By Lisa Seachrist
WASHINGTON — With the "Patient's Bill of Rights" taking center stage on Capitol Hill these days, the Senate is unlikely to entertain confirmation hearings for FDA commissioner nominee Jane Henney before this fall.
President Clinton announced his intention to nominate Henney, currently vice president for health sciences at the University of New Mexico, on June 23. Since then, the Clinton administration has filed formal nomination papers with the Senate, and Henney has initiated courtesy visits to Senate Labor and Human Resources Committee members.
However, amid big election year agenda items such as tobacco legislation and reform of health maintenance organizations, news on the progress of Henney's nomination has been muted and slow to surface.
A spokesman for Labor and Human Resources Committee Chairman Jim Jeffords (R-Vt.) said the nomination continues to move forward, but it was unlikely confirmation hearings could begin before the August recess.
"Henney continues to make courtesy visits and respond to members' inquiries," Jeffords' spokesman said. "By protocol, Jeffords would be last to meet with the nominee."
According to several industry sources, Henney has submitted written materials in response to requests from committee members. However, Jeffords' spokesman could not confirm written materials had been received, noting some members may have had questions after courtesy visits that would result in written responses by Henney.
Because the committee has a policy of announcing confirmation hearings seven days in advance of the event, Henney would need to complete her courtesy visits and the hearing would need to be announced before the end of this week in order for it to begin before the August break.
With the likelihood of summer hearings evaporating as congressional business days dwindle, both critics and supporters of Henney have been remarkably silent.
"We are seeing much less activity than would be expected under these circumstances and under this time frame," said Carl Feldbaum, president of the Biotechnology Industry Organization (BIO).
BIO Waiting For Hearings To Form Opinion
Feldbaum noted BIO has no position on Henney and intends to wait until confirmation hearings to form an opinion about the nominee.
"We are monitoring the situation closely, but we aren't really getting any signal," Feldbaum said. "There doesn't seem to be much of a process in this process."
Henney, an oncologist, served two years as deputy commissioner for operations at the FDA under former Commissioner David Kessler. Both BIO and the Pharmaceutical Research and Manufacturers of America (PhRMA) have stated they intend to withhold judgment on her qualifications to serve as FDA commissioner until they have the opportunity to get to know her through the confirmation process.
However, the Medical Device Manufacturers Association (MDMA) has voiced some concerns Henney's tenure at FDA was marked by consumer overprotection.
The MDMA noted that as co-chair of a task force on silicone breast implants, Henney was instrumental in the agency's decision to ban the material from the market. The organization considers the decision to be based on faulty science.
These issues will likely surface during confirmation hearings, but they are unlikely to be entertained before the Senate reconvenes Aug. 31. *