Will the FDA follow the rules when it announces Section 708 Rules ostensibly deigned to prevent unsafe medicines, or will it cater to Pharma to use Section 708 to destroy authentic, safe medicines?

Publisher’s Note:  This is the second and final installment in our reports on whether or not the Food and Drug Administration is playing by the rules as is considers issues of personal importation of safe, affordable brand-name medicines from licensed, registered pharmacies in Tier One countries whose standards of safety and efficacy meet or exceed those of the U.S.  In this installment we take a look at the overall rules affecting mandated guidelines of rules promulgation. We suggest that the FDA is indeed approaching the brink of a failure to meet required standards of rules promulgation, a failure that very likely could lead to establishing a right of judicial review, or at least should prompt Congress to impose its oversight of the administration of Section 708 to ensure that only unsafe, bogus, counterfeit medicines are subject to seizure and destruction. A highly helpful article on this issue may also be found at the paper of The Congressional Research Service report A Brief Overview of Rulemaking and Judicial Review (http://www.wise-intern.org/orientation/documents/crsrulemakingcb.pdf ).  For the record,  the conclusions of this post are mine, based on my understanding of the excellent review by CRS,  and my views as to why I believe they relate to the FDA rule promulgation of Section 708, to be announced Sept. 30, 2015.

The Food and Drug Administration is a particularly unique agency.  Likely, no other Federal agency has such a daily impact upon virtually every citizen of the United States.

It not only defines such vital items as what is a prescription drug, food, medical device, dietary supplement, vitamin, over-the-counter medicine, food coloring, cosmetic, and therapy, it has the authority to determine the many rules that affect how products and services in those categories are to be applied and administered to ensure the safety, health and well-being of U.S. citizens, virtually all of whom have a daily contact with one or more of the products and services that comprise a particular category.

That is why it is imperative that the FDA take extra-ordinary steps to ensure that it is representative of the best interests of all the people, and not merely those of a particular industry.

However, significantly, we are now approaching a threshold of prime importance that will define the shape of the FDA’s ability to carry forth its function, and its relationship and ability to meet its responsibilities to protect and enhance the health and well-being of millions of Americans for whom personally imported prescription medicines provide a vital health line of safe, affordable maintenance medications.

This is because America has the highest prescription drug prices in the world.  And a medicine that is unaffordable is unavailable. Also, a medicine denied is an open door to consequences of personal illness that will place a burden upon the American health care system as conditions that could have been treated with access to affordable medicines are allowed to increase in seriousness. 

This will be accelerated with the potential for abuse of Section 708 of the Food and Drug Administration Safety Innovation Act (FDASIA). 

Section 708 allows the seizure and destruction of personally imported medicines that are deemed to be counterfeit, bogus, potentially harmful to American health, or are ‘misbranded.’

Since any personally imported medicine is deemed to be misbranded, the FDA, an agency designed to protect American health, is in a position to seize and destroy valid, authentic medications. It will be free of any burden of testing the authenticity of the medicine.  This means that a brand name medicine that is virtually the same as that sold in the U.S.,  produced under license of the pharmaceutical company or in a facility approved by the FDA—yes, the very same FDA that would destroy American’s medicine—is subject to seizure and destruction.

As we await the ‘final rules’ announcement of Section 708 rules, it is significant to note that the FDA may not have followed the The Administrative Procedure Act (APA), which, provides the general procedures for various types of rulemaking that applies to all agencies.

There are different types of rules-making procedures:

• Informal/Notice-and-Comment/§ 553—  Generally used to ensure public participation by requiring that the public be provided with adequate notice in the Federal Register of a proposed rule followed by an opportunity to “comment on the rule’s content...” as a minimum, but adds that “although the APA sets the minimum degree of public participation the agency must permit, [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, should naturally be accorded more elaborate public procedures.” While the FDA has allowed preliminary comments from both opponents and supporters of Section 708, there is no indication that there will be additional opportunities for public comment.
• Formal—This does not apply to Section 708 since a Formal procedure requires that Congress require that rulemaking ‘’be on the record.” But therein lies a failure of the Senate which, in passing Section 708 , basically failed to consider the benefits of greater public participation, which would have providedthe opportunity for a ‘calling out’ of the Pharma misrepresentations about safety and efficacy of personally  imported medicines.  The FDA would have had to provide proponents the opportunity to make a case through oral or documentary evidence, in an almost ‘trial-like’ atmosphere since formal rulemaking proceedings must be presided over by an agency official or Administrative Law Judge who traditionally has the authority to administer oaths, issue subpoenas, and exclude “irrelevant, immaterial, or unduly repetitious evidence.”  Equally significant, ”the agency or proponent of the rule has the burden of proof, and such rules must be issued “on consideration of the whole record … and supported by … substantial evidence.”  One may doubt that the FDA could have done so. 
• Hybrid—Again, not applicable to Section 708, since Hybrid rulemaking statutes “may require that the agency hold hearings, allow interested persons to submit oral testimony; and grant participants opportunities for cross examination or questioning.” Interestingly, such Hearings require Congressional action, and were much more common in the 1970s, an indication that unelected rules-makers have gained additional powers. 
• Negotiated—Obviously, this format was not used by the FDA:  “Negotiated rulemaking represents an alternative to traditional informal rulemaking procedures that allows agencies to consult with interested persons and interest groups at the developmental stages of the rulemaking process. The goal of the negotiated rulemaking process is to increase administrative efficiency and decrease subsequent opposition to a promulgated rule by engaging the participation of outside groups with significant interest in the subject matter of the rule.”

It would appear that the FDA will claim that it is meeting the requirements of Informal/Notice-and-Comment/§ 553.  However, it can be said that if that is its stance, it is doing so in a limited manner by failing to deem that additional public hearings even though it is clearly evident that the potential for abuse of Section 708 creates “ [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.”

This begs the question that should be addressed to the FDA Commissioner: “What subject outside of national security is of greater importance that a decision that may deprive millions of Americans of their vital medicines created by the spectacle of valid medicines being subject to seizure and destruction when those medicines can be shown to be authentic, safe and affordable.”

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.

There are many instances that reflect this skewered relationship, too many to list in this post.  I have made many posts on these examples in RxforAmericanHealth.  I also recommend the website www.RxRights.org, the only American-based advocacy group totally dedicated to the role of the right—and need—of Americans to have access to personally imported prescription medicines as the primary source of relief from the predatory pricing of Pharma.

It is imperative that Congress direct the FDA Commissioner to extend the scope of the rules-making process and invite a broader representation of the American public to be able to have the same access to FDA rules-makers that Pharma enjoys and employs in its extensive and ‘rich’ attempts to protect the safe-haven of the U.S. for its predatory pricing. 

A failure by Congress or the FDA to act to provide such participation will reflect a disregard for the interests of millions of Americans whose health needs are in danger of harm from misappropriation of Section 708.