FDA admits drug, medical device approval process is a bribery system based on who pays the most
by: Ethan A. Huff
NaturalNews.com
Monday, May 09, 2016
The US Food and Drug Administration (FDA) is once again having to both defend the legitimacy of its bloated existence, and petition Congress to pass legislation that will allow it to continue collecting “user fees” from Big Pharma in exchange for drug approval. And during a recent testimony, FDA Commissioner Dr. Margaret Hamburg admitted that this lucrative process caters specifically to those industry players who are willing to pay the agency the most money.
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.
In 2005, the FDA’s annual budget was just over $1.8 billion, with about $350 million of that constituting user fees. For 2012, the FDA is proposing a budget of over $4.3 billion, with more than $1.6 billion of that to constitute user fees. So while the FDA’s overall budget has more than doubled within the past seven years, its user fees have skyrocketed nearly fivefold.
When trying to defend its budget proposal before Congress — many have accused the FDA of mishandling the drug approval process and using it to reward the highest bidders. Dr. Hamburg tried to quell the firestorm with anecdotes about how the agency has approved a number of new “life-saving” drugs within the past year, and how it needs more money to make sure it can keep approving them before other countries do (as if approving potentially dangerous, life-threatening drugs is some kind of competition).
FDA approval process more concerned with money than safety and efficacy
