Reauthorize PDUFA!

Congress’ House Energy and Commerce Health Subcommittee held a hearing yesterday on the reauthorization of the FDA’s Prescription Drug User Fee Act (PDUFA), which is set to expire later this year.  This is critically important legislation that needs to be renewed to have a safe and plentiful drug supply for American consumers at affordable prices.

PDUFA, originally passed in 1992, authorized the FDA to collect fees from drug sponsors that would be used to expand their review staff who examine the safety of new medicines before they go to the market, so that new drugs could be reviewed more quickly.  This Act has been occasionally assessed and expanded upon through reauthorizations, and is currently in its fourth iteration.

The PDUFA user fee program has been a great success for patients, providing FDA with the extra resources it needs to considerably decrease the time it takes to review new medicines, while protecting public health by assuring that the products are safe.  Since its passage 10 years ago, the U.S. has become the word leader in bringing new medicines to patients first and PDUFA has helped to improve America’s competitiveness around the world.

The FDA’s final recommendation for the renewal of the drug industry fees came after months of negotiations with drug makers.  It reflects a great deal of input from key stakeholders such as patient advocates, medical providers, health care professionals, and academia.  The FDA is seeking to renew the prescription drug user fees and 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.

Biopharmaceutical development, which has led to over 300 new medicines in the last decade, necessitates substantial investment, as a new medicine can surpass $1 billion and take 12 to 15 years to develop on average.  Developments in regulatory science, increased predictability and communication, and a commitment to a more efficient review are all incentives that can help encourage that investment.

If the PDUFA agreement passes as is, the FDA will have the much-needed resources and management tools to promote innovation through greater transparency, predictability, and efficacy in FDA’s drug review program.  This, in turn, can help address unmet medical needs, stimulate the economy and create American jobs.

It is key that the U.S. preserves a policy and regulatory environment that encourages an efficient, consistent and predictable drug review process to bring new medicines to patients in need, while keeping America competitive in today’s global economy. Because PDUFA has introduced better reliability, transparency and certainty into the review process, its reauthorization is critical in guaranteeing that biopharmaceutical companies sustain their high levels of job creation and economic growth.