FDA Accountability for Public Safety Act

Summary

FDA Accountability for Public Safety Act This bill requires the Commissioner of Food and Drugs to ensure that an advisory committee of the Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA) evaluates each new drug application for an opioid (a drug with effects similar to opium, such as morphine) and issues a recommendation regarding approval of the drug. If the decision to approve the drug is inconsistent with the committee's recommendation, the Commissioner must make the final decision on approval. If the committee recommends a drug not be approved but the Commissioner decides to approve the drug, the Commissioner must: (1) submit a report to Congress that includes the evidence regarding patient safety that supports the Commissioner's decision and a disclosure of any potential conflicts of interest of FDA officials involved in the decision to approve the drug; and (2) testify before Congress regarding the decision, upon request. Such a drug cannot be sold until the Commissioner has submitted the required report.

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3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 15 April 2015

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• Introduced in Senate (PDF)

  Introduced in Senate · EN · 15 April 2015

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• Introduced in Senate

  summary · EN · 15 April 2015

  Open at official source

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