Parkinson's Community Can Benefit from Additions to FDA User Fee Legislation
Within the next few weeks, the Parkinson’s Action Network (PAN) expects Congress to pass important Food and Drug Administration (FDA) legislation critical to the Parkinson’s community.
Every five years, Congress must reauthorize the Medical Device User Fee Act (MDUFA) and the Prescription Drug User Fee Act (PDUFA), which enable the FDA to collect fees from the pharmaceutical and medical device industries to partially fund the agency's efforts to approve new drugs and therapies. During this reauthorization process, Congress often simultaneously considers and approves other FDA-related legislation that may be significant to the Parkinson's community.
The 2012 reauthorizing legislation includes U.S. House of Representatives legislation called the FAST Act, H.R. 4132, which PAN supports and is intended to streamline and hasten the FDA's therapy approval process to ensure people with diseases like Parkinson's have quicker access to safe and effective therapies.
In the next few days, the Senate is expected to vote on its own version of this user fee legislation, which includes portions of the TREAT Act, S. 2113. PAN also endorsed the TREAT Act, which is very similar to the FAST Act and is intended to expedite drug and device approval and delivery.
FAST and TREAT include provisions to streamline the therapy-approval process by allowing researchers to use more types of scientific evidence that can be measured to prove the safety and effectiveness of drugs. The expectation is that this will result in fewer, smaller, or shorter clinical trials (while still upholding the FDA’s existing stringent safety guidelines) and accelerated approvals of much-needed drugs and other treatments.
“From PAN’s perspective, we welcome the opportunity to push for legislation that supports the patient community and people with Parkinson’s disease,” said PAN CEO Amy Comstock Rick. “While user fees are important – they now make up roughly 40 percent of the FDA’s total budget – our focus is the opportunity to advocate for additional legislation that increases efficiencies at the FDA and serves the patient community more effectively,” she added.
While the patient advocacy community welcomes appropriate patient-focused legislation being attached to the PDUFA and MDUFA reauthorizations, the pharmaceutical industry prefers a “clean” reauthorization bill.
“Reauthorization of PDUFA must be completed this summer in order for the FDA to continue to receive the resources that it needs to conduct its essential function – the review of applications for new medicines,” said Matt Bennett, Senior VP of Communications at the Pharmaceutical Research and Manufacturers of America (PhRMA). “Failure to reauthorize PDUFA in a timely manner would have catastrophic effects on the FDA’s ability to review new medicines, which provide hope to patients suffering from debilitating diseases. Unfortunately, additional provisions could create unintended burdens on the regulatory process or delay the legislative process. In order for patients to benefit from the new medicines that FDA reviews – including 35 new approvals in fiscal year 2011 – FDA needs the resources that it receives through the user fee program,” Bennett added.
It is expected that the reauthorizations and accompanying legislation will be finalized in June. The legislation must pass and be signed by President Obama by the end of September to keep the FDA functioning at its current levels. PAN advocates have weighed in on multiple levels of this advocacy effort, and their hard work has not gone unnoticed.
“One of the tent poles of PAN’s advocacy agenda is fighting for more expedient and efficient therapy review and approvals,” added Rick. “Parkinson’s is still generally being treated with the same symptomatic drug treatment that was discovered 40 years ago. We have to use our collective voice to change that, and fight for new and better treatments and, ultimately, a cure.”
Learn more about PAN’s work with the FDA by clicking here.
Watch PAN’s informative “How the FDA Impacts the Parkinson’s Community” webcast.
About the Food and Drug Administration:
The Food and Drug Administration (FDA), a government agency of the U.S. Department of Health and Human Services, is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA plays an essential role in speeding access to safe and effective therapies for Parkinson’s and other diseases. Before any medical product can be made publicly available, it must first go through a rigorous review and approval process by the FDA.