Daniel Hines, publisher of RxforAmericanHealth says that the FDA has not adhered to The Administrative Procedure Act (APA), which provides the procedures for various types of rulemaking that applies to all agencies.
“The FDA will claim that it is meeting the requirements of rules-making under the Informal/Notice-and-Comment/§ 553 procedure “ Hines explains.
“However, it is clearly evident that the potential for abuse of Section 708 creates a requirement for additional hearings, since, according to the ACA, ‘ [matters] of great importance, or those where the public submission of facts will be either useful to the agency or a protection to the public...’ and, as such, “should naturally be accorded more elaborate public procedures.”
“What subject outside of national security is of greater importance than a decision that may, by seizure and destruction, deprive millions of Americans of their vital, authentic and safe medicines," Hines asks.
He said the question is made even more germane by the relationship of the FDA to Pharma and its many front groups that has tarnished what should be the standard that guides the FDA.
“That is why it is time for patient/clients—and not just Pharma—to be recognized as ‘stakeholders’ whose experiences and health needs will offer a vital and previously lacking perspective on the role of personal importation of prescription medicines In the decision-making process of the FDA.”
A failure by Congress or the FDA to act to provide such hearings will reflect a disregard for the interests of millions of Americans whose health needs are in danger of harm from misappropriation of Section 708, Hines continues.
“The failure to act could result in the horrifying spectacle of the FDA, an agency ostensibly designed to protect the health and well-being of Americans instead destroying their lifeline of maintenance medications,” Hines concludes. “The results will be disastrous for patients and will have unintended consequences upon the quality and costs of American health care for generations simply because Americans had their medications destroyed by the American government.”