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FDA Moving at Turtle Speed

The Food and Drug Administration (FDA) is taking even longer than usual to approve life-saving products. On May 10, the agency announced it was delaying a decision to approve a vaccine for respiratory syncytial virus (RSV) to the end of May because of “administrative constraints” at the FDA. A decision had originally been slated for May 12.  Earlier, in March, the agency announced that it was delaying approval for Alzheimer’s drug donanemab even after trial data showing the medication slowed disease progression by 29 percent over 18 months. Clearly, something has gone very wrong at the agency often (wrongly) criticized for approving medications too quickly. It’s time for the FDA to clean out its cobwebs and commit to a speedier and more flexible approvals process. 

Unfortunately, regulatory delays over the RSV vaccine and donanemab are just the latest in a long line of FDA missteps. Despite the ample promise of a CAR-T therapy called Abecma for the treatment of heavily pre-treated relapsed or refractory multiple myeloma, the FDA pushed back its original decision date of December 16 to April 4. The FDA insisted on delaying its decision despite evidence that patients taking the medication lived nearly 9 months longer without their cancers getting worse. Meanwhile, the agency has earned the ire of parents for delaying coronavirus vaccine approval for young, at-risk children and failing to be transparent about the approvals process. The agency responded to pushback about its vaccine approval delays by claiming the data was incomplete, conveniently leaving out that the missing data was for cohorts of older children who were already cleared to get vaccinated. 

It has long been a trope that that the FDA is “underfunded.” Pundits and policymakers have called for more taxpayer funding and user fees for everything from generic drug approvals to food safety inspections to medical device cybersecurity.  In reality, the FDA’s fiscal year (FY) 2024 funding level of $6.7 billion ($3.5 billion in taxpayer funding and $3.2 billion in industry user fees) is about 15 percent higher than the FY 2014 total, even after adjusting for inflation. Increased FDA spending has not “delivered the goods” in increasing drug innovation or reducing foodborne illness. FDA malaise only succeeds in adding fuel to the fire of runaway healthcare costs and making it more difficult for Americans to access affordable medications. It costs an astounding $2.3 billion to bring a new therapy to market, with agency delays and nit-picking adding to these totals. 

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Agency watchers have also expressed concern that the FDA’s reliance on user fees is making bureaucrats too cozy with drug makers. In reality, the FDA is still risk-averse and reluctant to approve new medications. The agency has issued more than 80 Complete Response Letters (i.e., denials) for new molecular or biologic products since 2019, often for reasons that have little to do with clinical benefit. For example, the FDA recently rejected a drug called zolbetuximab designed to treat gastric/gastroesophageal cancer. The issue was neither safety nor efficacy. Clinical trials demonstrated that the medication improved median progression-free and overall survival by 2-3 months compared to chemotherapy alone. Apparently, the issue boiled down to “unresolved deficiencies following its pre-license inspection of a third-party manufacturing facility.” These issues apparently aren’t insurmountable for Japanese regulators, who approved the medication. But, in the U.S., patients are left to scramble for months due to a likely-minor issue that could probably be resolved post-approval. 

Another poorly reasoned rejection centered around a medication called omburtamab, designed to treat a rare pediatric brain cancer. Agency officials expressed concern that the datasets used to study the drug were too old to be reliably interpreted, even though the FDA acknowledged that, according to the evidence, patients taking omburtamab live 7-12 months longer than their non-medicated peers. As TPA’s 2023 report on drug approvals points out, omburtamab and zolbetuximab are hardly the only drugs to get this treatment. 

The truth is that the FDA is far too slow to approve promising drugs and all-too-eager to axe life-saving therapies. Until the agency embraces innovation and flexibility, patients will pay the price for FDA inaction. 

David Williams is the president of the Taxpayers Protection Alliance. 

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