The Conversation

FDA Delays Lifesaving Drug, U.S. Health Officials Import from Europe, Canada and Australia

On the New York Post's opinion page, Sally Pipes of Pacific Research Institute writes about two campuses with menegitis outbreaks and how current vaccines given don't prevent the disease from spreading.  However, a 20 year old vaccine available in Europe, Canada and Australia is still being delayed by the FDA.

Twenty years in the making, the vaccine has undergone numerous clinical trials involving nearly 8,000 infants, children, adolescents and adults. US health officials, alarmed by the outbreak, have taken the unprecedented step of importing the drug as part of an emergency vaccination campaign at Princeton.

Yet Bexsero is still awaiting approval by the Food and Drug Administration. A combination of excessive caution and regulatory inertia has left thousands of Americans vulnerable to this dangerous disease.

A strong dose of caution when it comes to approving new treatments may seem like a virtue. But as the students and families affected by these outbreaks know, excess caution can have grave consequences.

Obviously, this isn't the first time that FDA delays bureaucratic inertia have cost American lives.  Pipes notes:

For example, a seven-year delay in approving beta-blockers contributed to over 100,000 premature deaths among heart-disease sufferers. And during the 3½ years it took the FDA to approve the drug Interleukin-2, 3,500 patients died of kidney cancer even as the drug was being used successfully in nine other countries.

So, what is the process for FDA approval and why do many drug companies bypass it for markets in other countries?

Already, the average process of shepherding a potential drug from discovery through approval takes 14.2 years, according to Tufts University researchers. For every 5,000 compounds screened, the FDA will approve only five for human testing, and (eventually) license only one for marketing.

These are long odds, and they keep getting longer as the FDA pushes for ever-more data and ever-longer trials. In the case of rare diseases — like bacterial meningitis — many drug companies may find that there aren’t enough patients to make it financially feasible to jump through the hoops of the FDA’s approval process.

The result is a record number of drug shortages — many of which can be attributed to “actual or anticipated action by the FDA,” according to a joint report by the American Society of Oncology, the American Society of Health-System Pharmacists and other stakeholders.


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