New Government Report: Potential Effects of a Ban on Direct-to-Consumer Advertising of New Prescription Drugs

Potential Effects of a Ban on Direct-to-Consumer Advertising of New Prescription Drugs

by Sheila Campbell
Paperback, 8 pages, 2011, $10.00
ISBN: 1437986631

Concerns about direct-to-consumer advertising of prescription drugs have spurred recent proposals for a moratorium on advertising brand-name prescription drugs to consumers during the first two years following a drug’s approval by the Food and Drug Administration. This report examines some of the effects of such a moratorium, drawing on data documenting direct-to-consumer advertising and other promotional activities used by pharmaceutical producers as well as academic analyses of how advertising has affected the market for drugs. Charts and tables. This is a print on demand edition of an important, hard-to-find publication.

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New Government Report: Prescription Drugs

Prescription Drugs: Trends in Usual and Customary (U&C) Prices for Commonly Used Drugs

by John E. Dicken
Paperback, 28 pages, 2011, $20.00
ISBN: 1437983057

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Prescription drug spending in the U.S. in 2009 totaled $250 billion, of which $78 billion — or 31% — was spent by the federal government. Prescription drug spending by the federal government, patients, and third-party payers, including employers, is driven by many factors, including the prices paid for drugs. This report: (1) examines usual and customary price trends for commonly used prescription drugs from 2006 through the first quarter of 2010 and compares these trends to those of other medical consumer goods and services; and (2) examines price trends using drug prices other than usual and customary. Also provides information on the extent to which prices for individual brand-name drugs changed over the course of this analysis period. Charts and tables.

New Government Report: New Drug Approval

New Drug Approval: FDA’s Consideration of Evidence from Certain Clinical Trials
by Marcia Crosse
Paperback, 38 pages, 2010, $30.00
ISBN: 9781437938586

“Before approving a new drug, the FDA assesses a drug’s effectiveness. To do so, it examines information contained in a new drug application (NDA), including data from clinical trials in humans. Several types of trials may be used to gather this evidence. Non-inferiority trials aim to demonstrate that the difference between the effectiveness of a new drug and an active control is small enough to show that the new drug is also effective. FDA has issued guidance on these trials. This report: (1) identifies NDAs for new molecular entities — potentially innovative new drugs not FDA-approved in any form — that included evidence from non-inferiority trials; (2) examines the characteristics of these trials; and (3) describes FDA’s guidance on these trials.”

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New Government Report: Pharmaceutical R&D and the Evolving Market for Prescription Drugs (ISBN: 1437925057)

Pharmaceutical R&D and the Evolving Market for Prescription Drugs (ISBN: 1437925057)
By David Austen and Colia Baker
(Paperback, 8 pages, 2009, $10.00)

Investment in Research and Development (R&D) over the past several decades has produced a wealth of valuable new drug therapies that have made it possible to treat major illnesses that were not treated previously or were not treated as effectively.

As the scope of available drug therapies expanded, spending on prescription drugs became the fastest-growing category of total spending on health care in the U.S. Between 1994 and 2004, real (inflation-adjusted) spending on prescription drugs rose at an average annual rate of 11.1%, compared with 3.5% for hospital care and 4.3% for physicians’ services.

More recently, however, that growth has slowed: From 2004 to 2007, drug expenditures grew by an average of just 3.2% per year, slightly less than the rate of growth in overall health care spending. As a fraction of total spending on health care, spending on prescription drugs rose from 6% in 1994 to around 11% in 2004, where it has remained.

That slowdown in the rate of growth in spending reflects changes in both the supply of and the demand for prescription drugs. The greater the expected revenue from a prospective new drug, the more willing a drugmaker will be to invest to develop it. Those decisions will help determine which drug therapies become available in the future and thus will affect future growth in health care costs.

This report describes the current state of investment in drug R&D and the factors that influence it. It also examines how various policy options to control the growth in health care costs or to expand insurance coverage could affect R&D spending. Figures.

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