GLP-1 Drugs: Brand Companies Push FDA to Limit Compounding

Model firms who personal GLP-1 merchandise have been pushing the Meals and Drug Administration (FDA) to restrict their compounding. On August 28, 2024, Eli Lilly and Firm submitted a nomination to request that its GLP-1 product, tirzepatide, be added to FDA’s Demonstrable Difficulties for Compounding (DDC) lists. Extra just lately, on October 22, 2024, Novo Nordisk, the creator of the Ozempic® (semaglutide) and Wegovy® (semaglutide) injections, nominated its semaglutide glucagon-like peptide 1 (GLP-1) drugs to be listed. If FDA locations these medicine on the DDC checklist, the medicine won’t qualify for sure statutory exemptions beneath the Federal Meals, Drug, and Beauty Act (FDCA) and, most significantly, the medicine won’t be allowed to be compounded by pharmacists, physicians, or outsourcing amenities.

What are the DDC Lists?  The DDC lists don’t at present exist. FDA is statutorily mandated to create these lists and issued a Proposed Rule on March 20, 2024, with feedback being due by June 18, 2024. FDA is proposing to ascertain standards FDA will use in evaluating drug merchandise or classes of drug merchandise that current demonstrable difficulties for compounding beneath every part. The Proposed Rule has not but been finalized. 

What are the Proposed Rule’s Standards for Inclusion on the DDC Checklist? For evaluating drug merchandise or classes of drug merchandise for inclusion on the DDC checklist, FDA proposed to ascertain the next standards:

• formulation complexity,
• drug supply mechanism complexity,
• dosage type complexity,
• complexity of reaching or assessing bioavailability,
• compounding course of complexity, and
• complexity of physicochemical or analytical testing of the drug product or class of drug merchandise.

FDA proposes to contemplate these standards and the dangers and advantages to sufferers of the compounded drug product or class of drug merchandise in figuring out whether or not so as to add the drug product or class of drug merchandise to at least one or each lists.

How would the GLP-1 Medication Match the Proposed Rule’s DDC Standards? In its submission to FDA, Eli Lilly and Firm relied on these proposed standards and claimed that tirzepatide, the lively ingredient in Mounjaro® (tirzepatide) injection and Zepbound® (tirzepatide) injection, meets a minimum of two of those proposed standards—first due to the complexity of its formulation, and second due to the complexity in its required physiochemical or analytical testing. In its submission, Eli Lilly and Firm cited a number of cases of opposed occasions related to compounded tirzepatide and claimed such compounding introduces vital public well being dangers.

Beneath the Proposed Rule, FDA contains the next three classes of drug merchandise to be included on the DDC Lists: (1) oral strong modified-release drug merchandise that make use of coated programs (MRCs), (2) liposome drug merchandise (LDPs), and (3) drug merchandise produced utilizing sizzling soften extrusion (HMEs). Semaglutide liposomes, similar to Ozempic and Wegovy, would possible match beneath these proposed classes and be candidates for inclusion on the Proposed Rule’s DDC lists.

If Novo Nordisk and Eli Lilly and Firm are profitable of their submissions, semaglutide and tirzepatide merchandise can be deemed too complicated or too troublesome to compound and can be deemed to pose security dangers to sufferers if compounded or manufactured incorrectly.

What’s Subsequent

Inclusion on the DDC lists would restrict Ozempic and Mounjaro (marketed for kind 2 diabetes) and Wegovy and Zepbound (marketed for persistent weight administration) from being compounded by pharmacists, physicians, and outsourcing amenities, even throughout any present or future shortages of those merchandise.

Pharmacists, physicians, and outsourcing amenities might want to proceed to stay versatile and reply rapidly to new regulatory updates. Throughout latest shortages, many FDA-licensed amenities bought compounded GLP-1 merchandise. On October 2, 2024, nevertheless, FDA decided that the scarcity of tirzepatide injection had been “resolved,” and compounders have already got been required to regulate their practices to adjust to FDA’s necessities for what could be legally compounded exterior of a drug scarcity. See our prior weblog “GLP-1 Medication: FDA Removes Lilly’s Zepbound® and Mounjaro® (tirzepatide injection) from its Drug Scarcity Checklist,” dated October 8, 2024.

We anticipate continued authorized motion from model firms. Novo Nordisk beforehand challenged compounders by submitting a number of lawsuits in opposition to wellness clinics and medical spas advertising and marketing compounded semaglutide in June 2023, leading to a everlasting injunction in February 2024. However, lower than per week after FDA decided that the tirzepatide scarcity had been resolved, the Outsourcing Services Affiliation (OFA), a commerce affiliation representing FDA-registered 503B outsourcing amenities, filed a lawsuit in opposition to FDA regarding the company’s removing of tirzepatide from the FDA’s drug scarcity checklist. See our prior weblog “GLP-1 Medication: FDA Sued Over Eradicating Tirzepatide from the Drug Scarcity Checklist,” dated October 23, 2024. (Word that on November 19, 2024, the events filed a joint standing report within the case the place FDA indicated it has not but made a willpower in its reconsideration of the standing of tirzepatide and can present one other replace to the courtroom on December 19, 2024. Throughout this era, FDA has said it won’t take enforcement motion in opposition to compounders who proceed to make tirzepatide merchandise.)

Whereas it’s extremely possible that FDA won’t deal with both Novo Nordisk’s or Eli Lilly and Firm’s submission till after the Proposed Rule is finalized, it is crucial that any entities compounding these medicine are conscious that additional modifications to the principles might impression their potential to compound such medicine within the close to future. We suggest constant monitoring of recent developments and steerage on this concern.

We invite you to hitch our webinar titled “GLP-1 Medication: What’s Subsequent after FDA’s Decision of Drug Shortages” on December 4, 2024 to study extra about these points. Foley companions Nate Beaver, co-chair of the agency’s Medical Units Space of Focus, and David Rosen, chief of the agency’s FDA Observe Group, will talk about what the longer term has in retailer for compounded GLP-1 medicine.

Foley will proceed to watch these developments. Foley is right here that can assist you deal with the quick and long-term impacts within the wake of regulatory modifications. We’ve the assets that can assist you navigate these and different vital authorized concerns associated to enterprise operations and industry-specific points. Please attain out to the authors, your Foley relationship associate, or to our Well being Care Observe Group and Well being Care & Life Sciences Sector with any questions.