The proposed rule from the Department of Health and Human Services (HHS) that could potentially wipe away hundreds of health and food safety regulations is "radical" and is a reflection of the Trump administration's "disdain for science and governance," House Speaker Nancy Pelosi (D-Calif.) said Friday.
"This 'lame duck' Trump rule seeks to paralyze government and generations of life-saving protections and tries to burden a new president elected by the American people right out of the gate," Pelosi said during a press conference, adding that the administration may also try to put similar rules in place at other agencies.
"We do believe that regulations should be subject to review -- that's part of the process. But there is a way to do it -- and the way to do it is not to first zero in on the FDA at a time when we're trying to achieve a vaccine for the people." The FDA's regulations, including those relating to the drug and vaccine approval process, would be among those that HHS could look at.
A Diversion of Resources
Under the proposed rule, the department will review each of its regulations -- with some exceptions -- every 10 years. Those regulations that are currently more than 10 years old must be reviewed within 2 years of the enactment of the proposed rule; regulations that aren't reviewed during that time will expire, Harrison said.
In other words, any older rules that HHS fails to review during the 2-year window would simply vanish from the Code of Federal Regulations.
Exceptions to the review requirement include regulations that are jointly issued with other agencies, those that legally cannot be rescinded, and those issued with respect to a military or foreign affairs function or addressed solely to internal management or personnel matters. A 30-day comment period began Wednesday for most of the rule, though a few parts have 60-day periods.
In addition to the other concerns raised by the proposed rule, which was announced on Wednesday, "it also diverts resources," said Rep. Frank Pallone (D-N.J.), chairman of the House Energy & Commerce Committee, who also spoke at the press conference.
"If the staff working to crush the virus has to be diverted to justify and spend time dealing with regulations they would not want to sunset, it's a question of staff time that takes away from our ability to actually deal with the virus," he said.
He noted that the comment period for parts of the rule closes on Dec. 4, so the rule could be finalized as soon as early December and the president "could put it in place and start this whole process to undermine not only regulations that are now over 10 years old, but others that might become 10 years old later, during a Biden administration."
Executive Order on Civil Service Panned
Experts also have questioned whether the rule may violate the Administrative Procedures Act, which requires that any rule that is substantially changed must go through a notice and comment period. In addition, they say that 2 years is an extremely tight time frame to try to review the 2,480 rules that HHS said it would have to review during that period.
Pelosi and Pallone also criticized the president's Oct. 21 executive order creating a new class of civil service employee. "This includes people at the FDA and CDC and basically says over the next month or so, the president and his administration are going to put out a new schedule classifying career civil servants -- for example, somebody like Dr. Fauci -- essentially as non-civil-service employees who could be fired," said Pallone, noting that Trump has suggested he might fire Fauci after the election.
"Dr. Fauci is an example of the type of person who could be fired under this executive order, and possibly be replaced by people like Dr. Atlas who are not qualified to actually deal with this virus effectively because of their lack of background or their policies -- and all of this before he leaves office on January 19th," Pallone said.
"Some have said, 'Is he really going to fire these people?' I don't know, but the very fact this is in place is a threat," Pallone continued. "It's either 'I'm going to fire them' or 'I'm going to threaten them with the fact that if they speak out and do things contrary to what I want to do with regard to COVID-19, they'll know they might lose their civil service job,' which is really basically the same thing."
"Civil service is a very important part of democracy," said Pelosi. "It takes the politics out of the performance of civil service.... But if those civil servants are directed by certain political appointees to make certain scientific decisions or they'll lose their jobs, that undermines the purpose of safety and efficacy in term of the FDA but also the health and well-being of the American people."
She added that the executive order can be undone, "but it takes a great deal of time and effort to undo."
Call to "Crush the Virus"
"Why is the president doing things to undermine the ability to crush the virus, rather than working with the speaker and trying to put together a plan like the HEROES Act that would make a difference and actually effectively crush the virus?" Pallone said. "We need the scientists and we need the public health experts. We need to scale up testing, contact tracing, and treatment."
"Unfortunately, this is likely to be a dark winter, and it just doesn't make any sense for the president to use the short time he has left to undermine the national response, and it's also an insult to the civil servants," he added.
"And one thing we're certainly going to do is spend our time at Energy & Commerce and the other committees trying to shore up these agencies like HHS and CDC and FDA that he has been trying to dismantle for the last 4 years. Morale is very low, but I want everyone who works at these agencies to know that we as Democrats -- we're on their side," Pallone said. "We're committed to crushing this virus, and we're going to support public servants ... We're going to work to ensure civil service protections remain in place and we have a national response."
https://www.medpagetoday.com/publichealthpolicy/healthpolicy/89539
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