The Energy and Commerce Committee has announced that it will hold a hearing on PDUFA and MDUFA on April 18 at 10:15 AM EST, entitled "US Food and Drug Administration User Fees 2012: How Innovation Helps Patients and Jobs." Members of the committee will discuss how PDUFA's reauthorization will help the FDA speed the review of safe, effective new medicines, and how PDUFA ensures that the U.S. is able to maintain its global leadership in biomedical innovation. As usual, we'll be live-tweeting from the hearing--you can follow us at @ModernMeds and use the hashtag #PDUFA to join the discussion.
It is critical to patients, the FDA, and the biopharmaceutical industry that this year's PDUFA reauthorization is completed well before the September deadline, so that patients can have uninterrupted access to the medicines they need. On that note, we'd like to share this great video from Bloomberg Businessweek that focuses on how a Congressional delay in PDUFA V's passage would negatively affect the FDA's ability to review new drugs in a timely manner.
As Mr. Rye says, the delay of PDUFA's reauthorization in 2007 compromised the FDA's ability to review new drugs in a timely manner, which ultimately meant that patients had to wait longer to get access to lifesaving medicines. That's why we are urging Congress to avoid making costly, unrelated legislative additions to PDUFA V that would hamper the FDA's ability to safely and efficiently review new medicines.
If you'd like to join us in urging Congress to pass a clean, timely PDUFA you can also join the Campaign on Facebook or on Twitter, where we'll be sharing our thoughts during the hearing at @ModernMeds.