New, but Not Improved? Incorporating Comparative-Effectiveness Information into FDA Labeling  

Oleh:

Stafford, Randall S. ; Wagner, Todd H. ; Lavori, Philip W.

Jenis: Article from Journal - ilmiah internasional
Dalam koleksi: The New England Journal of Medicine (keterangan: ada di Proquest) vol. 361 no. 13 (Sep. 2009), page 1230-1233.
Topik: FDA

Ketersediaan

Perpustakaan FK Nomor Panggil: N08.K.2009.05 Non-tandon: 1 (dapat dipinjam: 0) Tandon: tidak ada

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Isi artikel

New technologies, including prescription drugs and medical devices, are a major driver of increases in U.S. health care expenditures, which have grown by an estimated 71% since 2000.1 The U.S. market for drugs and devices is regulated by the Food and Drug Administration (FDA), which scrutinizes clinical trial data for evidence of safety and efficacy. Although the FDA has been criticized for missteps and inefficiencies in its approval process, these are not the causes of increasing health care expenditures. More relevant is FDA oversight of the labeling and promotion of medical products. Requiring manufacturers to include disclamers of superiority in their marketing materials and drug compendiums would highlight this key information and allow it to reach more people.

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