Save Homeopathic Natural Medicines

Save Homeopathic Natural Medicines

The integrated and natural medicine professions urgently need you
to respond to an FDA ‘review’.

Tell FDA your Freedom to Choose these safe medicaments is important to you.Tell your health story.  Medicinal value shouldn’t just be measured in deaths-per-thousand reports in television ads.

We need your help.

Preserve Choice for you and your doctor to access all safe options for individualized care.

What’s at Stake?

See the Presentation to FDA Homeopathic Drug Review Hearing April 21, 2015

See a Sample of the Many Submissions.

What is Happening?

“Homeopathic Product Regulation: Evaluating FDA’s Regulatory Framework”

FDA made an unusually short-noticed announcement of a hearing in Washington DC to ‘review’ enforcement policy. We don’t understand why only 14 days notice was afforded to doctors across the country to respond. Many believe the extraordinary short-notice may frustrate any reasonable response from citizens and broad media interests in safer Health Choice issues.

The April 20 & 21 hearing was fortunately attended by several medical organizations and practitioner experts who confirm Homeopathy applied by trained practitioners maintains the highest safety record and progressively established efficacy among the drug categories that this regulator oversees. Efficacy studies continue to be published and these are showing both better understanding of mechanism of action as well as therapeutic value.

Homeopathy is most often not an island of medicinal approach. It is a toolbox item valued in an integrated medical approach.  Homeopathy is a very important efficacy/low toxicity option for doctors trained in its use in particular situations.

Announcement Issued:        March 27, 2015
Hearing Date:                         April 20 & 21, 2015
Written Submissions            until June 22, 2015

  • Less than 1 month of notice to the public and to professionals to gather presentations and schedule their departures from clinic patient schedules to attend.

See the FDA notice for yourself – Click Here

Doctors and other professionals working in the fields of complimentary, integrated, nutritional and naturopathic medicine dedicated to pushing innovation forward have witnessed a progressive erosion of access to modalities used successfully around the world.

Easy Access to Stories You Can Share With Others

Several past regulatory influences are made infamous in Hollywood movies and documentaries. These films, news articles and books try to alert the public of destructive regulatory activities conducted in the interest of ‘public protection’. Watch and read to see the history for yourself: Dallas Buyers Club , Under Our SkinThe China Study,  Breaking The Set,  FOOD INC. Forks Over Knives , Sicko , PBS Frontline , Breaking The Set. These are just a sample, there are many more.

Public participation has prevented disastrous results in the past.  We believe that participation of the people can have the same result again. We want to help you let the elected officials and regulators know what you think about this Freedom to Chooseissue..

Homeopathy at Work in a Swiss Integrated Approach -10 min film

Perhaps you found, as have many thousands of others, that Homeopathy has made a difference in your own outcomes.  Now we need you to tell the story that statistics did not measure.

Public participation has prevented disastrous results in the past. We believe that participation of the people can have the same result again.

We want to help you let the elected officials and regulators know what you think.

FDA’s Compliance Policy Guide – What’s at stake?

The CPG can be changed without consent or input from your elected officials.

Corporate media articles commonly lump homeopathic products into advertising and stories about non-homeopathic products such as herbal supplements, vitamins, tonics, medicinal foods, syrups etc.. We  see confusion in the interchange of commentary and it seems likely a  consumer goods survey reflects the same confusion. If commentary is sought, we want to get it from those who know the issues personally.

CAM (Comprehensive and Alternative Medicine) and natural medicine practitioner communities have been using these tools internationally for over 100 years.

From the FDA Announcement:  Since 1988, prescription and non-prescription drug products labeled as homeopathic have been manufactured and distributed without FDA approval under the enforcement policies set forth in FDA’s Compliance Policy Guide (CPG) 400.400 entitled “Conditions Under Which Homeopathic Drugs May be Marketed” (see 53 FR 21728, June 9, 1988). The CPG defines a homeopathic drug as any drug labeled as being homeopathic which is listed in the HPUS, an addendum to it, or its supplements. The CPG includes conditions specific to ingredients, labeling, prescription status, and current good manufacturing practice. The CPG can be found at:

http://www.fda.gov/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm074360.htm.

“FDA is seeking broad public input on the current enforcement policies related to drug products labeled as homeopathic in an effort to better promote and protect the public health.” – March 27, 2015

Send FDA Your Comments

We would like you to send your own comments about some of these subjects [we have included our own comments]. For a full unedited view of these bullets see the FDA announcements. See the ‘review’ topic categories here:

  • What are consumer and health care provider attitudes towards human drug and biological products labeled as homeopathic?[As a consumer are you concerned about homeopathy? Tell them why not?]
  • What data sources can be identified or shared with FDA so that the Agency can better assess the benefits of drug and biological products labeled as homeopathic?[Do you have a personal health experience you can share about yourself, family or friend?]
  • Are the current enforcement policies under the CPG appropriate to protect and promote public health? If so, please explain.[We would like to see FDA adopt Mutual Recognition Agreements with countries who have managed homeopathic remedies and other safe category production for over a century. This includes industrialized Europe and Asia approaches, the Ontario Canada approach. We deselect Australia because they don’t accommodate the unique statistical issues presented by the holistic medicine modalities. Several other studies and evidence records are available in journals and the literature marketplace.]
  • Are there areas of the current CPG that could benefit from additional clarity? If so, please explain.[We are satisfied the CPG does not require any changes. Implement MRAs as above and reduce international confusion and redundancy for safe medicinal categories.]
  • Is there information regarding the regulation of homeopathic products in other countries that could inform FDA’s thinking in this area?[Germany and Switzerland are great examples but similar global industrial lobbying is pushing access challenges there as well. Ironically Russia seems to welcome innovation and public freedom of choice in the CAM and Integrated medicine area, while the west considers how to block market access through imposition of fiscal barriers out-of-step with manageable risks. We believe FDA can obtain advice from regulators and practitioners within those jurisdictions. It is important to understand the actual innovations and significant benefits coming forward in individualized CAM and naturopathic healthcare approaches. Consult the international homeopathic pharmacopeia boards staffed by experts in these areas.]
  • A large majority of human drug products labeled as homeopathic are marketed as OTC drugs. Should there be a new regulatory process for evaluating indications for OTC use?[Many uses are in the International Homeopathic Pharmacopeias. In principle, scale the intensity of the evidentiary requirements with the safety/risks presented by an innovative remedy introduction. High risks = high burden; low risk = lower burden, similar to a Canadian approach. New evidence data collection methodologies and standards are in development now. This ‘review’ interrupts that progress.]
  • What processes do companies currently use to evaluate whether such products, including their indications for use, are appropriate for marketing as an OTC drug?[First evaluation is the safety aspects of mother ingredients. After safety is established clinicians will accrue recorded treatment experiences before asserting indications for reference by the public and other practitioners. There are international boards established to review and approve these ‘proovings’. The economic scale of the product development is very small, but the outcomes practitioners attribute to the remedies has been very high. The history of the outcome experiences is the very reason is why the public profile and interest in the importance of this access continues to persist]
  • Do consumers and health care providers have adequate information to make informed decisions?[Statistical Adverse Event evidence establishes homeopathy as one of the very safest OTC categories. That fact and the patient outcomes suggests: YES]

Please provide a short written submission that tells the importance of Homeopathy and Freedom to Choose in your personal health, or that of a friend or loved one.

Do you view homeopathy as a public safety risk? We don’t think actuarial and epidemiological statistics require a safety review. Let the FDA know your opinion.

If you like access to homeopathic medicaments, let FDA know you do not want changes to the Compliance Policy Guide. Please provide any other thoughts you have about access and safety.

Remember to UNCHECK the 3rd Party box on the submission form unless you are submitting on behalf of someone else.

Please provide a short submission: Submission to FDA Homeopathy Review

No Time? …….No Problem.

Copy the suggested letter below, make your own changes, then Paste into the FDA Submission window. Follow the FDA Send instructions.

Please send us a copy of your submission. Paste it into an email to: Healthyfuture@biomedicine.com

The professional medical community and other interested members of the public want to know what you are thinking. We will post opinions on this page as they come in.

We want to make sure the elected officials receive a copy too. If you are a practitioner please use the letter shown below this one.

Name:
Tel:
City:
Zip:

To the FDA regarding Docket No. FDA-2015-N-0540 – Homeopathic Medicine Review

I see no evidence in this announcement or in my experience that causes me to ask FDA for a review.

I wish to state my desire to sustain my full access to Homeopathic Medicaments registered in their country of origin and produced in facilities that are locally GMP certified for such activity there.

I have benefited from practitioner knowledge and product access (personal, friends and family) and wish to continue to enjoy that continuing accessibility. The existing product labels provide required directions for use just as they do for many other products. I regard the product category as very safe.

As a responsible and educated adult I want my doctor and I to have continuing and improving access to all innovative homeopathic medicaments as we may determine are best for incidental applications.

I do not accept erosion of my freedom to choose through new obstructive enactments or changes to the Compliance Policy Guide.

I would prefer to see FDA consider relaxation of marketplace access for internationally sourced GMP medicaments from international researchers and manufacturers to encourage more healthcare innovation and therapeutic benefits for my community. FDA should engage in Mutual Recognition Agreements with industrialized nations regarding many production and market issues, as exists among most other progressive and innovative nations.

I encourage FDA to engage with doctors and researchers who are continuing to record the accruing benefits of homeopathy as part of a CAM and naturopathic medical approach. This evidence collection requires development of specific considerations regarding data collection standards that fit the treatment modality models. FDA should advise government investment in assisting these studies. Guidance is available from existing foundations.

As a voter and a citizen very interested in preserving healthcare Freedom of Choice, I will be discussing this issue with friends and will watch for the outcome of this review.

A copy of my submission will be provided to my federal elected legislator

Doctors

Please provide a short written submission that tells the importance of Homeopathy and Freedom to Choose in your personal health, and that of your patients, friend or loved one.

Do you have a case example that comes to mind? How does Homeopathy fit into your daily practice and medicament options? Give FDA a short summary.

Do you view homeopathy as a public safety risk? We don’t think actuarial and epidemiological statistics require a safety review. Let the FDA know your opinion.

If you like access to homeopathic medicaments, let FDA know you do not want changes to the Compliance Policy Guide. Please provide any other thoughts you have about access and safety.

Remember to UNCHECK the 3rd Party box on the submission form unless you are submitting on behalf of someone else.

FDA Submission Link: Submission to FDA Homeopathy ReviewOur Story

Terra-Medica is a US company, owned by an American, conducting importation, distribution and education for US doctors using important homeopathic remedies and other healthcare products from Europe. Many of these remedy systems have been in global use for over 40 years.

We know the consequence of policy development conducted in isolation. We have 4 of our dear colleagues who have lost significant careers during the very time America needs jobs. America also  needs innovative, affordable and effective healthcare options during a globe-leading explosion of difficult chronic disease.

Terra-Medica is a US company, owned by an American, conducting importation, distribution and education for US doctors using important homeopathic remedies and other healthcare products from Europe.

The FDA has announced a ‘review’ that could fundamentally change access to medicines that have been winning the very successes and innovations we wish to help report.

 

The following is the verbal presentation by Terry Cotter, BSc, to the FDA Hearing on April 21, 2015

Watch This Presentation to FDA Homeopathic Drug Review Hearing April 21, 2015

Good afternoon panel members. Thank you for the opportunity to speak today. My name is Terry Cotter and I am a representative of the professional product distributor Terra-Medica Inc..

My background includes public policy development, much as you are conducting here today, and I respect the responsibilities of that task. I want to talk about consultation within the working culture of regulation.

Terra-Medica represents a homeopathic products from a manufacturer in Germany. They have been sold worldwide for over 40 years, and for roughly 25 years in North America without any safety incidents here or globally.

The manufacturer has been compliant with the local GMP oversight by the German Trade Supervisory Board, or TSB, since new programs there in 2004.

We’re a small company and we import approximately $1.5M of these products annually.

In March 2013 the FDA sent a 2 person GMP audit team to the manufacturing facilities. The auditors spent 7 intensive days at that site.

I, like many others, try to understand deployment of public resources like remote inspections and regulatory reviews like this to mitigate what seem to be relatively small safety risk issues.

In this case-example the FDA didn’t notify the local German TSB before the audit, or provide any post-audit results.

A year after the audit the FDA issued an unexpected surprising bulletin of a new theoretical risk of ‘antibiotic contamination’.

Neither the German GMP authority or the manufacturer were consulted about the intellectual property processes that prevent the ‘theoretical’ problem from arising.

FDA rejected an appeal to present a science dossier outlining the technical issues and Terra-Medica was immediatelyencouraged to conduct a ‘voluntary recall’ in 2014 despite zero evidence of any actual contaminations in 40 years of history.

FDA also sent a press release about this theoretical risk to global health authorities and that provoked international confusion for German authorities.

Most important to this proceeding is that after the press release was issued corporate media started printing flippant generalized headlines about CONTAMINATED HOMEOPATHIC products.

Many of those articles are still on the web. Since the FDA press release last year it seems corporate writers enjoy a new liberal license to write generalities about homeopathic products being contaminated.

This international incident motivated the German regulator to conduct a new site inspection and in December they reported to FDA the products continue to be safe and contamination is not a risk.

The German GMP authority continues to wait since December for any response from FDA. As you can imagine, we are anxiously waiting too.

It is now over 3 months with no response and then we saw the announcements for this Hearing appear.

The medical community here is still in shock. Terra-Medica laid off 4 Americans from significant technology careers at a time when the country needs jobs.

For 2 years I receive calls almost daily from doctors and patients desperate to resume treatment activity.

I have another example about consultation.

A Swiss company is a locally GMP compliant HOMEOPATHIC manufacturer distributing products globally since 1993 and in North America since 2002, and again, without any safety incidents.

In 2008 FDA required Terra-Medica to refer to the USDA because one of the ingredients is a diluted sterile extract of animal origin.

I read the USDA guidance documents and I was sure the products were exempt. But the USDA analyst didn’t agree and despite my insisting would not consult with any other experts. We proceeded to pay annual permits.

6 years later, in 2014 a shipment was stopped and I had to contact a Senior Staff member at USDA to add a ‘shipper name’ to the paper.

That senior official asked me “Is all the product in finished packages?”. I said yes. She said “Your products are actually exempt from our oversight anyway”.

I asked for a short letter to help other staff next time, but she said Terra-Medica must ‘take our chances’ with the system at each importation.

In both my stories I have watched while regulators seem to operate in isolation.

I hope this review will be proactive.  Engage with the right people, (which seems to be passively happening here because so many great people came), and get input from the practitioner experts who see the daily benefits of HOMEOPATHY. The people working at HPCUS would be a great resource for example.

In the many conferences I’ve attended in North America and Europe I want to pass on to you that Great Ground-breaking things are happening out there in integrated approaches.

Homeopathic medicine is not an island unto itself. but It is a part of a broad integrated approach that includes conventional medicine.

I’m not hear to complain about my services, I’m here to ask you to carefully consider the balance between real public safety in a low risk category against the interests of innovation.

We have heard from HPCUS that there have only been 9 new medicine monographs approved in 10 years.

Balance the height of the safety bar against the real risks. My fear is that innovation will be stifled in North America.

My written submission has much more detail for you.

Thank you for your attention.

* * * * * * * *

Our Written Submission:

The Review Process

I am a Bachelor of Science graduate in Biology. My education has included Parasitology, Microbiology, Histology and Toxicology.  For a short time I worked in a toxicology laboratory evaluating pesticide residues. Later I became interested in entrepreneurial activities and then business management in a larger corporation. My background includes experiences in trade association boards, chamber of commerce executives, as an elected official and as an appointed representative to intergovernment committees.

Today I am responding as a representative of the product distributor Terra-Medica Inc.. Our operations center is based in Ferndale WA. We are an importer, distributor and practitioner educator to professional markets on behalf of homeopathic remedy manufacturers in Germany and Switzerland. I am not a practitioner but I have spent a large part of the past 6 years in conferences and education programs connected to the CAM (Complementary and Alternative Medicine) and naturopathic medical modalities and its professional members.

The Homeopathy Review hearing dates were announced on March 27, 2015. I discovered the announcement via a peer link on social media. I do not know how the notice of the hearings was conveyed to the many medical boards, medical schools and professional/industrial associations who are aligned to homeopathy, CAM and natural medicine approaches. I hope it was but it seems to me many medical community members have not been aware of this announcement.

While I am typing my own submission to meet the 5pm deadline April 13, 2015, I am continuing to respond to calls from medical practitioners who do not understand what is happening. Many doctors seem to be getting home from spring vacations last week and this week.

It is my opinion that the HPUS Board, an important FDA Advisory Mechanism in recent decades, is comprised of the very professionals who should be helping gather valuable and broad input. They will know virtually all of the associations, initiatives and research projects building upon successes locally and internationally.

My own opinion is that there is no evidence provided to me by practitioners utilizing these medical applications that has ever suggested a need for a broad review or changes to the Compliance Policy Guide. I am convinced that Freedom to Choose, for doctors, patients and the public is the predominant subject at risk.

Of course, it is possible there may be a case for investigation of a specific homeopathic remedy. Homeopathy seems to generally possess an extraordinary reputation for safety. I recommend that FDA resolve product issues as they appear using open validation and consultation.

The story about ‘using a sledgehammer to swat a fly’ comes to mind again and again as I consider this review announcement. The rushed process seems entirely out of step with urgency of the reality and I detect that this causes great concern for many doctors.  I have found that these professionals, who are on the community’s side when it comes to medical safety and health innovations, always make themselves available for consultation.

I have told you about my own difficulty to respond to a short-notice hearing. I don’t think I am alone. I ask that in the course of this review that specific input be sought from other manufacturers, wholesalers and resellers of the OTC homeopathic drug products.

Safety, Risk and Efficacy

I meet healthcare practitioners at events across North America and in Europe. These licensed professionals have 8 to 10 years of post-graduate training in a variety of medical fields including MD, ND, DC, HD, DDS, LAc, TCM. These experts should be the go-to people for discussions about safety and efficacy issues. They are on the front lines of those daily experiences.

I have attended conferences hosted by Washington Association of Naturopathic Physicians, Oregon Association of Naturopathic  Physicians, Arizona Naturopathic Medical Association, SPARC, Marion Institute Biological Medicine Network, American College for Advancement in Medicine, A4M, Parker Chiropractic Seminars and several others. I have also attended conference events in Canada, Germany and Dubai. These organizations represent many thousands of practitioners and tens of thousands of patient experiences in recent decades.

In my experience doctors build their medicament toolbox with treatment options they regard to be reliable and safe. When a remedy is denied entry by the regulator for whatever reason the public rarely hear unless there is an amusing conflict or a fashion spin for daily magazine media. In daily healthcare consequences, it is the patient who ignorantly suffers from the loss when the doctor is forced to choose a less optimal option remaining in the toolbox.

I have evaluated the suggestion that there are adverse reaction reports attributed to homeopathy. This happens from time to time in all drug and food categories. I can say that in meeting many hundreds of practitioners at many conference events and I simply do not hear problems like this and it causes me to wonder if the reported ‘homeopathy’ reaction events in your announcement were sufficiently investigated for accuracy.

Print, broadcast and web media seem to regularly confuse homeopathy with herbal medicines, other OTC drugs, syrups, tonics, foods and supplements. It also seems very unlikely that a comment from a confused consumer working from memory would ever be further investigated for validity.

Considering the identification confusion in media already, I think about Jay Leno’s ‘Jay Walk’ segments where most people couldn’t identify which country is on the southern border of Nevada. I have asked myself how likely is it that a consumer goods poll can be accurately used to measure the market size of a specialty medical modality like this. If we want to measure the economic activity of homeopathy I prefer to use actual pharmaceutical trade statistics, not an extrapolation of a small-sample survey about general consumer good consumption. The $3 B estimate seems so out of step with the reality I see on the ground it causes me to negate any possible accuracy without more convincing evidence. I expect the estimate may be amiss by 300 – 400% but that is my intuitive opinion.

Dialogue: The Practitioners, Public and The Media

For years I have watched a fundamental advocacy weakness in the CAM and natural medicine communities in contrast to other industries. On the one hand the doctors are sought out through word of mouth by people needing help, and on the other hand doctors seem to be ill-equipped to tell their success stories effectively to the broader community.

These practitioners are too busy helping patients to be able to speak up. When they leave to attend a hearing that may or may not dramatically impact patient care and the practice, the entire business, employees and services must close.  Advocating for themselves is prohibitively costly.

A recent example of damage from a weak consultation process is the 2015 NY case. The regulator used the wrong tests in an effort to open a public gotcha campaign targeting herbal supplement dealers. We must doubt any industry consultation happened or proper testing would have been used.

Media of all types rushed to print flashy art and headlines that provoked judgement and inflicted reputation damage on the private sector for well over 48 hours. Later the regulator quietly agreed they used an invalid test method.  When these gross mistakes became known the popular media didn’t even notice. Many digital articles still carry the original headline. Worse, the regulator seems to continue to insist new rules are needed and I haven’t heard anything from industry at all. Is this style of oversight and the consequences something the public should expect in a regulator?

It seems to me this is a lesson about the damage to community health issues and private citizens that a regulator can precipitate unintentionally or intentionally. I think it also erodes public trust and that may be even more important. Consultation on complicated matters needs to engage the right people.

Remedies that do not provide competitive benefits to the users eventually lose to better choices anyway. In the case of access to homeopathy 100 years of safe patient benefits and continuing international innovation should tell it’s own story.

Another example that speaks to the responsibility of balancing risk, benefits, consultation and media is the case of Terra-Medica’s Pleo Sanum homeopathic product distribution. In this example I cannot speak directly for the manufacturer but I can relate the story from our own very public experience.

In March 2013 the FDA sent a 2 person GMP audit team to the German pharmaceutical manufacturing facilities and they spent 7 intensive days on the sites.

As a frame of reference in measuring the balance of ‘effort and resources spent vs measurable risk’, this German manufacturer had been exporting  +/- $1.5 M of product to us here annually. The cost to conduct the remote audit of a facility that is already GMP regulated by the German Trade Supervisory Board equals roughly 7% of the annual value of the entire importation. It’s an important consideration in trying to understand relative policy guidance that uses public resources like remote inspections and reviews in mitigation of measurably small public safety risks.

The German manufacturer prepared a calendar action plan for responsive housekeeping actions following the inspection and provided it to the FDA. I don’t find any information that the FDA notified the German Trade Supervisory Board before the audit or with any post-audit results. Perhaps it should be standard protocol as a courtesy to the local public health authority.

Five months of action plan progress was near conclusion in August 2013 when FDA issued an import alert when the second shipment arrived. There was no advance notice of the alert action provided to the manufacturer or to Terra-Medica. The shipment was held for weeks in Seattle while we sought information and eventually it was returned to Germany at great expense. The manufacturer expedited completion of all the inspection orders and provided that confirmation.

In March of 2014, a year after the audit inspection, the manufacturer received a new FDA bulletin of a theoretical risk of cross contamination. The German Trade Supervisory Board regularly monitors GMP aspects of the proprietary processes that were being noted. Neither the local GMP oversight authorities or the manufacturer were consulted for details relating to the process that prevents the ‘theoretical’ problem. No evidence of any contamination has ever been found, it was just a theory conjectured without the benefit of process details.

Despite a record of zero contaminations in over 40 years of production history and an available science dossier outlining the process in question, Terra-Medica was encouraged to conduct a ‘voluntary recall’ in the USA in 2014. Media accepted an FDA press release without any investigation of facts and began printing general and flippant headlines about contaminated products.

FDA sent their press release to many global health authorities and this provoked severe international surprise and confusion over a matter the German GMP authority has already understood for several years. This international incident caused the German regulator to conduct a new site inspection to resolve the matter.

The inspection confirmed the products are safe and there is no risk of contamination.

The Trade Supervisory Board has sent a report to FDA in December 2014 about these new conclusions and for 4 months there has been no response. The medical community here is still in shock and I receive update calls almost daily from both doctors and patients desperate to resume activity.

Again, the reason for the story is to underscore the importance of consultation with all the available expert resources. Poor outcomes have serious detrimental results. Interrupted medicament access for the professionals and the public here has been devastating for them and for us.

The lesson I convey today regarding the new review is to consult with the clinic experts who use the medications daily and know the risks and benefits first hand.

I have one other example pertaining to the desired culture of effective consultation in regulatory processes. Rubimed homeopathic remedies are produced by a Swiss GMP manufacturer and have been available for doctors and patients globally since 1993 and in North America since 2002. There is a European professional society of 1,200 members established in Zurich to foster a collaborative expansion of new medical applications.

In 2008 FDA required Terra-Medica to refer to the USDA because an ingredient in selected 3.5oz shelf-ready packages is a diluted sterile extract of animal origin. I reviewed the guidance rules and it seemed to me that our products were exempt from USDA oversight because they are all final dose forms. The analyst did not agree and would not consult with other experts.

USDA stated we required an annual permit to allow us to certify each shipment as biohazard-free. We did this annually and paid our fees on time.  In 2012 a staff person moved and she changed her address and contact information on the permit form. The USDA debated suitability of keeping her name on the document if she worked remotely from a different office. In late 2014, after 10 months of debate and stock-outs, we obtained a renewed permit.

I was frustrated to see the first importation stopped and I needed to contact a senior official at USDA to have a ‘shipper name’ added to the permit. In that conversation she asked “Is all the product in finished packages?”. I said yes. She said “Your products are actually exempt from our oversight anyway”. She charged me $75 to amend the paper and the delivery was completed.

I asked this senior official for a short letter to assist us if further questions would arise from less-knowledgeable staff again. She told me it’s not USDA policy to provide interpretive assistance to other staff through letters. We must ‘take our chances’ with the system at each importation.

In both stories we have watched while regulators have seemed to operate in isolation. It is a culture that is frustrating to watch as it unfolds.

Today’s message is not about our particular services, it is about this review and the working culture we hope it unfolds within.

I came to the hearing to present these illuminating stories because I want to provoke mindful consideration of the harm that can be caused by incomplete consultation.

I want to be considerate of the public trust and also remain a strong advocate for the public Freedom to Choose. Many of us in this profession believe the real risk at stake today is the consequence of an unbalanced review. We must trust you to take proactive steps to assure the correct expertise is heard and understood.


Regulatory Recommendations

It seems to me that especially in recent years a renewed effort has been widespread to develop education programming, research and data collection pertaining to efficacy of CAM and naturopathic approach in healthcare generally. This technology is moving forward at an exciting pace – both outcomes and opportunity to report new results data are moving forward in step with the modest resources and momentum available to this developing discipline.

Not long ago homeopathic hospitals and education were widespread in America. In the last century the fiscal boom in orthodox medicine saw new profit centers evolve and facilities changed hands. The value of holistic approaches didn’t leave the table, just the spotlight.

Publications and reviews regarding the healthcare opportunities presented by homeopathy specifically, including evidence supporting a wide variety of applications and co-applications is abundant. These many publications record the professional experiences and gathered evidence from many healthcare professionals and it is openly available in libraries, journals and the literature marketplace.  These public policy, application guides and case study documents collectively speak to a significant categorical record of safety, economy and efficacy in helping the public at home and abroad.

I don’t want to represent homeopathy as miracle medicine. Like any medicament category it has appropriate uses and there will be many circumstances where other methods will be recommended. The point to be made today is that homeopathic product access remains important in healthcare choice.

I recommend that FDA enter into Mutual Recognition Agreements with the European and other industrialized nations, just as most other progressive countries have done, specifically  regarding GMP and registration standards. This will prevent the many issues we have observed and presented here: international confusion, unnecessary administrative costs, staff redundancy, and improve the opportunity for innovation to grow and local employment to follow in those steps.

I believe there is a need for regulators to be cognizant of a responsibility to provide stewardship to industry that enables flexible function of the local economy within the informed parameters of safety, choice, community benefits and opportunity for innovation.

What I can say by own experience in all accounts over several years from many professionals and patients is that homeopathy is a very important, safe and effective treatment option.

I advise a determination to preserve the Compliance Policy Guide in the current state, and where possible, enhance access to similarly safe health technology innovations for the benefit of all our communities.

Thank you for your attention

Terry Cotter
1-888-415-0535

Advertisements

About Little Bitte

Artist - Entrepreneur Owner, Bitte Artisanal Catering
This entry was posted in Uncategorized. Bookmark the permalink.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s