Call for Public Hearings on rules about seizure, destruction of Americans’ authentic medicines

FDA has not adhered to The Administrative Procedure Act (APA), which provides the procedures for various types of rulemaking that applies to all agencies.

What subject outside of national security is of greater importance than a decision that the FDA may,by seizure and destruction, deprive millions of Americans of their vital, authentic and safe medicines

— Daniel Hines

ST.LOUIS, MO, USA, July 21, 2015 /EINPresswire.com/ -- The publisher of an advocacy website supporting the right of Americans to have access to personally imported brand-name prescription medicines from licensed, registered pharmacies in Tier One Countries has called for Congress to demand public hearings on Section 708 of the Food and Drug Administration Safety Innovation Act (FDASIA) for a 30-day period following the September 30 announcement of the rules for administering the controversial section that could lead to the seizure and destruction of authentic, safe personally imported medicines that provide a vital life line for millions of Americans. 
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.”

Study Identifies Factors Affecting Prescription Pain Reliever Misuse; Illicit drug users at increased risk, but differ by age in how drugs acquired

Newswise, July 13, 2015 — People who misuse prescription pain relievers all have one thing in common, University of Georgia researchers have discovered: a history of recent illicit drug use. How they acquire such drugs varies according to age, however. The findings, published in the journal Addictive Behaviors, may help health care providers and others curb painkiller misuse.

In a nationwide study, researchers from the UGA School of Social Work found that individuals of any age who used illicit drugs such as marijuana, cocaine or heroin within the past year had a higher likelihood of misusing prescription pain relievers as well. A study just released by the Centers for Disease Control, which found that heroin use was highest among those who abused cocaine or opioid pain relievers within the past year, buttressed the UGA research.

“Male or female, black or white, rich or poor, the singular thing we found was that if they were an illicit drug user, they also had many, many times higher odds of misusing prescription pain relievers,” said Orion Mowbray, an assistant professor in the School of Social Work and the UGA study’s lead author.

The UGA researchers also determined that adults aged 50 and above were more likely to acquire pain relievers through more than one doctor, whereas younger individuals were more likely to acquire them from friends, relatives or drug dealers.

The investigation was based on more than 13,000 responses to the National Survey on Drug Use and Health. The annual survey, sponsored by the U.S. Department of Health and Human Services, collects data on the use of tobacco, alcohol, illicit drugs, prescription drugs, and mental health problems among individuals aged 12 and older.

Prescription pain relievers represent the majority of all prescription drugs that are misappropriated in the U.S., and misuse has risen dramatically in recent years.

 The most over-used pain relievers are opioids—addictive painkillers such as codeine, oxycodone and morphine.

According to a 2013 report by the Substance Abuse and Mental Health Services Administration, a unit of the HHS, emergency room treatments for opioid misuse—including suicide attempts and accidental overdoses—increased 183 percent from 2004 to 2011.

The reason for the increase is not clear, but the report offers possible solutions to address the problem.

“If we know how people come to possess the pain relievers they misuse, we can design better ways to lower that likelihood,” said Mowbray. “This study gives us the knowledge we need to substantially reduce the opportunities for misuse.”

The study calls for greater coordination between medical care providers to reduce the possibility of over-prescription of painkillers, and for improving the communication between doctors, patients and the public.

“Doctors may conduct higher quality conversations with older patients about the consequences of drug use before they make any prescription decisions, while families and friends should know about the substantial health risks before they supply a young person with a prescription pain reliever,” said Mowbray.

Adam Quinn, a doctoral student in the School of Social Work, contributed to the research. The study, “Prescription pain reliever misuse prevalence, correlates, and origin of possession throughout the life course,” is available online at http://www.sciencedirect.com/science/article/pii/S030646031500194X.

UGA School of Social Work

Founded in 1964, the University of Georgia School of Social Work provides instruction, research and hands-on training in social work practice while emphasizing the integration of social work with social justice. For more information on the School of Social Work, see http://ssw.uga.edu/.

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.

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.