Bureaucratic oligarchy rules at the FDA.

• Author: Emord, Jonathan W.
• Position: Medicine & Health - Food and Drug Administration - Column

"The [Food and Drug Administration], like many other Federal agencies, wields way too much authoritarian power. The bureaucracy has become sovereign, governing in a manner not unlike the absolute monarchs who were detested for rights abuses by America's revolutionary leaders."

THE U.S. NO LONGER is a republic; it is a bureaucratic oligarchy. A republic depends on the consent of the governed; elected representatives to make laws; a separation of legislative, executive, and judicial powers; and limits to government that prevent it from violating the inalienable rights of the people. A bureaucratic oligarchy arises when unelected officials make the laws while possessing the combined powers of all three branches of government, and they enact each measure without having to account for their actions to the courts, Congress, or the people.

This transformation has occurred incrementally since 1938, as Congress has delegated ever more governing power to independent regulatory commissions, and as the Supreme Court has not struck down any Congressional delegation of lawmaking, enforcement, or adjudication power to the agencies as a violation of the separation of powers. Indeed, so profound is the Court's failure to defend the separation of powers deemed indispensable to liberty by America's Founding Fathers that U.S. Court of Appeals Judge Douglas Ginsburg has described that doctrine as part of a "Constitution in exile." With the growth of unaccountable government has come corruption, rights violations, and abuse of power, just as our nation's Founders predicted. There perhaps is no greater Federal government example of those combined ills than the Food and Drug Administration.

In Thoughts on Government (1776), John Adams warned, "A people cannot be long free, nor ever happy, whose government is in one assembly ... because a single assembly possessed of all the powers of government would make arbitrary laws for their own interest, execute all laws arbitrarily for their own interest, and adjudge all controversies in their own favor." Drawing from Montesquieu's explanation in Spirit of the Laws (1748) that liberty only can be preserved by a government of separated powers, the Founders of the American republic--George Washington, Alexander Hamilton, Thomas Jefferson, James Madison, and John Adams--warned that, if ever our national government were to devolve against the Constitution's design into "one assembly" for the creation, enforcement, and adjudication of laws, there would be an end of liberty and a birth of tyranny. Some 221 years later, this unfortunate reality has come to fruition. Today, more than 90% of all Federal law is not the product of our elected representatives who are given the exclusive power to make laws in the Constitution, but of unelected heads of Federal agencies. Based on the testimony and correspondence of more than a dozen FDA medical reviewers turned whistleblowers, the agency is a captive of its principal regulatee, the pharmaceutical industry, resulting in the approval of unsafe drugs onto the market.

Most Americans are shocked to learn that the FDA is not mandated to test any proposed new drug to determine if it is safe. Instead, the FDA relies on the drug companies to inform it if they find evidence of safety. Characteristic of just how entrenched drug company control is over the agency, the FDA presumes drugs under its review to be safe unless the sponsoring drug company informs the agency of evidence indicating otherwise. In addition, FDA medical reviewers do not have the first or last word on the prudence of approving a drug; that decision is made by the agency's political appointees--the agency's management, its head of the Center for Drug Evaluation and Research, and, ultimately, its commissioner, whose decrees are absolute.

Physician Richard Besser, ABC News' senior health and medical editor, well described the biased safety review process performed by the industry--that the FDA...