The Food and Drug Administration’s regulation of drugs in 2014 reflected the agency’s constant effort to balance a range of interests and pressures to ensure the safety and effectiveness of drugs marketed in the United States. Here are some of the drug regulation issues that garnered attention last year and will remain relevant in 2015 even as the FDA transitions to new leadership. Commissioner Margaret Hamburg announced on Feb. 5 that she will step down at the end of March. Dr. Stephen Ostroff, FDA’s chief scientist, will serve as acting commissioner until a replacement is confirmed. .
Biosimilars. The Biologics Price Competition and Innovation Act, enacted in 2010 as part of the Affordable Care Act, created an approval process for biosimilars — that is, highly similar copies of approved biologic products. In 2014, the FDA issued new draft guidance documents on biosimilars for the first time in more than two years. In July, the FDA accepted its first biosimilar application, for Sandoz Inc.’s version of Amgen Inc.’s Neupogen, and on Jan. 7 an FDA panel recommended that the agency approve Sandoz’s biosimilar..
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