By Chris Adams
In a country with a massively profitable drug industry and robust medical research sector, why are there often shortages of important and common vaccines?
Dr. Peter Marks, who heads the Center for Biologics Evaluation and Research at the Food and Drug Administration, detailed some of the reasons in a talk about the FDA’s oversight of the vaccines industry.
Marks’ division oversees the review of the safety, effectiveness, purity and potency of vaccines before they come to market. The job is equivalent to the reviews done by the Center for Drug Evaluation and Research for most prescription drugs in the nation.
But the FDA’s job doesn’t just involve those reviews. In fact, its role often starts before the drug is submitted for approval – and continues after it is approved.
Marks described initiatives by the FDA to spur development of new vaccines – something that drug companies on their own are often hesitant to do. “Vaccine manufacturing is somewhat frozen in time, because these are low-margin products,” he said. “There has not been a huge push to produce them.”
The FDA also has a role in post-marketing studies – or monitoring a product once it’s on the market to tease out any safety or efficacy issues that didn’t emerge during the approval process.
“We have a low tolerance for adverse effects – particularly for kids, who get so many vaccines,” he said.
That gets to the heart of one of the conundrums in the vaccine world: complacency.
“The problem is that they are so effective – particularly in the U.S. – that people forget what they can do for us,” Marks said.