NCPA - National Center for Policy Analysis

Have Faster FDA Approvals Caused Drug Safety Problems?

August 15, 2014

A new study led by Cassie Frank, a physician at Harvard Medical School, argues that the Food and Drug Administration has recklessly allowed unsafe prescription drugs into the American drug market. But NCPA Senior Fellow John Graham debunks that claim, explaining that drugs on the market today are no more dangerous than drugs in the past.

In 1992, Congress passed the Prescription Drug User Fee Act (PDUFA). Renewed every five years, PDUFA allows the FDA to extract user fees from drugmakers to pay for new drug approvals and facilities inspections. The Frank study contends that the PDUFA puts pressure on the FDA to rush the approval of new drugs, threatening patient safety.

The authors of the Frank study found that between 1975 and 2009, drugs approved after the passage of PDUFA were more likely to receive black-box warnings or be withdrawn from the market entirely. However, Graham identifies some problems with their conclusion:

  • Few drugs are actually withdrawn from the market. Black-box warnings, on the other hand, tell patients of drug side effects (effects that would have remained unknown were the drug not put on the market). Adding warnings allow doctors to more appropriately prescribe medicine.
  • There were actually more black-box warnings and withdrawals in the pre-PDUFA 16-year sample than post-PDUFA 16-year sample (80 versus 76). The Frank study reported the numbers as percentages rather than raw numbers, making it appear that larger numbers of drugs were receiving warnings post-PDUFA.

According to Frank, "In its hurry, the FDA is apparently failing to distinguish useful drugs from toxic ones, and more dangerous drugs are slipping through. By the time many drugs receive serious safety warnings, millions of Americans have already been exposed to their side effects, which can sometimes be fatal." Graham calls her conclusion "sensationalist."

Source: John R. Graham, "Have Faster FDA Approvals Caused More Drug Safety Problems? No!" August 11, 2014.


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