The FDA Ended Your Access to More Economical hCG and FSH

[Nelson Vergel]

These were the public comments received by the FDA (over 400 comments)

Regulations.gov

www.regulations.gov

Here is mine:

Dear FDA Representatives:

I am a consumer and advocate that comes to you with great concern about my and my community's access to fertility biologics such as hCG and FSH. I represent over 38,000 men and women who have joined my educational sites ExcelMale.com and ********'s Women's Health and HRT groups. I am also a long-term HIV survivor, activist, and author of four health books that educate consumers to increase their self-advocacy and health literacy about hormone treatment access.

As you are well aware, under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) - Protein-based drug products like hCG, FSH, and hMG that had previously been approved as "drugs" will now be considered Biologics and will fall under the jurisdiction of the FDA's Center for Biologics Evaluation and Research (CBER). The Drug Quality Security Act (DQSA), previously gave an exemption for not having the need to file and hold a New Drug Application (NDA) for "drugs" that were filed as drugs under DQSA under section 505. Biologics must now be approved and licensed (with a Biologics License Application -BLA) under section 351. DQSA gives no exemptions under section 351. In order to lawfully enter a Biologic product into US commercial distribution, even if the product is an old generic hCG, hMG or FSH that was previously exempted, the seller must hold a BLA for that product. By the plain letter of the statutory law, this would preclude all compounding or production by 503B or 503A without a BLA. Developing a BLA is a costly and long process that is required for new research products that are considered for FDA approval. Having old urinary based gonadotropins be required to go through this process as a new biologic is counterproductive and presents barriers to access to patients who have been using these products for years to improve their quality of life and their chances to procreate.

Compounders have been compounding urine-derived hCG, FSH, and hMG and increasing patient access to these medications for nearly 50 years. Specifically, Outsourcing Facilities have supplied HCG and Hyaluronidase so that clinicians may treat patients and come March 23, 2020 nothing in these drugs will change. For example, hCG will still be the same drug that it was in 1973 when it was approved by the FDA. It is my belief that patients should not suffer due to access issues as a result of a purely regulatory change. If FDA does not clarify that these old medications will be regulated as "drugs" for purposes of Section 503A and Section 503B of the Federal Food, Drug, and Cosmetic (FD&C) Act, significant disruptions to patient access and patient care may arise.

FDA can offer enforcement discretion to allow the continued compounding of certain transition biologics like Insulin, hCG, FSH, and hMG. However, at this time FDA has not offered any information regarding their enforcement intentions. The due date is fast approaching and the community just found out about this potential access disruption issue.

To protect patient access to these medications and resolved the current confusion, I request that the FDA immediately clarify that approved NDAs for biological products that have been compounded for many years continue to be regulated as "drugs" for purposes of compounding pursuant to Section 503A and Section 503B of the Federal Food, Drug, and Cosmetic ("FD&C") Act. This includes but is not limited to the following products: insulin, human chorionic gonadotropin (HCG), follicle-stimulating hormone (FSH), and human menopausal hormone (hMG).

I have written a brief background of what issues surrounding access to affordable hCG, FSH (and HMG) are in the following section.

Thank you so much for your consideration in this matter.

In health,

Nelson Vergel
Consumer and Advocate

File attached

 

[BackToRegular]

These were the public comments received by the FDA (over 19,000!!)

Regulations.gov

Great! Whats the path forward from here?

 

[Nelson Vergel]

We wait and see....

 

[Nelson Vergel]

Well, the FDA did not change its mind. But many compounding pharmacies (including Empower) will continue to make it while they negotiate other options. No supply issues are foreseen yet.

FDA Alerts Compounders of a Major Change in Practice

 

[HealthMan]

Oh great... what a disservice. Thanks for the update @Nelson Vergel

 

[Nelson Vergel]

From Empower Pharmacy:

Empower is still engaging with the FDA and pursuing legislative options to update the Biologics Price Competition and Innovation Act to allow compounders to continue making HCG and other biologics like we have always been able to. Just as there has never been a risk to a prescriber for prescribing a compounded biologic there will be none to further do so.

The Biologics Price Competition and Innovation Act was designed to improve access to important biologic medications including insulin. The effect on compounding pharmacies was unintentional, and to stop compounding pharmacies from producing certain transitional biologics that have been compounded for years goes against the intention of this policy.


In addition, the off-label use of HCG includes infertility and TRT protocols in men. Urologists and men’s health providers have used compounding pharmacies for years, and compounded prescription data is not reported to the government the same way commercial drugs are reported through insurances, therefore the very large patient population who uses HCG off label has not been accounted for. There isn’t enough commercial supply to meet all patients needs at this time. Until there is enough supply to meet patients needs and the discrepancy in policy has been properly addressed, several FDA registered outsourcing facilities are continuing to supply HCG until further notice.


If there is any concern with using compounded HCG, patients can always request a prescription for commercial HCG to fill at a retail pharmacy (You can use GoodRx coupons for 10,000 IU vials https://www.goodrx.com/hcg )

 

[mikeek1111]

Isn't it true that on March 23rd as much as we do not agree with the new laws and guidelines put fourth by the FDA, the FDA has still banned the manufacturing and selling of hCG for both 503a and 503b facilities unless they have the active license in place which could take years to get. Everyone agrees that the law is no good but who gives Empower or these other pharmacies the ability to break the law? Just because there is not enough commercial supply to meet patients needs, what gives these pharmacies like Empower the right to step in and continue to compound hCG? The law is still the law so what makes these pharmacies above the law? In 2019 Empower was cited by the FDA and was banned from compounding and selling hCG because it was not on the shortage list but they disregarded and still continued. So it seems at the end of the day these pharmacies, including Empower, will continue to not follow the law and eventually the FDA will respond.

 

[Nelson Vergel]

I am just glad they are selling it and that they have started legislative action. It seems to me that for someone who is looking for hCG as you are, you seem to be angry at compounding pharmacies that are pushing back on the FDA. That does not make sense to me. You should be rooting for them or anyone else that is still selling generic low-cost hCG in the United States. You can always try to get a prescription from your doctor for brand-name hCG and get it in a regular pharmacy. Why are you worked up about this? I would be worked up about the FDA's decision to make an old off patent generic drug be considered as a new biologic product that only pharma can sell. That should be the source of anger, unless you work for pharma or the FDA.

 

[Cataceous]

... Everyone agrees that the law is no good but who gives Empower or these other pharmacies the ability to break the law? ...

Who gives the majority of all drivers the right to speed on the nation's highways? It's not an ideal situation, but everyone perceives some benefit. The drivers like the lax enforcement and feel like they generally know what a safe speed is. The cops like the possibility of selective enforcement: Since virtually everyone ignores the law they can just about pull over anyone for any reason under cover of enforcing the speed limit. The politicians and regulators have plausible deniability if the higher traffic speeds are linked to higher numbers of deaths.

Anyway, the FDA may not be quite as accommodating in the case of hCG, but you'd think the current administration would be sympathetic to reducing regulation if the issue would get on their radar. Probably not much hope for that while the pandemic continues.

 

[Nelson Vergel]

you'd think the current administration would be sympathetic to reducing regulation if the issue would get on their radar.

We as consumers have not brought this up to the current administration. I am thinking about putting together a petition about this.
hCG is even more important for fertility programs in couples trying to conceive. The average cost of a cycle of in-vitro fertilization including hCG and FSH is $25,000 if you use pharma brands. Two to three cycles are usually required. Crazy!!

https://www.goodrx.com/blog/ivf-in-vitro-fertilization-prices-rose-50-percent-over-5-years/

 

[mikeek1111]

I am just glad they are selling it and that they have started legislative action. It seems to me that for someone who is looking for hCG as you are, you seem to be angry at compounding pharmacies that are pushing back on the FDA. That does not make sense to me. You should be rooting for them or anyone else that is still selling generic low-cost hCG in the United States. You can always try to get a prescription from your doctor for brand-name hCG and get it in a regular pharmacy. Why are you worked up about this? I would be worked up about the FDA's decision to make an old off patent generic drug be considered as a new biologic product that only pharma can sell. That should be the source of anger, unless you work for pharma or the FDA.

I am not angry at all and I am glad someone is pushing back against the FDA and I dont work for either lol just having a discussion. Big pharma used its power to control or try to control the HCG market and it just causes an inconvenience, whether for men on TRT like myself or woman. I welcome the low cost hCG being someone who does not have insurance and now will be paying out of pocket for it. My main point is that until the law is hopefully revised and a decision is made, isnt it true that Empower and others are still "breaking" the law? I don't believe cannabis should be illegal but im not going to grow or sell it while it is in the process of becoming legal and those that do are breaking the law. See the relevance? Just having a discussion on write vs wrong.

 

[Nelson Vergel]

I don't believe cannabis should be illegal but im not going to grow or sell it while it is in the process of becoming legal and those that do are breaking the law. See the relevance?

Imagine that Colorado decided today that selling pot in that state is illegal for the average store and that only large corporations can do it. That is a better analogy to this situation.

 

[DorianGray]

Unless it involves treating cancer or is a component of "women's health", don't expect rationality or a sympathetic ear from bureaucrats at the FDA. But, the more the compounding pharmacy industry, physicians and patients make their voices heard, it can have some weight. I signed one of the petitions and wrote a letter to my congress person also. I encourage others to do the same.

 

[HarryCat2]

Unless it involves treating cancer or is a component of "women's health"

hCG is a component of "women's health", it is used to induce ovulation in women undergoing fertility treatment.

 

[DorianGray]

hCG is a component of "women's health", it is used to induce ovulation in women undergoing fertility treatment.

That is true. But, the FDA could still restrict the product produced by compounding pharmacies as well as off-label use for males. And, even if it becomes an Rx, pharma only availability even for off-label there could be a discriminatory price differential as you see in pricing for Vylessi. No predicting here or purposely injecting negativity, just expressing possibles. The important point is to support compounding pharmacy business of providing that and other potentially beneficial peptides.

 

[HealthMan]

Any update on this issue @Nelson Vergel ?

 

[Nelson Vergel]

The FDA did not care about all our comments. This policy is now in place. Some compounding pharmacies with money are now trying to get their own Biologic License Application- BLA submitted to the FDA. Some are still selling their hCG inventory.

 

[HealthMan]

The FDA did not care about all our comments. This policy is now in place. Some compounding pharmacies with money are now trying to get their own Biologic License Application- BLA submitted to the FDA. Some are still selling their hCG inventory.

Can doctors prescribe HCG across state borders since it is a controlled substance in most places? Meaning when compounding pharmacies inventory ends will we be able to buy in a local pharmacy if an out of state doctor prescribes it and call in the pharmacy?

 

[TheyCallMeTrinity]

Any update on this issue @Nelson Vergel ?

FYI - I just ordered 2 more vials (powdered how I like it so it lasts long term until I reconstitute it) via my doctor who I think still orders through Empower Pharmacy.

 

[DorianGray]

When the last vial is gone, Mexico, here I come!