I agree with the commissioner’s assessment that efficient reviews and approvals of potential new medicines are vital for the patients who are waiting. As a scientist, I understand the complexity of discovering better treatments for serious illnesses like cancer and diabetes. As a son who watched my own mother suffer from the devastating effects of Alzheimer’s disease, I know the very real pain experienced by patients and their caregivers. With chronic diseases plaguing millions of people worldwide, biopharmaceutical companies like Lilly are focused more than ever on delivering innovative solutions. The need for quicker access has never been greater.


The fees and timelines generated by PDUFA make the review of new medicines more timely and efficient via much-needed resources for expert staffs, electronic systems modernization and investments in the regulatory sciences. This year, PDUFA is again scheduled for reauthorization by Congress – and even though 2012 is a presidential election year, PDUFA is one of the few pieces of legislation that must move through Congress.
Given PDUFA’s importance to medical innovation, Congress should avoid the temptation to use reauthorization as a vehicle for extra provisions – especially those that might be controversial or unrelated to reviewing new treatments for patients. PDUFA should remain focused on its intent: providing necessary resources to help bring innovation to life for the patients.
In the spirit of PDUFA’s original intent, the 2012 legislation contains new elements that will make the review process even more efficient. For example – based upon input from the patient community, the FDA and the biopharmaceutical industry – funding to improve methodologies and tools for evaluating benefits and risks of new treatments is included in the PDUFA proposal. Currently, benefits and risks are evaluated at three points during a medicine’s lifecycle: clinical development, at the time of the review and post-approval as new information becomes available. Under the new law, the FDA would work through a systematic framework – a tool that will aid their judgment as scientific experts. The expected result: high-quality, balanced and more timely decisions.
Through this framework, FDA decisions will be better understood by health care professionals – and, in turn, they will be able to more clearly explain benefits and risks of treatments to their patients. PDUFA will also target new resources to incorporate patient perspectives earlier in the review process.
PDUFA has a strong track record of facilitating the approval of innovative new medicines to patients. Since its inception in 1992, FDA review times have decreased by 60 percent. Today, the U.S. leads the world in the first approval of new medicines – which is an advantage we don’t want to lose. During the past 20 years, patients in the U.S. have had speedier access to more than 1,500 new medicines to treat medical conditions such as cancer, diabetes, cardiovascular disease, and neurological disorders. This is great news for patients and physicians alike – but we must continue to improve upon this progress.
To keep our nation at the forefront of medical innovation and give patients access to the therapies they so desperately need, politics must not get in the way of medical progress. Patients are waiting – and we can’t let them down.
Dr. Lundberg is executive vice president of Science and Technology and president of Lilly Research Laboratories.