Daily on Healthcare: Trump FDA plans to get tougher on dietary supplements that break the rules

By | February 11, 2019

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Trump FDA plans to get tougher on dietary supplements that break the rules. The Food and Drug Administration on Monday kicked off more aggressive oversight against dietary supplements such as vitamins and minerals by firing off warning letters to companies that illegally claimed to cure serious ailments. Agency officials sent 12 warning letters to companies telling them to either take down false information or stop selling the products. FDA Commissioner Scott Gottlieb said in a blog post that companies falsely said their products could treat or cure Alzheimer’s disease, diabetes, and cancer. Gottlieb pledged the agency would be more proactive in tackling supplements, including by alerting the public of potential dangers faster and considering ways it could more strictly enforce rules. Gottlieb suggested that the agency also may recommend Congress provide more authority on supplements, which 3 in 4 people in the U.S. take. The plan, he said, would be one of the most significant changes the industry has seen in more than 25 years. When Congress initially set rules around supplements 25 years ago, it was a $ 4 billion industry with 4,000 products. Now, it’s worth $ 40 billion and an estimated 80,000 products are on the market. While pledging greater oversight, Gottlieb also said he did not want to stifle innovation and admitted that he had “personally benefited” from taking dietary supplements. “We know that most of players in this industry act responsibly,” he said. “But there are opportunities for bad actors to exploit the halo created by quality work of legitimate manufacturers to instead distribute and sell dangerous products that put consumers at risk.”

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HELP leaders press CDC, HHS to act against measles spike. Sen. Lamar Alexander, R-Tenn., and Sen. Patty Murray, D-Wash., on Friday pressed the Centers for Disease Control and Prevention and the Department of Health and Human Services to respond to the latest measles outbreak and to find out what the federal government is doing to promote people’s confidence in vaccines. The senators asked whether the agencies needed more funding and what policies were best at getting families to vaccinate. At least 79 people have been infected with measles across 10 states, largely in pockets of the country where vaccination is low. “While vaccination rates in the U.S. continue to be generally high, pockets of unvaccinated people and decreasing vaccination rates, particularly in children, are concerning and of significant risk to public health,” wrote the senators, who lead the Health, Education, Labor and Pensions Committee. “There is no question that vaccines are an unparalleled public health success; the routine vaccination of four million children born annually in the U.S. results in 42,000 lives saved and 20 million cases of disease prevented.  Vaccines save lives. If vaccine hesitancy persists – or even expands – it could seriously undermine these important advances,” the Senators’ letter continued.

Trump doctor says president in ‘very good health.’ A White House physician said Friday that President Trump’s annual physical showed he is in “very good health.” “While the reports and recommendations are still being finalized, I am happy to announce the President of the United States is in very good health and I anticipate he will remain so for the duration of his Presidency, and beyond,” a statement from White House doctor Sean Conley said. Trump, 72, had his annual checkup at Walter Reed National Military Medical Center in Bethesda, Md. He spent about four hours at the facility Friday afternoon. Conley said he and 11 other board-certified specialists conducted the exam. Trump was not put under anesthesia or sedated. It’s not clear whether the White House will release the results of Trump’s latest medical report to the public.

2020 prospect Michael Bennet says his alternative to eliminating private health insurance ‘helps finish the work of Obamacare.’ Democrats should tread carefully when talking about a “Medicare for all” framework that eliminates the role of private insurers, according to one potential 2020 candidate. “Remember when President Obama said, ‘If you like your insurance, you can keep your insurance,'” Sen. Michael Bennet, D-Colo., said Sunday during an interview on NBC’s “Meet to Press.” “And then a few people in America actually lost their insurance because of the way that the plan worked. Now what Democrats are saying is, ‘If you like your insurance, we’re going to take it away from you,’ from 180 million people that get their insurance from their employer and like it, where 20 million Americans who are on Medicare Advantage, and love it. That seems like a bad opening offer for me.” A better starting point, Bennet said, was his “Medicare X” proposal with Sen. Tim Kaine, D-Va., which creates a public option. “It helps finish the work of Obamacare, and it says to America, ‘If you want to be in a public plan, you can choose to be in a public plan. If you want to keep your insurance, you can keep your insurance,'” the two-term senator said.

House Democrats raise alarm over uncovered abortions in Medicaid. Top House Democrats sent a letter to the Centers for Medicare and Medicaid Services on Friday about a Government Accountability Office report showing that states were violating rules about when they should be covering abortions under Medicaid. The report showed that in 14 states Medicaid was not covering the abortion pill in cases of rape, incest, or when a woman’s pregnancy threatens her life. Medicaid in South Dakota was not covering abortions in the cases of rape or incest.  The Democrats noted that the report said CMS was aware of the violations but didn’t act. They have asked CMS to outline how they will make sure states follow the rules.

Gottlieb asks Juul to explain how it will keep its commitments to keep products away from teens. Gottlieb told Juul in a letter that he wanted an explanation about how the company would keep its commitments to the FDA now that it was going to be acquired by Altria, one of the world’s biggest cigarette manufacturers. Juul came up with a plan in October to stop teens from using its products, and reducing the use of e-cigarettes among teens is a key goal of the FDA. Gottlieb is requesting another meeting with Juul.

RUNDOWN

Politico Republicans can’t wait to debate ‘Medicare for all’
STAT An ambassador to the Vatican. A GOP megadonor. And now, a rare Republican joining Democrats to take on pharma

Wall Street Journal A top Trump health administrator faces test from newly elected Democrats

Los Angeles Times OB-GYNs remain conflicted about abortion, survey shows, but pills may be changing attitudes

ABC News Nearly 100 children dead as world’s 2nd-largest Ebola outbreak surpasses 800 cases

MONDAY | Feb. 11

Feb. 11-13. Grand Hyatt. American Medical Association National Advocacy Conference. Agenda.

Feb. 11-14. Orlando. Healthcare Information and Management Systems Society annual meeting. Agenda.

TUESDAY | Feb. 12

10 a.m. 2358-A Rayburn. House Appropriations hearing on status of operations for the Food and Drug Administration. Live Stream.

10 a.m. 430 Dirksen. Senate Health, Education, Labor, and Pensions Committee hearing on “Managing Pain During the Opioid Crisis.” Details.

10 a.m. 1100 Longworth. House Ways and Means Committee hearing on “The Cost of Rising Prescription Drug Prices.” Details.

WEDNESDAY | Feb. 13

10:30 a.m. 2322. House Energy and Commerce hearing on “Strengthening Our Health Care System: Legislation to Reverse ACA Sabotage and Ensure Pre-Existing Conditions Protections.” Details.

2 p.m. Commonwealth Fund Teleconference on “Making Health Care Price Transparency Work for Consumers.” Details.

4 p.m. National Academy of Medicine Webinar on “Action Collaborative Countering the U.S. Opioid Epidemic.” Details.

FRIDAY | Feb. 15

1 p.m. 1789 Massachusetts Ave NW. American Enterprise Institute event on “Sense and severability: If one part of the Affordable Care Act is ruled unconstitutional, what is the proper remedy or resolution?” Details.

Healthcare