USA – The United States Senate has voted to confirm Dr. Robert Califf as Commissioner of the Food and Drug Administration, despite some senators arguing that his ties to the pharmaceutical industry and views on birth control made him unfit for the position.

Calif, 70, is a well-known cardiologist and researcher who takes over the FDA for the second time 13 months after the agency last had a permanent leader.

Califf’s confirmation comes at a critical time for the FDA, as it considers a number of high-profile issues, including COVID-19 vaccines for children under the age of five, whether e-cigarettes should be banned due to their appeal to teenagers, and the controversy surrounding the FDA’s approval of the divisive Alzheimer’s drug Aduhelm.

Califf previously served as FDA commissioner from February 2016 until January 2017, when President Barack Obama’s second term ended.

He will succeed longtime FDA veteran Janet Woodcock, who has been acting commissioner. On Tuesday, Woodcock congratulated Califf and announced that she would remain as principal deputy.

Woodcock faced backlash over the accelerated approval of Biogen’s Alzheimer’s drug aduhelm in June after a report revealed that company executives met with FDA officials outside of official channels.

The acting commissioner requested an inspector general investigation into the approval of Biogen’s Alzheimer’s drug.

The FDA is in charge of everything from drugs and medical devices to food, tobacco, and cosmetics.

President Joe Biden’s nomination was met with opposition from five of Biden’s Democratic colleagues, including Vermont Senator Bernie Sanders, who said Califf’s work with pharmaceutical companies rendered him unfit to regulate the industry impartially.

West Virginia Senator Manchin, on the other hand, chastised Califf for the FDA’s approval of three new opioid drugs during his tenure as commissioner.

Califf announced a review of the FDA’s opioid policy while serving as deputy commissioner for medical products.

“Dr. Califf was there five years ago. He’s coming back. Nothing’s changed; 400,000 people have died (from opioids) since he was there,” Manchin said before the vote

During his confirmation hearing, Califf admitted that the FDA erred when it approved OxyContin in 1995 without conducting long-term studies or assessing the drug’s addictiveness.

He believes the FDA should investigate aggressively the possibility of relabeling opioids to warn that they are not intended for long-term use.

According to CDC data, an all-time high of over 68,000 Americans died from opioid overdoses in 2020. According to the data, over 500,000 Americans have died as a result of opioid overdoses since 1999.

Hotly contested vote

Califf was confirmed by a slim margin three months after Biden nominated him, with six Republicans voting with the remaining Democrats, for a total of 50 votes in favor and 46 votes against. One senator abstained from voting.

Before the vote, Senator Richard Burr of North Carolina, the ranking Republican on the health committee, urged members of his party to support Califf.

“He has the robust agency and private sector experience needed to help build on the success of the FDA in helping Americans get back to normal life,” said Burr. “He’s the leader we need today, but also for the future.”

The fight over Califf contrasted sharply with the overwhelming bipartisan support he received ahead of his first confirmation hearing, when 89 senators voted to confirm him.

Previous Republican supporters said they backed out after Califf told the Senate health committee in December that he trusted the FDA to make the right decision as it considered loosening abortion pill restrictions, which it did two days later.

“It is clear that Dr. Califf will not fight for life, and I cannot support his nomination,” Republican Senator Jim Inhofe of Oklahoma, who voted in favor of Califf in 2016, said in a statement after the vote.

During his confirmation hearing, Califf stated that the American people want earlier access to potentially life-saving drugs.

However, he acknowledged that the fast-track process is inherently uncertain, and that the FDA needs to do a better job of tracking the performance of drugs approved early.

Liked this article? Sign up to receive our regular email newsletters, focused on Africa and World’s healthcare industry, directly into your inbox. SUBSCRIBE HERE