FDA Admits Drug, Medical Device Approval Process is a Bribery System Based on Who Pays the Most
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
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).”
Put another way, Dr. Hamburg basically insinuated that if medical device manufacturers were contributing as much in user fees as drug companies are, then they, too, would receive rapid and more frequent approvals. Until then, the agency will continue to focus its energies into approving drugs — because, after all, Big Pharma will be providing the FDA with nearly one-third of its overall budget in 2012.
This sad testament shows where the FDA’s true priorities lie — money. It does not matter whether or not a product is actually safe and effective — those companies willing to pay the most will be given special treatment and have their products approved more rapidly and efficiently than others. And if Congress once again re-approves the PDUFA, the FDA will continue to cater to the drug industry rather than objectively look out for the best interests of the people.
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