supply made by only one or two manufacturers often result in higher than normal prices for these drugs when they are available. If, for example, there is a lack of competition in the generic marketplace, we urge the committee to look at ways to stimulate more marketplace presence. One policy option that has been mentioned is to grant the U.S. Food and Drug Administration (FDA) authority to prioritize Abbreviated New Drug Applications (ANDAs) and to fast-track approval of products whose prices have significantly increased and that have little or no competition in the market. ASHP supports further examination of and dialogue in connection with this potential policy option.

ASHP recognizes that there may be limited circumstances in which constraints on the traditional drug supply system may be appropriate for reasons of patient safety, often implemented under a manufacturer-driven Risk Evaluation and Mitigation Strategy (REMS). However, we believe that these requirements are not appropriate to artificially inflate drug prices, nor should they interfere with the professional practice of pharmacists and prescribers. We believe that there may be current cases in which a manufacturer-driven REMS using restricted distribution is causing higher prices for those drugs, having adverse effects on access by patients, and delaying treatment. Therefore, we also urge Congress to require FDA to investigate restricted distribution under a REMS program as a potentially limiting factor in accessibility of critical medications.

ASHP is pleased to see that, in addition to the FDA and manufacturers, other sectors of the supply chain have been invited to testify at the hearing. As there is no single policy solution to the growing trend in drug prices, there is no single cause of these increases. Therefore, we believe that it is in the best interest of providers and the patients they serve to examine the role that all market participants serve to potentially identify additional factors that have led to the surge in certain prescription drug costs.

Conclusion

ASHP thanks the Committee on Oversight and Government Reform for holding this important hearing, and we look forward to learning more about the causes and potential solutions to this problem. Additionally, ASHP remains committed to working with Congress and industry stakeholders to ensure that patients have affordable access to life-saving and life-sustaining medications.

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We represent pharmacists who serve as patient care providers in acute and ambulatory settings.

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