HHS Assistant Secretary for Public Affairs Michael Caputo with HHS Secretary Alex Azar
More allegations emerged that political appointees in the Trump administration have been attempting to interfere with and impose influence on the scientific work of federal agencies to downplay the severity of COVID-19, which has killed nearly 200,000 Americans.
The most recent assertions involve political appointees seeking to review and edit the Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Reports, or MMWRs — scientific documents the agency describes as its "primary vehicle" for communicating "timely, reliable, authoritative, accurate, objective and useful public health information and recommendations" to the medical and public health communities.
Michael Caputo, assistant secretary for public affairs at the U.S. Department of Health and Human Services, told Politico he and one of his politically appointed advisers, Paul Alexander, wanted to "make sure that evidence, science-based data drives policy through this pandemic — not ulterior deep state motives in the bowels of CDC."
President Donald Trump made a similar unsubstantiated claim in an Aug. 22 tweet that scientists at the U.S. Food and Drug Administration are "deep state" operatives who are slowing down the regulatory process to harm him politically.
White House Chief of Staff Mark Meadows admitted Aug. 23 that Trump and the administration had exerted political pressure on the FDA and the National Institutes of Health over the COVID-19 response.
In a series of emails reviewed by Politico and The Washington Post, HHS' Alexander accused CDC's career scientists of "writing hit pieces" with the MMWRs in an attempt to upend Trump's reelection. Alexander and Caputo were successful in delaying at least one MMWR for a month and had sought to edit other reports, including some that had already been published, according to the newspapers.
The emails showed that Alexander had also sought to have Anthony Fauci, director of the NIH's National Institute of Allergy and Infectious Diseases, downplay the risks of COVID-19 in children, according to a Sept. 9 Politico report.
"I don't pay any attention to them at all," Fauci told MSNBC Sept. 11. "Anybody that tries to tell me what to say publicly, if they know anything about me, realized that's a fool's errand. No one is ever going to pressure me or muzzle me to say anything publicly."
Trump revokes, replaces favored nations order
President Donald Trump
Meanwhile, after waiting seven weeks for Trump to reveal the text of his so-called most favored nations executive order for the Medicare Part B program, he revoked the July 24 order on Sept. 13 and replaced it with an amended version, seeking to include the Part D program.
Executive orders simply instruct federal agencies to take certain actions. But the orders have limited authority, can be difficult to enforce without legislation, take months, if not years, to implement and can easily be challenged in court.
The administration in October 2018 initially sought to test an international pricing index model to pay for expensive injectable medicines covered by the Medicare Part B program and issued an advance notice of proposed rulemaking — a bureaucratic mechanism used to gauge public opinion ahead of making a formal proposal.
The proposal was shifted a year later to a favored nations approach to require drugmakers to offer Medicare Part B the lowest prices paid by foreign countries.
But that proposal has lingered at the White House Office of Management and Budget, or OMB, since June 2019.
Trump has struggled to deliver on his 2016 campaign promises to reduce U.S. drug prices.
If HHS moves forward with a notice of proposed rulemaking for the Sept. 13 order, it would involve months of public comment before being finalized, noted Rachel Sachs, associate professor of law at Washington University in St. Louis. If the administration attempts to bypass that stage, it would add legal challenges for the rule, Sachs tweeted.
Given HHS has not publicly released any Part D model, it cannot simply proceed to the interim final rule stage, she noted. The Part D benefit is provided through private plans and covers drugs picked up at the pharmacy counter.
To implement the favored nations program, HHS plans to use the legal authority Congress granted when it created the Center for Medicare and Medicaid Innovation under the Affordable Care Act — a law Trump has asked the Supreme Court to invalidate.
Trump has also vowed to veto a drug pricing bill from House Speaker Nancy Pelosi, D-Calif. — adopted by her chamber in December 2019 — which also seeks to use international reference pricing to lower the price of drugs in Medicare, Sachs noted.
The Pharmaceutical Research and Manufacturers of America called Trump's order an "irresponsible and unworkable policy" and a "reckless attack on the very companies working around the clock to beat COVID-19."
The Biotechnology Innovation Organization dubbed the order a "reckless scheme."
Importation rule, guidelines
The Trump administration last week submitted to the OMB for its review a final rule and final guidelines seeking to import drugs into the U.S. from Canada.
The U.S. drug industry and Canadian officials have opposed the Trump administration's import plans. HHS has not provided any projections on any cost savings from importing drugs into the U.S.
"Importation is a bad idea as scalable fix for drug pricing," tweeted former FDA Commissioner Robert Califf. "Why don't we address the problem directly?"