The Future Legal Environment for GLP-1 Inhibitors
If you prescribe or manufacture GLP-1 inhibitors, you are facing a rapidly changing marketplace. The one constant is that there is huge customer demand for these drugs. This demand is only going to grow in the future, as there will be more recognized uses for these medications. Accordingly, there may be potential shortages and patent protection issues of which you need to be aware. An experienced healthcare attorney at Innova Health Law can help you understand the current compliance environment, and what you may need to do to follow the law.
Meet with a healthcare attorney at Innova Health Care Law to learn how we can help your business stay on top of and follow the law as it relates to GLP-1 inhibitors. We offer free discovery calls to prospective clients, so you can learn more about our services.
The Use of GLP-1 Inhibitors Is Growing
Although the FDA is generally rethinking and reimagining how it regulates drugs in the United States, there is no current effort to revoke any approval for GLP-1 inhibitors. In fact, it is expected that the permissible usages of drugs like Wegovy and Ozempic will expand in the near future. Manufacturers and sellers need to worry more about their compliance with applicable regulations as opposed to whether GLP-1 inhibitors are going to remain legal.
Still, companies that manufacture, sell or prescribe these products need to be aware of current and future legal issues for purposes of compliance. They can face potential liability if they are unaware of regulatory developments and do not have the proper compliance programs in place.
Compounding Issues
GLP-1 drugs are in high demand as they have gained acceptance as weight loss medications. As such, there have been numerous shortages of these drugs over time. Certain compounding pharmacies may be able to manufacture their own versions of these drugs when there are shortages. However, these pharmacies must comply with strict quality control standards. Recently, the FDA has declared that shortages of certain medications that allowed for compounding were over, meaning that pharmacies no longer had the ability to make these drugs on their own. Drug manufacturers and pharmacies need to continue to monitor the situation to learn whether compounding is allowed for certain medications.
Pharmacies may also face issues with state regulators regarding both compliance with state regulators. Each state has its own rules and inspection regimes that could result in regulatory consequences and even a potential shutdown. Some states are passing new regulations that compounding pharmacies must follow. Compounding pharmacies with locations in more than one state need to follow a myriad of regulations that vary among jurisdictions.
In addition, compounding pharmacies also face potential challenges due to the composition of the products that they sell. Drug companies attempt to protect their own market and brand names. They may send a cease-and-desist letter to a compounding pharmacy if they believe that a substantially similar product is being sold. In a worst-case scenario, the pharmacy may even be sued for patent infringement. Compounding pharmacies need early intervention from their own compounding pharmacies lawyer if they have been contacted or sued by a pharmaceutical company.
Unapproved Versions of GLP-1 Drugs
In a similar regard, the FDA has recently expressed concern about adverse events that are associated with unapproved versions of GLP-1 medications. The regulator is aware that patients and their healthcare providers may be turning to these medications under certain circumstances. While it may be permissible in certain compounding situations, the agency is also aware of fraudulently compounded drugs that are illegal.
Adverse Event Reporting
As the use of GLP-1 prescriptions grows, there are more adverse events that have been filed. Patients file an adverse event report when they have experienced untoward health events in connection with their use of a certain drug or medical device. When there are adverse event reports filed, it may be an indication that there is a known or previously unknown negative effect of the medication. Those who are involved in manufacturing or selling GLP-1 medications should monitor adverse event reports to learn current trends. They could be on notice that there are medication defects if they see reports of previously unknown side effects.
Future Increased Indications
GLP-1 drugs are gaining acceptance for a broader range of purposes, besides weight loss and diabetes treatment. However, providers need to be careful about how they prescribe these medications for off-label use for unapproved indications. Doctors and healthcare providers can face significant legal liability if a patient experiences an adverse health effect when they are using a GLP-11 inhibitor for an off-label purpose.
At the same time, there is ongoing research about additional potential usage of these medications. Nonetheless, healthcare providers need to exercise caution about the uses for which they would prescribe GLP-1 inhibitors.
Telehealth Prescriptions
Patients are increasingly seeking out GLP-1 prescriptions from telehealth providers. While telehealth providers may have the ability to prescribe these medications, they also must be careful when doing so. They should have appropriate procedures in place to monitor the patient, both to ensure that GLP-1 inhibitors are right for them and that there are no dangerous side effects. Telemedicine providers must follow federal and state regulations when they are prescribing these medications.
Contact a Distributors and Emerging Therapies Lawyer Today
Speak to a distributor and emerging therapies attorney at Innova Health Law to learn more about how we can help your business meet its compliance and legal needs. You can schedule a free discovery call by sending us a message through our website or by calling us today at (281) 936-9904.