Thursday, May 16, 2019

98% of FDA Regulations are Illegal

Lawful regulations must be adopted in strict compliance with the Administrative Procedures Act (APA) which starts with someone in the public submitting a Citizens Petition at asking FDA to consider making a rule. 

The Petition usually has a 90 day comment period. Then the FDA can propose a draft regulation, which also has a comment period. It's important to comment since you must "exhaust your administrative remedies" if you want to complain (in Court) about the regulation after it's adopted. Finally the FDA responds to the comments and issues a final regulation.

Here is an example of that process, where we've filed a Citizens Petition demanding the suspension of all FDA vaccine drug approvals as violating the 1986 vaccine safety law.

 As my friend and colleague (and "The Dean of the Patriot Lawyers") Larry Becraft JD always reminds me, nearly all Fed Regulations are illegally adopted. The FDA is no exception. This report from the Pacific Legal Foundation confirms it. And here is the Report showing FDA fails to abide by the law: Report highlights:
The US Constitution makes lawmakers democratically accountable, yet Americans are subject to thousands of rules that are issued by bureaucrats without democratic accountability. But Who Rules the Rulemakers reviewed 2,952 final rules issued by the Department of Health and Human Services over a 17-year period. The report found that nearly 75% of these rules are unconstitutional because they were issued by low-level officials and employees with no authority to issue rules. The 2,094 unconstitutional rules we found have real consequences for individuals and small businesses. Among the thousands of rules issued without democratic controls by the Food and Drug Administration were 25 rules that each had an impact of $100 million or more. Each of the branches should act to rein in this undemocratic behavior—including striking down illegally issued rules and requiring senior appointees to take responsibility for rules issued by their agencies.
Supreme Court Justice Gorsuch was a strong voice in opposition to unlawful bureaucratic rule-making before he was appointed to the Supreme Court. I wrote a bit about him in January 2017 in comments about a bill that passed the GOP House and was directed at the administrative state. [*]   In August 2017 here is what then Judge Gorsuch said about the Chevron [**] case that allowed some "delegation" of rule-making power:
"There’s an elephant in the room with us today. We have studiously attempted to work our way around it and even left it unremarked. But the fact is Chevron and Brand X permit executive bureaucracies to swallow huge amounts of core judicial and legislative power and concentrate federal power in a way that seems more than a little difficult to square with the Constitution of the framers’ design. Maybe the time has come to face the behemoth."

[**] Here is how Wikipedia describes the Chevron case -,_Inc._v._Natural_Resources_Defense_Council,_Inc. "Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984), was a landmark case in which the United States Supreme Court set forth the legal test for determining whether to grant deference to a government agency's interpretation of a statute which it administers. Chevron is the Court's clearest articulation of the doctrine of "administrative deference," to the point that the Court itself has used the phrase "Chevron deference" in more recent cases."

No comments: