FDA & HCG Availability Mar 2020

[Quester]

I got an email from one of the clinics I have done business with that is of importance to most of us.





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We wanted to make you aware of FDA legislation going into effect on March 23, 2020 regarding availability of hCG and what you can do to make your voice heard.There is a great deal of misinformation circulating on the Internet, so we wanted to clarify for our patients. It is important to note that our pharmacy provider does not anticipate discontinuing hCG without further clarification from the FDA. We do not anticipate any disruption in our ability to source this medication for our patients. However, we expect that many other compounding pharmacies, clinics and patients will be negatively impacted. Read more for details. What is happening with HCG This change actually happened 10 years ago under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) and takes effect March 23, 2020. The FDA did not take compounding into consideration, so there was no commenting period to be able to oppose it at that time. We do not believe it was the intention of the FDA to harm the compounding industry by properly classifying HCG. We are waiting on clarification from the FDA to allow an exception for compounding pharmacies to continue to produce "transitional biologics". Transitional biologics include substances that were previously pharmaceuticals but are now reclassified as biologics. HCG and insulin are the primary drugs everyone is focusing on. What will happen on March 23rd Many compounding pharmacies will be forced to discontinue compounding all products containing HCG without further clarification from the FDA. During this time, compounded HCG and FSH will still be available through an FDA registered outsourcing facility that compounds under cGMP quality controls. (Defy Medical's pharmacy partners meet this high standard.) We believe the FDA will allow the exception but only for pharmacies who are following cGMP since HCG requires a specific environment and testing methodology to guarantee quality. What's Can YOU DO to help? This law was not established to limit access or be anti-compounding, but to expand access and lower pricing. Our pharmacy partners are exploring lobbying options to support a legislative change to the DQSA to provide permanent statutory access to transition biologics for compounding and to gain clarity on this immediate concern. We are confident there will be a positive long-term resolution but YOUR ACTION NOW can help make that a reality. TIPS FOR SUBMITTING EFFECTIVE COMMENTS to the FDA DEADLINE: February 15, 2020

Online FDA Feedback/Commenting Form

Letter Template for FDA Feedback/Commenting

Don't delay - the commenting period for patients ends on February 15, 2020 so there is a short window to submit comments. When more details are available, we will communicate them to you. In the meantime, please know that Defy Medical patients will continue to have access to these medications and we are working hard in support of permanent legislative solutions. Sincerely, Your Defy Medical team

FDA Docket # FDA-2015-D-4750 Synopsis: Under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) - Protein bases drug products that had previously been approved under 505 as drugs will now be considered Biologics and will fall under the jurisdiction of CBER and regulated as Biologics. The DQSA (compounding legislation) only give compounding pharmacies an exemption to not file and hold a New Drug Application for "drugs" that would otherwise be filed under section 505. The 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, 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.

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[C27H40O3]

Shit, let me call my lawyer to explain it to me.

[David LoPan]

Happened with my pharmacy that I got it from them. I have to get mine mail-ordered directly from where the doctor calls the RX and they direct shit it to me. All of this started with that stupid HCG diet years ago that was trying to make a come back. The PI on the drug states it is not used for weight loss. Only to get pregnant and for hypogonadism. I did hear from a doctor that he lost revenue, we well as a lot of other fertility clinics when it was so easy to get HCG. Women could just go get an RX and give themselves a shot and skip seeing a fertility doctor if that didn't work.