President Trump announced Friday that he would nominate Dr. Scott Gottlieb, who has deep ties to the pharmaceutical industry and has expressed anti-choice views, to head the Food and Drug Administration (FDA).
Gottlieb is a resident fellow at the conservative American Enterprise Institute and served as the deputy commissioner for medical and scientific affairs at the FDA under President George W. Bush. The physician sits on the boards of several major pharmaceutical companies.
Gottlieb has often attempted to stoke fears about the Obama administration’s birth control benefit, falsely claiming that under the Affordable Care Act, women “risk losing far more than they’ll gain.”
Dr. Michael Carome, director of Public Citizen’s Health Research Group, urged the Senate to reject Gottlieb’s nomination in a statement citing the nominee’s “unprecedented web of Big Pharma ties.”
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“Gottlieb’s ties span decades, and he currently is serving or has recently served on five pharmaceutical companies’ boards including GlaxoSmithKline—one of the world’s largest pharma companies,” Carome said. “Between 2013 and 2015, Gottlieb received a total of at least $413,000 from multiple pharma and medical device companies, most for consulting and speaking fees.”
“Gottlieb’s appointment would accelerate a decades-long trend in which agency leadership too often makes decisions that are aligned more with the interests of industry than those of patients,” he said.
Trump told pharmaceutical executives in January that he intended to ensure the FDA cuts back on regulations, though “drug safety advocates criticized his comments, saying that eliminating agency regulations would mean rolling back consumer protections on products as diverse as drugs, cosmetics, food and dietary supplements,” according to the New York Times.
Just weeks ago, a group of ten clinicians, public health and legal experts, and researchers published a commentary in the New England Journal of Medicine detailing the ways in which overregulation of the medical abortion drug Mifeprex is harmful to patients seeking abortion care. “The restrictions on mifepristone are a shameful example of regulation run amok—and they’re harming women’s health. Women and their health providers shouldn’t have to jump through hoops to get a medication that’s been safely and effectively used in this country for a decade and a half,” said Dr. Beverly Winikoff, president of Gynuity Health Projects and one of the authors.
Trump’s regulatory rollbacks likely won’t apply to reproductive health care given the anti-choice makeup of his administration and promises to further restrict access to abortion care. The 2016 Republican Party platform criticized the Obama-era FDA for updating regulations on Mifeprex and making some emergency contraceptives available without a prescription.
Gottlieb penned an op-ed in the Wall Street Journal in August 2015 pointing to deceptively edited videos from a discredited anti-choice group to claim that Congress should “tighten” laws on fetal tissue regulation. Gottlieb dismissed the importance of fetal tissue research, which has led to vaccines for polio, hepatitis A, chickenpox, rubella, and rabies, and it is being used to develop treatments for AIDS and research on Parkinson’s disease. “Defenders of Planned Parenthood also assert that medical research using fetal tissue is essential and saves many lives,” he claimed. “But that argument distorts the facts.”
Kelly Blanchard, president of Ibis Reproductive Health, said the FDA “works best for all Americans when it relies on rigorous evidence to approve safe, everyday products like ibuprofen, allergy medication, and condoms, which give people of all ages access to what they need to live fuller, healthier lives.”
Blanchard said she hoped her organization would work with Gottlieb and his agency to make some birth control available over the counter. Ibis recently partnered with pharmaceutical company HRA Pharma to begin the process of getting FDA approval for an oral contraceptive to be available over the counter in the United States.
“For too long, birth control pills have required a prescription, an outdated rule which limits access for too many people,” Blanchard said. “Birth control that is available over the counter without a prescription has promise for improving the health and well-being of millions of women and families across the country. We look forward to working with Dr. Gottlieb to ensure that science and evidence are front and center as the agency considers our application to make the first over-the-counter birth control pill a reality.”
Republicans, including Trump, have often pushed making oral contraceptives available without a doctor’s prescription as a way to counter the view that the GOP is waging a “war on women” and reproductive health care. The American College of Obstetricians and Gynecologists says doing so could “improve contraceptive access and use, and possibly decrease unintended pregnancy rates.”
However, reproductive health policy experts warn that making oral contraceptives available over the counter as a stand-alone measure would be insufficient in ensuring greater access to contraceptives.