THE BLOG
04/05/2013 04:47 pm ET | Updated Jun 05, 2013

Consider the End User: Meeting the Needs of Patients

The creation of many new treatments in this country was made possible due to the federal government's investment in drug research and development. To spur continued advancements in breakthrough drugs, lawmakers must carefully think through the long-term implications of their policy decisions.

Many diseases that were once fatal diagnoses, such as AIDS, are now managed by patients and their caregivers over a lifetime because our country has creatively used federal policies and initiatives to encourage companies to create new treatments.

The 1983 Orphan Drug Act has been successful in increasing the number of new drug approvals for rare diseases. The 1984 Hatch-Waxman Act provides incentives for the creation of low-cost generic drugs. Just last year, the National Institutes of Health began the collaborative Discovering New Therapeutic Uses for Existing Molecules program to match select molecular compounds provided by industry that have insufficient patent protection with researchers to test ideas for new therapeutic uses.

Even for compounds with existing patents, it may take too long to develop them into commercial products. For example, it can take 12 to 15 years to demonstrate that a potential new drug can impact the symptoms of a complex condition like Alzheimer's and Parkinson's disease. The life of the patent, usually 20 years, runs down during the research and development phase, negating any potential return on the investment made to bring the drug to market. The result is research may be discontinued; in some instances the research phase is not even begun.

Today's newer treatments, such as biologics, and the complicated drug development ecosystem require lawmakers to create nuanced policies to ensure that advances in science translate into clinical gains for patients. Policymakers must promote the type of research most likely to lead to treatments for people with unmet medical needs.

Take the example of the MODDERN Cures Act that was introduced last congressional session by Rep. Leonard Lance (R-NJ). This legislation would create a pathway for promising new treatments that would not otherwise be developed due to current legal and market failures. The bill also would promote personalized medicine by encouraging the development of companion diagnostics that predict the safe, effective, and efficient use of treatments.

Congress has demonstrated its willingness in the past to create a means to direct and encourage the development of new treatments so desperately needed by people living with chronic diseases. We need more innovative public-private cooperation today and well-thought-out policies to remove the barriers that impede progress in the development and use of new medicines. We need to develop policies that are first and foremost focused on improving the lives of the ultimate users of our health care system -- the patients.

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