An efficient, streamlined process that has brought innovative medicines to market safely and effectively for three decades needs to be renewed in the United States Congress. Patients in Colorado and across the country are concerned that this critically important bill will be delayed by the inclusion of controversial and unrelated measures.
Since 1992, the Prescription Drug User Fee Act (PDUFA) has collected fees from drug manufacturers who provide the federal Food and Drug Administration (FDA) with the resources it needs to reduce drug approval times and provide new treatments to patients much faster without compromising safety. . Through this program, an approval process that would take two years or more has been reduced to ten months. It is difficult to calculate the lives that have been saved due to earlier access to new drugs.
In 30 years, PDUFA has accelerated the approval of more than 1,700 drugs and biologics, for a wide range of cancers and infectious and rare diseases.
As this effective federal program serves patients today, it also provides a strong incentive to pursue research and innovation that will benefit Coloradans for decades to come. New drug development is difficult, time-consuming and laborious, long before a drug can enter the FDA review process. PDUFA sends the signal to innovative companies that the approval process can be safely shortened, reducing costs and allowing drugs to reach the market sooner. It is no coincidence that the United States leads the world in the introduction of new drugs.
Clearly, the stakes are high for patients, our healthcare system and our innovation economy through the reauthorization of PDUFA.
The urgent hope is that Congress will act quickly and not allow this must-have legislation to be weighed down by a wide range of foreign proposals. As is often the case in Congress, controversial measures that may not muster the support needed to convey their own snag on legislation need to be done. The challenge is that these additional measures can slow down vital legislation like the PDUFA.
One of the most discussed issues that some would like to attach to the PDUFA is the problematic, and potentially dangerous, proposal to import prescription drugs into the United States from other countries.
Although it is universally agreed that the high cost of prescription drugs needs to be tackled, there is significant and widespread doubt about the ability to ensure the safety and authenticity of imported drugs. In the United States, drugs are subject to strict government oversight that ensures their safety and effectiveness. In other countries, drugs are not subjected to this rigorous review, which opens the door to imported drugs that are less effective, dangerous or counterfeit.
In fact, over the years, leaders of the federal Department of Health and Human Services, whether Democratic or Republican presidents, have refused to certify that the department can guarantee the safety of imported drugs.
Importation is a risky business that could have devastating consequences for patients across America.
Given the deep and lingering questions about drug importation, it is critical that such a controversial measure not be allowed to impede the timely approval of the PDUFA program. His 30 years of success should earn him strong, bipartisan support in Congress without being weighed down by unproven, familiar issues that won’t convey their own merits.
Mark Spiecker is president of STAQ Pharma and past chairman of the board of the Colorado Bioscience Association.