Is the U.S. Food and Drug Administration playing by the rules in its own rules-making responsibility?

Publisher’s Note: This is the first of two articles on the misapplication of the implementation by the FDA of its own rules.  In the second article, we will explore the legal requirements for rules promulgation to ensure transparency and stakeholder involvement by the public in the rules-making process, and examine how potential abuses of  the soon-to-be announced rules for Section 708 of the Food and Drug Administration Safety and Innovation Act (FDASIA)passed by the U.S. Senate.

Section 708 legislative language authorizes the FDA to promulgate rules regarding the disposal of imported medicines valued at $2,500 or less by the Secretary of Health and Human Services (HHS) that are deemed to be counterfeit, from bogus pharmacies, pose a threat to the American health, or, are ‘misbranded.’

FDASIA is one of the most misnamed and misleading pieces of legislation ever, as the bill’s title would suggest that it will lead to improved safety of personally imported prescription medicines.

Actually it has the potential for abuse that could further limit the options available to millions of Americans for whom personal importation of their medicines offers the only sure, safe and affordable alternative to pharma’s predatory pricing practices.

The fact is that personally imported valid and affordable brand-name maintenance medications are medicines produced at FDA-approved manufacturing facilities outside the U.S., or at plants outside the U.S. licensed by pharmaceutical manufacturers themselves.

So, why are they subject to seizure?

A major area of potential abuse:  It’s a magic piece of paper—the label—that is the cause.

The medicines may be deemed ‘misbranded’ because they are labeled according to the rules of the country of origin of the shipment, and lack a particular U.S. identity code ‘required’ by the FDA. 

Significantly, there will be no attempt by the FDA to ensure the authenticity of the seized medicines, relying instead solely upon the ‘power’ of a label that it claims can make a safe and authentic medicine, potentially threatening to American health.

FDASIA does provide for an ‘appeals process’ by citizens whose vital medicines have been seized and are subject to destruction, but the format of this effort to satisfy the rights of Americas to due process will not be known until the rules are announced.

Thus, the legislation and the FDA rules will create a spectacle of the FDA, an agency ostensibly designed to protect the health and well-being of Americans actually destroying safe, valid medications.  

Shockingly, without Congressional oversight, this destruction will be done with the tacit approval of the U.S. Senate, even though prior to the passage of Section 708 and FDASIA in 2013, an aide to Senator Tom Harkin (D-IA), then the Chair of the Senate HELP Committee, assured us that Section 708 was in no way targeted for seizure and destruction of personally imported medicines.

All of which leads to the importance of ensuring that the FDA is ‘playing by the rules’ they claim to follow, and if not, how can we be sure they will not abuse Section 708 rules that are not yet announced.

For example, the FDA says that while personally imported medicines are traditionally subject to seizure, it also sets out guidelines under which it may consider exceptions: (the following is from the FDA page at http://www.fda.gov/ForIndustry/ImportProgram/ucm173751.htm :

“The General Guidance Section states that FDA should consider not taking enforcement actions against such importation:
"when 1) the intended use [of the drug] is unapproved and for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means;
 2) there is no known commercialization or promotion to persons residing in the U.S. by those involved in the distribution of the product at issue;
 3) the product is considered not to represent an unreasonable risk; and
4) the individual seeking to import the product affirms in writing that it is for the patient's own use (generally not more than 3 month supply) and provides the name and address of the doctor licensed in the U.S. responsible for his or her treatment with the product or provides evidence that the product is for the continuation of a treatment begun in a foreign country/area." (Emphasis added)”

The answers to 1) and 2) offer an opportunity for the FDA to engage in a unique double speak that characterizes that patient safety is not the determining issue of the FDA.

In 1), the FDA says that if the intended use of the drug is unapproved and for a serious condition for which effective treatment may not be available in the US, it might, therefore, be eligible for exemption from ‘enforcement actions.’ Ironically, FDA in many of its letters over the years in an attempt to justify  seizures states that the reason for the seizure is that it is for  ‘new’ or ‘unapproved’ medicines.  

Of course, they say this about Lipitor, all of which Pfizer has manufactured for years at a plant in Ireland.

 FDA can’t have it both ways as in 2) it says the drug may be turned away if there is a commercialization or promotion to Americans.  If it is, how can it be an unknown drug? If it is a known medicine,  can be shown to be a valid medication that is safe, the patient affirms that it is for the patient’s own use, and that his or her personal U.S –licensed physician has prescribed up to a 90-day supply, what are the grounds for a seizure?

More double-speak: What if the treatment for allowing the patient to have his or her medicines is dependent upon where the patient has started the treatment process in a foreign country?  

Does this mean that if someone orders a medicine and started the treatment procedure in Canada...or Australia...or New Zealand...that it is the geography of the launch of the treatment that is the determinant of the process, and not the medication itself? 

Finally, the recent surge of the obscene price increases of specialty medicines (the $1,000 pill) and the spike in generics shows that Pharma and even the generic industry will raise prices at will when they can, leading to the most telling evidence that proves the lie to 1) because a medicine that is unaffordable is unavailable.

This a fact being proven virtually every day as a growing number of Americans face life-or-death situations for specialty meds, and, as regards maintenance medicines, an estimated 55 million Americans forgo their prescribed medicines, denying themselves of the health benefits of access to a regimen of prescriptions simply because they can’t afford them. 

In our next installment, we examine the requirements upon rules promulgators, and the growing public concern about the power on unelected and unaccountable bureaucrats making vital decisions free of oversight and control.