The recent shortages of GLP-1 medications, essential for the treatment of obesity and type 2 diabetes, have highlighted the need for greater transparency and accountability in pharmaceutical supply chain management. This policy addresses the critical roles of drug manufacturers and 503B compounding pharmacies in ensuring patient access to these medications. By requiring pharmaceutical companies to maintain adequate buffer stocks and report transparently, we can protect patients’ access to vital GLP-1 medications, even during periods of fluctuating demand.
Objective:
To mandate that pharmaceutical companies provide transparent and public information on drug shortage data and supply chain management.
To require that drug manufacturers maintain sufficient buffer stocks to meet projected demand.
To secure the right of 503B pharmacies to compound GLP-1 medications during declared shortages, ensuring uninterrupted patient access.
Policy Recommendations:
Mandatory Public Transparency in Drug Shortage Reporting:
Detailed Reporting Requirements: Pharmaceutical companies experiencing, or anticipating, shortages in FDA-approved GLP-1 medications should submit detailed public reports to the FDA, including:
Specific causes of the shortage.
Expected duration of the shortage.
Mitigation efforts underway.
Estimated timelines for return to regular supply levels.
Public Access to Shortage Data: All data provided to the FDA regarding shortages—including manufacturing, inventory levels, and production schedules—should be designated as public information. This ensures patients, healthcare providers, and policymakers can access critical supply chain information and make informed decisions.
Periodic Public Updates: These reports should be updated every 30 days and made accessible to the public to inform healthcare providers, patients, and 503B compounding pharmacies of the current shortage status and anticipated availability.
2. Requirement for Six-Month Buffer Stock:
Buffer Stock Based on Demand Projections: Pharmaceutical companies must maintain at least six months of buffer stock for GLP-1 medications. The stock level should be calculated based on the most recent demand projections, including sales forecasts provided to investors.
Verification and Accountability: The FDA should have the authority to verify the accuracy of buffer stock reports and monitor compliance. Non-compliance could result in penalties, with provisions to increase buffer stock requirements for repeat offenders.
Annual Disclosure of Buffer Stock Data: Companies must publicly disclose buffer stock levels annually, allowing for independent review of whether adequate safeguards are in place to meet potential demand surges.
3. Empowering 503B Pharmacies to Compound GLP-1 Medications During Shortages:
Protections for Compounding During Shortages: In the event of an FDA-declared shortage of GLP-1 medications, 503B compounding pharmacies should be permitted to produce compounded versions of these medications to bridge supply gaps. This permission should automatically apply if a shortage persists beyond 30 days.
Streamlined Oversight for Rapid Response: FDA oversight should be maintained to ensure safety and quality standards. However, regulatory processes should be streamlined during shortages to expedite patient access to compounded versions without unnecessary delays.
Exemption from Duplication Restrictions: 503B pharmacies should be allowed to temporarily produce compounded GLP-1 medications that replicate FDA-approved formulations when commercial supply is insufficient to meet demand.
4. Annual Review and Congressional Oversight:
Annual Reporting to Congress: The FDA should submit an annual report to Congress on the status of GLP-1 shortages, the adherence of pharmaceutical companies to reporting and buffer stock requirements, and the role of 503B pharmacies in supplementing access during shortages.
Review of Policy Effectiveness: A yearly review committee should assess the policy’s effectiveness, evaluating patient access, pharmaceutical compliance, and the impact on compounding pharmacies. Adjustments to buffer stock requirements and reporting practices should be considered based on real-world outcomes.
Perhaps we should simply just prohibit pharmaceutical companies for price gouging Americans, charging us 10 times the price they charge citizens of other countries. If Mounjaro was $150 a month in the US like it is the most other countries, I wouldn’t care about the availability of compound at all.
Or maybe take a look at PBM Reform. That is who is making the money from the American citizens. The reason the price is so high in the USA, is because the PBMs.
These meds are life changing for over 20 yrs i had doctor after doctor not care and push birth control on me as a band aid that really just made it all worse! Now finally in my 30s all issues have subsided with this med! Also affordability is important just as much as availability! If we can make the exact same meds to send to other countries for a fraction of the price, but we pay 3x more and they are trying to remove access! This medicine has saved my life literally!!!
This is a very necessary problem that needs addressed. Microdosing of compounded Tirzepitide for MANY ailments is necessary for those of us who don’t respond to Eli Lilly’s traditional huge dosing jumps in their pre-set pens. I can barely tolerate their lowest dose, so I use a smaller dose of compounded Tirzepitide because it has wiped out my arthritis pain, my weight has gone down significantly, my blood pressure is back to normal, and so is my A1c!!
Pharmaceutical companies are keeping prices for essential medications like Wegovy and Zepbound prohibitively high, leaving many Americans unable to afford these obesity treatments—especially as insurance companies often refuse to cover them. To ensure access, the FDA should mandate a solution: either require insurance coverage, adjust out-of-pocket costs to match international pricing, or allow compounding pharmacies, regardless of 501A or 501B designation, to produce these medications at a more affordable rate.
I have PCOS, psoriasis and Psoriatic Arthritis since I have been on medication my health has become so much better. I can walk without issues. But because my bmi is now 26, my insurance will not cover my glp1, thats why i switched to compounded. Prior to glp1 I was obese. My life was miserable. But if compounded comes off the shelf, I am scared. I dont want to go back. I was miserable.
This medication is changing my life. We need transparency and truth in regulation and reporting the real shortages and financial burdens that Americans bear in this area!
The FDA should be working for us to ensure safe and available (and affordable) medication for all. The pharmaceutical companies have done amazing things, but need to be held to account. And if they cannot keep up with supply, then compounding pharmacies should be able to do what they have been legally allowed.
Would also love more medical insurance options for coverage of these medications. I could never afford the branded medication out of pocket so have only ever used compound and it has been life changing!
When you suffer with cronic disease like obesity your entire life while being told you are fat and lazy with the side eye from your Dr who just tells you to eat less move more and then turn to surgery to diet pills to starving yourself while living in a culture that pushes unhealthy habits you have no place to turn until a light at the end of the tunnel comes and you can now live healthfully and keep up with your kids and grand kids and can live longer to enjoy all that you have missed out on your entire life to then only be told nope you cant have this medication because you just cant come up with the funds to save your life monthly due to the high cost of these meds and no ins will cover it so now you are looking into compounded versions only to have that option taken away from you as well. It leaves us defeated and hopeless. this community deserves better and the FDA needs to do better
Disabled Americans on Medicare also suffer from the disease of Insulin Resistance/Obesity. We cannot access GLP medications as Medicare prohibits weight loss medications. The only option we have is compounding pharmacies and compounded GLPs. I was denied medical care, surgery, until I could lose weight. With Insulin Resistance it was literally impossible to lose weight. I am a Registered Nurse and have lost three years of my working career because I couldn’t access medical care due to my weight. Eight months on Tirzepatide has changed my life. I plan to remain on a GLP blocker for the rest of my life because my life depends on it. I will NEVER be denied medical care again because of weight. Changing the food in America is one step, but for many of us with insulin resistance it is not enough. Make “Make America Great Again” for disabled Americans too, by giving us access to medications available to non disabled Americans with commercial insurance.
We need to stop Big Pharma with the price gouging and as well as insurance companies. If you have insurance you should be able to get tirzepaitide at a very low cost or free if your paying for your insurance. Companies like Lilly selling 1 month supply of injections between $1000 - 1500 is absolutely insane when it only cost less than $100 to make. Even the compounded versions are expensive …it should never be this way if this is something that helps so many people.
Once we get these changes approved and implemented, I’d love the next phase to set a cap on the outrageous amounts that these pharmaceutical companies are allowed to charge us… Which we all know is often up to 10 times more than what people in other countries pay for the same medication. And implement reform where PBMs can’t overrule what doctors prescribe for their patients. Also they can’t cancel coverage for patients already on GLP-1s without notice and certainly not any time during a policy year when that person has agreed to pay for coverage promised at agreed to rates!
Please remember, these drugs/medications/peptide numbers have peoples lives behind them. The research was to “help improve peoples lives”. Great job! I have benefited from a compound pharmacy for 3 months. Best decision i ever made. Through my own physician, not telihealth.
Compound Tirzepitide has changed my life for the better and made me healthier. My insurance company doesn’t cover GLP1 even though I couldn’t lose weight, had high blood pressure, high cholesterol and chronic pain from a back injury that made exercise impossible. I started the medication in January 2024 and have lost 83 lbs. I am nearing my goal weight and feel so much better. My cholesterol is way down, and my blood pressure is normal. My inflammation is down and have the ability to exercise. Had it not been for compound I would have been able to get healthy costing me and my insurance company a lot of money. Make these medicines accessible, and affordable for all. Ensure the availability. Also, these companies are running adds trying to get new patients yet they can’t fill the demand and assure those already on it can still get it.
We need PBM reform stat!! Their greed is preventing too many Americans from being able to afford the exorbitant GLP-1 prices. We also need the manufacturers to lower their prices. Zepbound is between $550 & $650 with a savings card. For most of us, that’s unattainable on a monthly basis. I’m a state employee but my insurance does not cover weight loss meds. They wld rather wait until I get a disease which is ridiculous bc they’d end up paying more for my treatment. Absolutely counter-intuitive! Allow the compounders to produce the meds bc it’s at least somewhat affordable, although still expensive. Lastly, the manufacturers need to release the vials in ALL doses! Not everyone can tolerate titrating up at such high jumps in dose. Let us have control over how slow we go up in dose. That’s why I prefer the compound over the pens.