An effective, streamlined process that has brought innovative medicines safely and efficiently to the marketplace for three decades is up for renewal in the United States Congress. Patients in Colorado and across the country are concerned that this critically important bill may be delayed by the inclusion of controversial, unrelated measures.
Since 1992, the Prescription Drug User Fee Act (PDUFA) has collected fees from drug manufacturers that provide the federal Food and Drug Administration (FDA) with the resources it needs to reduce drug approval times and get new treatments to patients far quicker without compromising safety. Thanks to this program, an approval process that would take two years or more has been slashed to ten months. It’s difficult to calculate the lives that have been saved by earlier access to new medications.
Over the course of 30 years, PDUFA has sped 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 is serving patients today, it also provides a strong incentive for continued research and innovation that will benefit Coloradans for decades to come. The development of new medicines is difficult, lengthy, and painstaking, long before a drug can enter the FDA review process. PDUFA sends the signal to innovation companies that the approval process can be safely shortened, which reduces costs and allows medicines to reach the marketplace earlier. It is no coincidence that the United States leads the world in the introduction of new medicines.
Clearly, much is at stake for patients, our healthcare system and our innovation economy through the re-authorization of PDUFA.
The urgent hope is that Congress will act quickly and not allow this must-pass legislation to be weighed down with a wide range of extraneous proposals. As is often the case in Congress, controversial measures that might not muster the support to pass on their own hitch a ride on legislation that has to get done. The challenge is that these extra measures can slow vital legislation like PDUFA to a crawl.
One of the most talked-about issues that some would like to attach to PDUFA is the problematic, and potentially dangerous, proposal to import prescription drugs to the United States from other countries.
Though it is universally accepted that the high cost of prescription medicines must be addressed, there is significant and widespread doubt about the ability to guarantee the safety and authenticity of imported drugs. In the U.S., drugs are subject to strict government oversight that ensures safety and effectiveness. In other countries, medicines are not put through this rigorous scrutiny, which opens the door to imported drugs being less effective, unsafe or counterfeit.
In fact, over the years the leaders of the federal Department of Health and Human Services, whether they were serving Democratic or Republican Presidents, have declined 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…
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