Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

FDA COMMISSIONER KESSLER GETS WHITE HOUSE NOD TO REMAIN AT AGENCY HELM -- STABILITY IN THE MIDST OF SEA CHANGE; NIH DIRECTOR HEALY LEAVING JUNE 30

This article was originally published in The Gray Sheet

Executive Summary

FDA Commissioner Kessler is being reappointed on a permanent basis by the Clinton Administration, giving FDA an unusual continuity in contrast to the shake-ups throughout the rest of the federal government. Emerging a survivor of administration transition politics, Kessler accepted HHS Secretary Donna Shalala's Feb. 26 request to remain as commissioner. Kessler's being given the helm on a permanent basis sets a precedent. While Frank Young stayed on as commissioner through the change of two Republican administrations, no FDA commissioner in recent memory has survived a change of party rule and been allowed to continue an ongoing agenda. On the same day that Kessler was asked to stay on, National Institutes of Health Director Bernadine Healy announced her plans to leave June 30. Clinton's decision to keep Kessler and put a new face in at NIH may, in part, reflect the relative popularity of Kessler and Healy with staffs of key Capitol Hill Democrats. Kessler's public appearances after the general election have dovetailed with Clinton Administration philosophy. For example, at a speech in January, the commissioner criticized the cost of new drugs and spoke of his agenda for "change," a Clinton buzzword. FDA-regulated industries can expect a continuation of Kessler's stepped-up enforcement of agency regulations governing manufacturing and promotion of medical devices, drugs and food. Another top priority will be user fees, which are slated to be collected for drugs and biologics and were proposed for devices in the administration's budget plan ("The Gray Sheet" Feb. 22, p. 1). Healy told a Feb. 26 press conference that "over the past two weeks, I have had discussions with Secretary Shalala...and it was made clear that it would be best for the president to choose the NIH director." Healy will go back to the Cleveland Clinic Foundation where, she said, "I will write and do some speaking on health administration." Prior to becoming the NIH director in March 1991, Healy served as chair of the research institute at the Cleveland Clinic. In a statement following the announcement, HHS Secretary Shalala commended Healy's work as NIH director and noted that she will "be conferring with scientific leaders and the White House to establish a process for the selection" of a successor. Regarding the next four months at NIH, Healy noted they "are of critical importance to NIH. I am very pleased and delighted that I will be at her helm during that time." In particular, Healy noted that in the "next two weeks we will be announcing the 15 vanguard centers for the Women's Health Initiative." In addition, Healy indicated that the strategic plan "is done and at the printer. I hope that within a month to six weeks you will see it." Healy also suggested that she is "prepared fully to work on the budget." She noted that "I think it is pretty rough for the new NIH director or no director to be there defending the budget, particularly, at this difficult time economically."

You may also be interested in...



New EU Approvals

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add two new products, including Ryzneuta, Evive Biotechnology's treatment for chemotherapy-induced neutropenia.

Pair Of Deaths Linked To Recalled Vyaire Medical Respiratory Devices

The US FDA has labelled a recall of more than 6 million Airlife respiratory support devices class I. The recall covers devices manufactured in 2017 or earlier that can fail to provide adequate ventilation.

Over The Counter 2 Apr 2024: Analyzing The Spin-Out Trend In Consumer Health, With HBW’s Malcolm Spicer And Tom Gallen

In this episode, HBW Insight’s Europe and US editors bring their expertise to bear on the current the trend towards standalone OTC companies in global consumer health. We look at four major players: Haleon, which separated from GSK almost two years ago; Kenvue, soon to celebrate its first anniversary as a new company; Sanofi Consumer Healthcare, which is poised to split from its pharma parent; and Bayer, which has decided to buck the trend, holding on to its consumer health division. We discuss some of the advantages of becoming a standalone company, for example in leaning into a wider concept of self-care.

Latest Headlines
See All
UsernamePublicRestriction

Register

MT000255

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel