In recent months, the shortcomings of Tirzepatide (Mounjaro, Zepbound; Eli Lilly) and Semaglutide (Wegovy, Ozemic; Novo Nordisk) have been resolved by the FDA, and recently, such a peptide -1 (GLP -1) It was considered to have underestimated the pull and supply under the market pressure on demand for receptors. Without these FDA approval drugs, complex pharmacies and outsourcing have begun to prepare their own versions of treatment, and this complex drug is risk and concern because it is not approved by regulators.1,2,3
Compound GLP-1 drugs have become consistent for consumers. | Image credit: © kstock-stock.adobe.com
According to the round table panel adjusted by the Marc-andre Cornier, MD, FTOS, FTOS, FTOS, FTOS, and FTOS, the lack of these drugs remains in the market and gives up the risk of not knowing consumers. Experts on the panel are the president of the Angela Fitch, MD, FACP, FOMA, and Obesity Medical Association; Founders of Robert Popovian, Pharmd, MS, Conquest Advisors; And Lowell Schiller, JD, former Vice -President of Policy and former FDA.4
Fitch talked about the main interests surrounding the composition of the compound GLP-1 product. FDA approval GLP-1, such as Tirzepatide or Semaglutide, has a safe and effective active pharmaceutical (API). However, this API is not yet approved by the FDA, which means that the product that claims that it includes the same API as the approved GLP-1 is a consumer who misleads consumers.4
Fitch said, “Composite Tiri discipleship and semagluide are actually less than standard products.” What we worried about in this space is not necessarily a complex, but the fact that there is no generally approved API that can be said to be safe and effective. “4
Popovian explained that GLP-1 compounds have become “unprotected mass manufacturing” and are out of the original purpose of the drug compound, which provides individual and personalized treatment in the form of professional processing. Currently, complex products rely on consumer advertising, which is a marketing form that markets quite low compared to FDA approval, and claims that complex drugs have been “made in the United States”, and even promoting the equipment version of the drug that damages the industry and dangerous consumers.4
Popovian said, “I was very interested and seriously thought that the manufacturer had lowered the price when I started to recognize the advertisement.” They took me as a consumer and clinician based on information. Imagine what they are doing to an ordinary patient. “4
Schiller discussed other regulators provided to pharmaceutical manufacturers when there was a lack of drugs compared to the lack of drugs. The composite Tir discipleship and semagluide manufacturers have the ability to produce these versions while the drug is in the FDA shortage list, and once it is removed, the FDA has informed that the composite has a transient period to stop production. According to Schiller, ultimately, a combination of drugs, such as GLP-1, can be settled in patient treatment, but according to Schiller, certain patients must be produced.4
Schiller explained, “The complex version may have space, but the problem is the requirement of a specific and identified patient for the FDA approval version and other versions?”4
Since the complex is still in the market, it is still important for the patient to recognize the potential effect, which can be extended beyond treatment. For example, if a patient currently using a complex GLP-1 wants to be converted into an FDA approval product, Fitch explains that it is not as simple as exchanging complex drugs for the approved drug.4
Fitch said, “The patient does not understand, we cannot convert people into FDA approval because they do not know what they have gained with a compound product.The other main concern for the composite version is to develop immunity, where the patient incorrectly forms an antibody for his GLP-1 in his body, which ultimately affects the drug, ultimately ultimately ultimately. FITCH describes “how there is something different about these composite versions, and not produced in the same way.”4
As a former civil servant of PFIZER, Popovian said in a roundtable that the FDA has the authority to actually investigate the manufacturing practices of drug compounds. Schiller explained that it has the authority to set this point, to investigate the hygiene of the complex and to observe whether the appropriate ingredients are used. In addition, they can often combine these tools to crack down on illegal practices to provide consumer warnings to patients. Nevertheless, Schiller pointed out that the FDA should cooperate with other federal departments such as the Ministry of Justice to take legal action against the complex.4
Ultimately, expert panels are convinced of the bright future for GLP-1 and the patient economy of these therapies. Fitch explained that solving economic problems should be the main focus of pharmaceutical companies, and Fitch explained, “The marginalized group of marginalized patients offers food by lowering the price of inferior therapy.” Popovians are expected to compete in the form of biosimilars, which can be managed oral, and will help to lower prices. However, Popovian warns of pharmacy benefits managers and such companies’ future attempts to “manage the market for their own benefits.”4
Fitch said, “We must all approach more patients and try to approach them in an affordable way.4
