Date: December 13th, 2016
Even if you choose not to celebrate a holiday, it is difficult to ignore that it is the holiday season. That means it is time for our televisions to subject us to no fewer than 25 days of holiday classics. A favorite for many is Dr. Seuss’ “How the Grinch Stole Christmas.” In the cartoon adaptation of Dr. Seuss’ book, the lonely and small-hearted Grinch, dressed as Santa Claus, carries out an evening of indiscriminate pilfering of precious belongings across the town of Whoville. He does this to ensure that Christmas does not come. Despite his best efforts to thwart Christmas, the Whos’ inherent joy and determination enable them to endure the Grinch’s crime and make Christmas happen.
Aside from fairytale prose, you may ask how this story is similar to the upcoming reauthorization of the Food and Drug Administration’s (FDA) user fee programs. Drawing this parallel began as a shameless hook to get readers to care about a dry subject, but there are some important common themes that follow.
The purpose of the prescription drug and medical device user fee programs is to reduce the time it takes the FDA to review, and make decisions on drugs and medical devices. User fees provided through the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA) have advanced public health, safeguarded patient safety, and given patients greater access to life-improving medicines and medical devices for decades. PDUFA and MDUFA account for approximately 70 percent and 40 percent of FDA’s medical review activities, respectively. PDUFA and MDUFA are currently set to expire on September 30, 2017.
Like the Whos who spend their days leading up to Christmas organizing their perfect meals, elaborate decorations and thoughtful gifts for family and friends, FDA has been working tirelessly with drug and medical device industry representatives, patient organizations, and consumer groups for more than a year to get their plans for PDUFA and MDUFA reauthorization just right. This collective effort has resulted in negotiated agreements that provide the FDA with significant funding to hire talented staff that would evaluate new medicines and medical devices; work with researchers on the best ways to incorporate the needs of patients and their families throughout the drug and medical device development processes; guide clinical trials to be quicker and more effective in showing that drugs and devices work; and enable the use of information from electronic health records and patient registries in FDA discussions about how well drugs and medical devices are performing in the real world.
Because of the widespread involvement of all stakeholders during the 12-month negotiations, there is overwhelming public support for the PDUFA and MDUFA agreements. The trouble is that now these agreements will go before Congress to be enacted into law and all that is contained in the underlying agreements can be opened up to lengthy debate. Doing so will jeopardize FDA access to critical resources.
The Grinch struck at night and sought to destroy the Whos’ best laid plans. When the Whos went to sleep, they had no reason to believe that when they woke up on Christmas Day there would be no trees, no presents under their trees, no stockings full of treats, and no “roast beasts” on their dinner tables. Each year Christmas came for them so they all drifted off to their slumber anticipating that the same would happen. Why suspect otherwise?
PDUFA and MDUFA agreements are renegotiated by the FDA every five years and reauthorized by Congress before a set statutory deadline. The bill Congress develops to reauthorize PDUFA and MDUFA has historically been must-pass legislation because of the important funding it contains for the FDA. In the past, Congress has not made substantial changes to the underlying UFA agreements. The worst thing that occurred was when members of Congress approved more programs and activities for the FDA to carry out as part of the bill without adding more money, also called an unfunded mandate.
Word is that the 115th Congress may have a different approach to the UFAs in 2017, and some incoming congresspeople could hold up reauthorization of PDUFA and MDUFA not just by adding unfunded mandates to the reauthorization bill, but also by scrutinizing the underlying agreements. Once the agreements are presented to Congress, the FDA is limited in its ability to stop or have any influence over any proposed changes to PDUFA or MDUFA. This scenario makes an FDA that has planned for and is counting on the new resources just like sleeping Whos, defenseless targets.
Strong Wills Prevail
Just as the Grinch failed to stop Christmas from coming by raiding Whoville of everything, including its “last can of who-hash,” Congress cannot completely stop the FDA from fulfilling its mission. They can only make it more difficult. Because FDA regulates over 20 percent of products in the U.S. economy, it must continue to operate. While limited in scope, FDA is able to continue to protect our food and drug supply during government shutdowns and has even taken action in response to the recent Zika Crisis with no additional funding. The essential nature of FDA’s activities and the engrained dedication of FDA’s employees help them prevail.
We are fortunate to have public servants at the FDA who go to work each day because they want people living with diseases and disability to find relief and they believe that the drugs and medical devices we use in our bodies should be safe. Our hope is that the new Congress recognizes that PDUFA and MDUFA reauthorization should move forward quickly because the underlying agreements were developed through a deliberate process with the fiscal health of the FDA and patient needs as their foundation. If we are not that fortunate, you can help FDA avoid being a defenseless “Who” that has their plans destroyed on Christmas Eve by contacting your representative and senators and encouraging them to support a clean user fee reauthorization bill in 2017.