Here’s the issue: The FDA is once again overstepping by protecting the interests of Big Pharma rather than patient care by restricting access to compounded medicines. Physicians and patients will lose access to these safe, effective and cost effective medications unless we act using the legal methods demonstrated to defeat prior FDA overreach. The activities of FDA staff have been inspired to act quickly to approve the restrictive policies and ignoring the Presidents action to freeze new agency rules. FDA is claiming a “health and safety” exemption from Trumps federal policies freeze.
Background: The Food Drug and Modernization Act (FDMA) and the Drug Quality and Security Act (DQSA) were passed after the tragedy in Massachusetts by a compounding pharmacy that distributed steroids corrupted with mold that were used in epidurals that killed patients. FDA has recently approved rigid and illogical rules to restrict the availability of compounded medications with a long history of safe and effective use (such as glutathione). The new rules require FDA approval for all compounded medicines and requires proof of safety and effectiveness. If there is an approved drug that treats the same condition or disease, as the safe and effective compounded substance then the compounded drug is not needed and not approved unless it offers a definite unique therapeutic benefit. This is a very unusual and biased requirement for a medication and is illogical. There are approved drugs for cancer, arthritis and autoimmune conditions. Why would we discard the affordable, safe and effective compounded medications?
The FDA’s history is clear: give them an inch, and FDA will interpret it as a mile. What it all means: Currently the compounded medicines that we use daily are only available under a “safe harbor“ provision that will go away once the FDA rules process is finalized. Our actions will at least delay their removal and if successful with establish a sane-scientific procedure to evaluate which compounded medications shall remain available. FDA actions will severely limit your right to prescribe compounded medications either by oral or intravenous administration. Big Pharma wins by eliminating access to many safe, effective and affordable compounded medications. As a result, doctors and patients will be forced to buy only expensive, Big Pharma medications.
How to defend: We will be submitting a citizens petition to challenge the FDA (fools) rules. The citizen’s petition is an established legal procedure that has successfully defeated FDA. The Integrative Medical Consortium, http://integrativemedicineconsortium.org, has been working and funding this effort for 2 years. IMC member include ICIM, ACAM, American Academy of Environmental medicine and American Association of Naturopathic Physicians. Our esteemed attorney is Alan Dumoff, Esq. Another group; the IACP International Association of Compounded Pharmacists (IACP) has a focus on passing a new law that restricts FDA actions on office use and interstate commerce. Our efforts with the citizen’s petition are a back up to their efforts but also directly address practitioner concerns about the specifics about the drug approval process. If “office use” provisions become more reasonable but the substances we use daily are not approved then we have won a battle but lost the war.
What it would cost to defend: We expect a 2-year process that will cost upwards of $40,000 for the next 12 months. The outcome of our 2017 efforts will determine costs for the second 12 months. We have funded to date $30,000 in legal expenses.
What you can do: Contact your legislator with the attached link: Take action now! Please consider financial support our legal efforts. Here is a link to video that describes the situation. It also is a donation website all of which goes to legal costs. “Defend Glutathione Fund” Michael Cronin, ND Chair, Integrative Medicine Consortium

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Office Use

“Office use” is when a physician, in his or her office or other treatment area, administers a compounded medicinal preparation directly to a patient for the immediate treatment of a problem. In these instances, a doctor would need to have a reserve supply of the compounded drugs on hand. This enables doctors to provide immediate relief to ailing patients who come into their office, or to have a ready supply for patients whom they have a long history of treating.
For decades, the regulation of “office use” was left up to state pharmacy boards, and most state boards allowed physicians to keep a supply of compounded drugs on hand without prescriptions, recognizing that patients’ well-being depended on it. This changed with the passage of the DQSA.
Congress’s intent was to give the FDA clearer authority over compounding, and it did so by enacting an amended version of Section 503(a) of the Food, Drug, and Cosmetic Act. Congress essentially told the FDA to start enforcing the rules that were already on the books; the DQSA is completely silent on the issue of office use. The FDA, however, immediately indicated it would apply the DQSA in a way that would eliminate office use.
This apparently came as a surprise to some legislators, who wrote a letter to the FDA reiterating that it was Congress’s intent to leave office use up to the states. In a written response, the FDA was resolute in its decision: “A compounding pharmacist may not dispense compounded medications for office use, but rather, must obtain a prescription for an individually identified patient.”
As you might guess, this has caused a tremendous amount of confusion in the medical community and among many state pharmacy boards that have historically allowed office use. Fearing retaliation from the FDA, pharmacists are now reluctant to supply doctors with compounded drugs for office use.
A new amendment from Sen. David Vitter (R-LA)—the Saving Access to Compounded Medications for Special Needs Patients Act—clears up the confusion by amending 503(a) to unambiguously allow office use and preserve the ability of doctors to promptly and effectively treat their patients.

Interstate Commerce and the Memorandum of Understanding

Traditional compounding pharmacies are only allowed to ship 5% of their sales per month out of state, unless they enter into a memorandum of understanding (MOU) with the FDA. The law does not define the limit once a pharmacy has entered into an MOU, but the FDA has created a threshold of 30% in their new rules.
These limits are completely arbitrary and having nothing to do with the safety of consumers. If 30% is safe, why isn’t 10%, or 20%? Is 31% suddenly unsafe for consumers? Is 50%? Additionally, how can a pharmacy be sure that it has not or will not exceed any specific percentage until the end of the month, when it’s too late to do anything about it?
In addition, many states will refuse to sign an MOU with the FDA because by doing so they agree to assume full regulatory responsibility for the pharmacies. In all likelihood, the FDA designed the MOU offer in a way that they knew would be rejected. In our opinion, the objective behind all of this is to shut down compounding simply because it threatens Big Pharma profits, and Big Pharma funds the FDA.
Sen. Vitter’s amendment addresses this issue by stipulating that, if a compounded medication is for an individual patient, there will be no cap on the amount that a pharmacy can ship interstate. It also stipulates that the MOU will not create unfunded regulatory burdens for states, which makes the prospect of entering into an MOU less onerous for states.
The amendment doesn’t fix all the issues that have arisen with new compounding regulations, but it takes a number of strong steps to address some of the worst problems. If passed, this amendment would go a long way in preserving consumer access to important compounded medications.
Action Alert! Write to your senators and urge them to support the Vitter amendment, which would take major steps to preserve consumer access to compounded medications. Please send your message immediately.

The post New Amendment May Help Save Compounded Drugs first appeared on Alliance for Natural Health USA - Protecting Natural Health.

I have been using AMP [as I] suffer from chronic fatigue and muscle fatigue when carrying out simple tasks like hanging out the wash, brushing my teeth and making the bed.…[AMP] provides significant relief from muscle fatigue. It doesn’t take away all fatigue but it helps me to function and do tasks that I would struggle with otherwise.

Given the multiple uses and benefits of this treatment, why would the FDA seek to remove AMP from the market?
In 1997, the FDA Modernization Act called for the establishment of a list of drugs that have been withdrawn or removed from the market because they “have been found to be unsafe or not effective.” Drugs on this list would not be able to be compounded. In 1998-99, the FDA proposed and finalized an initial list of compounds for the Withdrawn or Removed list, which included adenosine phosphate. Documents from the Compounding Advisory Committee meeting at the time show that there was no safety concern with adenosine phosphate—it seems to have been included on the list because the Compounding Committee concluded that adenosine phosphate was not effective as an anti-inflammatory and a vasodilator. The committee’s discussion, as far as we can tell, did not include any mention of other therapeutic uses of adenosine phosphate or AMP.
Last year, the FDA published a proposed rulemaking and solicited public comments on a number of revisions to the Withdrawn or Removed list. One comment sought clarity on the list’s entry on adenosine phosphate: did the listing for “adenosine phosphate” include all three forms (mono-, di-, and triphosphate)? To answer this question, the FDA once again sought the advice of the Compounding Advisory Committee. The Committee concluded that the entry for adenosine phosphate should be amended to reflect that all three forms of the compound are included and may not be compounded.
It is not clear yet what the FDA will do with this recommendation. Normal procedure dictates, however, that any new inclusion on the Withdrawn or Removed list requires a proposed rulemaking so the public and other stakeholders can weigh in. If the FDA wants to include three forms of adenosine phosphate on its list, then it must go through the proper channels and give the public a chance to provide input. To our knowledge, no such rulemaking has been proposed for including AMP on the list following the Compounding Committee’s recommendation, leaving no option for the public to voice their concerns.
Apparently the FDA views public involvement on these matters as an unnecessary roadblock. Last year, the FDA proposed that future additions to the Withdrawn or Removed list not go through the rulemaking process at all, shutting out the public from having any input regarding which compounds are added to the list.
This strikes us as particularly sneaky—killing two birds (removing a helpful supplement, and keeping the public in the dark about it) with one illegal stone. The proposed rule to eliminate the public from this process has not yet been completed, so the FDA is legally required to respond to public comments on the rule and issue a revised, proposed final draft of the rule. It is therefore still illegal for the FDA to add AMP to the Withdrawn or Removed list without going through a proposed rulemaking.
We must not let the FDA and the Compounding Advisory Committee, which already have clear biases against compounding, remove important treatments from the market, especially without first going through a formal, public process.
Action Alert! Tell the FDA that they should not remove the public from decisions over what should be included on the Withdrawn or Removed list. The public has a right to voice concerns about losing access to important treatments. Please send your message immediately.

Action Alert! Write to the FDA and tell them to preserve consumer access to AMP, a treatment that has no safety concerns and has clear and demonstrable benefits to patients. Please send your message immediately.

 

The post The FDA Appears to Be Breaking the Law in Its Continuing Campaign against Compounding first appeared on Alliance for Natural Health USA - Protecting Natural Health.

• They are not within the USP’s purview or expertise. The USP is supposed to set standards to maintain the quality of drugs and drug components. Protecting compounding and environmental workers from hazardous exposures, while an important goal, is already covered elsewhere under current law. On the federal level there are EPA and OSHA laws that ensure worker safety, and there are state laws as well. There is simply no need for these additional standards—they will lead only to duplication, confusion, and overregulation.
• There has been no assessment by the USP on the extent to which the proposed standards would jeopardize patient access to compounded medicines.
• The USP’s list of drugs considered “hazardous” is overly broad. It includes many commonly used medications such as azathioprine, carbamazepine, and clonazepam, not to mention all contraceptives and hormone replacement therapies that contain estrogen—which means bioidentical estriol is also on the list! These drugs are dispensed by pharmacists, administered by nurses or medication aides, or are self-administered by patients every day.
• The USP is relying on the National Institute for Occupational Safety and Health’s (NIOSH) list of antineoplastic and other hazardous drugs (HDs) used in healthcare settings. However, NIOSH’s own list states in multiple place that there is uncertainty about the contents of their list. They even state that “no attempt has been made to perform drug risk assessments or propose exposure limits.” NIOSH acknowledges that there is little evidence that some of these drugs are hazardous to healthcare personnel, and explains that the organization was enlisted to provide guidance to healthcare facilities, not to provide a mandate—yet the USP is using that same list in its entirety without proper review.
• Many small pharmacies and healthcare facilities will be unable to comply with the requirements. The new standards require that HDs be unpacked from their shipping container and stored in negative-pressure rooms. These have to be entirely separate from so-called non-hazardous drugs. This would require many different physical spaces, which means new construction in most cases.Most small compounding pharmacies simply cannot afford to build entirely separate rooms—in fact, a compounding pharmacy told us that the cost to build new rooms and buy the negative-pressure equipment could cost several hundred thousand dollars. Some hospitals may have more money, but they and physicians’ offices may also lack the physical space for negative-pressure areas. Furthermore, the new standards do not discuss how to handle a combination of so-called hazardous and non-hazardous drugs—which many compounders mix on a daily basis. The requirement for separate rooms should be balanced with the level of risk compounders actually face, not to mention the economic burden being placed on them.
• The impact will be far-reaching. While these standards will have the greatest impact on compounding pharmacies—small traditional compounding pharmacies in particular—they will also affect the day-to-day practices of every healthcare facility that receives, stores, compounds, and administers HDs: regular pharmacies, wholesalers, distributers, hospitals, clinics, and all long-term care and assisted facilities. In the most likely scenario, compounding pharmacies will simply stop making vital drugs that millions of Americans depend upon, while other healthcare facilities will pass the new costs on to the consumer. Once again, regulators are not showing any common sense.

The USP predates the Food Drug and Cosmetic Act (FD&C) and has influenced the development of all drug, compounding, and supplement standards in the US. However, there is a great deal of crossover between the USP and the FDA. For example, FDA staff acts as liaisons to various USP standards committees, and they can ask USP to develop or modify standards. Moreover, FDA can comment on proposed USP standards. In return, USP staff have participated in FDA advisory committees.
That’s why we feel the timing of this revision is suspicious. It comes on the heels of the FDA’s draconian implementation of the new compounding law, which also threatens to force compounders out of business, leaving drugs only available from large pharmaceutical companies producing their one-size-fits-all (and often flawed) products. There has been no inciting incident, no official call to address HDs, as a letter to USP from the International Academy of Compounding Pharmacists makes clear—in short, there is simply no logical reason why USP should suddenly want to create these new standards.
Already some insurance companies are no longer covering certain compounded medications, restricting your access to them. If the USP formally adopts this draft proposal, it will likely only be a matter of time before these new standards are incorporated into federal or state law, just as previous USP standards have been—and that may mean the end of most important compounded drugs altogether.
These new USP standards could easily be the final nail in the coffin for small, traditional compounding pharmacies:

• As we’ve reported in earlier articles, the new compounding law allows traditional compounding pharmacies to ship no more than 5% of their products out of state, while the newly created category of compounder, massive “outsourcing facilities” (which are likely owned by Big Pharma) do not have the 5% restriction. Small pharmacies are crippled right from the start. Note also how nonsensical a small percentage limitation like this is. How can pharmacies know how much 5% really is until the end of the year? By then they have violated the rule!
• These massive outsourcing facilities may have the financial resources to build the new negative-pressure rooms required by the new USP standards—something that could further impoverish small, traditional pharmacies.
• If the traditional compounding pharmacies are forced to shut down, important medications like bioidentical estriol and time-released thyroid will almost certainly disappear with them: big outsourcing facilities are allowed to compound only those medications that appear on the FDA’s yet-to-be-released “allowed” list. As regular Pulsereaders will know, the FDA has attempted repeatedly to eliminate estriol, so it’s extremely likely it won’t be on the list.

We can’t stress strongly enough the importance of the small, traditional compounding pharmacies. Without them, natural health advocates will simply lose all access to some of the most important medications they rely upon.
Action Alert! The USP is accepting public comments until May 31, 2015. Tell the USP that General Chapter <800> should not be considered a mandate for healthcare facilities and compounding pharmacies, but instead should be listed in the “recommendations” section of the USP standards. Even more importantly, ask the USP to revise their standards to account for the concerns we raised above. Please send your message to USP today!

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The Committee notes that the Food and Drug Administration has begun implementing the Compounding Quality Act by releasing guidances and working to appoint members to the Pharmacy Compounding Advisory Committee. The Committee is concerned that the Food and Drug Administration is not meeting with any stakeholders before publicly releasing further guidance for public comment. The Committee directs the Food and Drug Administration to meet with stakeholders to help inform the implementation of the Compounding Quality Act to ensure continued access to safe compounded drugs for which there is a clinical need.

The language scolding the FDA was inserted into a committee report at the request of Sen. Lamar Alexander (R-TN), who has committed himself to making sure stakeholders are heard: “If FDA isn’t sitting down with doctors, patients, and pharmacists and communicating how it is implementing the law, then I will stay on FDA until it does.”
While we applaud Sen. Alexander for his attention to this matter, it’s difficult not to say, “We told you so!” When the compounding legislation was passed in 2013, we warned legislators that the FDA would exploit the bill to expand and abuse its powers. Unfortunately, we were right. Nevertheless, we thank Sen. Alexander for his support, and encourage further oversight!

In Case You’re New to the Story, Here’s the Saga in a Nutshell…

The Drug Quality and Security Act, which dramatically limited the freedom of compounding pharmacies, was passed in 2013. Ostensibly, the legislation was a reaction to the New England Compounding Center (NECC) meningitis tragedy. In practice, it demonstrated the influence of Big Pharma on the legislative process, and may affect your ability to obtain the individualized medicines you and your family rely on.
The Act will have far-reaching implications for millions of Americans:

• It will likely limit consumer and physician access to many compounded medications, including compounded IV-delivered nutrients and bioidentical estriol.
• Because traditional compounding pharmacies will be limited in how many drugs they can compound for out-of-state patients, you may not be able to get the drugs you need.
• Thanks to the FDA’s favoritism of outsourcing facilities over traditional pharmacies, your doctor may be forced to use large, semi-drug-manufacturers. This may also lead to the closure of many local, traditional pharmacies.
• Doctors are reporting that they’ve already been told by traditional pharmacies that their orders can’t be filled. It seems traditional compounders are hesitant to fill prescriptions out of fear of FDA reprisal or to act without completed regulations.

Congressional investigations have revealed that the FDA had over ten years to protect consumers from the NECC—but completely failed to do so. Even when the FDA’s ineptitude was unveiled, they didn’t admit wrongdoing. Instead, they demanded even more powers—and, thanks to Big Pharma’s lobbying dollars, they received it:
2002: The FDA receives reports that injectable drugs from the NECC are sickening Americans, and may have caused bacterial meningitis in two patients.
2003: FDA officials suggest the NECC be “prohibited from manufacturing” until it improved its quality and safety controls, as there is very real “potential for serious public consequences.” However, the FDA defers any real action to the state of Massachusetts.
September 2004: FDA inspects the NECC.
2006: Based on violations it found during its inspection, the FDA issues a warning letter to the NECC—a full two years after its inspection!
January 2007: NECC formally denies all FDA allegations.
2008: FDA receives a complaint from its Los Angeles District Office about problems with NECC products. Separately, a New England-based FDA official recommends that FDA inspect NECC. FDA declines to inspect NECC, and instead sends another warning letter.
Fall 2012: Fourteen thousand patients receive spinal injections from NECC that are contaminated with fungal meningitis. Over 700 people are sickened; fifty-three people die.
October 2012: Several members of Congress announce they will introduce bills focusing on compounding pharmacies. Some of the proposals circulated effectively outlaw all compounded drugs by classifying them as “new” drugs.
November 2012: Congress holds its first hearing on the NECC tragedy, and calls FDA Commissioner Margaret Hamburg to testify. She urges Congress to expand the agency’s powers over compounders. It is later revealed that Commissioner Hamburg failed to share vital information with the committee.
April 16, 2013: After a thorough investigation, the Senate Energy and Commerce Committee concludes that the FDA could have prevented the NECC tragedy:

After reviewing more than 27,000 documents, we found a dramatically different picture than the one painted by the FDA….We now know that doctors, patients, providers, and whistleblowers tried to warn FDA for years that NECC and Ameridose were operating as manufacturers and marketing their products nationwide without patient prescriptions. The FDA was also warned about sterility and safety issues with the companies’ products. Rather than do its job and protect the patients who were taking NECC and Ameridose drugs, FDA chose not to act. We found that FDA focused on perfecting their legal reasons for inaction instead of protecting families. Even the FDA staff wanted to go back and inspect these unsanitary manufacturers. And the FDA hierarchy said “no.”

April 26, 2013: The Senate Committee on Health, Education, Labor, and Pensions (HELP) releases compounding legislation that expands FDA powers to ban many compounded drugs. This bill:

• Broadly empowered the FDA to remove most compounded medications from the market—summarily eliminating drugs like bioidentical hormones (estriol) and clearing the way for more expensive patented drugs.
• Required that doctors add a disclaimer to prescriptions for compounding drugs, certifying that they produced a “significant difference from the marketed drug version.” This would have placed patient prescriptions directly under federal scrutiny.
• Outlined a standard for compounded drug safety and efficacy that would have required double-blind, random-controlled trials—a standard typically reserved for drugs!

May 2013: The Working Group on Pharmaceutical Safety goes public, revealing one of the most influential behind-the-scenes forces behind Congress’ extreme April legislation. WGPS is headed Tommy G. Thompson, former US Secretary of Health and Human Services (HHS) and current chairman of TherapeuticsMD, a founding member of WGPS.
July 2013: ANH-USA obtains a document in which TherapeuticsMD, pitching itself to potential investors, describes the safety and efficacy of bioidentical hormones. They also reveal that well over three-quarters of the market is currently held by compounding pharmacies—and state that this is the market they are going after.
May–November 2013: Several different versions of the compounding bill are considered by the House and Senate. ANH-USA lobbies on Capitol Hill to protect consumer interests and is called on by legislators for advice; thousands of ANH-USA grassroots supporters contact their legislators.
November 18, 2013: Congress passes the Drug Quality and Security Act of 2013. Although serious concerns remain, ANH-USA and its allies win several important concessions, including improved protections for drugs with USP monographs (like bioidentical estriol) and a guarantee that compounding pharmacies could continue to make individualized dosages of drugs.
However, the final legislation:

• Bans compounded drugs from traditional compounding pharmacies unless they are on a pre-approved list, have a USP monograph, or are components of FDA-approved drugs.
• Institutes a new category of compounding pharmacies, “outsourcing facilities,” that can only compound medications on a preapproved FDA list. Although this list has yet to be issued, it’s likely that it will be extremely limited. Meanwhile, traditional compounding pharmacies will only be able to compound drugs that have a USP monograph, are part of an FDA-approved drug, or are on a “pre-approved” FDA list. They’ll also only be able to send 5% of total prescriptions out of state.
• Puts in place large hurdles for doctors who desire to use traditional pharmacies, forcing many to use only outsourcing facilities, thus limiting them to the smaller list of only FDA approved drugs for compounding.

November 2013: The Act enters the regulatory phase, in which the FDA translates the compounding law into rules for doctors and industry.
December 2013: The FDA revokes its 1999 draft list of drugs that can be compounded by traditional pharmacies, leaving doctors in the dark about what drugs they can compound until FDA produces a new list.
December 4, 2013–March 4, 2014: When the FDA issues its request for information supporting their to-be-created list of bulk drug substances that may be compounded, the agency sets a deadline of three months in which to submit formal comments. Although ANH-USA and its allies do the best they can, it is impossible to give FDA the information they requested in such a short timeframe. In fact, we estimated it would have taken over thirty months, not three—that’s 15,000 hours, or 1,875 business days—to properly gather the data.
May 2014: Congress chastises FDA for its treatment of stakeholders.
Action Alert! Thank Sen. Alexander and the Senate Appropriations Committee for their support, and encourage your own senators to exercise greater oversight over the FDA in their power grab. Make sure they know how important compounded drugs are to your family. Please take action today!

The post Congress Chastises FDA: “You’re Not Listening!” first appeared on Alliance for Natural Health USA - Protecting Natural Health.

Technically it was a “unanimous” voice vote. But they didn’t keep a tally, so there’s no record of which senators didn’t vote at all.

• The previous version of the bill would have allowed the FDA to identify bulk ingredients that are allegedly not “suitable for compounding” based on “public health concerns,” even if they have a USP monograph. We managed to strike the language that a USP monograph would not provide protection. Since important ingredients like bioidentical estriol have a USP monograph, this change will ensure that estriol is protected from the FDA and remains available for the millions of women who rely on it! This was a major victory.
• We ensured that compounders could make non-standardized dosages of drugs.
• The new version of the bill maintains the standard we inserted (from current law) for the definition of “difficult to compound.” Previously the bill had no standard, giving the FDA far too much freedom—it would have let them ban whatever they wanted. Importantly, the language no longer includes time-released medications among those deemed “difficult to compound” and therefore potentially banned.
• The provision that compounders needed to perform random controlled trials (RCTs) in order to meet a “safety and efficacy” standard was removed. This was a backdoor approach to banning compounded medicines, because everyone knows that no one could afford to pay for those trials of non-patentable or off-patent drugs, and RCTs in any case are inappropriate for medicine that is—by definition—individualized as compounding is.
• We were also able to remove the requirement from the previous version of the Senate bill that doctors must substantiate the need for a compounded prescription.
• The bill no longer sets up the impossible-to-measure standard that physician office use of compounded drugs can only represent 10% of compounding pharmacy sales, as well as the provision requiring physician reporting within a few days.

What’s still wrong with the bill? It would ban doctors from prescribing compounded nutrients delivered intravenously unless they are on a pre-approved list, have a USP monograph, or are components of FDA-approved drugs. Such IVs are some of the best tools that integrative doctors have. The language about needing to have a USP monograph or being components of FDA-approved drugs came from an old section of the Food, Drug, and Cosmetics Act that had been deemed invalid by federal courts, so in 47 states, physicians have recently had the freedom to prescribe and dispense compounded nutrients of their choice by IV. Another section of the bill makes compounded “copies” of FDA-approved and marketed drugs illegal. This would enable drug companies to raise prices on some drugs to astronomical levels.
We’ll monitor the FDA’s rulemaking process (that is, how they’ll implement the legislation), and we’ll be sure to notify you of problems and opportunities for comment and action.
 
Time and time again, you’ve proven that through your unyielding activism and our combined strength in numbers, we can make a difference in Washington. Thank you again for your hard work on this bill.

The post Congress Passes Compounding Bill—Still Flawed But WITH Your Hard-Won Amendments first appeared on Alliance for Natural Health USA - Protecting Natural Health.

Could it be because the author of the CDC-funded study has ties to the pharmaceutical industry?

The post Why Does a New Study Push Dangerous Estrogen Drugs but Ignore Bioidentical Estriol? first appeared on Alliance for Natural Health USA - Protecting Natural Health.

The post There is Still Time to Take Action to Amend the Compounding Bill first appeared on Alliance for Natural Health USA - Protecting Natural Health.

The House bill is much better than the Senate bill, which is all about giving freebies to Big Pharma under the pretense of making compounding safer. Very importantly, the House bill does not endanger estriol. We are very grateful to our congressional ally, Congressman Morgan Griffith (R-VA) for that. However, there are still some areas of major concern in the House bill, and we are working on Capitol Hill to address them:

• As in the Senate bill, compounders must receive the names of patients who received compounded drugs “for office use.” But in the House bill, they have only seven days to obtain them instead of the Senate’s fourteen days. Logistically and administratively, this is a nightmare.
• Compounded versions of FDA-approved drugs may be banned as “copies of FDA-approved drugs” depending on how strictly that term is interpreted. As in the Senate version, the House’s definition is far too broad, and we fear that it could eliminate access to much less expensive pregnancy medications such as 17P in favor of outrageously expensive FDA-approved drugs like Makena, which costs $690 per dose, or as much as $14,000 over the course of a pregnancy. We are working to tighten the language as to what qualifies as a “copy” of a drug.
• The bill prevents pharmacies from compounding non-standardized dosages of commercially available, FDA-approved drugs. This means that consumers are left to play with the dosages of drugs on their own (such as cutting a pill in half), instead of receiving an accurate, tailor-made dosage from a compounding pharmacy.
• The bill makes the falsification of a prescription a federal criminal act. This may not seem controversial until you realize that prescriptions fall under the practice of medicine, which is regulated by the states, and making such a law allows the FDA to interfere in states’ autonomous practice of medicine. This is especially ominous in light of our recent article highlighting the collusion between state medical boards and the FDA.

Meanwhile, the Senate version of the bill remains the biggest problem, for the following reasons:

• Limits office use: The bill says pharmacies can compound only 10% of the products they dispense each month for doctors’ office use. And compounders must receive, within fourteen days, the name of the patient who received the compounded medication. We are working to get the bill amended to remove the limitations on compounding for “office use” and increase the amount of time pharmacies have to reconcile patient records with the compounded drugs from fourteen to ninety days.
• Bulk ingredients: The bill would allow FDA to identify bulk ingredients not suitable for compounding based on “public health concerns” even if they have a USP monograph which, under current law, is sufficient to allow compounding. The FDA has already attempted to ban bioidentical estriol based on vague “health concerns.” A USP monograph provides ample evidence of safety, so there is no reason it should be overruled in the government’s misguided effort to ban bioidentical estriol.

Let’s keep in mind that the FDA-approved drugs whose monopoly the FDA is trying to safeguard are not bioidentical and have been proven by extensive medical research to be very dangerous for women, specifically representing heart and cancer risks. The FDA is not a department of Big Pharma. And this kind of behavior is really reprehensible when the risks of the FDA approved drugs are at this point settled science and beyond dispute.

• “Difficult to compound”: The bill allows the FDA to disallow entire categories of drugs that are supposedly “difficult to compound,” and specifically names extended-release products (i.e., time-release thyroid medication) and transdermal patches. We are working to remove extended-release products and patches from this classification. Millions of patients rely on these products, which would simply disappear.

• Places limitations on selling out-of-state compounded drugs: Pharmacies that compound for interstate commerce face stricter scrutiny from the FDA. This could affect everyone, but especially those who do not have a compounding pharmacy within their state that can supply all their needs. Those of us on the ANH staff who use compounding pharmacies often have to go out of state to find what we need.

We have already been successful in making some very positive changes to the Senate bill because of the thousands of messages from our readers and grassroots activists like you, together with our meetings with Capitol Hill decision-makers. We got lawmakers to create a standard for the phrase “difficult to compound” so that FDA is forced to meet a burden of proof before they limit consumer access to medications based on this provision. Specifically, we included language that exists in current law: compounding must be “reasonably likely to lead to an adverse effect on the safety or effectiveness of that drug or category of drugs, taking into account the risks and benefits to patients.” We also made sure that the provision that compounders needed to perform random controlled trials in order to meet a “safety and efficacy” standard was removed. This was a real “poison pill” in that no one could afford to pay for these trials. Such a requirement would have inevitably led to the disappearance of many compounded medications, as the FDA (and the drug industry) know well. We were also able to remove the requirement that doctors must substantiate the need for a compounded prescription. This was another gross federal interference in the practice of medicine, which is supposed to be regulated by the states.



As you can see, there is still a lot of work to be done on this bill on both sides of Capitol Hill. Action Alert! We need to flood both the House and the Senate with emails, highlighting our various concerns over each of the bills. Please send your messages to Congress today, even if you sent a message about the Senate version previously!

Action Alert to the House:

Action Alert to the Senate:

The post New Compounding Bill in the House—and More Work to be Done! first appeared on Alliance for Natural Health USA - Protecting Natural Health.

Nutritional deficiencies such as iodine, iron, selenium, zinc, vitamin A, riboflavin, pyridoxine, and B12, along with the use of certain medications including beta-blockers, birth control pills, estrogen, iodinated contrast agents, lithium, phenytoin, and theophylline, can inhibit the conversion of T4 into T3. Other factors that can cause this inhibition include aging, alcohol, alpha-lipoic acid, diabetes, fluoride, lead, mercury, pesticides, radiation, stress, and surgery.

Another problem is that too much T4 can convert to something called “reverse T3,” which has only 1% of the effect of T3, but also binds to the T3 receptor, thus blocking T3 from doing its job:

Factors that may lead to a preferential conversion to reverse T3 include high cortisol, glucocorticoids, stress, excess estrogen, and nutritional deficiencies such as selenium, iodine, zinc, and iron.

All of these factors are common. Some—such as aging, stress, fluoride, and pesticides—are so ubiquitous that it is easy to imagine that a large percentage of thyroid patients are inadequately converting T4 to T3, and thus need a thyroid preparation that contains some T3. There is also the possibility that T1 and T2 are performing functions in the body that we are not yet aware of, and that they need to be supplemented along with T3 and T4 (as they are with DTE).
The basic screening test for hypothyroidism is the TSH test, which is short for thyroid-stimulating hormone. TSH is secreted by the pituitary gland when it senses that thyroid levels in the blood have dropped too low, so low levels of TSH generally mean that there is plenty of thyroid hormone in circulation. But for a variety of reasons, the pituitary can sometimes fail to produce enough TSH (even though thyroid levels are low), in which case a low TSH level would give the false impression of having plenty of thyroid. And even under optimal circumstances, TSH levels can fluctuate.
In 2002, the American Association of Clinical Endocrinologists (AACE), recognizing that many patients are misdiagnosed, lowered the upper end of acceptable TSH levels from 5.0 to 3.0, doubling the number of people needing treatment for hypothyroidism. Under the old guidelines, these people had been considered totally normal, and many had been denied treatment despite predisposing family histories and symptoms such as weight gain, depression, fatigue, hair loss, constipation and high cholesterol, all of which can be caused by low thyroid.
Is it any wonder that best-selling thyroid author Mary Shomon’s motto is, “We’re patients, not lab values”?
Speaking of the acceptable TSH ranges, Shomon notes:

This narrow-minded means of diagnosis has been the “standard of care” for conventional doctors and endocrinologists for decades, based on a near-slavish reliance on the TSH test—often to the exclusion of clinical evidence, symptoms and medical observation.

On About.com, Shomon has questionnaires to assess the risk of both hypothyroidism (too little) and hyperthyroidism (too much).
Another approach followed by some integrative doctors is to use an underarm temperature test, which may be more reliable than the TSH test. One simply measures underarm temperature before getting out of bed. A temperature below 97.4 for several days running generally indicates a problem.
In 2009, thyroid patients on DTE were thrown a loop when the two major makers of DTE—Armour and Nature-throid—both experienced mysterious shortages and could not meet demand at the same moment. Many patients spent hours on the phone, calling pharmacy after pharmacy to find a source of DTE. Fortunately, compounding pharmacies were able to fill in, as they can make DTE in any dose, using the same raw materials as Armour and Nature-throid (although at a higher price).
We’ve been telling you over the past few months (here and here) about a bill moving through Congress to outlaw certain compounded medications. This bill is a blatant move by pharmaceutical companies to eliminate the competition from compounding pharmacies and force people to buy the mass-marketed version of the drugs. That would mean that in the event of future shortages of DTE, people might be forced to switch to the T4-only preparations that leave so many patients with unresolved symptoms.
If you haven’t sent an Action Alert yet on the compounding bill, it’s not too late. We’re asking the Senate to vote No on S.959, to ensure that we don’t lose access to the important therapies supplied by compounding pharmacies. Please take action today!

The post Help Us Protect Natural Thyroid Hormone first appeared on Alliance for Natural Health USA - Protecting Natural Health.