Conflicts of Interest Mar FDA Pharmacy Committee

Individualized and natural medications are under threat. Action Alert!

Millions of Americans rely on customized medicines made at compounding pharmacies, including bioidentical hormones like estriol. That access is threatened by an FDA advisory committee that is rife with conflicts of interest, including the pharmaceutical industry, which competes with compounding pharmacies.

For years now, we’ve been reporting on the FDA’s Pharmacy Compounding Advisory Committee (PCAC). The committee plays an important role in advising the FDA on implementation of the Drug Quality and Security Act of 2013 (DQSA). Thus far PCAC’s main role has been to make recommendations regarding which substances should or should not be included on the Bulk Drug List as well as the Difficult to Compound list. When finalized, these lists will dictate which medicines can continue to be made at compounding pharmacies—specialized pharmacies that make customized, oftentimes natural medications to meet the needs of individual patients.

Unfortunately, the track record so far has been abysmal, with PCAC routinely following the FDA’s lead and voting to exclude almost every natural medicine with which they’re presented.

A big part of the problem is PCAC’s composition. As we’ve pointed out before, the committee is a stacked deck against pharmacy compounding. Only one member of the committee is a compounder, and he cannot vote. Of the remaining eleven PCAC members, four are academics, three are government officials (one from FDA and two from the National Institutes of Health), and three are non-profit representatives.

Of particular concern is Pew Charitable Trusts’ representation on the committee. Pew presents itself as “an independent, nonpartisan research and public policy organization with a longstanding focus on drug quality issues, including pharmaceutical compounding.” Upon closer examination, though, it seems to us that Pew isn’t so “independent” and may have aligned itself with the pharmaceutical industry.

On June 12, 2017, Pew signed a letter with PhRMA, the trade association for the drug industry, directed to the House Appropriations Committee Chairs and Ranking Members. The letter advocated positions that would financially benefit drug companies, encouraging tighter regulation of compounding pharmacies—which of course make medicines that compete with pharmaceutical drugs.

Then in September 2017 Pew sponsored a Congressional Briefing in partnership with Biotechnology Innovation Organization (BIO), another trade group boasting the biggest names in the pharmaceutical industry. Once again the message was to restrict consumer access to compounded medications, a position that would financially benefit members of BIO.

Pew holds a voting seat on PCAC, but we believe it has a conflict of interest as it partners with pharmaceutical interests on public facing efforts to restrict patient access to compounded medications. Two members of PCAC represent the pharmaceutical industry and compounding pharmacy. Both are non-voting members, in order to mitigate potential conflicts of interest. We don’t believe Pew should hold a voting position on PCAC when it advocates in partnership with pharmaceutical companies and takes positions that could greatly benefit these private entities.

PCAC should be comprised of voting members with an expertise on compounding who can form objective opinions. The rules governing the compounding industry, which is so crucial to millions of Americans, should not be set by competing companies—and their allies—who would benefit if the industry was regulated out of existence. We believe Pew should be replaced with an organization that can fulfill this important function.

Action Alert! Write to the FDA and Congress, telling them that Pew must be removed from PCAC due to conflicts of interest. Please send your message immediately.

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Will Your State Block Access to Natural Healthcare Choices or Supplements?

New bills introduced throughout the US. Will you and your family be affected?  State-based action alerts!

It’s the beginning of many states’ legislative sessions, and there are a number of bills being considered that could affect your access to naturopaths, nutritionists, and supplements, as well as vaccine choice. Check below to see if your state is one of them, and click the link to take action!

Dietetics

ANH believes that the market for nutrition services should be open and transparent, where consumers can decide for themselves the level of education and experience, and the kind of training they prefer in a nutrition professional. Too often, particular trade associations, such as the Academy of Nutrition and Dietetics (AND), the trade association for Registered Dieticians, try to exclude other professionals from practicing and instead create a monopoly for one particular type of professional. In practice this often means that practitioners who don’t ascribe to a narrow set of conventional practices are unable to compete. ANH supports state bills that allow nutrition professionals to practice to the full extent of their knowledge and training. Click on your state to take action below.

Oppose:

New York SB 2231 provides for licensure of dieticians and nutritionists but does not allow unlicensed practitioners to practice “medical nutrition therapy”—meaning that unlicensed individuals could not provide consumers with information related to specific conditions, which we believe is overly restrictive and does not allow all professionals to practice to the full extent of their education and training.

Florida SB 758/HB 561 restricts who can provide diabetes self-management training to someone who is registered and is a certified diabetes educator from the American Association of Diabetes Educators (AADE). This unfairly restricts the market for diabetes education to those certified to the AADE. Patients should be afforded the choice to seek advice from the practitioner best suited to help them, and not have their choices arbitrarily limited by the state government. It is also not the government’s role to deliver business to the AADE, and help them win a monopoly over the diabetes education field.

Support:

Florida HB 1047 opens up the practice of nutrition in the state. The bill allows health coaches, holistic professionals, nutritional therapy practitioners, and others to provide nutrition services, advice, and recommendations without needing a license.

Naturopathic Licensure

ANH believes that naturopathic doctors (NDs) who have been educated at accredited naturopathic, four-year medical schools should be able to practice medicine consistent with that training. This involves a licensure program that provides a scope of practice similar to a conventional medical doctor, keeping in mind that NDs expertise is in natural approaches to health and healing. However, an ANH-supported licensure law for NDs would not exclude traditional naturopaths – those trained by other institutions – from practicing. Although they would not have the same scope as naturopathic doctors, they would be free to continue their current practices. ANH believes that natural health practitioners should be able to practice to the full extent of their training and experience, and consumers—not the government—should decide which credentials they prefer when seeking natural health services.

Support:

Pennsylvania SB 834 sets up a licensure program for naturopathic doctors and defines their scope of practice, while still allowing traditional naturopaths to continue to practice.

Minnesota HB 1138/SB 1514 sets up a licensure program for naturopathic doctors and defines their scope of practice, while still allowing traditional naturopaths to continue to practice.

Supplements

Supplements are a key component of natural medicine. ANH defends consumer access to quality dietary supplements and opposes state efforts to restrict consumer access.

Oppose:

Massachusetts HB 1195 would force retailers to place supplements marketed for weight-loss and muscle-building behind sales counters, accessible only by store managers or pharmacists, and available only to those who are 18 years of age and older.  The major problem with this bill is that we just don’t know how many supplements will fall under its loosely defined categories. Will your protein powder suddenly become over the counter? Or consider weight-loss supplements: will they include natural laxatives? This law will force people into the embarrassing situation of having to announce needing a laxative for a health condition they have—some might even stop buying products they need to avoid this embarrassment. Will probiotics be considered “weight-loss” supplements? We just don’t know, which is why this bill must be opposed.

Vaccines

Many states will be considering bills that limit vaccine choice, whether by eliminating or restricting exemptions or mandating vaccines for children or certain workers. Patients deserve a right to decide which medical treatments to receive, especially when there are safety concerns. There is plenty of scientific data that throws the safety of vaccine ingredients into serious question.

Florida: S 1558/HB 1343 adds HPV to the list of vaccines required for school.

Hawaii: HB 779 would establish a philosophical belief exemption to vaccination.

Iowa: HF 261 and SF 116 would restrict or eliminate the religious belief exemption for parents who don’t want their children to be vaccinated. Support HF 7, which would add a personal exemption to vaccination.

Illinois: SB 741 and HB 2984 would require healthcare workers to get the flu shot and allow any facility licensed by the health dept. to mandate flu vaccines for health care personnel, respectively.

Kansas: HB 2205 would mandate the meningitis vaccine for school children.

Maine: LD 1664 and LD 272/HP 205 mandate the meningitis vaccine for school children.

MN: HF 2379/SF 1994 and SF 1129/HF 2469 would allow minors to consent to HPV vaccination.

Minnesota: SB 760 requires flu vaccines for healthcare workers. SB 741 creates a new law that no mercury-containing vaccines can be administered to children; and HB 1560 prohibits discrimination against unvaccinated children. 

Mississippi: SB 2059, HB 47, and HB 414 would establish religious and philosophical belief exemptions to vaccination, allow adults to deny vaccines, and prohibit Hep B vaccination at birth unless parents request it.

New Hampshire: HB 1503 would allow minors to consent to all medical procedures, including vaccination.

New Jersey: S941, A1847, and A3968/S2332 mandate the meningitis vaccine for college students, the HPV vaccine for sixth through twelfth graders, and mandate vaccines for healthcare workers.

New York: S52/A1810, S3546, A2469, A1230, A933, A738, and S132 would eliminate or restrict the religious belief exemption for parents who don’t want their children to be vaccinated, mandate certain vaccines, including the incredibly dangerous HPV vaccine, and allow health care workers to administer the HPV/Hep B vaccine to minors without parental consent. S163 strengthens and expands the medical exemption to vaccination.

Oklahoma: SB 1123 would eliminate all exemptions to vaccines except for an extremely restrictive medical exemption. There is also a resolution SJR 57, that would put a question on the next general election ballot about eliminating all non-medical exemptions to vaccines.

Oregon:
HB 4157 would mandate the meningitis vaccine for school children.

Pennsylvania: SB 217 would eliminate the conscientious belief exemption, making it more difficult for concerned parents to protect their children.

Rhode Island: H5681 would eliminate the religious belief exemption for parents who don’t want their children to be vaccinated. SB 47 adds a personal belief exemption to vaccines, and H5986 adds a personal belief and philosophical exemption.

Virginia: HB 664 would mandate the meningitis vaccine for school children.

West Virginia: SB 318 would require all healthcare workers to get the flu shot every year. HB 2945 and SB 330 would establish religious and conscientious belief exemptions to vaccination.

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USDA Forgives and Forgets: Fraudulent Organics Certifier to be Reinstated

Organic certifier, banned in EU and Canada, to be reinstated by US. Action Alert!

Sources at the US Department of Agriculture (USDA) have told us that they are planning to recertify ETKO, a Turkish-based organic certifier. As we’ve reported previously, ETKO has been singled out by some countries, notably Canada and the European Union, for its fraudulent certifications. These countries have “decertified” the organization—meaning that they no longer accept ETKO-certified products as organic.

The USDA has had problems with ETKO as far back as 2009, but instead of decertifying this company, it actually reached a settlement agreement with them in 2016. The firm has been under audit by USDA for about a year.

Millions of pounds of fake organic products from overseas have been flooding US markets and threatening domestic producers who follow the rules. One would think that the USDA’s organic program would take the matter seriously and protect consumers from fraud. The agency’s dealings with ETKO, however, paint a different picture.

It’s time for the USDA to protect consumers, domestic farmers, and the integrity of the organic seal by holding fraudulent certifiers accountable.

Action Alert! Write to the USDA and tell them NOT to recertify ETKO. Please send your message immediately.

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FDA Back Channel Lets Pharma Turn Nutrients Into Drugs

Supplements become drugs and you pay. Tell FDA- Not this time! Action Alert!

By failing to finalize a key supplement policy, the FDA has provided a way for pharmaceutical companies to take natural compounds and turn them into costly drugs. The longer the agency delays, the greater the danger that more and more nutrients will be nabbed by pharmaceutical companies, forcing cheaper supplement forms from the market.

L-glutamine is the most recent example. Last year, the FDA announced the approval of a new drug for sickle cell disease called Endari. Endari is an oral powder comprised of L-glutamine, an important amino acid. The drug company, Emmaus Medical, Inc., says in its materials that an IND (investigational new drug) application for L-glutamine was originally filed on May 15, 1997. According to the FDA’s website, there is no new dietary ingredient (NDI) notification for L-glutamine.

If a drug company files an IND application on a nutrient before an NDI notification on that nutrient is filed, the company can ask the FDA to have supplement version removed from the market.

This means Emmaus can enforce its IND and petition the FDA to remove all L-glutamine supplements from the market, at any time. Keep in mind this is the same thing that happened to the pyridoxamine version of vitamin B6 in 2008, and is fast becoming a standard business practice for Big Pharma.

If Emmaus enforces its IND, the only way that L-glutamine supplements could survive is if the FDA decides to consider L-glutamine an “old dietary ingredient” (ODI) that does not require an NDI notification. In other words, a company would have to prove that L-glutamine was marketed “in or as” a dietary supplement before 1994.

This is a key point, and another tactic the FDA has used to benefit the pharmaceutical industry. Defining an ODI as a substance marketed “in or as” a supplement, rather than anything “sold” or in the food supply before 1994 as Congress intended, is an FDA invention. Fewer supplements will qualify as ODIs under FDA’s definition, which means more nutrients could become Big Pharma’s next target.

This would be a critical loss. L-glutamine helps maintain muscle, boosts the immune system, supports gastrointestinal health, and helps to maintain healthy growth hormone levels.

The crux of the problem is the FDA’s NDI notification guidance that we’ve been writing about since the revised draft was released in August 2016. It has now been 24 years since the Dietary Supplement Health and Education Act (DSHEA) was passed, and the supplement industry has been waiting for the NDI policy ever since. Supplement companies do not know which supplements require an NDI notification or the requirements and protocol necessary for such a submission. In the meantime, pharmaceutical companies are taking advantage of the confusion by snatching up nutrients and turning them into drugs.

The FDA must solidify its NDI notification policy, but finalizing the draft guidance in its current form is unacceptable. As we wrote in 2016, defining ODIs as substances marketed “in or as” a supplement before 1994 was an improvement over the original guidance—but it’s not good enough and will mean many more supplements that consumers rely on could be eliminated. ODIs should be defined as supplements sold in the food supply, in any form, before 1994, period. The agency must fix the problems with the draft guidance, and then finalize the guidance.

Action Alert! Tell the FDA to fix the NDI guidance, and then finalize it to prevent more natural medicines from being taken by the pharmaceutical industry. Please send your message immediately.

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