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Op-Ed: FDA barring life-saving chemotherapies from market

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Every year, 2 million Americans receive the dreadful news that they have cancer. Getting a handle on the devastating disease requires immediate and continuous treatment ranging from chemotherapy to surgical intervention. Unfortunately, recent medication shortages have made beating cancer far more difficult than it needs to be. According to a June survey by the National Comprehensive Cancer Network, more than 90 percent of cancer centers are facing shortages of carboplatin and cisplatin, which are platinum-based chemotherapies. The shortages were spurred by the Food and Drug Administration’s (FDA’s) temporary closure of an Indian drug manufacturing facility, and the agency has done little to offset the disruption. America’s drug regulator must act fast to get chemotherapies to patients who desperately need them.

The trouble began in December 2022 when the FDA wrapped up an inspection on India-based chemotherapy manufacturer Intas Pharmaceuticals and subsequently wrote a scathing 36-page report detailing the many problems at the plant. Test procedures and laboratory control mechanisms were “not being followed,” and critical documents related to “Good Manufacturing Practices” guidelines were nowhere to be found. Operations grinded to a halt, and the ripple effects were almost immediately felt in the U.S. Clinics have started switching patients to other platinum-based chemotherapy treatments less impacted by the Intas fiasco, but this has resulted in a “whack-a-mole” game of substandard substitutions and shortages.

The FDA has since allowed Intas to partially resume production under strict supervision and permitted importation of unapproved, China-manufactured medications. But, the FDA’s decision to allow imports from foreign companies such as Qilu Pharmaceutical is likely a one-off, and unlikely to lead to bolstered supply over the long-term. Indian and Chinese drug manufacturers often face difficulties recruiting a diverse population to conduct clinical trials, making it less likely that their products will garner FDA approval. In March 2022, the FDA issued a denial for a Chinese-produced drug called sintilimab for the treatment of nonsquamous non-small cell lung cancer. In briefing documents for the Oncologic Drugs Advisory Committee, agency regulators cautioned that, “[t]he current trend of marketing applications to the FDA, based on foreign data from single country trials, is a departure from decades of MRCTs [multiregional clinical trials] as the consistent approach to drug development.” While the FDA acknowledged that the drug has been studied using a randomized, double-blind trial design and the study (called “ORIENT-11”) met its primary endpoint (progression-free survival), the agency voiced skepticism about the results’ applicability to the U.S. population.

According to the FDA, “ORIENT-11 was conducted exclusively in China and enrolled a patient population which lacks the racial and ethnic diversity of the U.S. population, notably with regards to currently underserved groups.” However, this rationale for rejection ignores the agency’s history of approving drugs with subgroup/ethnic group designation should the need arise. The FDA recommends that sponsors note in product labeling when “analyses were not useful because of inadequate sample size,” implying that these medications can be approved as long as the manufacturer provides necessary warnings for doctors and patients. But, the FDA has clearly deviated from its own advice in rejecting therapies such as sintilimab. These concerns are also likely holding back approval of Chinese-manufactured, platinum-based chemotherapies, given that there are likely significant ethnic differences in patients’ responses to these drugs.

The FDA can alleviate shortages of these and all life-saving medications by relaxing its approval criteria and approving promising medications manufactured abroad. While these companies’ clinical trials are not as broad as the FDA would prefer, the agency shouldn’t let the perfect be the enemy of the good. Regulators could use post-approval monitoring to ensure that warnings on labels are up-to-date and reflect the experiences of different populations of users. Millions of lives depend on a flexible regulatory approach grounded in free trade and international cooperation.

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