The response outside the Supreme Court to the June 13, 2024 decision in the case of FDA v. Alliance for Hippocratic Medicine was more a “phew” than a “hooray.” The reason being, rather than ruling on the merits, the court dismissed the plaintiffs’ attempt to nullify FDA approval of the abortion drug mifepristone on a technicality, lack of standing. Speaking for the Court, Justice Brett Kavanaugh, acknowledging the plaintiffs “have sincere legal, moral, ideological, and policy objections to to elective abortion,” wrote:
But under Article III of the Constitution, those kinds of objections alone do not establish a justiciable case or controversy in federal court. Here, the plaintiffs have failed to demonstrate that FDA’s relaxed regulatory requirements likely would cause them to suffer an injury in fact. For that reason, the federal courts are the wrong forum for addressing the plaintiffs’ concerns about FDA’s actions. The plaintiffs may present their concerns and objections to the President and FDA in the regulatory process, or to Congress and the President in the legislative process.
Standing in court requires evidence of actual harm. And while the plaintiffs argued that the availability of abortion drugs such as mifepristone might weigh heavily on their consciences, Kavanaugh said, in not so many words, “No one is forcing you to recommend it for your patients.”
Kavanaugh, in the above language, wittingly or unwittingly, exposed an example of the massive conspiracy MAGA world calls the “deep state” dating back to the drafting of the Constitution and applied specifically to FDA with the passage of the Federal Food and Drugs Act in 1906. According to FDA historian John P. Swann, the 1906 legislation created the FDA to replace the Bureau of Chemistry in the Department of Agriculture and authorized the new agency to (1) go into plants where food and drugs were produced and (2) regulate the labeling on such products. However, it did not require pre-commerce approval for drugs.
Pre-market approval of drugs was authorized by the Congress in 1938, following over 100 deaths related to the production and sale of elixir sulfanilamide which contained a toxic ingredient. With the sole focus on safety, the 1938 amendments did not address the efficacy of a marketed drug.
In response to the 1962 deaths and infant deformities connected to the use of thalidomide, Congress passed the Kefauver-Harris Drug Act which expanded FDA’s regulatory authority related to the efficacy of a drug before it could be marketed in the United States. In subsequent years, Congress further expanded FDA’s regulatory authority including, but not limited to, “orphan” drugs which were used to treat rare diseases, requirements to inform users of the specific dangers and side effects of a medication and the ability to charge drug manufacturers fees to cover the the agency’s cost of drug evaluations.
One point of contention in the mifepristone case was the FDA’s use of REMS (Risk Evaluation and Mitigation Strategies) to make the the drug available initially and later to expand its use up to 10 weeks following conception. REMS was authorized by Congress in 2007 amendments to the FDA Act. REMS purpose, according to the Center for Health Policy at the Brookings Institute, “…is to ensure that the benefits of a given medical product outweigh the associated risks.”
To recap, four private organizations argued before the Supreme Court that a cabal of bureaucrats in the FDA have exceeded their authority by making a drug available to the general public in violation of the Constitution. Where could they get such an idea? Maybe from former House Speaker Newt Gingrich. In a March 6, 2017 interview with New York Times reporter Julie Davis, Gingrich shared the following.
What President Trump is discovering is that he has a huge, huge problem underneath him, and I think he’s shocked that the system is as hostile as it is. We’re up against a permanent bureaucratic structure defending itself and quite willing to break the law to do so.
If that is the case, why didn’t Donald Trump direct the Department of Justice to investigate, indict, convict and jail these renegade conspirators? Perhaps because the defendants would include the Founding Fathers who in Article I, Section 8 of the Constitution granted Congress the power “to regulate Commerce with foreign Nations, and among the several states, and with Indian Tribes.” And while the Supreme Court denied Congress could wholesale delegate this regulatory authority, it authorized delegation by legislation for specific activities. And then there are all those Senators and Representatives who, over time, authorized FDA and added specific regulatory authorities to its portfolio. And finally, all the staff at the FDA who followed the Administrative Procedure Act to promulgate and implement the regulations assuring public input. To paraphrase Amity Island sheriff Martin Brody in Jaws, “We’re going to need a bigger courtroom!”
As if that was not enough proof, let us not forget the latest affirmation that the so-called “deep state” is grounded in the Constitution, using plain English even Clarence Thomas and Samuel Alito can understand. Reviewed and affirmed by the Supreme Court. And authorized by the ELECTED representatives of the American people. And last week blessed by Justice Kavanaugh, who suggested the plaintiffs in the mifepristone case can address their grievance through the appropriate regulatory and legislative processes.
“Deep state,” consider yourself exposed.
For what it’s worth.
Dr. ESP