The next forum for unraveling FDA off-label marketing rules: State and federal legislatures

English version České info

In a Guest Editorial, Aaron S. Kesselheim and Michael S. Sinha show how federal and state legislation to allow promotion of drugs for non-approved uses threatens to undermine the FDA's public health mission.

Vyšlo v časopise: The next forum for unraveling FDA off-label marketing rules: State and federal legislatures. PLoS Med 15(5): e32767. doi:10.1371/journal.pmed.1002564
Kategorie: Editorial
prolekare.web.journal.doi_sk: https://doi.org/10.1371/journal.pmed.1002564

Souhrn

Zdroje

1. Federal Food, Drug, and Cosmetic Act of 1938, P.L. No. 75–717, §52 Stat. 1040.

2. Cortez N. The statutory case against off-label promotion. U Chi L Rev Online. 2016;83 : 124–142. doi: 10.2139/ssrn.3035413

3. Food and Drug Administration. Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products. January 2017. [Cited 27 March 2018]. Available from: https://www.regulations.gov/document?D=FDA-2016-N-1149-0040.

4. Almashat S, Wolfe SM, Carome M. Twenty-Five Years of Pharmaceutical Industry Criminal and Civil Penalties: 1991 Through 2015. [Internet] 2016. [Cited 27 March 2018]. Available from: https://www.citizen.org/sites/default/files/2311.pdf.

5. Gillick MR. Antipsychotic Drug Prescribing in Nursing Homes. JAMA. 2017;318(18): 1829.

6. United States v. Caronia, 703 F.3d 149 (2d Cir. 2012).

7. Kesselheim AS, Connolly J, Rogers J, Avorn J. Mandatory disclaimers on dietary supplements do not reliably communicate the intended issues. Health Aff (Millwood). 2015;34(3): 438–446. doi: 10.1377/hlthaff.2014.0515 25732494

8. Guidance for industry: distributing scientific and medical publications on unapproved new uses—recommended practices: revised draft guidance. Food and Drug Administration. February 2014. [Cited 27 March 2018]. Available from: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm387652.pdf.

9. Guidance for industry: distributing scientific and medical publications on risk information for approved prescription drugs and biological products—recommended practices: draft guidance. Food and Drug Administration, June 2014. [Cited 27 March 2018]. Available from: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm400104.pdf.

10. Avorn J, Sarpatwari A, Kesselheim AS. Forbidden and Permitted Statements about Medications—Loosening the Rules. N Engl J Med. 2015;373(10): 967–973. doi: 10.1056/NEJMhle1506365 26332553

11. st Century Cures Act of 2016, P.L. 114–255, §130 Stat. 1033. See Section 2101, Facilitating Dissemination of Health Care Economic Information.

12. Free Speech in Medicine Act, AZ ST § 32–1997.

13. Lopez Bauman N, Sandefur C. Restoring Free Speech in Medicine: How state lawmakers can overcome FDA regulations that keep doctors and payers in the dark. [Internet] June 6, 2017. [Cited 27 March 2018]. Available from: https://goldwaterinstitute.org/wp-content/uploads/2017/06/Restoring-Free-Speech-in-Medicine-Policy-Paper.pdf.

14. Medical Product Communications Act of 2017, H.R.1703, 115th Congress (2017)

15. Pharmaceutical Information Exchange Act of 2017, H.R.2026, 115th Congress (2017).