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Regulatory Updates

Bulletin 17-6

May 25, 2017

FDA Launches New ORA Structure to Align Inspections with Expertise

The US Food and Drug Administration (FDA) released details on the structure of its newly realigned Office of Regulatory Affairs (ORA). The move is part of FDA's program alignment, which transitions from geographic management to FDA-regulated product type based management. "Specializing by FDA-regulated product type more closely mirrors the organizational model of FDA's centers and the industries we regulate," FDA writes.​

The agency is replacing the five regional offices-Central, Pacific, Northeast, Southeast, and Southwest-with seven product or operations aligned offices:

  • Office of Bioresearch Monitoring Operations (OBIMO) - Map, Fact Sheet
  • Office of Biological Products Operations (OBPO) - Map, Fact Sheet
  • Office of Medical Device and Radiological Health Operations (OMDRHO) - Map, Fact Sheet
  • Office of Pharmaceutical Quality Operations (OPQO) - Map, Fact Sheet
  • Office of Human and Animal Food Operations (OHAFO) - Map, Fact Sheet
  • Office of Enforcement and Import Operations (OEIO) - Map, Fact Sheet
  • Tobacco Operations Program - Map, Fact Sheet

Each office, with the exception of the Tobacco Operations Program, is further broken up into two or more regional divisions, which in turn will be served by the agency's 20 existing districts and 13 field laboratories.

Gottlieb Confirmed by Senate to Head FDA

Scott Gottlieb, a physician who has been a venture capitalist and a conservative expert on health care policy, was confirmed by the Senate by a vote of 57 to 42 to be Commissioner of the Food and Drug Administration. He faced limited resistance during his Senate committee hearing for his close financial ties to industry. Gottlieb has promised to divest himself from several health care companies and recuse himself for one year from decisions involving those businesses.

Gottlieb stated during his confirmation hearing that his first priority would be to take on the nation's opioid crisis. He will also be charged with restructuring the FDA to comply with President Trump's directives to roll back regulations.

House Subcommittee Passes FDA Reauthorization Act

On May 18, the House Energy and Commerce Subcommittee on Health approved, by voice vote, the Food and Drug Administration (FDA) Reauthorization Act (H.R. 2430), as amended. The measure would reauthorize FDA's authority to collect fees on prescription and generic drugs, medical devices, and biosimilar products.

The Senate Health, Education, Labor, and Pensions Committee passed its version of the bill, S. 934, on May 1.

WHO Confirms New Ebola Outbreak in Democratic Republic of Congo

A fourth person has likely died from Ebola in a remote northeastern region of the Democratic Republic of Congo , the World Health Organization said on Sunday. Of the 37 cases of hemorrhagic fever discovered since early May:

  • Two have been confirmed as Ebola.
  • Three, including the latest death, are considered probable.
  • Thirty-two are suspected.

Health authorities are monitoring 416 people who came into contact with sufferers and have dispatched mobile laboratories to the zone to more quickly test people who display symptoms, according to WHO's Congo spokesman Eugene Kabambi. The affected zone's extreme isolation has helped contain the highly contagious virus' spread, though a lack oftelecommunications and few paved roads have hindered the response.

HCV Infection Rate Surges to 15-Year High

New hepatitis C virus (HCV) infections have reached a 15-year high, tripling between 2010 and 2015, according to new preliminary surveillance data from the Centers for Disease Control and Prevention. The agency noted that while the reported number of new cases reached 2,436 in 2015, the true number was estimated to be much higher - approximately 34,000 - given the high proportion of asymptomatic infections. Not only is the overall number of new cases on the rise, but infections are increasing most rapidly among young white persons who live in non-urban areas and that "this is primarily a result of increasing injection drug use associated with America's growing opioid epidemic."

FDA Releases Emerging Tick-Borne Diseases and Blood Safety Transcript

The FDA released the meeting transcript for their public workshop entitled "Emerging Tick-Borne Diseases and Blood Safety."

With thanks to the source of this content, the Eye Bank Association of America.