Coalition Comments to FDA Urging Stronger FDA Guidelines on Drug Ads

May 2, 2014. We strongly oppose the guidance. These guidelines are aimed at clarifying guidelines developed before the law regarding distributing scientific and medical publications on unapproved new uses (off-label) of medical products sunset in 2006. It fails to follow the law or to protect patients and the public health.

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NCHR Comment on the Importance of Including Women, Minorities, and the Elderly in Studies for New Drugs and Devices (FDASIA Section 907 Hearing)

April 1, 2014. The responsibility of collecting sufficiently representative demographic subgroup data sits solely on the shoulders of device and drug companies. The companies know how to persuade – they do it everyday in commercials. Similarly, if they identify persuasive incentives for patients to participate in studies, and minimize disincentives, patients will participate and be available for follow-up.

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