FDA to Device Makers: Want Faster Approval? Then Pay Up! | Pharma Industry Regulation | Scoop.it

The US Food and Drug Administration (FDA) is once again having to … petition Congress to pass legislation that will allow it to continue collecting "user fees" from Big Pharma in exchange for drug approval.

 

Every five years, Congress must decide whether or not to re-approve the Prescription Drug User Fee Act (PDUFA), which allows the FDA to charge drug companies millions of dollars for agreeing to review new drug applications (NDI). It is essentially a "pay for play" system where the FDA gives preference to those who play, even if the drugs or devices they have to offer are neither safe nor effective.

 

Dr. Hamburg also admitted that the agency has essentially "lowered some approval standards." These are the words used by The New York Times (NYT) to make this all happen for the drug industry. But when asked why medical devices were not being given the same rapid approval treatment, Dr. Hamburg stated that "[a] higher percentage of our overall drug program (is supported by fees from drug makers)."