America has a love-hate relationship with weight-loss drugs. A silver bullet to ward off obesity always seems to be around the corner, but there’s always the risk of a “miracle drug” turning into the next Fen-Phen and causing life-threatening injuries.
Now, a new crop of weight-loss medications is coming on the market that can seemingly burn fat without the infamous side effects of yesteryear. These therapies can save millions of lives but only if the Food and Drug Administration green-lights patient access. It’s time for America’s drug regulator to trim the regulatory fat, turbocharge innovation and transform healthcare.
For the 50 percent of American adults actively trying to lose weight, a class of diabetes medications offers some much-needed hope. These glucagon-like peptide 1 (GLP-1) agonists are designed to help regulate blood sugar levels, but the medications also appear to curb appetite. Studies indicate that medications such as semaglutide (approved by the FDA for diabetes control in 2017 and weight loss in 2021) can help patients lose 10 percent to 15 percent of their starting weight with minimal side effects.
The craze has caught on, and celebrities ranging from Elon Musk to Michael Rubin have publicly touted the appetite-suppressing effects of diabetes drugs. Too much of a good thing can have serious unintended consequences.
Through-the-roof demand for Wegovy, the version of semaglutide for weight loss, has led to supply shortages. Patients have responded by getting their doctors to prescribe Ozempic, the version approved for diabetes. As a result, diabetes patients have had difficulty getting access to the medications they need to control their disease. Spikes in patients’ blood sugar levels spurred by supply snafus can lead to long-term health complications, including heart and kidney disease.
The FDA could help by approving new, similar drugs and green-lighting weight loss indications for medications currently approved only to fight diabetes. The agency is considering approval of the anti-diabetes drug tirzepatide for weight loss and is expected to make a decision in 2023. Expanded indications would go a long way in giving manufacturers the certainty they need to bolster production instead of guessing how often patients will request diabetes drugs off-label.
But, the FDA’s turtle-speed approach may hamper access. The agency approved fewer new drugs in 2022 than at any point since 2016, and there’s little indication the FDA is willing to let up its scrutiny. Last year, the agency rejected hepatitis medication bulevirtide even though the drug had already been approved by the European Medicines Agency without incident. The FDA cited concerns regarding the manufacture and delivery of bulevirtide, even though these (unspecified) problems have proven non-issues on the other side of the Atlantic.
Additionally, drug manufacturer Gilead received a rejection for the HIV drug lenacapavir for “Chemistry Manufacturing and Controls issues relating to the compatibility of lenacapavir with the proposed container vial.” The agency was concerned that vials made of borosilicate glass could produce sub-visible glass particles in the lenacapavir solution, potentially endangering patients.
Gilead resubmitted its application in June, proposing an alternative, safer vial made of aluminosilicate glass. Despite this workaround and ample evidence of the drug’s safety and efficacy via the Phase 2/3 CAPELLA trial, the FDA waited an additional 6 months before finally approving the medication in December.
The European Medicines Agency approved the product in August, allowing Europeans with multidrug-resistant HIV to construct an effective regimen for their illness.
The FDA’s reluctance to green-light drugs for easily resolvable issues doesn’t bode well for future GLP-1-related approvals. While manufacturing issues should not be ignored, they must be weighed against dire public health issues such as obesity.
It is time for the FDA to embrace innovation and expand options for millions of patients. The right regimen of weight-loss drugs can save millions of lives, bureaucracy permitting.
