US device industry and FDA “colluded” on legislation to weaken regulatory oversight

BMJ 2015; 351 doi: (Published 17 December 2015) Cite this as: BMJ 2015;351:h6820
  1. Jeanne Lenzer
  1. 1New York

US Food and Drug Administration officials had multiple meetings with leaders of the medical device industry to craft legislation that critics say will severely weaken regulatory oversight of the industry, an investigation by the online news service Inside Health Policy has found.

The revelations, discovered in emails and documents obtained under the Freedom of Information Act, have led to renewed calls by professional and public interest watchdog groups to defeat companion legislation to the proposed 21st Century Cures Act, which has been referred to the Senate. They have also called to oppose the approval of Robert Califf as a nominee for the role of FDA commissioner because he took part in meetings with the Advanced Medical Technology Association (AdvaMed), a trade association for medical technology companies.

The bill, which was passed in the US House of Representatives in July,1 is set to substantially boost funding for the National Institutes of Health, but critics have long said that it will …

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