Lawmakers are on a course to put the FDA even deeper into the pocket of the pharmaceutical industry. Action Alert!
House and Senate leaders are looking to fast-track legislation that will reauthorize the Prescription Drug User Fee Act (PDUFA), the law that allows the US Food and Drug Administration to collect fees from pharmaceutical companies to approve their drugs. The user fee program must be renewed before the August recess.
The kicker is that early drafts of the reauthorization bill allow the FDA to collect $160 million more in user fees in fiscal year 2018. This means the agency can make a total of $878.6 million this year from drug companies.
This is still less than what was included in President Trump’s budget, which had user fees to the FDA doubling to a whopping $2 billion in 2018.
User fees are collected by the FDA to fund the agency’s drug approval process, which includes testing both the safety and the effectiveness of drugs. As we’ve said before, we believe it was a wrong move for Congress to mandate that the FDA ensure the efficacy of drugs, following the passage of the Kefauver-Harris Amendment in 1962. This mandate sent the cost of drug approval into the stratosphere, since it requires expensive double-blind random controlled trials (RCTs).
It is easy to see why engaged citizens around the country are taking issue with all of this Big Pharma cash flowing into the FDA—the agency that was meant to be a watchdog of the drug industry. Abuses of this system are rampant. Our FDA Death Meter website documents some of the most egregious examples of FDA officials knowingly approving dangerous drugs; examples of the revolving door between the drug industry and the FDA; and patterns of the agency protecting Big Pharma’s interests by putting profits before people.
Now, our elected officials want to incentivize the FDA’s bad judgment, all in the name of balancing the budget!
With the trendy political cry of the day being “Drain the Swamp,” it is time for that attitude to apply to this abusive agency. When the FDA’s own scientists send a letter to Congress exposing outrageous cases of retaliation against those refusing to sign off on unsafe, unproven, ineffective products, it’s clear that the Food and Drug Administration’s waters are among the most infested and polluted in our nation’s capital.
It is past time for reform. By deepening the financial ties between the FDA and the pharmaceutical industry, we as a country are inviting more scandal and abuse that will cost even more Americans their lives.
Action Alert! Write to Congress and tell them NOT to increase the user fees that the FDA can collect from the pharmaceutical industry. Please send your message immediately.
Other articles in this week’s Pulse of Natural Health: