Healio Special Report: Health Care and Politics
Healio Special Report: Health Care and Politics
Source/Disclosures
Source: Press Release

Disclosures: Bigelow, Ely, Feldman, Huberfeld, March, Tummalapalli and White report no relevant financial disclosures.
August 24, 2020
4 min read
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Trump’s recent health initiatives draw mixed reactions

Source/Disclosures
Source: Press Release

Disclosures: Bigelow, Ely, Feldman, Huberfeld, March, Tummalapalli and White report no relevant financial disclosures.
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President Donald J. Trump’s recent executive order to ensure the production of essential medicines in the United States and cut down on the country’s reliance on foreign production of medical supplies drew mixed reactions from experts.

The president also recently indicated that he may issue a separate executive order that would require health insurers to cover Americans with pre-existing conditions — a move that drew conflicting views on its necessity.

 “The most important thing is to make sure the FDA has the resources it needs to ensure consistent access to safe and effective treatments.” The source of the quote is Thomas L. Ely, DO.

Safe access to prescription drugs

Trump’s executive order, signed Aug. 6, requires the FDA commissioner to provide a list of medicines “that are essential for public health in America” by mid-October. The Office of Management and Budget director would then ensure that these medicines are produced in the U.S. and procured from companies with e-commerce platforms that are compliant with federal guidelines geared toward reducing counterfeit and pirated goods.

Jon Bigelow

Jon Bigelow, executive director of the Coalition for Healthcare Communication, noted that this executive order should not be confused with another one involving prescription drugs the president signed earlier this year.

“The argument for the current executive order concerns availability,” he told Healio Primary Care. “The administration’s [other executive order] concerns price.”

Raymond March, PhD, research fellow and director of FDAReview.org at the Independent Institute, and Robin Feldman, JD, the Arthur J. Goldberg Distinguished Professor of Law at the University of California, Hastings College of the Law, speculated that drugs used to treat diabetes, HIV, opioid addiction, depression and other mood disorders, high BP, allergic reactions and COVID-19 may make the FDA commissioner’s list.

Raymond March

March cautioned that an executive order requiring essential medicines be made in America may put many drugs out of customers’ financial reach.

“Many drugs produced overseas are cheaper to produce,” he explained in an interview. “As a result, stateside manufacturing will be felt more by patients than the producers.”

Feldman noted that there is some justification for addressing the safety of prescription drugs in the executive order.

Robin Feldman
Robin Feldman

“The carcinogenic substance that sparked the Zantac and metformin recalls” — nitrosamine impurity N-Nitrosodimethylamine, or NDMA — “may stem from manufacturing outside the United States,” she said. “This raises concerns about the country’s ability to effectively monitor safety at all moments of the drug supply chain when parts of that chain occur overseas. So, his executive order might calm concerns about the safety of ingredients.”

Researchers have demonstrated the safety issues of drug manufacturing outside the U.S. An article by C. Michael White, PharmD, FCP, FCCP, professor of pharmacy practice at the University of Connecticut, published in Annals of Pharmacotherapy, showed that one-third of 842 oversees manufacturing plants in 2015 were never inspected by the FDA. That same year, 46 Indian drug manufacturing facilities were barred from shipping drugs to the U.S. for a variety of reasons, including altering or manipulating product information, clinical trial data and employee training records. Warning letters from the FDA to international manufacturing plant facilities increased from approximately 19 to 94 actions a year from 2015 to 2018.

C Michael White 2019
C. Michael White

“I’m shocked at the number of manufacturers who are implicated, the extent of the issues that have arisen, and that the FDA allowed it to happen by not inspecting most of these sites for years and still not following through with unannounced inspections like they do with drugs manufactured in the United States,” White told Healio Primary Care.

However, Bigelow questioned whether the executive order to shore up medical supplies in the U.S. was needed.

“The FDA has done a lot in recent years to make its approval process very efficient. It is not clear that there is a problem to be solved here,” he said.

Thomas L. Ely, DO, president of the American Osteopathic Association, countered by saying the FDA can always use more tools to fulfill its mission of protecting public health.

“We have seen drug shortages and other supply chain issues, regardless of the country a product is manufactured in,” Ely told Healio Primary Care. “The most important thing is to make sure the FDA has the resources it needs to ensure consistent access to safe and effective treatments.”

Insurance for patients with pre-existing conditions

According to reporting by CNBC, Trump is considering issuing an executive order requiring health insurers to cover Americans with pre-existing health conditions but gave no details about his plan.

However, such coverage already exists. experts argued.

“The idea of an executive order to cover pre-existing conditions is absolutely necessary, but bizarre, since coverage of pre-existing conditions is already mandated by the Affordable Care Act,” Nancy Nielsen, MD, PhD, a senior advisor at CMS during the Obama administration and now senior associate dean for health policy at the University at Buffalo, told Healio Primary Care.

Nancy Nielsen
Nancy Nielsen

"This must be a signal to reassure people that he will protect pre-existing conditions by executive order to be covered if the ACA is overturned, which is something the Trump administration is trying to do," she continued.

Gabriel A. Brooks, MD, MPH, assistant professor of medicine at the Dartmouth Giesel School of Medicine, said it is hard to defend or oppose such an executive order.

Gabriel A. Brooks

“Taken at face value, this executive order is neither good nor bad,” he told Healio Primary Care. “My main concern is that it could be used as part of an effort to dismantle or repeal the ACA.”

Sri Lekha Tummalapalli

The U.S. has much more important public health priorities right now than wondering about this redundancy, added Sri Lekha Tummalapalli, MD, MBA, a nephrologist at the University of California, San Francisco. “We need to focus on the pressing issue — a comprehensive, coordinated response to the COVID-19 pandemic."

Nicole Huberfeld

Nicole Huberfeld, JD, professor of health law, ethics and human rights at Boston University School of Public Health and School of Law, agreed, saying that such an executive order “has no practical or legal purpose at this time.”

HHS did not respond to a request to comment about the possible executive order to insure people with pre-existing conditions.

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