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

In 2015, then-deputy commissioner at the Food and Drug Administration Robert Califf worked closely with pharmaceutical and medical device lobbyists on an industry-backed bill designed to accelerate the approval process for new drugs. Califf attended frequent meetings with individuals from 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 InsideHealthPolicy based on a review of internal 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 went to work as a consultant and compensated board member for several health industry companies including Cytokinetics, 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 he held before his stint in the Obama administration at Duke University, where he told Time in 2015 that his salary was contractually underwritten by pharmaceutical companies including Merck and Bristol-Myers Squibb.

Califf has also amassed millions of dollars worth of pharmaceutical company stocks. His holdings include shares worth up to $500,000 in both Amgen and Bristol-Myers Squibb, up to $250,000 in Gilead Sciences stock, more than $2 million in Cytokinetics stock and options, and up to $5 million in Centessa stock options.

Now, Califf may be about to spin through the revolving door once again and take a job as the commissioner of the FDA, a position he held for nearly a year during the tail end of the Obama administration. President Biden nominated Califf in November for the position, and a vote by the Senate Health, Education, Labor and Pensions (HELP) Committee to send his nomination to the Senate floor is scheduled for 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.) and Richard Blumenthal (Conn.) have said they will vote against confirming Califf because of his ties to the pharmaceutical industry, and Sen. Ed Markey (D-Mass.), who voted against Califf in 2016, also appears to be leaning no. 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.

Even with these Democratic voting no, however, Califf may be able to squeak through and find the votes he needs to be confirmed because four Republican HELP Committee members have already told reporters that they plan to cross the aisle and vote for him. Each of these Republicans have entrenched pharmaceutical industry ties themselves, according to research provided by the Revolving Door Project and a Sludge analysis of campaign finance and financial disclosure data.

HELP Committee Ranking Member Sen. Richard Burr (R-N.C.) has told reporters he will vote for Califf and 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.

Burr announced in 2016 that he is retiring at the end of 2022, but he has still received at least $173,600 from pharmaceutical and health products industry PACs since 2017, according to OpenSecrets. The industry has given his campaign and leadership PAC more money since 2017 than any other industry, including maximum donations from the PACs of companies including 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. That total makes Burr the third-largest Senate Republican recipient of money from that industry ever.

Burr, who is being investigated by the SEC for possible insider trading after dumping stocks following a confidential covid briefing in February 2020, has also sought to profit from personal financial holdings in the industry. A 2020 review of his trades by ProPublica found that Burr and his wife bought and sold up to $1.1 million worth of stock in companies that make medical devices, equipment, supplies, 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 only disclosed by the senator months after they were made, a violation of the STOCK Act that requires financial transactions of members of Congress to be disclosed within 45 days. His annual financial disclosure shows holdings in several pharmaceutical and medical device companies as of the end of 2020 that he does not appear to have sold since, including Pfizer stock worth up to $150,000, investments worth up to $50,000 each in AmerisourceBergen, Abbvie, Allergan, and Eli Lilly, and smaller stakes in Zoetis, Edwards Lifesciences, and Novo Nordisk shares.

Sen. Susan Collins (R-Maine) has also told reporters that she is voting for Califf. Collins has benefited from $541,000 in contributions from the pharmaceutical and health products industry over the course of 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 report from Beacon.

HELP member Sen. Roger Marshall (R-Kan.), who initially told Politico on Dec. 17 that he would support Califf, has taken $102,000 in campaign contributions from the pharmaceutical and health products industry since first running for congressional office in 2016. His pharmaceutical PAC donors have included PhRMA member companies like Amgen, 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 last confirmation in 2016 was approved by a vote of 89-4, with seven not voting.