Government Report: Medical Devices: FDA Should Enhance Its Oversight of Recalls

Medical Devices: FDA Should Enhance Its Oversight of Recalls

by Marcia Crosse
Paperback, 57 pages, 2011, $25.00
ISBN: 1437988067

Recalls are an important tool to mitigate serious health consequences associated with defective or unsafe medical devices. Typically, a recall is voluntarily initiated by the firm that manufactured the device. The FDA oversees implementation of the recall. FDA classifies recalls based on health risks of using the recalled device. FDA also determines whether a firm has effectively implemented a recall, and when a recall can be terminated.

This report identifies: (1) the numbers and characteristics of medical device recalls and FDA’s use of this info. to aid its oversight; and (2) the extent to which the process ensures the effective implementation and termination of the highest-risk recalls. Charts and tables. A print on demand report.

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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: 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: Commonwealth Brands, Inc. vs. U.S.: Legal Judgment on Marketing Restrictions in the New Federal Tobacco Law

Commonwealth Brands, Inc. vs. U.S.: Legal Judgment on Marketing Restrictions in the New Federal Tobacco Law
by Joseph H. McKinley Jr.
Paperback, 47 pages, 2010, $30.00, ISBN: 9781437936704

The opinion and order of U.S. District Judge Joseph H. McKinley Jr., U.S. District Court, Western District of Kentucky, Bowling Green Division, which overturns two of the marketing restrictions in the new federal tobacco law.

Several tobacco makers sued in August 2009 to block the restrictions. Judge McKinley agreed that the ban on color and graphics in labels and advertising that children might see intruded too broadly on commercial free speech.

He noted that, instead, Congress could have exempted certain types of color and graphic images. Judge McKinley did uphold the authority of the U.S. Food and Drug Administration (FDA) to restrict tobacco marketing, as well as a specific provision which requires new, graphic warning labels to cover the top half of cigarette packages.

In fact, he upheld most of the new marketing restrictions, including a ban on tobacco companies sponsoring athletic, social and cultural events or offering free samples or branded merchandise.

Lawyers on both sides affirmed that this case will probably be appealed to the U.S. Court of Appeals for the Sixth Circuit and eventually to the Supreme Court.

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