Last week, the Trump administration released its proposed 2018 budget. The document includes a proposal to increase the user fees the FDA collects from pharmaceutical companies to $2 billion—twice as much as in 2017, according to the president’s budget.
The rationale provided in the budget for this change is to speed the approval of new drugs.
User fees are connected to the FDA’s mandate to ensure not just the safety but also the efficacy of drugs. This was instituted following the passage of the Kefauver-Harris Amendment in 1962. We believe this was a wrong turn. The agency has never shown itself qualified to handle the task of proving that the drugs it approves are effective. This system also caused the cost of approval to soar, because it required effectiveness to be demonstrated through outrageously expensive double-blind random-controlled trials (RCTs).
When drug companies pay the FDA to review drugs, there is obviously a tremendous conflict of interest, and many opportunities for cronyism. The result is the approval of a huge number of dangerous drugs, which have been responsible for thousands of deaths—not to mention the glacial pace of approving substances or devices already proven safe.
We shouldn’t be doubling down on this system by having drug companies give even more money to the FDA. We should be doing the exact opposite by dismantling the current drug regime—by eliminating the requirement for the government to prove the efficacy of drugs. Once a drug has been deemed safe, effectiveness should be worked out by the medical profession, not by unqualified government employees whose salaries are covered by Big Pharma.