A Bill to Improve Existing Medicines
Innovation is all around us. We see it in electronics, automobiles, and many other sectors of our economy. American consumers regularly use products with new features they believe will make their lives a little more interesting, more convenient, more efficient, or otherwise better.
But while a thinner phone or a faster computer certainly may seem significant and exciting, these innovations pale in comparison to the life-changing and life-saving improvements in medicines that should be reaching patients. Innovations like these -- ones that could, for example, make it easier to stay with your drug regimen by deterring abuse or reducing side effects -- are simply not being brought to market with any regularity.
Many American patients, including many of my neighbors in Florida, rely on medications each and every day due to chronic conditions. New innovations can improve their lives. But the current approval system for medicines does not effectively invite the robust development of drug improvements.
This is why I am introducing the PATIENT Act, which will provide an increased incentive for innovators who seek to make existing medications better. I want to help bring our friends, families, and neighbors improved medicines -- ones that have less severe side effects or can be taken just once a day instead of several times.
It turns out that my legislation is very much in the spirit of what the authors of existing law envisioned when they set out to ensure a fair market for medications. That law, called "Hatch-Waxman," includes an incentive for drug manufacturers to develop improvements to existing medicines. In return for such improvements, manufacturers receive 36 months of "market exclusivity" -- a time period in which competitors cannot copy the new innovation. This, in theory, allows manufacturers to recover the cost of developing the medicine.
So, problem solved, right? Not quite. Three years of exclusivity is simply not enough time for companies to recoup the investment needed to bring improved medicines to patients. My proposal seeks to expand this incentive by two years if meaningful improvements are demonstrated.
We must make this happen. Encouraging incremental innovation for medicines is health-care reform we can all support.
Rep. Gus Bilirakis (R., Palm Harbor), a member of the Energy and Commerce Subcommittee on Health, represents the 12th congressional district, which includes all of Florida's Pasco County and northern parts of Hillsborough and Pinellas counties.