U.S. Approves Cancer Drugs Faster Than Europe

New Cancer Drugs Reach Patients Sooner in the United States Than in Europe”: This kind of headline, from a study published in the July 2011 Health Affairs medical journal, may come as a surprise to some people, since the Food and Drug Administration (FDA) is often criticized as being inefficient compared to its European counterpart, the European Medicines Agency (EMA).

The researchers examined all 35 new cancer drugs approved by either the FDA or the EMA between 2003 and 2010 and identified 23 that had been approved in both countries. The results showed that the review times were shorter in the U.S. for 20 of the 23 drugs, but that even with shorter review times for the other three in Europe, all of the drugs were approved in the U.S. before they had been approved in Europe.

The authors explained the latter finding (regarding three of the 23 drugs) by stating that pharmaceutical companies typically submit their clinical findings to the FDA prior to submitting them to the EMA. But for the findings on the other 20 drugs, the main explanation was that the review times were faster here than there.

Most of Public Citizen’s criticism of the FDA has been directed at the approval of or failure to remove from the market those drugs that have no advantage over existing drugs in treating a certain disease but which have clearly unique risks, compared to other drugs for the particular disease, making their presence on the market dangerously unacceptable.

For cancer drugs, many of them do have serious risks. But especially if they are found to be uniquely beneficial treatment for a type of cancer or for metastases for certain cancers, the benefits may well outweigh the risks.

That is not to say we have never criticized the FDA concerning cancer drugs. For a once widely used cancer drug, gefitinib (IRESSA), the approval had been based on studies showing a shrinkage of tumor size, but there had been no evidence of an improvement in survival. Under these circumstances of such an expedited approval, the FDA should have taken the drug off the market if survival benefits were not shown. After several subsequent studies failing to demonstrate improved survival, the FDA had failed to remove the drug from the market, and we submitted a petition to the agency criticizing this inaction.

But getting back to the topic of this column, despite drug industry rants about the FDA endangering Americans with cancer, because drugs get approved sooner in Europe than in this country — if you believe drug company ads — you now have proof that those claims are nonsense.