Biden and GOP May Find Bipartisanship in Elevating Big Pharma’s Pick to FDA Head

Robert Califf, the then-deputy Commissioner at the Food and Drug Administration, worked closely with lobbyists from the pharmaceutical and medical devices industries to create a bill that would accelerate the approval process of new drugs. Califf attended frequent meetings with individualsFrom Johnson & Johnson and other drug companies, as well as Pharmaceutical Research and Manufacturers of America (PhRMA) CEO Stephen Ubl, then at trade group AdvaMed, helping to jointly write legislative text that would become part of Republican Rep. Fred Upton’s (Mich.) 21st Century Cures Act, according to a report from InsideHealthPolicyBased on an internal review of emails and documents.

When the 21st Century Cures Act passed the House, PhRMA’s Ubl released a statement praising it for including “reforms which enhance the competitive market for biopharmaceuticals and drive greater efficiency in drug development.” The bill relaxes some methodological standards for drug trials, for example by setting up a way for drug companies to submit “real world evidence” about their products’ safety and effectiveness, rather than information from double-blind randomized clinical trials.

Watchdog group Public Citizen blasted Claiff’s ties to industry in 2016, as he was facing confirmation to become FDA commissioner. “The attitudes he has developed over his decadeslong history of extensive financial ties to pharmaceutical and medical device companies leave him all too willing to promote the interests of regulated industries over those of public health and patient safety,” the group said in a blog post. “These entrenched attitudes do not befit the position of FDA commissioner.”

After leaving the government in 2017, Califf began working as a consultant and a compensated board member for various health industry companies, including Cytokinetics and Bitterroot Bio, Centessa Pharmaceuticals and Boehringer Ingelheim Pharmaceuticals. Since 2017, he has also worked as an advisor for Google and Alphabet’s life sciences research company Verily, according to his financial disclosure. He also returned to a job that he held prior to his stint at Duke University under the Obama administration. TimeHis 2015 salary was contractually underwritten in 2015 by pharmaceutical companies such as Merck and Bristol-Myers Squibb.

Califf also owns millions of dollars in stock of pharmaceutical companies. His holdings include shares in Amgen and Bristol-Myers Squibb worth up to $500,000, up to $250,000 each in Gilead Sciences stock and options, more than $250,000 in Cytokinetics stock options and stock, and up $5 million in Centessa options stock options.

Now, Califf may be poised to leave the revolving doors and take up a position as commissioner of FDA. He was in that position for almost a full year during the Obama administration. In November, President Biden nominated Califf for the position. A vote by the Senate Health, Education, Labor and Pensions Committee to send his nomination down to the Senate floor is scheduled to take place on Jan. 12.

Califf’s nomination was quickly celebrated by the pharmaceutical industry. “Congratulations to Dr. Robert Califf for being nominated as the next commissioner of the U.S. Food and Drug Administration” lobbying group PhRMA said in a statement. “It’s vital that we have a commissioner who understands the important role the FDA plays in promoting public health and providing science-based oversight of our nation’s medicine supply.”

But Califf’s confirmation is not certain. Democratic Sens. Joe Manchin (W.V.). Richard Blumenthal (Conn.), and Joe Manchin (W.Va.) said that they would vote against confirming Califf due to his ties with the pharmaceutical industry and Sen. Ed Markey, D-Mass.He also voted against Califf in 2016. HELP Committee members Maggie Hassan (N.H.) and Ben Ray Luján (N.M.) have told reporters that they are undecided or have qualms. Vermont Independent Sen. Bernie Sanders, also a HELP Committee member, has also vowed to vote against Califf’s confirmation. “At a time when the American people pay the highest prices in the world for prescription drugs and as drug companies continue to be the most powerful special interest in Washington, we need leadership at the FDA that is finally willing to stand up to the greed and power of the pharmaceutical industry,” Sanders said in his statement opposing Califf’s nomination.

Despite these Democratic votes no, Califf may still be able to squeeze through and get the votes he needs to be confirmed. Four Republican HELP Committee members have already stated to reporters that they will vote for him. According to research by the Revolving Door Project, and a Sludge analysis based on financial disclosure data and campaign finance data, each of these Republicans has deep ties to the pharmaceutical industry.

Senator Richard Burr (R.N.C.), a ranking member of the HELP Committee, has stated to reporters that he will vote in favor of Califf. He also praised the former FDA Commissioner at his hearing last month. “Dr. Califf’s unique perspective as a former FDA commissioner coupled with his understanding of partnerships with the private sector and academia that assist in fueling innovation will be vital if confirmed as the next FDA Commissioner,” Burr said in his opening statement.

OpenSecrets revealed that Burr had announced in 2016 that Burr would be retiring at the end 2022. However, he has still received $173,600 in PAC donations from the pharmaceutical and healthcare products industries since 2017. Since 2017, the industry has donated more money to his campaign and leadership PAC than any other industry, including maximum donations by the PACs of companies like Abbott Labs Merck, AstraZeneca and Pfizer. Over the course of his entire Senate career, OpenSecrets says that Burr’s campaigns have taken in more than $1.6 million from the pharmaceutical and health products industry, including donations from company PACs and employees in the industry. This total makes Burr, the third-largest Senate Republican beneficiary of money from that sector.

Burr, who is under investigation by SEC for insider trade after dumping stocks in response to a confidential briefing in February 2020 has also sought to benefit from personal financial holdings in this industry. An SEC 2020 review of his trades. ProPublicaBurr and his spouse bought and sold stock worth up to $1.1million in companies that make medical supplies, equipment, and pharmaceutical drugs.

Another Republican HELP Committee member that plans to vote for Califf, Sen. Tommy Tuberville (R-Ala.), is also an investor in many of the drug companies whose main trade association has applauded Califf’s nomination. In 2021, Tuberville bought and sold stock in Johnson & Johnson, Merck, Regeneron, West Pharmaceuticals, and Bristol-Myers Squibb. Some of these transactions were not disclosed by the senator until months after they were made. This is a violation of Section 145 of the STOCK Act, which requires that financial transactions of members are disclosed within 45 days. His annual financial disclosure includes holdings in several pharmaceutical companies and medical device firms as of the end 2020. These include Pfizer stock valued at $150,000 and investments in AmerisourceBergen and Abbvie, Allergan and Eli Lilly of up to $50,000 each. He also has smaller stakes in Zoetis and Edwards Lifesciences shares.

Sen. Susan Collins (Republican from Maine) also stated to reporters that she will vote for Califf. Collins has received $541,000 from the pharmaceutical and healthcare industry during her career. The senator’s husband, former lobbyist Thomas Daffron, has up to $100,000 invested in the stocks of drug companies Johnson & Johnson and Merck, according to Collins’s 2020 annual disclosure. Collin’s 2020 campaign was chaired by pharmaceutical company lobbyist Josh Tardy, whose clients in Maine have included Eli Lilly and PhRMA, according to a reportFrom Beacon.

Senator Roger Marshall (R-Kan.), a HELP member, initially told Politico Dec. 17, that he would support Califf. Since 2016, he has received $102,000 in campaign contributions. His pharmaceutical PAC donors included PhRMA member firms like Amgen and Pfizer, Boehringer Ingelheim and Teva Pharmaceuticals.

Update, Jan. 7: In a note today, Sen. Marshall’s spokesperson says that he will not be supporting the FDA nominee.

If Califf’s nomination gets out of the HELP Committee, he is expected to easily be confirmed by the full Senate. His 2016 confirmation was approved by a vote. 89-4Seven of them are not eligible to vote.