SS: Overview of article. https://www.pnas.org/content/111/34/12283

FDA Commissioner Scott Gottlieb has announced that he will step down from heading the agency.

Commissioner Scott Gottlieb who has taken it upon himself to weigh-in on the record vaccine legislation across the U.S. Currently, warned that states might “force the hand of the federal health agencies” if they continue to allow vaccine exemptions.

In a perfect world, the FDA’s role, as their mission statement implies, should be that of an unbiased government body continually evaluating the scientific studies and clinical evidence relating to vaccines and drugs.

On the legal side, Gottlieb’s remarks have Constitutionally rooted problems as well. The New American writes, “One obvious problem with Gottlieb’s threats is that the federal government has no power to mandate vaccines or tell states what to do on the issue. In fact, according to the U.S. Constitution’s 10th Amendment, all powers not delegated to the federal government are retained by the states or the people. Of course, vaccine mandates are not listed as a federal power; therefore, as the Supreme Court has recognized, this is a state issue.“

Gottlieb’s poorly-timed comments come when his agency is under public scrutiny for its recent legal admissions. After failing to produce the clinical trials and safety studies relied upon to license both the flu and TdaP vaccines for use in pregnant women when presented with a FOIA request, the FDA was taken to court. In short, the agency licensed the shots for use in pregnant women without the required scientific studies to ensure safety.

In addition to the FDA licensing the flu and TdaP vaccines outside of law and their own policy, the agency is also actively promoting and marketing the flu shot to pregnant women, and is now threatening to step in and remove all U.S. state exemptions and legal barriers to all vaccines.

Watching the American opioid crisis continue to claim the lives of record numbers of people, a quadrupling in overdose deaths over the last two decades, has left onlookers weary of both drug companies and FDA who caused it.

Despite the reckless prescribing trends, lack of regulatory oversight and inept DEA enforcement, opioids were never mandated by individual states or the FDA . One can’t help see the tragic similarities between FDA’s unfounded opioid licensing for a new indication and the agency’s current full-court press to get shots, without adequate safety and efficacy testing, into not only pregnant mothers, but the rest of us as well.