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Drug Safety Is FDA’s Job, Not CDC’s

Scott Gottlieb, M.D.
 

By Scott Gottlieb

The Biden administration made a reasonable decision last week to pause the rollout of Johnson & Johnson’s Covid vaccine while it investigates reports of rare blood clots. But it was a surprise, and the path forward is cloudy. Regulators need a clear process for evaluating issues that crop up, and the Food and Drug Administration should lead it.

All drugs and vaccines have rare side effects, not all of which can be ferreted out in clinical trials. The FDA collects safety information after approval and is charged with making decisions about how to balance the risks and benefits of medical products. This is an essential part of the drug-safety system, and so is the FDA’s authority to make adjustments to a product’s recommended use.

But now it isn’t clear who will have the final word. The Centers for Disease Control and Prevention has been thrust into a new and challenging role of judging a safety question, as well as how and when the vaccine should be restored to use. The discomfort of the CDC’s advisers seemed evident at an emergency meeting convened last week. The panel adjourned without a decision.

We need a thorough, predictable process to assess emerging data on vaccines and advise doctors on their benefits and risks. That’s the FDA’s historical mandate. Putting the issue before the CDC confused the process and slowed the decision.

Covid vaccines are under especially intense scrutiny, but it isn’t uncommon for the FDA to recommend narrowing or suspending use while looking into a safety issue. Sometimes the risks turn out to be remote or can be mitigated by changing how the product is used. This dynamic review process allows regulators to take new information into account.

If the agency needs advice, it can ask its own vaccine advisory committee. The committee might propose additional counseling to doctors and patients on what to watch for and how to treat side effects or recommend the vaccine’s use be narrowed while surveillance continues.

Large, rigorous trials across geographies, populations and viral variants have shown the Johnson & Johnson vaccine’s overall benefit. The vaccine is administered in a single dose and easier to store than Pfizer’s and Moderna’s, making it an important part of the Covid arsenal, especially in low- and middle-income countries.

In the past week, however, it has been associated with at least eight cases in which patients developed unusual and dangerous blood clots triggered by the destruction of platelets. Most cases have been in women under 50 who were vaccinated in the past two weeks.

The condition, which may be the result of an immune reaction, is serious and requires special management. The FDA needed to alert doctors and patients to keep a lookout. Supply of the Johnson & Johnson vaccine ramped up in the past few weeks, so more cases could emerge in the next week or two.

Barring significant new findings, Johnson & Johnson’s vaccine should return to use soon. The FDA’s expert staff are the right people to collect and analyze the data and figure out how to use the vaccine safely.

Dr. Gottlieb is a resident fellow at the American Enterprise Institute and was commissioner of the Food and Drug Administration, 2017-19. He serves on the boards of Pfizer and Illumina.

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