Ten-year Core Study Data for Sientra’s Food and Drug Administration–Approved Round and Shaped Breast Implants with Cohesive Silicone Gel

This article summarizes the regulatory actions of the Food & Drug Administration as related to gel-filled silicone breast implants. It also relates the actions to the influences of outside forces such as press coverage, congressional investigations, and consumer activism.

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Sulfites—A Food and Drug Administration Review of Recalls and Reported Adverse Events

Journal of Food Protection ◽

10.4315/0362-028x-67.8.1806 ◽

2004 ◽

Vol 67 (8) ◽

pp. 1806-1811 ◽

Cited By ~ 31

Author(s):

BABGALEH TIMBO ◽

KATHLEEN M. KOEHLER ◽

CECILIA WOLYNIAK ◽

KARL C. KLONTZ

Keyword(s):

Drug Administration ◽

Fruits And Vegetables ◽

Adverse Reactions ◽

Food And Drug Administration ◽

Study Data ◽

Current Status ◽

Food Labels ◽

Passive Surveillance ◽

The Public ◽

Passive Surveillance System

Sulfite-sensitive individuals can experience adverse reactions after consuming foods containing sulfiting agents (sulfites), and some of these reactions may be severe. In the 1980s and 1990s, the U.S. Food and Drug Administration (FDA) acted to reduce the likelihood that sulfite-sensitive individuals would unknowingly consume foods containing sulfites. The FDA prohibited the use of sulfites on fruits and vegetables (except potatoes) to be served or presented fresh to the public and required that the presence of detectable levels of sulfites be declared on food labels, even when these sulfites are used as a processing aid or are a component of another ingredient in the food. In the present study, data from FDA recall records and adverse event reports were used to examine the current status of problems of sensitivity to sulfites in foods. From 1996 through 1999, the FDA processed a total of 59 recalls of foods containing undeclared sulfites; these 59 recalls involved 93 different food products. Fifty (55%) of the recalled products were classified as class I, a designation indicating that a consumer reasonably could have ingested ≥10 mg of undeclared sulfites on a single occasion, a level that could potentially cause a serious adverse reaction in a susceptible person. From 1996 through mid-1999, the FDA received a total of 34 reports of adverse reactions allegedly due to eating foods containing undeclared sulfites. The average of 10 reports per year, although derived from a passive surveillance system, was lower than the average of 111 reports per year that the FDA received from 1980 to 1987, a decrease that may have resulted in part from FDA regulatory action.

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Transparency at the U.S. Food and Drug Administration

The Journal of Law Medicine & Ethics ◽

10.1177/1073110517750616 ◽

2017 ◽

Vol 45 (S2) ◽

pp. 24-28

Author(s):

Robert M. Califf

Keyword(s):

Drug Administration ◽

Food And Drug Administration ◽

Study Data ◽

Critical Examination ◽

Misleading Information ◽

The Public ◽

The Public Sphere ◽

Innovation Knowledge ◽

Medical Products Industry ◽

The U.S

Given the profound public health and economic ramifications of decisions made by the U.S. Food and Drug Administration, the degree to which FDA activities should reflect an approach founded on complete transparency versus one focused on preserving confidentiality of information deserves public discussion. On one hand, reasonable requirements for transparency are critical to stimulating effective innovation, knowledge dissemination, and good business practice. On the other, ensuring the vitality of the medical products industry requires protecting legitimately proprietary information. With current standards reflecting a lengthy accumulation of legal, regulatory, and practical precedent, recent significant changes in the environment in which the FDA operates should prompt a critical examination of current practices. In this article, I comment on Sharfstein and colleagues’ “Blueprint for Transparency,” which calls for multiple specific actions to increase transparency at the agency across five key areas, including interactions between FDA and industry, public disclosure of internal FDA analyses, deliberations concerning generics and biosimilars, expanded access to raw study data, and approaches to countering misleading information in the public sphere. I evaluate these recommendations in light of my experience as a clinician, researcher, and former FDA Commissioner, and reflect on possible outcomes that could result from enacting these practices.

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