Weight Loss Drugs and FDA Compliance

Many Americans are overweight. Many of these Americans can’t lose the weight necessary to stay healthy – even with diet and exercise. According to Very Well Health, the FDA has approved some drugs to help with the loss of weight.

Weight loss drugs need to be pre-approved by the FDA because the drugs provide a therapeutic benefit – the loss of weight helps improve a patient’s health starting with improving their heart and diabetes outlook. The FDA is a US agency, within the U.S. Department of Health and Human Services. “The agency protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.”

Doctors may recommend FDA-approved medications if a patient:

• Has a BMI (body mass index of 30 or more)
• Has a BMI of 27 and other medical conditions including type 2 diabetes, high cholesterol, and high blood pressure.

FDA approved weight loss medication for Zepbound in November 2023

One weight loss drug that was approved recently, November 8 2023, by the FDA is called Zepbound (tirzepatide). A review of the FDA approval documentation helps to illustrate the criteria the FDA uses to approve weight-loss drugs and other medications.

General summary. The US FDA approved Zepbound injection for chronic weight management in adults according to the obesity criteria explained above.

“Tirzepatide, the active ingredient in Zepbound, is already approved under the trade name Mounjaro to be used along with diet and exercise to help improve blood sugar (glucose) in adults with type 2 diabetes mellitus.”

The FDA found that nearly 70% of all American adults are obese or overweight – an alarming statistic. Losing 5% to 10% of body weight through diet and exercise is connected with a reduced risk of cardiovascular disease in adults with obesity or who are overweight.

Zepound is administered by an injection under the skin. The injection is given once a week. The dosage is required to be increased over 4 to 20 weeks to achieve the target dosage of 5mg, 10mg, or 15 mg once a week.

“Zepbound activates receptors of hormones secreted from the intestine (glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) to reduce appetite and food intake.”

The clinical trials for Zepbound

Generally, clinical trials are used to show that drugs are effective. The effectiveness of Zepbound for chronic weight management (weight reduction and maintenance) – combined with a reduced-calorie diet and increased physical activity – “was established in two randomized, double-blind, placebo-controlled trials of adults with obesity or overweight with at least one weight-related condition.” More than 2,500 patients were studied for their weight loss – after 72 weeks – where the patients received either 5, 10, or 15 mg of Zepbound once a week. Another 958 patients received a weekly placebo injection.

In both trials, patients who received dosages at the three different dosages “experienced a statistically significant reduction in body weight” compared to the patients who received the placebo. Many obtained at least a 5% weight reduction compared to the patients who received a placebo.

The second of the trials enrolled adults who had diabetes. In this trial, The average weight of the participants was 231 pounds with an average BMI of 38 kg/m2. The adults who received the strongest dosage lost, on average, 18% of their body weight compared to the adults who received a placebo.

Possible side effects of Zepbound

The FDA found these possible side effects: diarrhea, vomiting, nausea, constipation, abdominal discomfort and pain, fatigue, allergic reactions, injection site reactions, hair loss, burping, and gastroesophageal reflux disease. Other reactions were reviewed.

“Zepbound should not be used in patients with a personal or family history of medullary thyroid cancer or in patients with Multiple Endocrine Neoplasia syndrome type 2.”

Other tests such as the safety and effectiveness of the drug with other weight management drugs were not established. The FDA did provide many concerns about using Zepbound such as the need to stop taking the medication immediately (and seek immediate medical help) if a patient develops a severe allergic reaction.

Zepbound received Priority Review and Fast Track designations for this indication.

The FDA approved Zepbound on behalf of Eli Lilly and Co.

Other FDA-approved weight loss drugs

According to Very Well Health, other FDA-approved medications include the following drugs. The Very Well Health analysis of the drugs (and presumably the FDA analysis) reviewed when the drug should not be taken, drug interaction problems, possible side effects, the effectiveness of the drug, safety warnings, and other considerations.

Xenical (Orlistat). This drug belongs to the class of medications called lipase inhibitors.

“Orlistat reduces the amount of fat absorbed in the gut after eating. When taking it, no more than 30% of your calories should come from fat. Because of how orlistat works, orlistat is often a better choice for people who tend to eat fatty foods.”

The drug dosage is usually 120 mg – three times a day. The medications come in capsules that should be taken with food or up to 60 minutes after eating.

“Clinical trials have suggested that orlistat provides modest weight loss in people with obesity.” Very Well Health suggests that other weight loss drugs may help users lose more weight.

Alli (Orlistat). This drug also contains the active ingredient orlistat. Alli is an OTC drug that comes in a 60 mg capsule. The weight loss drug works like Xenical. It’s only for adults 18 and older. While the side effects and safety concerns are similar to Xencial, “Alli tends to be better tolerated than Xenical because it is a lower dose.” “In clinical studies, most people who took the 60 mg version of orlistat lost 5 to 10 pounds over six months.”

Other weight loss drugs include:

• Contrave (Bupropion-Naltrexone)
• Saxenda (Liraglutide)
• Qsymia (Phentermine-Topiramate)
• Imcivree (Setmelanotide)

Very Well Health states that:

• Generally, it’s not advisable to take more than one weight loss medication at a time.
• It’s not advisable to take weight loss medications if you’re pregnant.
• The medications are only for people who are obese or overweight.

Additional healthcare compliance concerns for weight loss medications

In addition to obtaining FDA approval, other compliance issues health drug manufacturers and medical providers who prescribe or fill these medications should review with our experienced healthcare lawyers include the following:

• Can the manufacturer show that the drugs are safe and effective?
• The possible side effects. The drugs need to be labeled properly. The drug should have information about the possible side effects, contraindications, and precautions. The medication should come with proper dosage recommendations and guidelines.
• Manufacturing practices. The manufacturer must comply with the appropriate manufacturing practices standards, quality control, and labeling requirements.  These standards help prevent “contamination, adulteration, or misbranding.”
• Consumer protection. Medical companies and practices need to ensure that the claims the companies and practices make about weight loss drugs don’t mislead consumers. The limitations and potential risks of the drugs should be noted.
• Ethical standards. Healthcare providers need to know the current ethical standards.
  • Compliance prevents unethical practices such as the indiscriminate use of weight loss drugs without proper medical assessment or the exploitation of vulnerable individuals seeking quick weight loss solutions.
• Oversight and monitoring. The FDA and other regulatory agencies provide oversight and monitoring of weight loss medications once they’re on the market to detect any safety concerns and adverse events – to protect the public and continually evaluate the safety of the weight loss drugs.

Manufacturers, distributors, and healthcare providers who fail to comply with the various federal and state regulations may be subject to warning letters, civil actions, and even criminal actions.

The agencies and regulations involved with weight loss medication compliance include:

• The FDA which approves the drugs – after an intense evaluation process which includes preclinical studies and clinical studies to ensure the safety and effectiveness of the medications.
• United States Pharmacopeia (USP). This “nonprofit organization sets quality standards for medicines, dietary supplements, and other healthcare products in the United States.”
• The requirement for a prescription to obtain most weight loss medications – from a licensed healthcare provider.
• Weight loss drugs must comply with FDA labeling regulations.
• “Manufacturers, healthcare professionals, and consumers are required to report any adverse events or side effects associated with weight loss medications to the FDA.”
• Weight loss drugs must be manufactured according to Good Manufacturing Practices (GMP) standards.
• “Some weight loss medications, such as certain appetite suppressants or stimulants, may be classified as controlled substances under the Controlled Substances Act.”
• Off-Label Use Restrictions.
  • “Weight loss medications are approved for specific uses as determined by the FDA. However, healthcare providers may sometimes prescribe medications off-label, meaning for uses not specifically approved by the FDA. While off-label use is legal and within the provider’s discretion, it must adhere to medical standards and be based on scientific evidence and professional judgment.”

Weight loss medications should generally be prescribed and supervised by medical professionals.

The developers of weight loss medications need to understand the requirements for obtaining approval of their medications as drugs. They need to understand good manufacturing practices, labeling requirements, and other regulations. Physicians need to understand when patients qualify to be prescribed weight loss drugs, how to monitor the use of the weight loss drugs by their patients, when and how to report adverse events, off-label use restrictions, and other legal regulations and ethical standards that govern weight loss medications.

Pharmaceutical companies and medical practices should contact Cohen Healthcare Law Group, PC to discuss their legal and healthcare compliance requirements. Our experienced healthcare attorneys advise medical businesses and healthcare providers about healthcare compliance laws and regulations.