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"Something very rare": FDA's Gottlieb aggressively attacked difficult problems




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                  FDA leaders have often focused a lot on their attention on a variety of medical topics, but Scott Gottlieb has been active and aggressive on many issues such as Commissioner. | Drew Angerer / Getty Images </p>
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<p>  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 an overview of activism and regulatory action. </p>
<p>  FDA leaders have often focused a lot of their attention on a handful of medical topics, but Gottlieb has been active and aggressive on many issues as a commissioner without giving in to a strictly conservative or liberal ideology, an approach that has won him praise from many in health care while at the same time creates criticism from several of the targeted businesses such as tobacco companies and the rapidly growing e-cigarette industry. </p><div><script async src=

History continues under

"He was in a state l do something very rare: H I have never been involved in a scandal, have never been marked with a toxic management brush and had a good relationship with the president at the same time, a former White House official said.

Nevertheless, his independent streak, in some cases, stuck with others in the administration. Gottlieb pushed regulatory matters under a mandate from a president who pushed deregulation as one of his core goals. He was also quoted on Twitter during the 35-day government's suspension and hesitated to lead the responsibility for drug imports, a pet policy proposal by President Donald Trump. A working group for the import of substances that HHS asked the FDA to start last year moved back to the parent company months later, because Gottlieb did not want to lead the group, according to former officials.

Nor did he embrace the original Right-To-Try proposals, and worked to modify that law to allow people access to experimental drugs. Here is a roundup of remarkable politics from his tenure:

The work of both speed new gene and cell therapy to the market. Gottlieb worked to promote cell and gene therapies, a promising new area of ​​medicine. Under his leadership, the FDA has developed a framework for regenerative drugs designed to accelerate the approval of the most promising gene therapies. At the same time, Gottlieb balanced with legitimate new treatments with oppression on bad actors who took advantage of patients by marketing unauthorized, untested and potentially dangerous treatments.

Speaking on drug prices. Although the cost of medication has been mentioned, for years it has been seen as a taboo for FDA chiefs, because the FDA has no authority over drug costs and is not going to assess the cost of its decisions. More than six months before HHS formally proposed to overhaul the drug payment system by changing how pharmaceutical companies and payers negotiate discounts on medicines, Gottlieb suggested that the government reconsider regulations that shield discounts from antitrust controls. He was also critical of brand users who used discounts to block cheaper competition from generic-like medicines known as biosimilar.

Pressure for generic competition. Gottlieb was vocal about increasing the drug competition to bring down prices. While some of the momentum – such as record-high approval in 2018 – came from the Obama era law, which increased FDA generic drug professionals, Gottlieb suffered the work of mentioning and shameful brand users who made generic development more difficult. He also sped on the list of generic drugs that would be the first to compete with a branded product.

Lead attacks on tobacco and e-cigarettes. Gottlieb launched a sweeping strategy last year to deal with what he noticed an "epidemic" of juvenile gunfire with plans to push child-friendly flavors from the stores and curb miracle sales. A few days ago, he indicated that several political changes were on the way, including a controversial plan to ban cigarette and cigar flavors altogether. It gave him the law to legislators such as Richard Burr (RN.C.) who is from a leading tobacco producing state. The commissioner also told the public that he would increase the purchase age to 21, which conservative lawmakers also opposed.

Laid out to modernize medical equipment. Just as media surveys questioned the safety of some medical devices, Gottlieb announced that they would undergo the review process so that manufacturers would test their potential products against more modern technology. He also recognized problems with women's products such as breast implants and long-term contraception, and planned to actively monitor problems with these products.

Drew attention to cyber security threats. Gottlieb pushed the FDA to investigate the role of the software in health care, especially with cyber security and hacking issues that may arise with new technology. The FDA relocated to increase technical safety requirements for medical devices by providing guidance on what concerns manufacturers have to take into account by obtaining units approved or approved by the FDA. The position was cheered by hospitals and IT groups seeking more robust regulatory protection.

Raised profile of nutrition policy. Gottlieb surprised many in the public health service by focusing on nutrition policy, which has been a minor priority for former FDA commissioners. During his tenure, the agency continued much of the Obama administration's food agenda, such as by mandating menu marking and banning trans fat. He also launched a comprehensive new nutrition strategy to try to cope with diet-related illness, although much of these plans have not yet been implemented.

Preserved Michelle Obama's sugar labeling. The FDA resisted conversations from some in the food industry to scrape a new mandate to reveal "added sugar" to Nutrition Facts labels, a change that had been marked by former first lady Michelle Obama.

Pressure for FDA role in cell-based meat. The FDA was unusually aggressive in claiming it had jurisdiction over the budding cell-based meat sector, which grows cellular tissue from tissue to make sausages, chicken nuggets and other products. After a strange public turf match with the USDA, the Trump administration finally decided that the FDA and USDA would oversee the products.

Darius Tahir contributed to this report.


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