Modernizing Our Drug & Diagnostics Evaluation and Regulatory Network Cures Act of 2013

More than 133 million Americans, or 45 percent of the population, have at least one chronic condition. A quarter of Americans have multiple chronic conditions.

Chronic diseases have become the leading cause of death and disability in the United States. Seven out of every 10 deaths are attributable to chronic disease. Chronic diseases also compromise the quality of life of millions of Americans.

Despite $80 billion spent annually on research and development, many diseases and conditions lack effective treatments.

Many commonly used drugs are effective in only 50 to 75 percent of the patient population, which can lead to devastating long-term side effects, resulting in the potential risks outweighing the benefits for some patients.

Advanced and innovative diagnostic tests have the potential to dramatically increase the efficacy and safety of drugs by better predicting how patients will respond to a given therapy.

Despite their promise, many drugs and diagnostics may go undeveloped due to uncertain regulatory and reimbursement processes, among other reasons.

In addition, there is reason to believe that potential treatments with tremendous value to patients are never developed or are discontinued during research and development due to insufficiencies in the intellectual property system.

It is in the public interest to address the hurdles that may be precluding new treatments from reaching patients and to remove the disincentives for the development of therapies for these unmet needs.

The term biological product has the meaning given to that term in section 351 of the Public Health Service Act (42 U.S.C. 262).

The term drug has the meaning given to that term in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).

The term “medicine” means a biological product or a drug.

The term Secretary means the Secretary of Health and Human Services.