Despite having received little attention from the media, the Senate may vote on one of the most crucial and serious pieces of health policy next week.
Contrary to what one might expect, this bill has nothing to do with Obamacare. Instead, the Senate is going to vote soon on a bill that reauthorizes the Prescription Drug User Fee Act (PDUFA), which is set to expire later this year.
PDUFA generates the bulk of the federal government’s budgets for reviewing new medications, thus influencing how quickly we get access to new drugs and how safe our health care system is. The renewal of this legislation is critical to ensuring that there is a safe and plentiful drug supply for American consumers at affordable prices.
PDUFA was originally passed in 1992, in response to frustrations from pharmaceutical companies about the length of time it took for drug approvals, which was about two years. The FDA said they simply did not have enough staff to move faster, and thus PDUFA was passed to collect “user” fees from drug makers to expand the FDA’s review staff, so that new drugs could be reviewed more quickly with the same safety precautions taken.
The PDUFA user fee program has been a great success over the past two decades, as the increased funding from the pharmaceutical companies has allowed the FDA to add about 200 staff members and reduce the drug review process by nearly half. A 2002 Government Accountability Office report found that the average approval time dropped from 27 months to 14 months over the first eight years of the act, and user fees increased new drug reviewers by 77 percent.
This Act has been occasionally assessed and expanded upon through reauthorizations, and is currently in its fourth iteration. After months of deliberations, the bill passed its first hurdle last week when the Senate Health Committee approved its version of a PDUFA bill.
The FDA’s final recommendation for the renewal of the drug industry fees reflects a great deal of input from key stakeholders such as patient advocates, medical providers, health care professionals, and academia. In addition to renewing the prescription drug user fees, the FDA is seeking to create two new user fees for generic drugs and more complex biosimilars.
The agreement between the FDA and the pharmaceutical companies will strengthen America’s health care system and foster greater innovation. It will benefit patients by facilitating efficient, transparent, and comprehensive drug reviews that will result in timely access to safe and valuable new medicines.
The industry fees will also be used to advance the development of drugs for rare diseases, increase communications with small or new companies, and boost standardized electronic data usage to improve quality and effectiveness.
The new generic drug user fees would help minimize the backlog of 2,500 generic drug applications awaiting review, as generic drugs continue to be on the rise. While most new drugs are reviewed in 10 months, the standard review time for a generic drug is 30 months. Under the new agreement, the FDA would collect $299 million in fees annually to hire additional generic drug reviewers.
The biosimilars fee comes in response to President Obama’s healthcare law, which produced a pathway for drugs that are nearly identical to complex biologic drugs for the first time. Collected fees will be used to expedite the review process of biosimilar biological product applications, including post-market safety activities. Under the FDA agreement, the biosimilar application fee will be waived for a small business submitting its first biosimilar biological product application.
