Robert M. Califf, MD was confirmed by the U.S. Senate to be commissioner of the Food and Drug Administration (FDA) by a vote of 50-46 on Feb. 15, 2022. Dr. Califf’s financial ties to the pharmaceutical industry was cited by some Senators as a reason they could not support his appointment. Similar concerns were expressed by a number of Senators during deliberations on Dr. Califf’s first nomination to head the FDA under the Obama administration in 2015.1
Dr. Califf earned a $2.7 million salary as an executive for biotech company Verily Life Sciences in addition to owning up to $5 million in company stock. He also sits on the board of two pharmaceutical companies and holds millions of dollars of stock in several other pharmaceutical and biotech companies. In addition to his financial ties to the biopharmaceutical industry, major objection from Senators of both parties included the fact that he failed to address the opioid crisis effectively when he served as FDA commissioner from February 2016 to January 2017.1 2
Dr. Califf has stated that he would resign from Verily and divest his pharmaceutical stock holdings within 90 days of appointment to his position.1
Califf Criticized for Lack of Action During Opioid Crisis
A prominent cardiologist and clinical researcher, Dr. Califf was nominated by President Biden in November 2021. Democratic Senator Joe Manchin of West Virginia called on President Biden to withdraw Dr. Califf’s nomination, citing his failure to address the opioid crisis “in a meaningful way,” which may have worsened it.1
I have made it abundantly clear that correcting the culture at the FDA is critical to changing the tide of the opioid epidemic. Instead, Dr. Califf’s nomination and his significant ties to the pharmaceutical industry take us backwards not forward.3
During his nomination hearing in the Senate, Dr. Califf acknowledged that the FDA did not exercise enough caution when it approved OxyContin without long term studies or assessing the drug’s capabilities of addictive behavior in those for whom it was prescribed. Since Oxycontin was approved in 1995, more than 500,000 Americans have died from opioid related overdoses.1 4
Senators Say FDA Enabled Pharma “to choose profits over American lives”
Sen. Manchin and Republican Senator Mike Braun of Indiana, representatives from two states hit especially hard by the opioid crisis, penned an opinion piece for USA Today strongly condemning Dr. Califf’s nomination. In the article, the Senators state that it has become “increasingly clear that the FDA has stood by, and even enabled, the pharmaceutical industry’s decision to choose profits over American lives.”4
The Senators also pointed out that, during Dr. Califf’s first tenure as FDA commissioner, the FDA only removed one opioid drug from the market while approving five new opioids.4
Manchin and Braun wrote:
There are other qualified, experienced leaders who can implement the culture changes so badly needed at the FDA who also understand the gravity of the drug epidemic and the role the FDA can play in fighting the greed of the pharmaceutical industry.4
Senators Supporting Califf Also Have Pharma Financial Ties
Several of the U.S. Senators ,who praised Dr. Califf and supported his appointed as FDA commissioner, have strong pharmaceutical ties themselves to the pharmaceutical industry with a history of making campaign donations in the millions and also owning stock in various drug companies.5
Voting in support of Dr. Califf, Republican Senator Richard Burr of North Carolina stated:
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.5
Through the years, Sen. Burr’s campaigns have received more than $1.6 million from the pharmaceutical and health products industry, which makes him the third-largest Senate Republican donation recipient of pharmaceutical industry money. Sen. Burr is also being investigated for insider training after a review of his stock trades, which revealed that he sold up to $1.1 million worth of stock in companies that make medical and drug-related equipment following a confidential COVID-19 briefing in February 2020.5
Califf Acted as Consultant for a Company That Helps Manipulate FDA Regulations
From 2009-2015, Dr. Califf received an estimated $215,000 in consulting fees from a company called Faculty Connection LLC, which provides consultations with industry experts to help pharmaceutical companies navigate FDA regulations. In an article for MintPress News, Carey Wedler writes that the company’s “sole purpose” is to “help pharmaceutical companies evade and manipulate FDA regulations.”6
Harvard political science professor Daniel Carpenter, PhD has called Dr. Califf “the ultimate industry insider.”6
Drug Companies Fund Majority of FDA Clinical Trials, Pay to Fast Track the Process
The revolving door between U.S. government health agencies and the pharmaceutical industry has long been scrutinized by journalists, politicians, medical ethicists and the general public. Yet another common area of ethical concern is the fact that pharmaceutical companies provide the funding for the majority of FDA’s clinical trials.7
In 1992, Congress passed the Prescription Drug User Fee Act (PDUFA) which directed drug companies to pay the FDA a fee to review drug and vaccine license applications. Manufacturers could also pay an annual fee to help fast track experimental drugs and vaccines to market. Former U.S. Department of Health and Human Services official Michael Carome has long criticized this public-private business partnership approach to government regulation of the pharmaceutical industry, stating:
Instead of a regulator and a regulated industry, we now have a partnership. That relationship has tilted the agency away from a public health perspective to an industry friendly perspective.7
When Dr. Califf was pressed about the FDA’s fast track approval process during the Senate nomination hearing, he admitted that the fast track licensing process inherently comes with uncertainty and better tracking of drug safety and performance is necessary.1
General Public Trust in Government Health Agencies Waning
The FDA is charged with regulating food, drug, and biological products including vaccines to protect the health of the American public.8 Between flip flopping and contradictory public health guidelines, little to no discussion about healthy lifestyles or disease management, lack of effective therapies, one-size-fits-all vaccine mandates, and disregard of natural immunity, guidelines from the U.S. health agencies during the COVID pandemic response have been consistently confusing at best. With Americans losing trust in government and advice from public health officials during the COVID era8, the nomination of an FDA commissioner with deep-rooted financial interests in the pharmaceutical industry has been met with further skepticism.
Michael Weinstein, president of the AIDS Healthcare Foundation said in a prepared statement:
While Dr. Califf’s contributions to the research and clinical science community are well-known and commendable, his cozy relationship with the pharmaceutical industry is simply too close for comfort—especially for those of us who are desiring tougher regulation of the industry.9
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Click here to view References:
1 Kimball S. Senate confirms Biden FDA pick Califf, despite objections to drug industry ties. CNBC Feb. 15, 2022.
2 Flork N. Califf, Biden’s pick to lead FDA, has millions invested in pharma and tech companies. STAT News Nov. 23, 2021.
3 Ruoff A , Baumann J, Castruonuovo C. Biden’s drug agency nominee returns with deeper industry ties. Bloomberg Law Nov. 23, 2021.
4 Manchin J, Braun M. President Biden should withdraw nominee to lead the Food and Drug Administration. USA Today Feb. 11, 2022.
5 Shaw D. Four Republicans with extensive ties to the pharmaceutical industry have already said they plan to cross the aisle and support Califf’s confirmation to be commissioner of the Food and Drug Administration. Read Sludge Jan. 6, 2022.
6 Cáceres M. Nominee for FDA commissioner has pharma industry ties. The Vaccine Reaction Nov. 17, 2015.
7 Hobley N. The FDA has a history of rushed drug approvals. The Vaccine Reaction Sept. 6, 2021.
8 Robertson N. Health agencies have lost public trust. Can that be fixed? The Christian Science Monitor Mar. 2, 2022.
9 Fang L. FDA nominee helped medical industry find and pay faculty for “regulatory consulting.” The Intercept Oct. 15, 2015.