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‘Something very rare’: FDA’s Gottlieb aggressively tackled difficult issues

Scott Gottlieb, M.D.
 

FDA Commissioner Scott Gottlieb, who shocked Washington with news of his resignation on Tuesday, will leave the agency at the end of this month with a track record of activism and regulatory actions.

FDA leaders have typically focused much of their attention on a handful of medical topics, but Gottlieb has been active and aggressive on many issues as commissioner without hewing to a strictly conservative or liberal ideology. It’s an approach that’s won him praise from many in the health sector, while garnering criticism from several of the targeted businesses like tobacco companies and the fast-growing e-cigarette industries.

“He was able to do something very rare: He never got embroiled in a scandal, never got labeled with a toxic administration brush and had a great relationship with the President all at the same time,” said one former White House official.

Still, his independent streak sometimes stoked tension with others in the administration. Gottlieb pushed regulatory issues under a mandate from a president that pushed deregulation as one of his core goals. He was also outspoken on Twitter during the 35-day government shutdown and hesitated to lead the charge on drug importation, a pet policy proposal of President Donald Trump. A drug importation working group that HHS asked FDA to start last year moved back into the parent agency months later because Gottlieb did not want to lead the group, according to former agency officials.

He also did not embrace the original Right-To-Try proposals, and worked on modifying that legislation to allow people access to experimental medicines. Here’s a roundup of notable policies from his tenure:

Worked to both speed new gene and cell therapies to market. Gottlieb worked to advance cell and gene therapies, a promising new area of medicine. Under his leadership, the FDA put out a framework for regenerative medicines, designed to accelerate the approval of the most promising gene therapies. At the same time, Gottlieb balanced promoting legitimate new treatments with crackdowns on bad actors who were taking advantage of patients by marketing unapproved, unproven and potentially dangerous treatments.

Spoke out on drug prices. Even mentioning the costs of medicines has for years been seen as taboo for FDA chiefs, because FDA has no authority over drug costs and is not supposed to consider cost in its decisions. More than six months before HHS formally proposed to overhaul the drug-payment system by changing how pharmaceutical companies and payers negotiate rebates for medicines, Gottlieb suggested the government reexamine regulations that shield rebates from antitrust scrutiny. He was also critical of brand drug makers using rebates to block cheaper competition from from generic-like medicines known as biosimilars.

Pushed for generic competition. Gottlieb was vocal about increasing drug competition to bring prices down. While some of that momentum — like record high approvals in 2018 — came from Obama-era legislation boosting FDA generic drug staff, Gottlieb led efforts to name and shame brand drugmakers that were making generic development harder. He also sped the review of generic drugs that would be the first to compete with a branded product.

Led attack on tobacco and e-cigarettes. Gottlieb launched a sweeping strategy last year to tackle what he labeled an “epidemic” of teen vaping with plans to push kid-friendly flavors out of retail stores and curb underage sales. He indicated just days ago that more policy changes were in the pipeline, including a controversial plan to ban entirely cigarette and cigar flavors. That earned him the ire of lawmakers like Sen. Richard Burr (R-N.C.), who is from a leading tobacco-producing state. The commissioner also publicly said that he would back raising the purchase age to 21, which conservative lawmakers also opposed.

Laid groundwork to modernize medical devices. Just as media scrutiny called into question the safety of some medical devices, Gottlieb announced plans to overhaul their review process so manufacturers would test their potential products against more modern technology. He also acknowledged problems with women’s products like breast implants and long-term birth control and set out plans to actively monitor issues with those products.

Drew attention to cybersecurity threats. Gottlieb pushed FDA to examinesoftware’s role in health care, especially with cybersecurity and hacking issues that could arise with new technologies. FDA moved to boost tech security requirements for medical devices, by issuing guidance about what considerations manufacturers needed to take into account in getting devices approved or cleared by FDA. The stance was cheered by hospitals and IT groups seeking more robust regulatory protections.

Raised profile of nutrition policy. Gottlieb surprised many in the public health sector by focusing on nutrition policy, something that’s been a lesser priority for previous FDA commissioners. During his tenure, the agency continued much of the Obama administration’s agenda on food, such as by mandating menu labeling and banning trans fat. He also launched a wide-ranging new nutrition strategy to try to tackle diet-related disease, although much of those plans have not yet been implemented.

Preserved Michelle Obama’s sugars labeling. FDA resisted calls from some in the food industry to scrap a new mandate to disclose “added sugars” on Nutrition Facts labels, a change that had been championed by former first lady Michelle Obama.

Pressed for FDA role in cell-based meat. FDA was unusually aggressive in asserting it had jurisdiction over the budding cell-based meat sector, which grows meat tissue from cells to make sausages, chicken nuggets and other products. After a strangely public turf battle with USDA, the Trump administration ultimately decided that FDA and USDA will share oversight over the products.

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