Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

FDA COM. YOUNG HAS FOUR-WEEK LAME DUCK PERIOD AND TWO PENDING BIOTECH DECISIONS; LEGACY INCLUDES TINKERING WITH NDA PROCESS IN RESPONSE TO AIDS

Executive Summary

FDA Commissioner Young has two pending decisions in his four-week lame-duck period at the agency that could solidify his reputation from five years at FDA as the first biotech commissioner of the agency. Both decisions -- one a product approval decision (the Chugai/Upjohn Marogen application) and one a regulation proposal (the orphan drug regs) -- deal with the thorny issue of product differentiation and exclusive license positions in the biotech drug business. The two issues appear ripe and could be a tempting policy legacy for Young away from the generic drug industry and ANDA scandals that have blemished his last year-and-a-half at the agency. HHS announced Nov. 13 that Young will be moving upstairs in the department hierarchy. Effective Dec. 18, Young is being reassigned to a staff position as a deputy assistant secretary for health reporting to Assistant Secretary for Health James Mason. "Dr. Young will provide coordination for the development and utilization of technology," a Nov. 13 press release explains. He will be responsible for coordinating functions of "biotechnology, nutrition and food safety, and for physical science within the Public Health Service." HHS also said that Young will study "technological developments that can be expected to impact on the nation's health care system." When he originally joined the Reagan Administration in July 1984, Young was believed to be interested in an eventual step-up in the HHS hierarchy. However, at the time of the Reagan-Bush transition, Young favored staying in the FDA post for its visibility and public impact. The decision for Young to move was announced one week after the commissioner represented the agency in discussions about European Community approvals. First word of his change in positions was publicized early on Monday, Nov. 13. One of the leading candidates to replace Young in the interim, Scripps Clinic President Charles Edwards, was in Washington by mid-week to discuss the position on Capitol Hill and with the D.C. health establishment (see related story next page). The key factor in the timing of the decision was almost certainly the Nov. 17 session in the generic drug investigations scheduled before Chairman Dingell's (D-Mich.) House Energy & Commerce Oversight Subcommittee. By announcing Young's lame-duck status, HHS took some of the remaining fervor out of the generic hearings. The Dingell subcommittee promises to continue the investigations, but it will be difficult to try to tie a new commissioner to situations that happened on a different commissioner's watch. Dingell downplayed the importance of losing Young as a scapegoat for his hearings with a statement blaming the agency's problems on the deregulatory and budget-cutting philosophies of the Bush and Reagan Administrations. Commissioner Young "had the misfortune," Dingell declared, "to preside at FDA during a time when it was virtually guaranteed that rogues and knaves would prosper, and honest people would face great difficulties." Young's "intentions were good and he did his best when problems were brought to light"; however, "he was handicapped by both the budgets and attitudes of an administration that let the agency go to seed." Young was actually appearing to do well at weathering the generics scandal; it already seemed to have spent some of its headline appeal. However, the weight of two other issues may have helped to force the necessity of a change. One issue is the possibility of similar medical device approval inquiries arising from a series of hearings on medical device malfunctions starting up again in Chairman Waxman's (D-Calif.) House Energy & Commerce Health Subcommittee. The other is the lingering issue of Young's much-publicized ban on Chilean fruits. A replacement for Young at this point also makes sense as a legislative strategy. Young had already committed himself to efforts to seek more retribution from ANDA offenders. That position, necessary to mollify the investigatory phase of the scandal, may not have been a comfortable posture for HHS going into a period of possible legislative wrangling with the Dingell committee next year over changes to the FD&C Act. The pending biotechnology decisions could help to cement Young's reputation and counter-balance the public image created by the generic scandals. Even without any final actions in the biotech area, Young can point to FDA's ability to keep up with new products from that area as a significant feature of his tenure at the agency. Young's most important legacy to FDA appears to be the agency's willingness under his guidance to adopt expedient solutions and not view FDA procedures as inviolate. As a commissioner, Young was skillful at absorbing criticism and responding to attacks. The several different -- and sometimes overlapping -- changes to the IND/NDA process that he championed to respond to the vocal AIDS lobby indicate an unusual willingness to tinker with entrenched FDA processes. It is ironic that he was berated by the AIDS activists while effecting substantial changes in the system. In a comment on Young's reassignment, the Pharmaceutical Manufacturers Association praised Young's openness to "experimentation." PMA also praised Young for his receptiveness to comments from outside the agency. FDA "became more open to communications and ideas from its many constituencies." He appeared to thrive on the heavy public demands of the FDA job and rarely shied away from a meeting with critics or supporters. His relish for the politics of the FDA office was perhaps most evident in his international duties as the U.S. representative to the World Health Assembly. His assiduous efforts with that group helped fend off the pharmaceutical marketing code proposal at mid-decade. Young's tenure also will be remembered for the large drug approval totals during his first years at the agency, peaking with 30 new chemical entity approvals in calendar 1985. Republican Sen. Hatch (Utah) commended Young for his efforts to get FDA more resources. "Frank Young has been the principal advocate for improving the FDA, for consolidating the buildings and obtaining state of the art equipment," Hatch said in a Nov. 13 statement.(ITEM 190)Picture, no caption Chart omitted.

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth

UsernamePublicRestriction

Register

LL035386

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