Author: Elianne Sato Morinigo

Considering recent declines in research grants, the federal scientific workforce, and public access to research, the future of medical innovation is uncertain. However, even before these challenges arose, there were already parts of the system that limited progress. 

One problem is that pharmaceutical patents held by large drug manufacturers limit generic drug production. This is because a generic drug maker cannot apply for a generic drug approval if the brand name drug is still patented. The Food and Drug Administration will not approve a generic drug that infringes on an approved brand drug. 

One of the issues is that the FDA generally avoids getting involved with drug patents. The FDA publishes the Orange Book, in which it collects all the drugs it approves and their active patents, but these patents are reported by the pharmaceutical companies that hold them. While the FDA will ensure that all patents directly related to the drug or its method of use are published, the agency generally does not check or remove any other reported patents. The FDA’s role in Orange Book patent policing is “purely ministerial.” 

This can become a problem because many large pharmaceutical companies do not only patent the active ingredient and method of use of a drug; they usually build patent thickets. These are overlapping patents for the same drug that expire at different times; sometimes more than twenty years after the first patent related to a drug is filed. Pharmaceutical companies reported these additional patents to the FDA alongside the active ingredient and method of use patents. 

In the last two years, the Court of Appeals for the Federal Circuit has addressed some of this excessive reporting. In 2023, the Federal Circuit held in Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC. that only drug and method of use patents, as narrowly defined by patent law, should be listed in the Orange Book. In December 2024, the Federal Circuit held in Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC. that these drug and method of use patents must specifically claim the active ingredient in the approved drug, and the approved drug product must infringe on the listed patents. A drug product includes the drug substance (active ingredient) and any other substance used to make the finished administrable medicine. In both cases, the court ordered the FDA to delist other patents they listed in the Orange Book. 

Overall, if drug developers are limited in the patents that they can list in the Orange Book, then the FDA is less likely to refuse to approve a generic drug because this approval would infringe on a listed patent. This would remove one hurdle to generic drug approval and allow more of these accessible drugs to enter the market. Of course, given the complexity of drug patenting, it is unclear how useful these changes will be. 

Pediatric obesity has been called “an epidemic within an epidemic” by the American Academy of Pediatrics. This condition causes hypertension, type 2 diabetes, and more, but has the potential to cause severe illnesses in adulthood such as cancer and cardiovascular disease. The number of cases diagnosed every year has been increasing, and within the different severity levels of the condition, severe obesity diagnoses have been increasing at the highest rate. This particular diagnosis raises a grave public health concern because it has been linked to extreme health conditions such as premature mortality. 

In the past, federal government legislation that addressed childhood obesity centered on the prevention of the condition, as opposed to treatment. As recently as 2021, the Reducing Obesity in Youth Act was introduced to the U.S. Senate. It was meant to prevent and manage this disease after the COVID-19 pandemic exacerbated the number of cases and their potential repercussions. This act focused on the need for food security, and fitness and nutrition education in schools. It did not address possible medical interventions. 

However, in the last five years, there has been a shift towards the adoption of pharmaceutical and surgical interventions as treatment for this condition. In 2019, the FDA approved Victoza, a GLP-1 receptor agonist, which is also used in Ozempic, for patients aged ten and older. Then in 2020, the agency approved Saxenda, another GLP-1 receptor agonist drug, for patients over the age of 12. Now, a recent study released in September 2024 in the New England Journal of Medicine asserted that Saxenda is safe for patients as young as six. 

The stance on surgical intervention for young obesity patients has also changed. In 2019, the American Academy of Pediatrics published a policy statement addressing current treatments for childhood obesity and discussed the use of surgical intervention to treat the disease. 

Pediatric obesity disproportionately affects Black and Hispanic children, and also becomes more prevalent as a child’s household income decreases. This could restrict access to treatment for those who most need it, but the Affordable Care Act of 2010 mandates Medicaid coverage for obesity treatment and intervention for any insured patient over the age of 6.

While the government has an interest in ensuring the health of younger generations as an investment in the future, the long-term effects of these pharmaceutical and surgical interventions are unknown.  These treatments have only been made available to children and teenagers in the last few years. Given the absence of longitudinal studies, the government finds itself in a difficult position where it must act to combat the current childhood obesity epidemic, but it does not know what the eventual repercussions of these early interventions will be. 

There must be consideration of the long-term efficacy of these methods, the issue of informed consent in pediatric surgery, the growing contention around surgical weight loss interventions, and the personal, medical, and financial costs of a possibly lifelong reliance on GLP-1 drugs. There are also concerns about the legality of these government projects, including accusations of government overstepping and the creation of a so-called “nanny state.” On a more personal level, there are concerns about the social and psychological effects of addressing obesity in such a clinical manner. 

Pediatric obesity is a critical issue that is affecting some of the nation’s most vulnerable children. The shift in health policy from prevention and education to direct medical intervention has occurred rapidly, but we must proceed cautiously. After all, these children are the future, and we must be wary of hurting them in our haste to save them.