FDA's agenda is in limbo after Biden's nominee for president stalls in Senate

WASHINGTON (AP), -- The narrowly divided Senate has stalled President Joe Biden’s choice to lead the Food and Drug Administration. This unexpected setback could delay decisions regarding electronic cigarettes and a host of other important health issues pending at this agency.

FDA's agenda is in limbo after Biden's nominee for president stalls in Senate

WASHINGTON (AP), -- The narrowly divided Senate has stalled President Joe Biden’s choice to lead the Food and Drug Administration. This unexpected setback could delay decisions regarding electronic cigarettes and a host of other important health issues pending at this agency.

After a 10-month-long search, Biden appointed Dr. Robert Califf to the position in November. Critics complained that there was a leadership gap at the powerful regulatory agency. This agency has been a key player in the COVID-19 response efforts.

Given his 2016 confirmation by an overwhelming vote of 89-4, Califf was seen as a safe choice and could easily pass the Senate.

However, his Senate bid is being hampered by political controversies from both the left- and right. These controversies threaten to sink his nomination. The FDA could be in limbo for months.

As Senate Democrats, the White House, and other administration officials press full-court to secure the votes required to pass the 50-50 chamber, no vote has been held on Califf’s nomination. Former FDA officials warn against failure to act on Califf’s nomination. This will make it harder to find and confirm future nominees.

Dr. Stephen Ostroff served twice as acting FDA commissioner. "What you see here is a lot extraneous issues inserting theirself into the confirmation process. The same thing would happen for virtually any other nominee."

Californiaf is being opposed by five Senate Democrats because of his work as a consultant for drugmakers and FDA's record of oversight of addictive painkillers that contributed the U.S. epidemic. This group includes Sens. Joe Manchin of West Virginia and Maggie Hassan of New Hampshire, both from Republican-controlled states ravaged by the epidemic.

To confirm Califf, Democrats require the support of six Republicans as Sen. Ben Ray Lujan from New Mexico is currently recovering from a stroke and is absent.

According to a White House official, the Biden administration is "incredibly confident" that Califf would be confirmed. The official spoke under anonymity to discuss the matter.

According to an official, Califf will have met with 49 senators this week. This is a very aggressive outreach effort for an FDA nominee. Xavier Becerra, Health and Human Services Secretary, and top White House aides are also lobbying Senators in his behalf.

Given his strong support by the pharmaceutical lobby, the White House assumed that enough Republicans would support Califf and overcome any Democratic defections. After a cordial hearing before Senate's health committee in December that included friendly exchanges between most of its Republican members, Califf appeared to be on track for confirmation.

Two days later, the FDA relaxed long-standing restrictions on abortion pills and allowed women to order them via the mail. Although Califf was not involved in the decision, many anti-abortion organizations lobbyed Republicans to vote against him on the basis of earlier changes that had an impact on the medications while he worked at the FDA.

Susan B. Anthony List, a prominent anti-abortion group, warned that any Republican senators who support Califf would lose their 'A+ rating' from the group. The group has raised millions to support its preferred candidates.

Only a few Republicans support Califf at the moment, including Senator Richard Burr from North Carolina, who represents Califf’s home state, and is retiring this year. Sen. Susan Collins from Maine, one of only two remaining pro-choice Republicans, is also supporting Califf.

The agency is in dire need of a permanent chief FDA. It has been struggling for months with a heavy pandemic workload, as well as numerous scientific disputes that have damaged its reputation.

FDA advocates fear that the FDA will be further disoriented by the politicization of its nomination process.

Steven Grossman, of the Alliance for a Stronger FDA said that Dr. Califf is being judged on issues that only a small portion of FDA's responsibilities. He also spoke out for the Alliance for a Stronger FDA which represents the interests of industry, patients, and consumers who interact with the agency. This narrow focus increases the chances that FDA will lose permanent leadership for longer periods.

Grossman, an ex-Senate staffer and HHS employee, stated that the White House won't send another FDA nominee to Capitol Hill, if Califf doesn't win 50 votes.

Dr. Janet Woodcock could still be acting FDA chief in this scenario -- possibly even into next year. As long as Califf's nomination remains pending, she can continue to serve as acting chief until it is withdrawn, or expires under federal law.

However, this is far from ideal. Acting commissioners are primarily caretakers, and cannot generally set new goals or prioritize the agency.

The FDA is expected to make a number of important decisions with the input of the new commissioner. These include the decision to ban ecigarettes due to the rise in youth vaping to millions.

Ostroff stated that the more controversial decisions are, the more difficult it is to make them when acting.

According to observers, Califf could be pushed over the finish line by realizing that vaping restrictions are in place and other Democratic priorities may not be in order.

Senator Elizabeth Warren, D.Mass., supported Califf last week after he committed to working for no pharmaceutical company for at most four years following his departure from the FDA. According to his ethics disclosure form, Califf served as an adviser or board director to more than half a dozen biotech and drug companies in the past.

Diana Zuckerman, a member of the non-profit National Center for Health Research, stated that "maybe Califf won't make it" will help people focus on why they want Califf there. "I believe he still has a very strong chance."

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