Food and Drug Administration Guidance Documents and New Medical Devices: The Case of Breast Prostheses

Rachel E. Weitzman; Ariel Dora Stern; Daniel B. Kramer

Article | American Journal of Therapeutics | Forthcoming

Food and Drug Administration Guidance Documents and New Medical Devices: The Case of Breast Prostheses

by Rachel E. Weitzman, Ariel Dora Stern and Daniel B. Kramer

Abstract

As pressure mounts on the Food and Drug Administration (FDA) to speed its review process for novel devices, and budgetary pressures further strain its resources, the critical role of guidance documents in assuring consistent, rigorous, and scientifically grounded review across device types has never been more important. In this article, we use the regulatory experience of one medical device class, specifically implantable breast prostheses, to illustrate the crucial role of FDA guidance documents. We find that the emergence of FDA guidance preceded significant growth of scientific publications around breast prostheses, with 0.30 +/- 0.57 papers/year published in the period 1987–2006 compared with 2.27 +/- 1.56 papers/year in the period 2007–2017, P=0.0017. This illustrates the importance of supporting the FDA to enhance guidance document drafting, revision, publication, and updating to reflect evolving scientific consensus and the needs of sponsors, regulators, and patients for transparent and consistent standards in a broad range of fields.

Keywords: medical devices; FDA; Health Care and Treatment; Government Administration; Information; Standards;

Format: Print

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Citation:

Weitzman, Rachel E., Ariel Dora Stern, and Daniel B. Kramer. "Food and Drug Administration Guidance Documents and New Medical Devices: The Case of Breast Prostheses." American Journal of Therapeutics (forthcoming). (Pre-published online, November 12, 2018.)

Reimbursement is a key challenge for many new digital health solutions, whose importance and value have been highlighted and expanded by the current COVID-19 pandemic. Germany’s new Digital Healthcare Act (Digitale–Versorgung–Gesetz or DVG) entitles all individuals covered by statutory health insurance to reimbursement for certain digital health applications (i.e., insurers will pay for their use). Since Germany, like the United States (U.S.), is a multi-payer health care system, the new Act provides a particularly interesting case study for U.S. policymakers. We first provide an overview of the new German DVG and outline the landscape for reimbursement of digital health solutions in the U.S, including recent changes to policies governing telehealth during the COVID-19 pandemic. We then discuss challenges and unanswered questions raised by the DVG, ranging from the limited scope of the Act to privacy issues. Lastly, we highlight early lessons and opportunities for other countries.

Remote patient monitoring is a subset of telehealth that involves the collection, transmission, evaluation, and communication of patient health data from electronic devices. These devices include wearable sensors, implanted equipment, and handheld instruments. During the pandemic, such monitoring programs have proven valuable. But special measures and conditions made that possible. By encouraging regulators to make permanent the temporary measures introduced during the pandemic and by following six guidelines to integrate these programs into health care, providers realize their tremendous promise.

Article | Health Affairs | July 2020

Lessons From The Impact of Price Regulation on The Pricing Of Anticancer Drugs in Germany

Victoria D. Lauenroth, Aaron S. Kesselheim, Ameet Sarpatwari and Ariel Dora Stern

Worldwide spending on prescription drugs has increased dramatically in recent years. Although this increase has been particularly pronounced in the U.S., it remains largely unaddressed there. In Europe, however, different approaches to regulating drug prices have been implemented. Under the 2011 German Pharmaceutical Market Restructuring Act (Arzneimittelmarktneuordnungsgesetz, or AMNOG), for example, manufacturers freely set the prices of newly authorized drugs during their first year on the market. Benefit assessments are carried out during this year and then used in price negotiations between manufacturers and representatives of the country’s statutory health insurers. Using data on 57 anticancer drugs launched in Germany from 2002 to 2017, we found that implementation of AMNOG was associated with drug prices being more closely aligned with clinical benefit. Introducing price negotiations led to a 24.5% decrease in negotiated prices relative to launch prices. We did not find evidence that manufacturers responded by setting higher launch prices. AMNOG is an example of how government price negotiation can be designed to better align prices with clinical benefit without delaying patient access.

Keywords: Pharmaceuticals; prescription drug costs; drug pricing; Access to care; cost reduction; Health Care and Treatment; Price; Governing Rules, Regulations, and Reforms; Cost Management; Germany;

Citation:

Lauenroth, Victoria D., Aaron S. Kesselheim, Ameet Sarpatwari, and Ariel Dora Stern. "Lessons From The Impact of Price Regulation on The Pricing Of Anticancer Drugs in Germany." Health Affairs 39, no. 7 (July 2020): 1185–1193. View Details

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Food and Drug Administration Guidance Documents and New Medical Devices: The Case of Breast Prostheses

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