Trump’s FDA and PenceWorld: The Battles Ahead

“The president has left his stamp on government in ways that could outlast him, but the NWHN will be there to shine a spotlight.”

As I write this, it’s impossible to know what is going to become of Donald Trump, currently mired in controversy. Each day brings new scandal and, with it, the possibility that he won’t complete his first term, let alone run for a second. But his appointment of far-right conservatives to key posts throughout our government will have a significant impact on women’s health no matter what happens to Trump the individual.

One concern commonly voiced by women’s health advocates is that Trump’s ouster would leave us with Vice President Mike Pence, a long-time opponent of women’s health whose war on Planned Parenthood in Indiana set off an HIV epidemic. But this concern understates just how much Pence is already running the show when it comes to women’s health. While Trump campaigned as an outsider willing to take on the Republican establishment, in practice he has largely left the details of governing to movement conservatives—with Pence helming the operation. At the Department of Health and Human Services (HHS), for example, Trump has appointed so many long-time Pence allies—from the leadership down—that some advocates have branded HHS as “PenceWorld.”

Trump’s HHS Secretary Tom Price spent years serving with Pence in Congress, where they were both leaders in the House’s anti-abortion caucus and hard-right Republican Study Committee. At HHS’s Centers for Medicare and Medicaid Services (CMS), Administrator Seema Verma was chosen for her close collaboration with Pence on Indiana’s conservative Medicaid waiver. The waiver has had negative consequences for women’s access to health services and has become a model for other red states (read our research brief on Medicaid waivers and women’s health at www.tinyurl.com/RWVresearch).

One Pence ally, Charmaine Yoest, the former president of anti-abortion extremist group Americans United for Life, has been appointed head of public affairs at HHS. Another, Teresa Manning—known for declaring that “contraception doesn’t work”—has been named to the position overseeing $286 million in Title X family-planning grants.

Pence’s influence is also seen in Trump’s choice of conservative physician and former Bush official Scott Gottlieb to head the U.S. Food and Drug Administration (FDA). Trump reportedly considered several unconventional right-wing candidates promoted by Silicon Valley libertarian Peter Thiel before ultimately settling on Gottlieb, a movement conservative with a long track record of both carrying water for industry and politicizing women’s health care.

Like Pence, Gottlieb has long defended the practice of allowing ideology and profit to trump science. And like both Trump and Pence, Gottlieb is a proponent of skipping critical parts of FDA oversight in order to rush drugs to market—even though the FDA is already the fastest drug approval agency in the world.

Numerous examples demonstrate the real-world consequences of approvals without adequate testing in women, people of color, older people, and more. In 2103, for example, the FDA was forced to cut the approved dose of popular sleep-aid Ambien in half for women after the previously approved dose was shown to contribute to sleep-driving episodes that not only endangered those prescribed Ambien, but also resulted in the deaths of individuals who’d never taken the drug at all. Yet Gottlieb has consistently pushed for faster approvals of under-tested products—accepting millions of dollars from drug and device makers along the way—even when it means skipping the critical clinical trials that uncover serious problems.

Gottlieb has also established himself as a committed opponent of women’s reproductive health. Throughout the 2000s, he defended the Bush Administration’s unprecedented decision to overrule agency scientists on Plan B emergency contraception, argued that women should not have been informed about the dangers of menopause hormone therapy, and fear-mongered against the Affordable Care Act’s contraception mandate. During his Senate confirmation hearing this April, Gottlieb refused to answer a direct question from committee vice chair, Senator Patty Murray (D-WA), when asked, “Can you commit to me today that you will not allow [the Trump Administration] to use the FDA to further a political agenda against women’s health?”

This spring, the NWHN released a retro-themed social media campaign to spread awareness of Gottlieb’s proposal to roll back consumer protections to an era before the FDA prioritized safety and effectiveness. The campaign highlighted Gottlieb’s multiple financial conflicts, his dangerous proposals to speed up the drug approval process, and his demonstrated disregard for women’s health. Senate rules made blocking his confirmation impossible from the start but—building upon the strategies we adopted during the Bush Administration—we see this as the first phase of a multi-part campaign to shine a bright spotlight on misdeeds at Trump’s FDA.

Gottlieb’s first few weeks as commissioner have confirmed that we were right to sound the alarm about the impact his ties to industry would have on consumer safety at the FDA. Prior to his confirmation, Gottlieb had a large financial stake in an e-cigarette company. In his first speech to FDA staff, he signaled a willingness to reconsider Obama-era safety regulations on e-cigarettes.

In the same spirit, Trump’s FDA has moved to unwind critical consumer protections around “off-label promotion.” Drug and device-makers are pushing for the ability to market their products to a much bigger population, and for many more uses, than they’ve been tested for. In January, before Trump’s inauguration, the FDA released a strong memo rebuffing industry claims and enumerating examples of how allowing companies to promote off-label drug use harms patients. The memo specifically named the menopause hormone therapy drugs Prempro and Premarin. (Prempro, it is worth noting, is made by Pfizer, a company from which Scott Gottlieb has received thousands of dollars as a consultant—and possibly more.) As one of its first actions, Trump’s FDA re-opened the issue, but this time with a particular emphasis on industry’s “First Amendment” concerns.

If that seems like a stretch, in 2013 the New Republic wrote an insightful and relevant piece detailing the ways that the First Amendment “has become the darling of economic libertarians and corporate lawyers who have recognized its power to immunize private enterprise from legal restraint.” 1

As a fellow at the American Enterprise Institute, a conservative think tank, Gottlieb wrote in 2008 that there is a “robust, sound constitutional protection” for “commercial communication,” and criticized attempts to rein in industry.2 In the NWHN’s comments to the FDA opposing an expansion of “off-label promotion,” we noted that these “First Amendment defenses” should be viewed in the context of a larger, cross-industry effort to undermine regulatory public health, safety, and environmental protections in order to expand markets and reap larger profits. And, we called on the FDA to reject them as such.

With the right information, we wrote, women can and do make the health care decisions that are best for them. But, this ability depends on women having access to scientific evidence about safety and efficacy gained through clinical trials, which are circumvented when a manufacturer can turn to off-label communications. Without these trials, women are left to play guesswork when it comes to their health and how a drug or medical device will act in their body.

But all hope isn’t lost. One of the biggest lessons for advocates from the George W. Bush years is that a number of fights can be won at the FDA when we shine a spotlight on efforts they’d rather keep hidden. For example, when the Bush Administration sought to form a contraceptive safety committee stacked with contraception opponents like Joseph Stanford from the University of Utah, we were able to prevent the committee from ever meeting by shining a light on their plans.

No matter what happens to the man in the Oval Office, the next four years at Trump’s FDA are going to be critical for women’s health. We aren’t going to win every battle. But with your help, we’ll keep shining our spotlight.

Sarah Christopherson is the NWHN Policy Advocacy Director

Article originally published in the July/August 2017 Women’s Health Activist Newsletter


References

1. Wu T, “The Right to Evade Regulation: How corporations hijacked the First Amendment,” The New Republic, June 3, 2013.
2. Troy and Gottlieb, “Pharmaceutical Promotion and First Amendment Rights,” NEJM 2008; 359:536-537.