(Bloomberg Opinion) -- By now, Robert Califf, the cardiologist picked by President Joe Biden to be the next commissioner of the Food and Drug Administration, should’ve already been questioned by the relevant Senate committee and be well on his way to confirmation. Because the administration failed to submit its paperwork on time, however, the hearing won’t happen until Tuesday. At this rate, Califf may not be confirmed until sometime next year.
Amid a national health crisis, this bit of incompetence is difficult to excuse. Biden was already late in nominating a commissioner — the agency has been without a permanent head for almost a year — and his team has clumsily made him even later. The FDA needs a strong and able leader right away to protect public health, help lead the administration’s Covid response, and reform an agency with increasingly obvious flaws.
Among other things, the FDA has vital Covid-19 treatments to approve. It needs to regulate electronic cigarettes — especially those with child-friendly flavors still on the market — and carry out plans to further restrict combustible cigarettes by banning menthol flavoring and reducing nicotine content. It has any number of new drug and medical device applications to consider.
The agency also needs to make its operations more transparent and improve communication with the public. Drug and device evaluations have traditionally taken place behind closed doors. But it’s become apparent during the pandemic that such opacity isn’t always in the public interest. Last summer, as Americans waited months to learn whether Covid-19 vaccines would be granted full approval, they were left to wonder whether the emergency authorization the FDA had already bestowed was adequate assurance that the shots were safe.
The FDA has also given reason to worry that it might sometimes approve drugs too easily. In June, it gave “accelerated approval” to an Alzheimer’s treatment against the near-unanimous advice of its own panel of scientific advisers. The agency said its rogue decision was based on evidence that it might be effective, but none clearly demonstrating that it was. Now patients and insurers, including Medicare, may be charged $56,000 annually for the questionable treatment. Under President Donald Trump’s administration, the FDA also seemed to bow to political pressure to approve inadequately tested treatments for Covid-19, including convalescent plasma and hydroxychloroquine.
By contrast, the agency has been all too slow to approve fast Covid-19 tests — in part because of a lack of resources. The U.S. has only a dozen approved rapid tests for the coronavirus, which is one reason they’re more expensive and harder to find than in much of Europe.
No wonder there are reports of low morale at the FDA. It’s fair to say the agency has never been in more dire need of a strong leader who can manage its 18,000 employees and $6 billion budget, explain its operations to people on the outside, and restore public trust in American drug regulation.
Califf, who was the FDA commissioner during President Barack Obama’s final year, has experience and familiarity with the job. Some senators are understandably wary of his ties to drug and tech companies, but he has promised to sever his relationships with them. The Senate should make up for White House bumbling on this appointment by approving Califf’s appointment as soon as it can.
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- Approving Biogen’s Alzheimer’s Drug Is a Big Mistake — Max Nisen
- Merck’s New Covid Drug Will Do — For Now — Therese Raphael and Sam Fazeli
Editorials are written by the Bloomberg Opinion editorial board.
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