What does health care reform mean for clinical research?

by Emily Butler, content coordinator

As the dust begins to settle after President Obama signed into law the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act this week, the national news media are scrambling to answer the question that bill advocates and opponents alike are asking: What does health care reform mean to me?

While media attention is primarily focused on changes to the ways in which individuals will access and pay for health insurance, the bill carries several provisions that will affect the health care system as a whole, including clinical research. Even though many of these provisions will not take effect for several years, and even though many of the implementation strategies have not been fully defined, the research community is beginning to grapple with the laws’ potential impact.

The following provisions, pulled from the Kaiser Family Foundation’s “Health Reform Implementation Timeline,” represent a sample of the types of changes that could affect research:


  • Authorize the Food and Drug Administration to approve generic versions of biologic drugs and grant biologics manufacturers 12 years of exclusive use before generics can be developed.
  • Support comparative effectiveness research by establishing a nonprofit Patient-Centered Outcomes Research Institute.


  • Impose new annual fees on the pharmaceutical manufacturing sector.


  • Require disclosure of financial relationships between health entities, including physicians, hospitals, pharmacists, other providers, and manufacturers and distributors of covered drugs, devices, biologics and medical supplies.

Recent articles published in Applied Clinical Trials and Kaiser Health News call health reform a boon for the pharmaceutical industry. But how might the changes affect other sectors of clinical research?

If you work in the field, we are curious to hear your perspective. How do you think health reform will impact clinical research?